Is it possible to diagnose therapeutic adherence in mild cognitive impairment and dementia patients in clinical practice?

Background: Non-adherence is common and contributes to adverse health outcomes, reduced quality of life, and increased healthcare expenditure. The objective of this study was to assess the diagnostic validity to estimate the prevalence of non-adherence in patients with mild cognitive impairment (MCI) and dementia using two self-reported methods (SRMs) that are useful and easy in clinical practice, considering the pill count as a reference method (RM). Methods: The cohort study was nested in a multicenter randomized controlled trial NCT03325699. A total of 387 patients from 8 health centers were selected using a non-probabilistic consecutive sampling method. Inclusion criteria were as follows: a score of 20-28 points on the Mini-Mental State Examination (MMSE); older than 55 years; taking prescribed medication; and are in charge of their own medication use. Participants were followed up for 18 months after the baseline visit, i.e., 6, 12, and 18 months. Variables related with treatment adherences were measured in all visits. The variables included age, sex, treatment, comorbidities, and the MMSE test. Adherences included pill counts and Morisky-Green test (MGT) and Batalla test (BT) as SRMs. Statistical analysis included descriptive analysis and 95% confidence intervals (CIs). The diagnostic validity included the following: 1) open comparison statistical association between SRMs and RMs and 2) hierarchy comparison: the RM as the best method to assess non-adherence, kappa value (k), sensitivity (S), specificity (Sp), and likelihood ratio (PPV/PPN). Results: A total of 387 patients were recruited with an average age of 73.29 years (95% CI, 72.54-74.04), of which 59.5% were female. Comorbidities were 54.4% HTA, 35.9% osteoarticular pathology, and 24.5% DM. The MMSE mean score was 25.57 (95% CI, 25.34-25.8). The treatment adherence for the RM oscillates between 22.5% in the baseline and 26.3%, 14.8%, and 17.9% in the follow-up visits. For SRMs, the treatment adherence oscillates between 43.5% in the baseline and 32.4%, 21.9%, and 20.3% in the follow-up visits. The kappa value was statistically significant in all the comparison in all visits with a score between 0.16 and 035. Regarding the diagnostic validity, for the MGT, the sensibility oscillated between 0.4 and 0.58, and the specificity oscillated between 0.68 and 0.87; for the BT, the sensibility oscillated between 0.4 and 0.7, and the specificity oscillated between 0.66 and 0.9; and when both tests were used together, the sensibility oscillated between 0.22 and 0.4, and the specificity oscillated between 0.85 and 0.96. Conclusion: SRMs classify non-adherent subjects correctly. They are very easy to use and yield quick results in clinical practice, so SRMs would be used for the non-adherence diagnosis in patients with MCI and mild dementia.

Barriers and drivers of public engagement in palliative care, Scoping review.

BACKGROUND: The integral model of Palliative Care recognizes the community as essential element in improving quality of life of patients and families. It is necessary to find a formula that allows the community to have a voice. The aim of this scoping review is to identify barriers and facilitators to engage community in PC. METHODS: Systematic search was conducted in NICE, Cochrane Library, Health Evidence, CINAHL and PubMed database. KEYWORDS: Palliative care, End of life care, community networks, community engagement, public engagement, community participation, social participation, barriers and facilitators. RESULTS: Nine hundred seventy-one results were obtained. Search strategy and inclusion criteria yielded 13 studies that were read in detail to identify factors influencing community engagement in palliative care, categorized into: Public health and public engagement; Community attitudes towards palliative care, death and preferences at the end of life; Importance of volunteers in public engagement programs; Compassionate communities. CONCLUSION: Societal awareness must be a facilitated process to catalyse public engagement efforts. National policy initiatives and regional system support provide legitimacy and focus is essential for funding. The first step is to get a sense of what is important to society, bearing in mind cultural differences and to channel those aspects through health care professionals; connecting the most assistential part with community resources. The process and long-term results need to be systematically evaluated.

Effectiveness of an educational intervention about inhalation technique in healthcare professionals in primary care: a cluster randomized trial.

Background: Incorrect inhalation technique (IT) is an important issue for chronic obstructive pulmonary disease (COPD) patients and healthcare professionals. Studies in which counseling is carried out with healthcare professionals beforehand so that they can properly educate their patients are required. The objective of the present trial is to assess the improvement in the performance of the IT in subjects with COPD and prescribed inhaled therapy after the implementation of an educational intervention conducted by their general practitioners. Methods: A cluster randomized clinical trial was conducted. A total of 286 COPD patients received scheduled inhalation therapy from 27 general practices in seven primary care centers. A teach-back educational intervention was implemented for both healthcare professionals and patients. The primary outcome of this study was the performance of the correct inhalation technique. It is considered a good technique if all steps in the inhalation data sheet are correctly performed. The secondary outcomes were assessed using forced spirometry, the basal dyspnea index, the Medical Research Council dyspnea scale, St George's Respiratory Questionnaire (SGRQ), and EuroQoL5D-5L for health-related quality of life. A one-year follow-up was conducted using an intention-to-treat analysis. Results: After the intervention, incorrect IT was observed in 92% of professionals and patients, with rates reaching 50% and 69.2%, respectively. The effectiveness in patients was significant, with a number needed to treat of 2.14 (95% CI 1.79-2.66). Factors related to correct IT in patients included the type of intervention, length of intervention (>25 min), good pulmonary function, age (youngest <=65, oldest >83), and less limitation of activity due to dyspnea. There was no relation with the cluster. Conclusion: This study shows the effectiveness of direct inhaler technique training provided by a trained professional on an appropriate timescale (for example, a specific consultation for medication reviews), aiming to help subjects improve their performance using the teach-back method. This could be an encouraging intervention to improve medication adherence and health promotion in people with COPD. Clinical Trial Registration: clinicaltrials.gov, identifier ISRCTN93725230.

ITV-Pal programme: protocol of evaluation of the implementation of tech-volunteer programme in palliative care services.

INTRODUCTION: Volunteer support for patients and families at the end of life provides many benefits for the beneficiaries. New technologies could be a necessary resource in the accompaniment although, if there is little literature on palliative care volunteering in general, specifically on volunteering and new technologies, we find little information on the subject.Therefore, the aim of this study is to implement and evaluate a training program for palliative care volunteers using new technologies in order to begin accompanying patients and families in hospital or at home. METHODS AND ANALYSIS: A mixed-method study design will be conducted. We will recruit 20 volunteers and 70 patients in two years. INTERVENTION: training of volunteers in new technologies and volunteer accompaniment of patients/relatives using technologies. The control group will accompany patients as usual. ETHICS AND DISSEMINATION: Ethics approval for the ITV-Pal Programme project was granted by the Malaga Regional Research Ethics Committee. As new knowledge is gained from this project, findings will be disseminated through publications, presentations and feedback to clinicians who are participating in this study. TRIAL REGISTRATION NUMBER: NCT04900103.

Reimbursed medication adherence enhancing interventions in 12 european countries: Current state of the art and future challenges.

Background: Medication non-adherence jeopardises the effectiveness of chronic therapies and negatively affects financial sustainability of healthcare systems. Available medication adherence-enhancing interventions (MAEIs) are utilised infrequently, and even more rarely reimbursed. The aim of this paper was to review reimbursed MAEIs across selected European countries. Methods: Data on reimbursed MAEIs were collected from European countries at the ENABLE Cost Action expert meeting in September 2021. The identified MAEIs were analysed and clustered according to their characteristics, direct vs. indirect relation to adherence, and the targeted adherence phase. Results: Out of 12 contributing countries, 10 reported reimbursed MAEIs, 28 in total, of which 20 were identified as MAEIs targeting adherence directly. Reimbursed MAEIs were most often performed by either doctors (n = 6), nurses (n = 6), or pharmacists (n = 3). The most common types of MAEIs were education (n = 6), medication regimen management (n = 5), and adherence monitoring feedback (n = 4). Only seven reimbursed MAEIs were technology-mediated, whereas 11 addressed two interlinked phases of medication adherence, i.e., implementation and persistence. Conclusion: Our review highlights the scarcity of reimbursed MAEIs across the selected European countries, and calls for their more frequent use and reimbursement.

Reimbursed Medication Adherence Enhancing Interventions in European Countries: Results of the EUREcA Study.

Introduction: Current literature lacks detailed understanding of the reimbursement framework of medication adherence enhancing interventions (MAEIs). As part of the ENABLE COST Action, the EUREcA ("EUropen REimbursement strategies for interventions targeting medication Adherence") study aimed to provide an in-depth overview of reimbursed MAEIs currently available in European countries at national and regional levels and to pave the way for further MAEIs to be implemented in the future. Methods: A web-based, cross-sectional survey was performed across 38 European countries and Israel. The survey questionnaire was developed as a result of an iterative process of discussion informed by a desk review. The survey was performed among invited ENABLE collaborators from June to July 2021. Besides descriptive analysis, association between country income and health care expenditure, and the availability of reimbursed MAEIs were also assessed. Results: The survey identified 13 reimbursed MAEIs in nine countries: multi-dose drug dispensing (n = 5), medication review (n = 4), smart device (n = 2), mobile application (n = 1), and patient education (n = 1). The median GDP per capita of countries having ≥1 reimbursed MAEI was significantly higher compared to countries having no reimbursed adherence intervention (33,888 EUR vs 16,620 EUR, respectively; p = 0.05). Conclusions: Our findings highlight that to date only a small number of MAEIs have been reimbursed in European countries. Comprehensive health technology assessment recommendations and multi-stakeholder collaboration could help removing barriers related to the implementation and reimbursement of MAEIs.

Relevancia clínica de la técnica de utilización de inhaladores en pacientes con enfermedad pulmonar obstructiva crónica / The clinical relevance of inhalation technique in chronic obstructive pulmonary disease patients

Introducción:Numerosos estudios muestran que los pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC) realizan una técnica de inhalación (TI) incorrecta. Nuestra investigación pretende describir los errores cometidos y la Importancia Clínica de dichos Fallos (ICF), e identificar los factores relacionados con ello.Pacientes y métodos:Estudio descriptivo transversal de 995 pacientes seguidos en 20 Centros de Salud de Andalucía. Se recogieron variables sociodemográficas, calidad de vida, estado mental-cognitivo, espirometría, gravedad, número de dispositivos, realización correcta de la TI, instrucción previa e ICF.Resultados:906 pacientes (91,1%) realizaban una TI incorrecta. Los errores más frecuentes presentaban ICF2-moderada y se relacionaron con nivel cognitivo bajo, pico flujo inhalatorio bajo y menos visitas al neumólogo. Los errores críticos-ICF3 mostraron relación con mayor gravedad, uso de Turbuhaler® y peor calidad de vida.Discusión:Altísima tasa de técnica incorrecta cuyos errores más frecuentes comprometen de forma moderada la eficacia del fármaco, se relacionan con el modo de realizar la TI y no con la dificultad en el manejo del dispositivo. Esto muestra la importancia de entrenar correctamente a nuestros pacientes. (AU)

Introduction:Numerous studies show that patients with chronic obstructive pulmonary disease (COPD) perform an incorrect inhalation technique (IT). This research aims to describe inhalation errors committed and their clinical importance, and to identify factors related to them.Patients and methods:A total of 995 patients were recruited in this cross-sectional, descriptive study that was conducted across 20 Andalusian Health Care Centres. The following variables were collected: socio-demographic data, quality of life, mental and cognitive status, spirometry tests, severity, number of IT devices, IT correct performance, previous instruction and clinical importance of errors.Results:Of the 995 patients, 906 (91,1%) performed an incorrect IT. The most common errors showed moderate errors, which were related to low-cognitive level, low-peak expiratory flow and fewer medical consultations with the pulmonologist. Critical errors were correlated with greater severity, usage of Turbuhaler® and worse quality of life.Discussion:Soaring incorrect technique rate, whose most common errors sparingly compromise the drug effectiveness. These errors are related to the way the patients perform the IT, and not to the difficulty in handling the device. This information demonstrates the relevance of training patients in a proper way. (AU)

Developing a medication adherence technologies repository: proposed structure and protocol for an online real-time Delphi study.

INTRODUCTION: An online interactive repository of available medication adherence technologies may facilitate their selection and adoption by different stakeholders. Developing a repository is among the main objectives of the European Network to Advance Best practices and technoLogy on medication adherencE (ENABLE) COST Action (CA19132). However, meeting the needs of diverse stakeholders requires careful consideration of the repository structure. METHODS AND ANALYSIS: A real-time online Delphi study by stakeholders from 39 countries with research, practice, policy, patient representation and technology development backgrounds will be conducted. Eleven ENABLE members from 9 European countries formed an interdisciplinary steering committee to develop the repository structure, prepare study protocol and perform it. Definitions of medication adherence technologies and their attributes were developed iteratively through literature review, discussions within the steering committee and ENABLE Action members, following ontology development recommendations. Three domains (product and provider information (D1), medication adherence descriptors (D2) and evaluation and implementation (D3)) branching in 13 attribute groups are proposed: product and provider information, target use scenarios, target health conditions, medication regimen, medication adherence management components, monitoring/measurement methods and targets, intervention modes of delivery, target behaviour determinants, behaviour change techniques, intervention providers, intervention settings, quality indicators and implementation indicators. Stakeholders will evaluate the proposed definition and attributes' relevance, clarity and completeness and have multiple opportunities to reconsider their evaluations based on aggregated feedback in real-time. Data collection will stop when the predetermined response rate will be achieved. We will quantify agreement and perform analyses of process indicators on the whole sample and per stakeholder group. ETHICS AND DISSEMINATION: Ethical approval for the COST ENABLE activities was granted by the Malaga Regional Research Ethics Committee. The Delphi protocol was considered compliant regarding data protection and security by the Data Protection Officer from University of Basel. Findings from the Delphi study will form the basis for the ENABLE repository structure and related activities.

The Impact of COVID-19 Confinement on Cognition and Mental Health and Technology Use Among Socially Vulnerable Older People: Retrospective Cohort Study.

BACKGROUND: COVID-19 forced the implementation of restrictive measures in Spain, such as lockdown, home confinement, social distancing, and isolation. It is necessary to study whether limited access to basic services and decreased family and social support could have deleterious effects on cognition, quality of life, and mental health in vulnerable older people. OBJECTIVE: This study aims to explore the impact of the COVID-19 outbreak on cognition in older adults with mild cognitive impairment or dementia as the main outcome and the quality of life, perceived health status, and depression as secondary outcomes and to analyze the association of living alone and a change in living arrangements with those outcomes and other variables related with the use of technology and health services. Likewise, this study aims to analyze the association of high and low technophilia with those variables, to explore the access and use of health care and social support services, and, finally, to explore the informative-, cognitive-, entertainment-, and socialization-related uses of information and communications technologies (ICTs) during the COVID-19 outbreak. METHODS: This cohort study was conducted in Málaga (Spain). In total, 151 participants with mild cognitive impairment or mild dementia, from the SMART4MD (n=75, 49.7%) and TV-AssistDem (n=76, 50.3%) randomized clinical trials, were interviewed by telephone between May 11 and June 26, 2020. All participants had undergone 1-3 assessments (in 6-month intervals) on cognition, quality of life, and mood prior to the COVID-19 breakout. RESULTS: The outbreak did not significantly impact the cognition, quality of life, and mood of our study population when making comparisons with baseline assessments prior to the outbreak. Perceived stress was reported as moderate during the outbreak. After correction for multiple comparisons, living alone, a change in living arrangements, and technophilia were not associated with negative mental health outcomes. However, being alone was nominally associated with self-perceived fear and depression, and higher technophilia with better quality of life, less boredom, perceived stress and depression, and also less calmness. Overall, health care and social support service access and utilization were high. The most used ICTs during the COVID-19 outbreak were the television for informative, cognitive, and entertainment-related uses and the smartphone for socialization. CONCLUSIONS: Our findings show that the first months of the outbreak did not significantly impact the cognition, quality of life, perceived health status, and depression of our study population when making comparisons with baseline assessments prior to the outbreak. Living alone and low technophilia require further research to establish whether they are risk factors of mental health problems during lockdowns in vulnerable populations. Moreover, although ICTs have proven to be useful for informative-, cognitive-, entertainment-, and socialization-related uses during the pandemic, more evidence is needed to support these interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04385797; https://clinicaltrials.gov/ct2/show/NCT04385797. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/26431.

[The clinical relevance of inhalation technique in chronic obstructive pulmonary disease patients]. / Relevancia clínica de la técnica de utilización de inhaladores en pacientes con enfermedad pulmonar obstructiva crónica.

INTRODUCTION: Numerous studies show that patients with chronic obstructive pulmonary disease (COPD) perform an incorrect inhalation technique (IT). This research aims to describe inhalation errors committed and their clinical importance, and to identify factors related to them. PATIENTS AND METHODS: A total of 995 patients were recruited in this cross-sectional, descriptive study that was conducted across 20 Andalusian Health Care Centres. The following variables were collected: socio-demographic data, quality of life, mental and cognitive status, spirometry tests, severity, number of IT devices, IT correct performance, previous instruction and clinical importance of errors. RESULTS: Of the 995 patients, 906 (91,1%) performed an incorrect IT. The most common errors showed moderate errors, which were related to low-cognitive level, low-peak expiratory flow and fewer medical consultations with the pulmonologist. Critical errors were correlated with greater severity, usage of Turbuhaler® and worse quality of life. DISCUSSION: Soaring incorrect technique rate, whose most common errors sparingly compromise the drug effectiveness. These errors are related to the way the patients perform the IT, and not to the difficulty in handling the device. This information demonstrates the relevance of training patients in a proper way.

Cognitive Outcomes During COVID-19 Confinement Among Older People and Their Caregivers Using Technologies for Dementia: Protocol for an Observational Cohort Study.

BACKGROUND: The COVID-19 pandemic has led to worldwide implementation of unprecedented restrictions to control its rapid spread and mitigate its impact. The Spanish government has enforced social distancing, quarantine, and home confinement measures. Such restrictions on activities of daily life and separation from loved ones may lead to social isolation and loneliness with health-related consequences among community-dwelling older adults with mild cognitive impairment or mild dementia and their caregivers. Additionally, inadequate access to health care and social support services may aggravate chronic conditions. Home-based technological interventions have emerged for combating social isolation and loneliness, while simultaneously preventing the risk of virus exposure. OBJECTIVE: The aim of this cohort study is to explore, analyze, and determine the impact of social isolation on (1) cognition, quality of life, mood, technophilia, and perceived stress among community-dwelling older adults with mild cognitive impairment or mild dementia and on the caregiver burden; (2) access to and utilization of health and social care services; and (3) cognitive, social, and entertainment-related uses of information and communication technologies. METHODS: This study will be conducted in Málaga (Andalucía, Spain). In total 200 dyads, consisting of a person with mild cognitive impairment or mild dementia and his/her informal caregiver, will be contacted by telephone. Potential respondents will be participants of the following clinical trials: support, monitoring, and reminder technology for mild dementia (n=100) and television-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (n=100). RESULTS: As of May 2021, a total of 153 participants have been enrolled and assessed during COVID-19 confinement, of whom 67 have been assessed at 6 months of enrollment. Changes in the mean values of the variables will be analyzed relative to baseline findings of previous studies with those during and after confinement, using repeated-measures analysis of variance or the nonparametric Friedman test, as appropriate. The performance of multivariate analysis of covariance (ANCOVA) to introduce potential covariates will also be considered. Values of 95% CI will be used. CONCLUSIONS: If our hypothesis is accepted, these findings will demonstrate the negative impact of social isolation owing to COVID-19 confinement on cognition, quality of life, mood, and perceived stress among community-dwelling older adults with mild cognitive impairment and mild dementia, the impact on technophilia, caregiver burden, the access to and utilization of health and social care services, and the cognitive, social, and entertainment-related use of information and communication technologies during and after COVID-19 confinement. TRIAL REGISTRATION: ClinicalTrials.gov NCT04385797; https://clinicaltrials.gov/ct2/show/NCT04385797. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26431.

Attitudes and Use of Information and Communication Technologies in Older Adults With Mild Cognitive Impairment or Early Stages of Dementia and Their Caregivers: Cross-Sectional Study.

BACKGROUND: Information and communication technologies are promising tools to increase the quality of life of people with dementia or mild cognitive impairment and that of their caregivers. However, there are barriers to their use associated with sociodemographic factors and negative attitudes, as well as inadequate knowledge about technologies. OBJECTIVE: The aim of this study was to analyze technophilia (attitudes toward new technologies) and the use of smartphones and tablets along with associated factors in people with dementia/mild cognitive impairment and their caregivers. METHODS: Data from the first visit of the Support Monitoring and Reminder for Mild Dementia (SMART4MD) randomized multicenter clinical trial were used for this analysis. Data were obtained from two European countries, Spain and Sweden, and from three centers: Consorci Sanitari de Terrassa (Catalonia, Spain), Servicio Andaluz de Salud (Andalusia, Spain), and the Blekinge Institute of Technology (Sweden). Participants with a score between 20 and 28 in the Mini Mental State Examination, with memory problems (for more than 6 months), and who were over the age of 55 years were included in the study, along with their caregivers. The bivariate Chi square and Mann-Whitney tests, and multivariate linear and logistic regression models were used for statistical analysis. RESULTS: A total of 1086 dyads were included (N=2172). Overall, 299 (27.53%) of people with dementia/mild cognitive impairment had a diagnosis of dementia. In addition, 588 (54.14%) of people with dementia/mild cognitive impairment reported using a smartphone almost every day, and 106 (9.76%) used specific apps or software to support their memory. Among the caregivers, 839 (77.26%) used smartphones and tablets almost every day, and 181 (16.67%) used specific apps or software to support their memory. The people with dementia/mild cognitive impairment showed a lower level of technophilia in comparison to that of their caregivers after adjusting for confounders (B=0.074, P=.02) with differences in technology enthusiasm (B=0.360, P<.001), but not in technology anxiety (B=-0.042, P=.37). Technophilia was associated with lower age (B=-0.009, P=.004), male gender (B=-0.160, P<.001), higher education level (P=.01), living arrangement (living with children vs single; B=-2.538, P=.01), country of residence (Sweden vs Spain; B=0.256, P<.001), lower depression (B=-0.046, P<.001), and better health status (B=0.004, P<.001) in people with dementia/mild cognitive impairment. Among caregivers, technophilia was associated with comparable sociodemographic factors (except for living arrangement), along with a lower caregiver burden (B=-0.005, P=.04) and better quality of life (B=0.348, P<.001). CONCLUSIONS: Technophilia was associated with a better quality of life and sociodemographic variables in people with dementia/mild cognitive impairment and caregivers, suggesting potential barriers for technological interventions. People with dementia/mild cognitive impairment frequently use smartphones and tablets, but the use of specific apps or software to support memory is limited. Interventions using these technologies are needed to overcome barriers in this population related to sociodemographic characteristics and the lack of enthusiasm for new technologies. TRIAL REGISTRATION: ClinicalTrials.gov NCT03325699; https://clinicaltrials.gov/ct2/show/NCT03325699.

TV-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (TV-AssistDem): study protocol for a multicentre randomized controlled trial.

BACKGROUND: Mild cognitive impairment and mild dementia progressively compromise the ability of people to live independently and can have a negative impact on their quality of life. Within the current European Active and Assisted Living programme (AAL), project TV-AssistDem has been developed to deliver a TV-based platform service to support patients with mild cognitive impairment or mild dementia and provide relief to their caregivers. The application is intended to be used daily at home, mainly by the participants themselves, with the help of their informal caregivers. The aim of this study is to evaluate the effectiveness of TV-AssistDem to improve quality of life in people with mild cognitive impairment or mild dementia. METHODS: This is a 12-month European multicentre randomized controlled trial which will be performed in two countries: Spain and Romania. Two hundred and forty older adults will be recruited using identical inclusion/exclusion criteria. The primary outcome will be the change from baseline of TV-AssistDem on patient quality of life at 12 months. The secondary outcomes will be the changes from baseline of: 1) informal caregiver quality of life, 2) informal caregiver burden, 3) patient treatment adherence, 4) patient treatment compliance, 5) patient functional status, and 6) healthcare cost-effectiveness at 12 months. Patients in the intervention group will have access to an interactive platform which offers remote assistive services through a device connected to the television. The core services of the platform are: 1) Calendar and reminders, 2) Health monitoring and data transmission to a health server and 3) Videoconference; service-oriented applications are: 4) Cognitive stimulation; 5) Reminiscences; and 6) Patient and caregiver healthcare education. The analysis will be made following an intention-to-treat procedure. Linear and Generalized Mixed Model analysis will be performed. DISCUSSION: We hypothesize that the regular use of TV-AssistDem will result in an improvement in patient quality of life. The uniqueness of this home TV-based intervention lies on its widespread accessibility and its integrative approach to quality of life in people with mild cognitive impairment or mild dementia and their informal caregivers. However, several anticipated challenges will need to be faced: poor engagement and connectivity problems. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03653234 , Date of registration: 31 August 2018.

The Effects of the Digital Platform Support Monitoring and Reminder Technology for Mild Dementia (SMART4MD) for People With Mild Cognitive Impairment and Their Informal Carers: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Many countries are witnessing a trend of growth in the number and proportion of older adults within the total population. In Europe, population aging has had and will continue to have major social and economic consequences. This is a fundamentally positive development where the added life span is of great benefit for both the individual and the society. Yet, the risk for the individual to contract noncommunicable diseases and disability increases with age. This may adversely affect the individual's ability to live his or her life in the way that is desired. Cognitive conditions constitute a group of chronic diseases that predominantly affects older people. Recent technology advancements can help support the day-to-day living activities at home for people with cognitive impairments. OBJECTIVE: A digital platform (Support Monitoring and Reminder for Mild Dementia; SMART4MD) is created to improve or maintain the quality of life for people with mild cognitive impairment (PwMCI) and their carers. The platform will provide reminders, information, and memory support in everyday life, with the purpose of giving structure and lowering stress. In the trial, we will include participants with a diagnosed neurocognitive disorder as well as persons with an undiagnosed subjective memory problem and cognitive impairment, that is, 20 to 28 points on the Mini-Mental State Examination. METHODS: A pragmatic, multicenter RCT is being conducted in Spain, Sweden, and Belgium. The targets for recruitment are 1200 dyads-split into an intervention group and a control group that are in usual care. Intervention group participants will be provided with a data-enabled computer tablet with the SMART4MD app. Its core functionalities, intended to be used daily at home, are based on reminders, cognitive supporting activities, and sharing health information. RESULTS: Inclusion of participants started in December 2017, and recruitment is expected to end in February 2019. Furthermore, there will be 3 follow-up visits at 6, 12, and 18 months after the baseline visit. CONCLUSIONS: This RCT is expected to offer benefits at several levels including in-depth knowledge of the possibilities of introducing a holistic multilayered information and communication technology solution for this group. SMART4MD has been developed in a process involving the structured participation of PwMCI, their informal carers, and clinicians. The adoption of SMART4MD faces the challenge of this age group's relative unfamiliarity with digital devices and services. However, this challenge can also be an opportunity for developing a digital device tailored to a group at risk of digital exclusion. This research responds to the wider call for the development of digital devices which are accessible and affordable to older people and this full scale RCT can hopefully serve as a model for further studies in this field. TRIAL REGISTRATION: ClinicalTrials.gov NCT03325699; https://clinicaltrials.gov/ct2/show/NCT03325699. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13711.

Efficacy of an educational intervention in primary health care in inhalation techniques: study protocol for a pragmatic cluster randomised controlled trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) accounts for 10-12 % of primary care consultations, 7 % of hospital admissions and 35 % of chronic incapacity related to productivity. The misuse of inhalers is a significant problem in COPD because it is associated with reduced therapeutic drug effects leading to lack of control of both symptoms and disease. Despite all advice, health care professionals' practice management of inhalation treatments is usually deficient. Interventions to improve inhaler technique by health care professionals are limited, especially among primary care professionals, who provide the most care to patients with COPD. The aim of this study is to evaluate the efficacy of an educational intervention to train general practitioners (GPs) in the right inhalation technique for the most commonly used inhalers. METHODS/DESIGN: We are conducting a pragmatic cluster randomised controlled trial. The sample population is composed of 267 patients diagnosed with COPD using inhalation therapy selected from among those in 20 general practices, divided into two groups (control and intervention) by block randomisation at 8 primary care centres. The sample has two levels. The first level is patients with COPD who agree to participate in the trial and receive the educational intervention from their GPs. The second level is GPs who are primary health care professionals and receive the educational intervention. The intervention is one session of the educational intervention with a monitor given to GPs for training in the right inhalation technique. The primary outcome is correct inhalation technique in patients. Secondary outcomes are functional status (spirometry) and quality of life. The follow-up period will be 1 year. GPs will have two visits (baseline and at the 1-year follow-up visit. Patients will have four visits (at baseline and 3, 6 and 12 months). Analysis will be done on an intention-to-treat basis. DISCUSSION: We carried out three previous clinical trials in patients with COPD, which showed the efficacy of an educational intervention based on monitor training to improve the inhalation technique in patients. This intervention is suitable and feasible in the context of clinical practice. Now we are seeking to know if we can improve it when the monitor is the GP (the real care provider in daily practise). TRIAL REGISTRATION: ISRCTN Registry identifier ISRCTN93725230 . Registered on 18 August 2014.

Cómo vivir con EPOC: percepción de los pacientes / How to live with COPD: patient´s perception

Este estudio pretende conocer la representación mental sobre la Enfermedad Pulmonar Obstructiva Crónica (EPOC) que tienen los pacientes que la presentan, siguiendo el Modelo de Autorregulación de Sentido Común de Leventhal. Para ello llevamos a cabo un estudio exploratorio descriptivo mediante metodología cualitativa. Incluimos pacientes diagnosticados de EPOC atendidos en 3 centros de salud urbanos y 1 rural. Utilizamos la entrevista grupal video-grabada y analizamos el contenido utilizando el programa Atlas.Ti. 5.2. Realizamos 22 entrevistas grupales (2009- 2011) incluyendo 58 pacientes y 3 sesiones de validación del informe por los participantes. Los resultados muestran que no existe un modelo mental compartido de la EPOC: la enfermedad tiene poco reconocimiento como tal; se diagnostica en descompensaciones y se confunde con otras enfermedades; la causa se atribuye no sólo al tabaco sino a "algo más" (humos, resfriados, trabajos duros); se minimizan los síntomas, incluyendo también los no respiratorios (dolor, cansancio) y se confunden con los de otras enfermedades. Existen creencias erróneas sobre los "resfriados", efecto del "fumar poco" y efecto "nocivo" de los inhaladores. Aparecen sentimientos de desesperanza, resignación y miedo. Concluimos que los pacientes con EPOC manifiestan confusión en muchos aspectos de la enfermedad mostrando dificultades para identificar un modelo mental sobre ella

The aim of this study is to determine the mental model that patients with COPD (chronic obstructive pulmonary disease) have about their illness analyzed by the Leventhal´s Common Sense of Self-Regulation Model. An exploratory-descriptive study using qualitative methodology was performed. We included COPD-diagnosed patients attending three urban and a rural primary care centres. We used video-taped group interviews and transcribed them using Atlas.Ti 5.2 program. 22 group interviews (2009 - 2011) and 58 patients were included. There were 3 additional sessions to final inform validation. The results show that patients did not have a defined mental model about COPD: this disease was insufficiently recognized; diagnosis was made in exacerbations and it was confused with other diseases; the cause of illness was related to tobacco consumption and to "something else": fumes, colds and hard work. Patients tended to minimize their symptoms and limitations. Participants had wrong beliefs about colds, smoking only a few cigarettes effects and damage of inhaled treatment. Emotions as despair, resignation and fear were reported. We conclude that COPD patients showed confusion about many aspects of the disease (causes, symptoms, treatments). It was difficult to identify a mental model of the disease among COPD patients

Study protocol for a randomized, controlled trial comparing the efficacy of two educational interventions to improve inhalation techniques in patients with chronic obstructive pulmonary disease (COPD): TIEPOC Study.

BACKGROUND: An appropriate inhalation technique and adherence to treatment are both critical determinants of the success of chronic obstructive pulmonary disease (COPD) management. We have observed that up to 75% of patients do not use a successful inhalation technique. Knowledge evaluation and frequent reassessment of inhaler use, together with education of patients and healthcare professionals, can significantly improve the benefits that patients with COPD will derive from inhaler therapy. The objective of this study is to test the efficacy of two educational interventions to improve inhalation techniques in patients with COPD. METHODS: Multicenter randomized controlled trial with 296 patients diagnosed with COPD selected by a non-probabilistic method of sampling from seven Spanish Primary Care Centers. The patients will be divided into three groups by block randomization. The three groups are: 1) control; 2) Intervention A; and 3) Intervention B. The control group will comprise patients with no explanations or written information; the Intervention A group will comprise patients to whom we give written information only; and the Intervention B group will comprise patients to whom we give written information plus instructor training. Every patient in each group will be visited four times during the year of the study at the health centers. DISCUSSION: Our hypothesis is that the application of educational interventions (A or B) in patients with COPD who use inhaler therapy will increase the number of patients who perform a correct inhalation technique by at least 25%. We will evaluate the effectiveness of these interventions on patient inhalation technique improvement, where feasible within the context of clinical practice.

Efficacy of a multifactorial intervention on therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD): a randomized controlled trial.

BACKGROUND: Therapeutic adherence of patients with chronic obstructive pulmonary disease (COPD) is poor. This study evaluated the effectiveness of a multifactorial intervention on improving the therapeutic adherence in chronic obstructive pulmonary disease (COPD) patients with scheduled inhalation therapy. METHODS: The study design consisted of a randomised controlled trial in a primary care setting. 146 patients diagnosed with COPD were randomly allocated into two groups using the block randomisation technique. One-year follow-ups with three visits were performed. The intervention consisted of motivational aspects related to adherence (beliefs and behaviour) in the form of group and individual interviews, cognitive aspects in the form of information about the illness and skills in the form of training in inhalation techniques. Cognitive-emotional aspects and training in inhalation techniques were reinforced during all visits of the intervention group. The main outcome measure was adherence to the medication regimen. Therapeutic adherence was determined by the percentage of patients classified as good adherent as evaluated by dose or pill count. RESULTS: Of the 146 participants (mean age 69.8 years, 91.8% males), 41.1% reported adherence (41.9% of the control group and 40.3% of the intervention group). When multifactorial intervention was applied, the reported adherence was 32.4% for the control group and 48.6% for the intervention group, which showed a statistically significant difference (p = 0.046). Number needed to treat is 6.37. In the intervention group, cognitive aspects increased by 23.7% and skilled performance of inhalation techniques increased by 66.4%. The factors related to adherence when multifactorial intervention was applied were the number of exacerbations (OR = 0.66), visits to health centre (OR = 0.93) and devices (OR = 2.4); illness severity (OR = 0.67), beta-2-adrenergic (OR = 0.16) and xantine (OR = 0.19) treatment; activity (OR = 1.03) and impact (OR = 1.03) scales of the Saint George Respiratory Questionnaire. CONCLUSION: Application of the multifactorial intervention designed for this study (COPD information, dose reminders, audio-visual material, motivational aspects and training in inhalation techniques) resulted in an improvement in therapeutic adherence in COPD patients with scheduled inhalation therapy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN18841601.

Efficacy of two educational interventions about inhalation techniques in patients with chronic obstructive pulmonary disease (COPD). TECEPOC: study protocol for a partially randomized controlled trial (preference trial).

BACKGROUND: Drugs for inhalation are the cornerstone of therapy in obstructive lung disease. We have observed that up to 75 % of patients do not perform a correct inhalation technique. The inability of patients to correctly use their inhaler device may be a direct consequence of insufficient or poor inhaler technique instruction. The objective of this study is to test the efficacy of two educational interventions to improve the inhalation techniques in patients with Chronic Obstructive Pulmonary Disease (COPD). METHODS: This study uses both a multicenter patients´ preference trial and a comprehensive cohort design with 495 COPD-diagnosed patients selected by a non-probabilistic method of sampling from seven Primary Care Centers. The participants will be divided into two groups and five arms. The two groups are: 1) the patients´ preference group with two arms and 2) the randomized group with three arms. In the preference group, the two arms correspond to the two educational interventions (Intervention A and Intervention B) designed for this study. In the randomized group the three arms comprise: intervention A, intervention B and a control arm. Intervention A is written information (a leaflet describing the correct inhalation techniques). Intervention B is written information about inhalation techniques plus training by an instructor. Every patient in each group will be visited six times during the year of the study at health care center. DISCUSSION: Our hypothesis is that the application of two educational interventions in patients with COPD who are treated with inhaled therapy will increase the number of patients who perform a correct inhalation technique by at least 25 %. We will evaluate the effectiveness of these interventions on patient inhalation technique improvement, considering that it will be adequate and feasible within the context of clinical practice. TRIAL REGISTRATION: Current Controlled Trials ISRTCTN15106246.

Efficacy and safety of a multifactor intervention to improve therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD): protocol for the ICEPOC study.

BACKGROUND: Low therapeutic adherence to medication is very common. Clinical effectiveness is related to dose rate and route of administration and so poor therapeutic adherence can reduce the clinical benefit of treatment. The therapeutic adherence of patients with chronic obstructive pulmonary disease (COPD) is extremely poor according to most studies. The research about COPD adherence has mainly focussed on quantifying its effect, and few studies have researched factors that affect non-adherence. Our study will evaluate the effectiveness of a multifactor intervention to improve the therapeutic adherence of COPD patients. METHODS/DESIGN: A randomized controlled clinical trial with 140 COPD diagnosed patients selected by a non-probabilistic method of sampling. Subjects will be randomly allocated into two groups, using the block randomization technique. Every patient in each group will be visited four times during the year of the study. INTERVENTION: Motivational aspects related to adherence (beliefs and behaviour): group and individual interviews; cognitive aspects: information about illness; skills: inhaled technique training. Reinforcement of the cognitive-emotional aspects and inhaled technique training will be carried out in all visits of the intervention group. DISCUSSION: Adherence to a prescribed treatment involves a behavioural change. Cognitive, emotional and motivational aspects influence this change and so we consider the best intervention procedure to improve adherence would be a cognitive and emotional strategy which could be applied in daily clinical practice. Our hypothesis is that the application of a multifactor intervention (COPD information, dose reminders and reinforcing audiovisual material, motivational aspects and inhalation technique training) to COPD patients taking inhaled treatment will give a 25% increase in the number of patients showing therapeutic adherence in this group compared to the control group.We will evaluate the effectiveness of this multifactor intervention on patient adherence to inhaled drugs considering that it will be right and feasible to the clinical practice context. TRIAL REGISTRATION: Current Controlled Trials ISRCTN18841601.