Psychometric testing of the caregiver contribution to self-care of coronary heart disease inventory.

BACKGROUND: Caregivers are important contributors to the self-care of patients with coronary heart disease (CHD). AIMS: The aims of this study are to describe the development and psychometric properties of the caregiver contribution to self-care of coronary heart disease inventory (CC-SC-CHDI). METHODS: The CC-SC-CHDI was developed from the patient version of the scale, the Self-care of Coronary Heart Disease Inventory (SC-CHDI) and translated into Italian using forward and backward translation. Baseline data from the HEARTS-IN-DYADS study were used. Confirmatory factor analysis (CFA) was conducted to assess factorial validity; Cronbach's alpha and the model-based internal consistency index were used to test internal consistency reliability, and Pearson's correlation coefficient was used to test convergent validity, by investigating the association between the CC-SC-CHDI and the SC-CHDI scores. RESULTS: We included 131 caregivers (mean age 55 years, 81.2% females, 74% married) of patients affected by CHD (mean age 66 years, 80.2% males, 74% married). The CFA confirmed two factors in the caregiver contribution to self-care maintenance scale ("consulting behaviors" and "autonomous behaviors"), one factor for the CC to self-care monitoring scale, and two factors in the CC to self-care management scale ("consulting behaviors and problem-solving behaviors"). Reliability estimates were adequate for each scale (Cronbach's alpha and model-based internal consistency indexes ranging from 0.73 to 0.90). Significant and positive correlations were observed between CC-SC-CHDI and SC-CHDI scales. CONCLUSION: The CC-SC-CHDI has satisfactory validity and reliability and can be used confidently in clinical settings and research to assess caregiver contributions to CHD self-care.

Health Literacy and Self-Care in Patients with Chronic Illness: A Systematic Review and Meta-Analysis Protocol.

Self-care plays a critical role in symptom recognition, management, and risk factor modification for patients with chronic illnesses. Despite its significance, self-care levels in this population are generally poor. Health literacy (HL) is pivotal for promoting effective self-care, yet the association across specific chronic illnesses remains fragmented and conflicting. Therefore, a systematic review and meta-analysis will be conducted. Inclusion criteria encompass quantitative studies involving adult patients with at least one chronic illness reporting on the association between a measure of HL and one or more elements of self-care behaviors as outcomes. Databases to be searched include PubMed, CINAHL, APA PsycINFO, Embase, Web of Science, and Cochrane Central Register of Controlled Trials. The studies will undergo risk of bias and certainty of evidence assessment using ROBINS-E and GRADE. Extracted data will include authors, publication date, aim(s), study location, design, sample characteristics, chronic illness type, study length, HL, and self-care measures. Understanding the link between HL and self-care can aid healthcare providers in implementing strategies to enhance health-promoting behaviors, contributing valuable insights to the scientific community and fostering nuanced discussions. This protocol ensures methodological transparency, stimulates discourse, and paves the way for informed interventions to improve overall health outcomes.

The Rising Challenge of Poor Health Literacy of Patients with Systemic Sclerosis: Preliminary Data Identify Important Unmet Needs in an Italian Cohort.

RATIONALE AND AIM: Health literacy (HL) is pivotal for the successful self-management of chronic diseases. Little HL information is currently available in SSc patients; therefore, the present study aims at evaluating the HL levels in an Italian cohort of SSc patients. METHODS: SSc patients were enrolled with the support of Italian patient associations, from September 2022 to March 2023. Health literacy characteristics were derived from the Health Literacy Scale European Questionnaire-16 (HLS-EU-Q16), consisting of 16 items designed on a four-point Likert scale ranging from "very difficult" to "very easy", and three HL levels were identified: inadequate HL (0-8 score); problematic HL (9-12 score); and sufficient HL (13-16 score). RESULTS: Enrolled patients (n = 57, mean age = 59 years, SD = 13.2) were mostly female (98.2%), partnered (73.7%), and unemployed or retired (67.9%). Almost half of SSc patients were diagnosed more than 10 years ago, with first symptoms appearing on average 19 years ago (SD 10.5). In 63% of the participants, the overall health literacy skills were inadequate, or problematic, especially in the health care and disease prevention domains. Indeed, 49.2% of the patients declared difficulty in finding information on treatments for illnesses and where to get professional help (42.1%), 47.6% found difficulty in retrieving information on how to manage mental health problems, and 40.4% declared difficulties in judging whether the information on health risks in the media was reliable. CONCLUSIONS: Our findings show that SSc patients have inadequate or problematic levels of HL, suggesting the need for periodic screenings to uncover poor health literacy skills and to provide tailored and understandable educational material. This study was not registered.

The relationship between caregiver contribution to self-care and patient quality of life in heart failure: A longitudinal mediation analysis.

BACKGROUND: Patients with heart failure may experience poor quality of life due to a variety of physical and psychological symptoms. Quality of life can improve if patients adhere to consistent self-care behaviors. Patient outcomes (i.e., quality of life) are thought to improve as a result of caregiver contribution to self-care. However, uncertainty exists on whether these outcomes improve as a direct result of caregiver contribution to self-care or whether this improvement occurs indirectly through the improvement of patient heart failure self-care behaviors. AIMS: To investigate the influence of caregiver contribution to self-care on quality of life of heart failure people and explore whether patient self-care behaviors mediate such a relationship. METHODS: This is a secondary analysis of the MOTIVATE-HF randomized controlled trial (Clinicaltrials.gov registration number: NCT02894502). Data were collected at baseline and 3 months. An autoregressive longitudinal path analysis model was conducted to test our hypotheses. RESULTS: We enrolled a sample of 510 caregivers [mean age = 54 (±15.44), 24% males)] and 510 patients [mean age = 72.4 (±12.28), 58% males)]. Patient self-care had a significant and direct effect on quality of life at three months (ß = 0.20, p < .01). Caregiver contribution to self-care showed a significant direct effect on patient self-care (ß = 0.32, p < .01), and an indirect effect on patient quality of life through the mediation of patient self-care (ß = 0.07, p < .001). CONCLUSION: Patient quality of life is influenced by self-care both directly and indirectly, through the mediation of caregiver contribution to self-care. These findings improve our understanding on how caregiver contribution to self-care improves patient outcomes.

Complementing Braden scale for pressure ulcer risk with clinical and demographic-related factors in a large cohort of hospitalized Italian patients.

AIMS: To determine the prevalence, risk, and determinants of pressure ulcer risk in a large cohort of hospitalized patients. DESIGN: A prospective cross-sectional study with data collection in January 2023. METHODS: Registered nurses collected data from 798 patients admitted to 27 health care units of an Italian hospital. The pressure ulcer risk was assessed using the Braden scale. The presence of comorbidities was collected from clinical reports. Obesity was assessed according to international indicators (Body Mass Index). The receiver operating characteristic (ROC) curve was used to estimate the sensitivity and specificity of different Braden scores for identifying participants with pressure ulcers. RESULTS: The prevalence of pressure ulcers was 9.5%, and 57.4% of the sample were at risk of developing pressure ulcers. The area under the ROC curve was 0.88. The best sensitivity and specificity were found for a Braden cutoff score of 15.5 (sensibility = 0.76; specificity = 0.85). The determinants of lower Braden scores were older age (p < 0.001), comorbidities (p < 0.001), wounds of other nature (p = 0.001), urinary incontinence (p < 0.001), fecal incontinence (p < 0.001), and urinary catheterization (p < 0.001). CONCLUSION: Several demographic factors and specific clinical indicators have been identified as determinants of the risk of developing pressure ulcers, which are easily ascertainable by healthcare providers; thus, they may routinely complement the Braden Scale in the assessment of pressure ulcer risk in order to reinforce and accelerate clinical judgment.

Use of ancient grains for the management of diabetes mellitus: A systematic review and meta-analysis.

AIMS: A systematic review and meta-analysis of published randomized controlled trials was conducted to collate evidence from studies implementing ancient grains and investigate the impact of ancient grain consumption on health outcomes of patients with Diabetes Mellitus (DM). DATA SYNTHESIS: Twenty-nine randomized controlled trials were included, and 13 were meta-analyzed. Interventions ranged from 1 day to 24 weeks; most samples were affected by DM type 2 (n = 28 studies) and the ancient grains used were oats (n = 10 studies), brown rice (n = 6 studies), buckwheat (n = 4 studies), chia (n = 3 studies), Job's Tears (n = 2 studies), and barley, Khorasan and millet (n = 1 study). Thirteen studies that used oats, brown rice, and chia provided data for a quantitative synthesis. Four studies using oats showed a small to moderate beneficial effect on health outcomes including LDL-c (n = 717, MD: 0.30 mmol/l, 95% CI: 0.42 to -0.17, Z = 4.61, p < 0.05, I2 = 0%), and TC (n = 717, MD: 0.44 mmol/l, 95% CI: 0.63 to -0.24, Z = 4.40, p < 0.05, I2 = 0%). Pooled analyses of studies using chia and millet did not show significant effects on selected outcomes. CONCLUSIONS: For adults affected by DM type 2, the use of oats may improve lipidic profile. Further experimental designs are needed in interventional research to better understand the effects of ancient grains on diabetes health outcomes. PROSPERO REGISTRATION: CRD42023422386.

Improving adherence to rehabilitation for heart failure patients through immersive virtual reality (VIRTUAL-HF): A protocol for a randomized controlled trial.

BACKGROUND: To improve symptoms and reduce poor outcomes related to heart failure (HF), international guidelines recommend cardiac rehabilitation (CR), particularly for those with a reduced ejection fraction. Unfortunately, patient adherence to rehabilitation programs remains suboptimal, with dropouts ranging from 15.4 to 63.3%. An innovative and promising intervention that could improve adherence to rehabilitation is virtual reality (VR). This study aims to evaluate the effects of VR in patients with HF who undergo CR using this technology in terms of adherence (primary outcome), functional capacity, perceived exertion, angina, quality of life, heart rate, oxygen saturation, blood pressure, maximum oxygen uptake, minute ventilation/carbon dioxide production slope, oxygen pulse, blood values of NT-proBNP and HF related rehospitalization rates (secondary outcomes). METHODS: A randomized controlled trial will be conducted in a sample of 80 patients referred to CR. Participants will be enrolled in a cardiological rehabilitation unit of a large university hospital in Italy and randomized (1:1) to the experimental intervention consisting of CR performed with high-quality immersive VR with PICO 4® Head Mounted Display headset and TREADMILL XR® software (Arm 1) or standard CR (Arm 2). Patients, according to guidelines, will perform 30-min of CR sessions with moderate intensity, twice a week for one month. RESULTS: Significant improvements in primary and secondary outcomes are expected in patients in the intervention group. CONCLUSIONS: If proven to be effective, VR could be an innovative, safe, and easy digital health intervention to improve adherence to CR in patients with HF, as well as important clinical outcomes.

Cluster analysis of heart failure patients based on their psychological and physical symptoms and predictive analysis of cluster membership.

AIM: Patients with heart failure experience multiple co-occurring symptoms that lower their quality of life and increase hospitalization and mortality rates. So far, no heart failure symptom cluster study recruited patients from community settings or focused on symptoms predicting most clinical outcomes. Considering physical and psychological symptoms together allows understanding how they burden patients in different combinations. Moreover, studies predicting symptom cluster membership using variables other than symptoms are lacking. We aimed to (a) cluster heart failure patients based on physical and psychological symptoms and (b) predict symptom cluster membership using sociodemographic/clinical variables. DESIGN: Secondary analysis of MOTIVATE-HF trial, which recruited 510 heart failure patients from a hospital, an outpatient and a community setting in Italy. METHODS: Cluster analysis was performed based on the two scores of the Hospital Anxiety-Depression scale and two scores of the Heart-Failure Somatic Perception Scale predicting most clinical outcomes. ANOVA and chi-square test were used to compare patients' characteristics among clusters. For the predictive analysis, we split the data into a training set and a test set and trained three classification models on the former to predict patients' symptom cluster membership based on 11 clinical/sociodemographic variables. Permutation analysis investigated which variables best predicted cluster membership. RESULTS: Four clusters were identified based on the intensity and combination of psychological and physical symptoms: mixed distress (high psychological, low physical symptoms), high distress, low distress and moderate distress. Clinical and sociodemographic differences were found among clusters. NYHA-class (New York Heart Association) and sleep quality were the most important variables in predicting symptom cluster membership. CONCLUSIONS: These results can support the development of tailored symptom management intervention and the investigation of symptom clusters' effect on patient outcomes. The promising results of the predictive analysis suggest that such benefits may be obtained even when direct access to symptoms-related data is absent. IMPLICATIONS: These results may be particularly useful to clinicians, patients and researchers because they highlight the importance of addressing clusters of symptoms, instead of individual symptoms, to facilitate symptom detection and management. Knowing which variables best predict symptom cluster membership can allow to obtain such benefits even when direct access to symptoms-data is absent. IMPACT: Four clusters of heart failure patients characterized by different intensity and combination of psychological and physical symptoms were identified. NYHA class and sleep quality appeared important variables in predicting symptom cluster membership. REPORTING METHOD: The authors have adhered to the EQUATOR guidelines STROBE to report observational cross-sectional studies. PATIENT OR PUBLIC CONTRIBUTION: Patients were included only for collecting their data.

Reciprocal associations between beliefs about medicines, health locus of control and adherence to immunosuppressive medication in allogeneic hematopoietic cell transplant patients: Findings from the ADE-TRAM study.

PURPOSE: Patients undergoing allogenic hematopoietic stem cell transplantation (allo-HSCT) are required to strictly adhere to immunosuppressive medications to avoid rejection and infective complications. Since medication adherence is among the most important modifiable behaviors to achieve better outcomes, the aims of this study were to measure the baseline and longitudinal trends of medication adherence and investigate the psychological factors associated with medication adherence in allo-HSCT patients. METHODS: This was a single-center, longitudinal study of patients who underwent allo-HSCT to treat hematological malignancies at the University hospital of Florence (Italy). Adherence was measured with the Immunosuppressive Medication Self-Management Scale; psychological factors (i.e., beliefs about medicines and health locus of control) were measured with the Beliefs About Medicines Questionnaire and Multidimensional Health locus of Control Scale. Data were collected 1, 3, 6 and 12 months after discharge. A mixed effects model was performed after adjusting for demographic characteristics. RESULTS: 50 adult patients were included in this study. Adherence to immunosuppressant was optimal and increased significantly 3 months after bone marrow transplantation (B = 0.23, p = 0.041). Patients with lower concerns about immunosuppressive medications were more likely to be adherent (B = 0.02, p = 0.040), while those having beliefs that their disease was due to external factors were less likely to be adherent (B = -0.02, p = 0.026) than their counterparts. CONCLUSIONS: These results underline the importance of psychological factors in affecting adherence to immunosuppressants of allo-HSCT patients. Healthcare providers and researchers should target medication beliefs and reorient locus of control with appropriate interventions, in order to improve adherence.

Sleep Quality and Its Relationship to Anxiety and Hardiness in a Cohort of Frontline Italian Nurses during the First Wave of the COVID-19 Pandemic.

INTRODUCTION: The COVID-19 pandemic has had a considerable impact on the psychological and psychopathological status of the population and health care workers in terms of insomnia, anxiety, depression, and post-traumatic stress disorder. The primary aim of this study was to describe and evaluate the impact of the pandemic on insomnia levels of a cohort of Italian nurses, particularly those involved in the care of COVID-19 patients. The secondary aim was to identify the interaction between insomnia and hardiness, anxiety, and sleep disturbances. MATERIALS AND METHODS: A descriptive-exploratory study was conducted using an online survey during the first wave of the COVID-19 pandemic (March to July 2020). The questionnaire consisted of multiple-choice, open-ended, closed, and semi-closed questions. The psychometric tools administered were the Dispositional Resilience Scale (DRS-15), the State-Trait Anxiety Inventory (STAI-Y), and the Insomnia Severity Index (ISI). RESULTS: a cohort of 1167 nurses fully completed the questionnaire (86.2% of total respondents). The insomnia scale survey showed an increase in post-pandemic scores compared to those before the pandemic, implying that insomnia levels increased after the first pandemic wave. Insomnia scores were directly correlated with anxiety levels (r = 0.571; p ≤ 0.05) and inversely correlated with hardiness levels (r = -0.324; p < 0.001). Multivariate analysis revealed the following protective factors: not having worked in COVID-19 wards, high levels of hardiness (commitment), and the presence of high pre-pandemic insomnia disorder. The main risk factor for insomnia reported in the analysis was a high anxiety score. DISCUSSION AND CONCLUSION: Anxiety represented the main risk factor for insomnia severity in our sample, while hardiness was confirmed as a protective factor. Thus, it is necessary to design further studies to identify additional risk factors for poor sleep quality and to develop educational courses and strategies aimed at enhancing rest and sleep quality, especially for frontline nurses.

The Influence of Caregiver Contribution to Self-care on Symptom Burden in Patients With Heart Failure and the Mediating Role of Patient Self-care: A Longitudinal Mediation Analysis.

BACKGROUND: Patients with heart failure experience high symptom burden, which can be mitigated with adequate self-care. Caregiver contribution to self-care has been theorized to improve patient symptom burden. The mediating role of patient self-care in this relationship has not been tested yet. OBJECTIVES: The aim of this study was to test whether (a) caregiver contribution to self-care influences patient self-care, (b) patient self-care influences symptom burden, and (c) patient self-care mediates the relationship between caregiver contribution to self-care and symptom burden. METHODS: In this study, the authors conducted a secondary analysis of the baseline and 3-month data from the MOTIVATE-HF trial, which enrolled 510 dyads (patient with heart failure and caregiver) in Italy. Multigroup confirmatory factor analysis was used to test measurement invariance. Autoregressive longitudinal path analysis with contemporaneous mediation was used to test our hypotheses. RESULTS: On average, caregivers were 54 years old and mainly female, whereas patients were 72.4 years old and mainly male. Better caregiver contribution to self-care maintenance was associated with better patient self-care maintenance (ß = 0.280, P < .001), which, in turn, was associated with lower symptom burden (ß = -0.280, P < .001). Patient self-care maintenance mediated the effect of caregiver contribution to self-care maintenance on symptom burden (ß = -0.079; 95% bias-corrected bootstrapped confidence interval, -0.130 to -0.043). Better caregiver contribution to self-care management was associated with better patient self-care management (ß = 0.238, P = .006). The model significantly accounted for 37% of the total variance in symptom burden scores (P < .001). CONCLUSIONS: This study expands the situation-specific theory of caregiver contribution to heart failure self-care and provides new evidence on the role of caregiver contribution to self-care and patient self-care on symptom burden in heart failure.

Virtual Reality and Augmented Reality Training in Disaster Medicine Courses for Students in Nursing: A Scoping Review of Adoptable Tools.

Nurses and paramedics play a pivotal role when mass casualty incidents (MCI) occur, yet they often feel unprepared for such events. Implementation strategies for training activities, including virtual reality (VR) and augmented reality (AR) simulations, offer realistic and immersive learning experiences, enhancing skills and competencies for nursing students. The aim of this work was to investigate the adopted tools in studies on VR and AR simulations for training nursing and paramedic students in managing MCI. A scoping review was performed following the PRISMA-ScR statement, and the search strategy was conducted through five electronic databases from December 2022 to March 2023. Of 162 records identified, 27 full texts were screened and, six studies were included in this review. These studies involved students who were assigned to different training methods, including immersive VR simulation, written instruction, and traditional lecture. VR and AR and immersive simulation generally show promising evidence in enhancing practical skills and knowledge in MCI management. VR and AR showed to be promising in disaster education and preparedness training, offering different levels of immersiveness and engagement, encouraging active and experiential learning. Further research is needed to determine their long-term effectiveness. The choice of training method should consider program goals, target population, and available resources.

Psychometric properties and measurement invariance of the 7-item General Anxiety Disorder scale (GAD-7) in an Italian coronary heart disease population.

BACKGROUND: Generalized Anxiety Disorder is predominant in coronary heart disease (CHD) patients. 7-item Generalized Anxiety Disorder (GAD-7) scale psychometric properties have never been tested in CHD populations. This study aims to verify the GAD-7 psychometric properties and measurement invariance in an Italian CHD sample. METHOD: A baseline data secondary analysis from HEARTS-IN-DYADS study. Several healthcare facilities enrolled an adult inpatient sample. Anxiety and depression data were collected using GAD-7 and Patient Health Questionnaire 9 (PHQ-9). Factorial validity was assessed with confirmatory factor analysis; construct validity was tested by correlating GAD-7 scores with PHQ-9 scores and other sociodemographic characteristics; internal consistency reliability was assessed using Cronbach's alpha and the composite reliability index, while confirmatory multigroup factor analysis was employed to investigate measurement invariance across gender and age (65 vs. 65). RESULTS: We enrolled 398 patients (mean age 64.7 years; 78.9 % male; 66.8 % married). Factor structure was confirmed as unidimensional. Construct validity was confirmed with significant associations between GAD-7 and PHQ-9 scores, female gender, having a caregiver, and being employed. Cronbach's alpha and composite reliability index were 0.89 and 0.90, respectively. Measurement invariance across gender and age was confirmed at the scalar level. LIMITATIONS: A convenience sample in one European country, a small female sample, validity testing against a single criterion. CONCLUSION: Study results demonstrate adequate validity and reliability of the GAD-7 in an Italian CHD sample. It showed satisfactory invariance properties; GAD-7 is suitable for measuring anxiety in CHD while making significant comparisons of scores among stratified gender and age groups.

The influence of patient and caregiver depression on patient self-care and caregiver contribution to self-care in ostomy: A dyadic analysis.

AIMS AND OBJECTIVES: To explore the association between patient and caregiver depression and patient self-care and caregiver contribution to self-care in the context of ostomy care. BACKGROUND: Self-care is essential for ostomy patients and their caregivers. The ostomy self-care process can be considered a dyadic phenomenon in which the patient and the caregiver interact together and work as a team. The presence of depressive symptoms may limit the patient's ability to perform self-care and caregivers' abilities to engage in caregiving tasks. Research into the dyadic influence of depression on self-care behaviours from the perspective of ostomates and their caregivers is still in its infancy. DESIGN: Secondary analysis of a multicentre, cross-sectional study. The STROBE checklist was used to report the present study. METHODS: Patient-caregiver dyads were recruited from eight ostomy outpatient clinics from February 2017 to May 2018. Depression was assessed with the nine-item Patient Health Questionnaire in both patients and caregivers. Patient self-care was evaluated with the Ostomy Self-Care Index, and caregiver contribution to self-care was assessed with the Caregiver Contribution to Ostomy Self-Care Index. Both instruments measure the dimensions of maintenance, monitoring and management. The actor-partner interdependence model was performed for the dyadic analysis. RESULTS: In total, 252 patient-caregiver dyads (patients: 69.8% male, mean age 70.05; caregivers: 80.6% female, mean age 58.7) were enrolled. Patient depression was positively associated with caregiver contribution to self-care maintenance. Caregiver depression was negatively associated with self-care management. RELEVANCE TO CLINICAL PRACTICE: These findings add a better understanding of the reciprocal influence of dyadic depression on patient and caregiver contributions to self-care in ostomy contexts was found. Patient and caregiver depression influence patient self-care and caregiver contribution to self-care. Therefore, clinicians should assess and treat depression in both members of the dyad to improve self-care.

A Middle-Range Theory of Social Isolation in Chronic Illness.

Chronic illnesses and social isolation are major public phenomena that drive health and social policy worldwide. This article describes a middle-range theory of social isolation as experienced by chronically ill individuals. Key concepts include social disconnectedness, loneliness, and chronic illness. Antecedents of social isolation include predisposing factors (e.g., ageism and immigration) and precipitating factors (e.g., stigma and grief). Outcomes of social isolation include psychosocial responses (e.g., depression and quality of life), health-related behaviors (i.e., self-care), and clinical responses (e.g., cognitive function and health service use). Possible patterns of social isolation in chronic illness are described.

Development and validation of two versions of the Nurse-Patient Mutuality in Chronic Illness scale.

AIMS: The aim of the study was to develop and psychometrically test the Nurse-Patient Mutuality in Chronic Illness (NPM-CI) scale in two versions, one for nurses and one for patients. METHOD: A multiphase methodological study was conducted. In the first phase, a qualitative investigation was conducted through interviews and an analysis of the content; inductively, the items of two instruments were generated, one for nurses and one for patients. In the second phase, the content and face validity were assessed through the expert consensus method. In the third phase, exploratory factor analysis (EFA), Cronbach's alpha test, intraclass correlation and Pearson correlation coefficients were conducted to estimate construct, criterion validity and instrument reliability. For each phase, the sample included nurses and patients recruited from a large hospital in Northern Italy. Data collection was conducted between June and September 2021. RESULTS: Nurse and patient versions of the NPM-CI scale were developed. Two rounds of consensus reduced the items from 39 to 20; content validity index ranged between 0.78 and 1, content validity ratio was 0.94. Face validity indicated clarity and comprehensibility of the items. EFA identified three latent factors for both the scales. Internal consistency was satisfactory, with Cronbach's alphas ranging between .80 and .90. Test-retest stability was suggested, with an intraclass correlation coefficient of .96 (nurse scale) and .97 (patient scale). Predictive validity was established, with a Pearson correlation coefficient of .43 (nurse scale) and 0.55 (patient scale) between the mutuality scales and satisfaction in providing and receiving care. CONCLUSION: The results suggest that the NPM-CI scales are sufficiently valid and reliable for the clinical practice among chronic illness patients and the nurses caring for them. A more in-depth exploration of this construct in the context of nursing and patient outcomes is warranted. PATIENT OR PUBLIC CONTRIBUTION: Patients were involved in all study phases. IMPACT: Mutuality is fundamental in the relationship between nurse and patient, based on trust, equality, reciprocity, and mutual respect. The NPM-CI scale was developed and psychometric estimated through a multiphase study in both nurse and patient versions. The NPM-CI scale measures the factors of 'developing and going beyond', 'being the point of reference' and 'deciding and sharing care'. The NPM-CI scale allows us to measure mutuality in clinical practice and research. Expected outcomes and influencing factors for patients and nurses could be associated.

Self-care in coronary heart disease patient and caregiver dyads (HEARTS-IN-DYADS)-Protocol of a multicenter longitudinal study.

Self-care performed by patients and the caregiver contribution to this self-care are essential for improving cardiovascular outcomes; however, so far, no studies have sufficiently investigated this field in Italy. This paper describes a research protocol of a multi-center longitudinal study designed to investigate the self-care of patients affected by coronary heart disease (CHD), the caregiver's contribution to this self-care, the predictors of patient and caregiver self-care, the mediating role of self-efficacy, and the self-care outcomes. Data collection will be performed across seven Italian inpatient settings at baseline and 3 and 6 months from enrollment. Multilevel modeling and actor partner interdependence models will be implemented on a sample of 330 patient-caregiver dyads to adjust for the interdependence of measurements. The study received approval from an ethics committee in Italy and was financed in January 2021 by a grant from the Solidal Foundation in Alessandria. This research will advance the knowledge about the self-care process in CHD. The results will guide research and clinical practice by identifying variables sensitive to educational interventions.

Remote motivational interviewing to improve patient self-care and caregiver contribution to self-care in heart failure (REMOTIVATE-HF): Rationale, design, and methodology for a multicentre randomized controlled trial.

In patients with heart failure (HF), self-care, and caregiver contribution to self-care (i.e., the daily management of the disease by patients and caregivers) are essential for improving patient outcomes. However, patients and caregivers are often inadequate in their self-care and contribution to self-care, respectively, and struggle to perform related tasks. Face-to-face motivational interviewing (MI) effectively improves self-care and caregiver contribution to self-care, but the evidence on remote MI is scarce and inconclusive. The aims of this randomized controlled trial will be to evaluate whether remote MI performed via video call in patients with HF: (1) is effective at improving self-care maintenance in patients (primary outcome); (2) is effective for the following secondary outcomes: (a) for patients: self-care management, self-care monitoring, and self-efficacy; HF symptoms; generic and disease-specific quality of life; anxiety and depression; use of healthcare services; and mortality; and (b) for caregivers: contribution to self-care, self-efficacy, and preparedness. We will conduct a two-arm randomized controlled trial. We will enroll and randomize 432 dyads (patients and their informal caregivers) in Arm 1, in which patients and caregivers will receive MI or, in Arm 2, standard care. MI will be delivered seven times over 12 months. Outcomes will be assessed at baseline and 3 (primary outcome), 6, 9, and 12 months from enrollment. This trial will demonstrate whether an inexpensive and easily deliverable intervention can improve important HF outcomes. With the restrictions on in-person healthcare professional interventions imposed by the COVID-19 pandemic, it is essential to evaluate whether MI is also effective remotely.