A post-market cluster randomized controlled trial of the effect of the TENA SmartCare Change Indicator™ on urinary continence care efficiency and skin health in older nursing home residents.

BACKGROUND: Urinary continence care for residents of nursing homes who are unable to communicate their toileting needs usually involves care aides manually checking continence products (pads) to determine the level of urine saturation prior to changing. The TENA SmartCare Change Indicator is a medical device which estimates urine saturation and notifies caregivers of the optimal time for pad changes. This study will seek to examine the effect of the TENA SmartCare Change Indicator on urinary continence care efficiency and skin health, in comparison to usual care. METHODS: This cluster randomized controlled trial (NCT05247047) involving older nursing home residents with urinary incontinence unable to consistently indicate their toileting needs, and their care aides, will compare technology-based and usual continence care over a period of 8 weeks. Co-primary endpoints of superiority in continence care efficiency and non-inferiority in the maintenance of skin health will be assessed. Secondary outcomes will examine the resident quality of life, sleep quality, responsive behaviours, changes in pad use and leakage episodes outside the pad. Change in care aide work engagement, job satisfaction and rushed tasks will be assessed. Benefits and challenges with the use of the device for continence care will be identified from the perspectives of the care staff. DISCUSSION: Urinary continence assessment and care in nursing homes is reported as suboptimal and threatening to dignity. Data on the utility and effect of technological solutions for improving urinary continence care are few and conflicting. If shown effective, this technological solution has the potential to improve the care for older residents and improve the working lives of caregiving staff who look after this most vulnerable section of the population. TRIAL REGISTRATION: ClinicalTrials.gov NCT05247047. Registration date is Feb 18, 2022.

Continence care for people with dementia living at home in Europe: a review of literature with a focus on problems and challenges.

AIMS AND OBJECTIVES: To report the findings of a review of literature relating to the continence care of community-dwelling people with dementia in Europe. BACKGROUND: More than two-thirds of people with dementia live at home, and many experience continence problems. Incontinence is a significant contributor towards institutionalisation. Care and support is often inadequate or inappropriate, and guidelines are lacking. This represents a failure to respect the human rights and dignity of this group. DESIGN: A structured review of the literature relating to the continence care of community-dwelling people with dementia in Europe with a focus on problems and challenges. METHODS: Search terms reflecting dementia, continence, care/management and guidelines for community-dwelling people with dementia were applied to four databases. Hand-searching was also carried out. A total of 208 articles were searched for content relating to problems and challenges linked to continence care for this group. RESULTS: Six relevant articles were fully reviewed. The main difficulties and challenges included the following: (1) perceptions, (2) availability/provision of support and care, (3) financial cost, (4) mobility and the environment, (5) relationships and social inclusion and (6) emotional issues. CONCLUSION: Dementia and incontinence have profound effects on quality of life. The dearth of good quality data within this area and the findings of the review confirm the need for expert, consensus-based guidelines and appropriate research to ensure that the rights and dignity of people with dementia are respected. RELEVANCE TO CLINICAL PRACTICE: The findings of the review will hopefully raise awareness amongst healthcare professionals in community practice of unmet needs of people with dementia and continence problems, and their caregivers, especially those related to social, financial, emotional and relational issues. The review does not provide solutions or guidance but is helpful in highlighting some of the key areas where special attention is needed.

Efficacy and experiences of telephone counselling for informal carers of people with dementia.

BACKGROUND: Informal carers of people with dementia can suffer from depressive symptoms, emotional distress and other physiological, social and financial consequences. OBJECTIVES: This review focuses on three main objectives:To:1) produce a quantitative review of the efficacy of telephone counselling for informal carers of people with dementia;2) synthesize qualitative studies to explore carers' experiences of receiving telephone counselling and counsellors' experiences of conducting telephone counselling; and3) integrate 1) and 2) to identify aspects of the intervention that are valued and work well, and those interventional components that should be improved or redesigned. SEARCH METHODS: The Cochrane Dementia and Cognitive Improvement Group's Specialized Register, The Cochrane Library, MEDLINE, MEDLINE in Process, EMBASE, CINAHL, PSYNDEX, PsycINFO, Web of Science, DIMDI databases, Springer database, Science direct and trial registers were searched on 3 May 2011 and updated on 25 February 2013. A Forward Citation search was conducted for included studies in Web of Science and Google Scholar. We used the Related Articles service of PubMed for included studies, contacted experts and hand-searched abstracts of five congresses. SELECTION CRITERIA: Randomised controlled trials (RCTs) or cross-over trials that compared telephone counselling for informal carers of people with dementia against no treatment, usual care or friendly calls for chatting were included evaluation of efficacy. Qualitative studies with qualitative methods of data collection and analysis were also included to address experiences with telephone counselling. DATA COLLECTION AND ANALYSIS: Two authors independently screened articles for inclusion criteria, extracted data and assessed the quantitative trials with the Cochrane 'Risk of bias' tool and the qualitative studies with the Critical Appraisal Skills Program (CASP) tool. The authors conducted meta-analyses, but reported some results in narrative form due to clinical heterogeneity. The authors synthesised the qualitative data and integrated quantitative RCT data with the qualitative data. MAIN RESULTS: Nine RCTs and two qualitative studies were included. Six studies investigated telephone counselling without additional intervention, one study combined telephone counselling with video sessions, and two studies combined it with video sessions and a workbook. All quantitative studies had a high risk of bias in terms of blinding of participants and outcome assessment. Most studies provided no information about random sequence generation and allocation concealment. The quality of the qualitative studies ('thin descriptions') was assessed as moderate. Meta-analyses indicated a reduction of depressive symptoms for telephone counselling without additional intervention (three trials, 163 participants: standardised mean different (SMD) 0.32, 95% confidence interval (CI) 0.01 to 0.63, P value 0.04; moderate quality evidence). The estimated effects on other outcomes (burden, distress, anxiety, quality of life, self-efficacy, satisfaction and social support) were uncertain and differences could not be excluded (burden: four trials, 165 participants: SMD 0.45, 95% CI -0.01 to 0.90, P value 0.05; moderate quality evidence; support: two trials, 67 participants: SMD 0.25, 95% CI -0.24 to 0.73, P value 0.32; low quality evidence). None of the quantitative studies included reported adverse effects or harm due to telephone counselling. Three analytical themes (barriers and facilitators for successful implementation of telephone counselling, counsellor's emotional attitude and content of telephone counselling) and 16 descriptive themes that present the carers' needs for telephone counselling were identified in the thematic synthesis. Integration of quantitative and qualitative data shows potential for improvement. For example, no RCT reported that the counsellor provided 24-hour availability or that there was debriefing of the counsellor. Also, the qualitative studies covered a limited range of ways of performing telephone counselling. AUTHORS' CONCLUSIONS: There is evidence that telephone counselling can reduce depressive symptoms for carers of people with dementia and that telephone counselling meets important needs of the carer. This result needs to be confirmed in future studies that evaluate efficacy through robust RCTs and the experience aspect through qualitative studies with rich data.