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A home-based exercise intervention for caregivers of persons with dementia: study protocol for a randomised controlled trial.

ABSTRACT: Family members, who provide the majority of care for persons with dementia, are especially vulnerable to developing depression. Interventions targeting their depressive symptoms have been proposed but their efficacies vary considerably. It has been suggested that interventions carried out in the home setting and involving both caregivers and care recipients are more efficacious. This study aims to compare the efficacy of a home-based structured exercise programme involving both persons with dementia and their caregivers with nonexercise social contact control in treating depression among caregivers.This is a parallel-group, assessor-blind, randomised controlled trial. A total of 136 caregiver-care-recipient dyads (i.e. 272 participants in total) will be recruited and randomly allocated to either a home-based structured exercise (sitting Tai Chi) group or a social contact control group. The trial comprises a 3-month intervention phase followed by an extended observation phase of another 3 months. All participants will be assessed at baseline, 6th week, 12th week and 24th week. The primary outcome will be the reduction in depression among caregivers as measured by the Hamilton Rating Scale for Depression. The secondary outcomes will be burden, quality of life, cognitive performance and balance ability of the caregivers, as well as the neuropsychiatric symptoms, cognitive function, balance and functional abilities of the persons with dementia. We will also examine whether the brain-derived neurotrophic factor gene modulates mood changes in response to exercise.The findings offer a potential avenue of intervention by providing a low-cost, safe and effective treatment for depression among dementia caregivers, which may in turn also benefit the care recipients.ClinicalTrials.gov Identifier: NCT02132039 , registered on 28 April 2014.

SUBMITTER: Chan WC

PROVIDER: S-EPMC5031263 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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A home-based exercise intervention for caregivers of persons with dementia: study protocol for a randomised controlled trial.

Chan Wai Chi WC Lautenschlager Nicola N Dow Briony B Ma Suk Ling SL Wong Corine Sau Man CS Lam Linda Chiu Wa LC

Trials 20160921 1

<h4>Background</h4>Family members, who provide the majority of care for persons with dementia, are especially vulnerable to developing depression. Interventions targeting their depressive symptoms have been proposed but their efficacies vary considerably. It has been suggested that interventions carried out in the home setting and involving both caregivers and care recipients are more efficacious. This study aims to compare the efficacy of a home-based structured exercise programme involving bot ...[more]

PMID: 27655115

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Project description:ObjectivesTo develop and evaluate the effectiveness of a home based intervention in reducing caregiver burden, promoting caregiver mental health and reducing behavioural problems in elderly persons with dementia.Methodology and principal findingsThis was a randomised controlled trial in which the person with dementia-caregiver dyad was randomly allocated either to receive the intervention immediately or to a waiting list group which received the intervention after 6 months. It was carried out in communities based in two talukas (administrative blocks) in Goa, India. Mild to moderate cases with dementia (diagnosed using the DSM IV criteria and graded using the Clinical Dementia Rating scale) and their caregivers were included in the trial. Community based intervention provided by a team consisting of Home Care Advisors who were supervised by a counselor and a psychiatrist, focusing on supporting the caregiver through information on dementia, guidance on behaviour management, a single psychiatric assessment and psychotropic medication if needed. We measured caregiver mental health (General Health Questionnaire), caregiver burden (Zarit Burden Score), distress due to behavioural disturbances (NPI-D), behavioural problems in the subject (NPI-S) and activities of daily living in the elder with dementia (EASI). Outcome evaluations were masked to the allocation status. We analysed each outcome with a mixed effects model. 81 families enrolled in the trial; 41 were randomly allocated to the intervention. 59 completed the trial and 18 died during the trial. The intervention led to a significant reduction of GHQ (-1.12, 95% CI -2.07 to -0.17) and NPI-D scores (-1.96, 95%CI -3.51 to -0.41) and non-significant reductions in the ZBS, EASI and NPI-S scores. We also observed a non-significant reduction in the total number of deaths in people with dementia in the intervention arm (OR 0.34, 95% CI 0.01 to 1.03).ConclusionHome based support for caregivers of persons with dementia, which emphasizes the use of locally available, low-cost human resources, is feasible, acceptable and leads to significant improvements in caregiver mental health and burden of caring. ClinicalTrials.gov NCT00479271.

Project description:BackgroundApproximately 7.5 million older adults are homebound, who have difficulty and/or need assistance to leave their homes. In this growing population, the prevalence of people living with dementia (PLWD) is approximately 50%. Current dementia care models in the USA were developed for traditional office-based primary care and have not been tailored to home-based primary care (HBPC) delivery models. Literature has shown that office-based collaborative interventions can improve caregiver outcomes including caregiver stress, well-being, and morbidity and patient outcomes including improved quality of life and reduced emergency department visits (Possin KL, Merrilees JJ, Dulaney S, Bonasera SJ, Chiong W, Lee K, JAMA Int Med 179:1658, 2019). To date, the evidence for HBPC dementia interventions is lacking. Though HBPC has demonstrated benefit in homebound older adults, there is limited literature on the effects of HBPC on persons living with dementia (Nguyen HQ, Vallejo JD, Macias M, Shiffman MG, Rosen R, Mowry V, J Am Geriatr Soc 70:1136-46, 2021). Our goal is to develop a HBPC-focused dementia care intervention that integrates the components of two previously developed dementia care models and test the feasibility of implementing it in HBPC practices to improve the quality of life and wellbeing of homebound PLWD and their caregivers.MethodsWe will first conduct qualitative focus groups at two HBPC practice sites, one in the Southeast and one in Hawaii in order to obtain preliminary feedback on the proposed intervention. At each site, there will be one focus group with caregivers of PLWD and another with HBPC clinicians and staff to help develop and refine our intervention. We will then conduct an open-pilot trial of the refined intervention at the two HBPC practices. A total of up to 25 patient/caregiver dyads will be recruited at each site (N = 50 total). Outcomes measured through pre-and-post assessments and exit interviews will include (a) feasibility for the caregiver to engage with and complete baseline assessments and access educational materials and community resources and (b) feasibility for the practice to identify potential caregivers/patients, assess eligible patient/caregiver dyads, use patient and caregiver assessments, recruit patient/caregiver dyads, recruit racial and ethnic minorities, use care modules, and engage with the tele-video case conference, (c) net promoter score, (d) acceptability of the intervention to caregivers and patients to participate in the intervention, (e) caregivers feeling heard and understood, and (f) caregiver well-being.DiscussionTesting the feasibility and acceptability of the adapted intervention in these two HBPC practices will provide the basis for future testing and evaluation of a fully powered intervention for PLWD and their caregivers cared for in HBPC with the goal of disseminating high-quality and comprehensive dementia-care focused interventions into HBPC practices.Trial registrationThis trial was registered with ClinicalTrials.gov NCT05849259 in May 2023.

Project description:BackgroundFirearm safety among individuals with Alzheimer disease and related dementias (ADRD) is an underdiscussed and underresearched concern in the United States, especially given the growing population of community-dwelling adults with ADRD. The "Safety in Dementia" (SiD) web-based decision aid was developed to support caregivers in addressing firearm access; the efficacy of SiD is unknown.ObjectiveThrough the SiD decision aid, the Safe at Home (S@H) study aims to support caregivers in making decisions about home safety that align with their goals and values, and behaviors regarding firearm access for persons with ADRD and firearm access.MethodsThe S@H study is a 2-armed randomized controlled trial to test the effect of the SiD decision aid on caregivers of community-dwelling adults with ADRD who have firearm access. S@H aims to recruit 500 ADRD caregivers (age ≥18 years, fluent in English or Spanish, and in the United States) through online or social media advertisements and through relevant organizations. Participants are randomized to view SiD or a control website at their own pace; all participants complete web-based questionnaires at baseline, 2 weeks, 2 months, and 6 months. The primary outcome is immediate preparation for decision-making; secondary outcomes include longitudinal decision outcomes and self-reported modifications to firearm access. The relative reach and effectiveness of each recruitment method (online/social media and through relevant organizations) will be assessed by examining differences in caregiver participation, retention rates, and relative cost.ResultsThe study enrollment began in May 2022. As of December 2022, a total of 117 participants had enrolled.ConclusionsThe S@H study is the first randomized trial of a firearm safety decision aid for ADRD caregivers. The results from this study will inform how best to support caregivers in decision-making regarding firearm safety. Further, results may guide approaches for recruiting caregivers and for dissemination of resources.Trial registrationClinicalTrials.gov NCT05173922; https://clinicaltrials.gov/ct2/show/NCT05173922.International registered report identifier (irrid)DERR1-10.2196/43702.

Project description:ObjectivesFamily caregivers of people with dementia (FC-of-PWD) suffer from a high level of stress and depressive symptoms, which usually require different interventions at different stages. Although some standalone interventions such as behavioural activation (BA) and mindfulness practice (MP) have been shown to be potentially effective at reducing depressive symptoms, the best sequence and combination of these interventions for caregivers are unknown. This study aims to develop and identify a two-stage adaptive intervention with prespecified rules guiding whether, how or when to offer different interventions initially/over time to reduce depressive symptoms in FG-of-PWD.MethodsA sequential multiple assignment randomised trial design will be adopted. 272 FG-of-PWD with mild to moderate depressive symptoms will be recruited from the community. Four two-stage, embedded adaptive interventions involving BA and MP of different sequences and dosages (eg, 8 weeks of BA followed by booster sessions for responders and 8 weeks of MP for non-responders) will be assigned to the participants following a set of decision rules. The primary outcomes will be depressive symptoms (measured using the Patient Health Questionnaire-9), assessed after the second stage of the intervention. Other outcomes, such as positive aspects of caregiving (measured using the Positive Aspects of Caregiving Scale), sleep quality (measured using the Pittsburgh Sleep Quality Index) and time points will also be assessed. The analyses will follow the intention-to-treat principle. Several process indicators (eg, engagement in meaningful activities and level of mindfulness) will also be assessed. The findings will have strong implications for the further development of psychosocial adaptive interventions to reduce depressive symptoms among FC-of-PWD.Ethics and disseminationThis study has received ethical approval from the Human Research Ethics Committee at The Hong Kong Polytechnic University (HSEARS20211223001). The findings will be presented at academic conferences and submitted to peer-reviewed journals for publication.Trial registration numberNCT05634317.

Project description:IntroductionThe prevalence of dementia is increasing without a known cure, resulting in an increasing number of informal caregivers. Caring for a person with dementia results in increased stress and depressive symptoms. There are several behavioural interventions designed to alleviate stress and depressive symptoms in caregivers of persons with dementia with evidence of efficacy. Two of the best-known interventions are the New York University Caregiver Intervention (NYUCI) and the Resources for Enhancing Alzheimer's Caregivers Health (REACH). The effectiveness of the NYUCI and REACH has never been compared. There is also a paucity of data on which interventions are more effective in Hispanics in New York City. Thus, we proposed the Northern Manhattan Hispanic Caregiver intervention Effectiveness Study (NHiCE), a pragmatic clinical trial designed to compare the effectiveness of adaptations of the NYUCI and the REACH in informal Hispanic caregivers of persons with dementia in New York City.Methods and analysisNHiCE is a 6-month randomised controlled trial comparing the effectiveness of adaptations of the NYUCI and REACH among 200 Hispanic informal adult caregivers of persons with dementia. The planned number of sessions of the NYUCI and REACH are similar. The primary outcome measures are changes from baseline to 6 months in the Zarit Caregiver Burden Scale and Geriatric Depression Scale. Our primary approach to analyses will be intent-to-treat. The primary analyses will use mixed random effects models, and a full information maximum likelihood approach, with sensitivity analyses using generalised estimating equation.Ethics and disseminationNHiCE is approved by the Institutional Review Board of Columbia University Medical Center (protocol AAAM5150). A Data Safety Monitoring Board monitors the progress of the study. Dissemination will include reports of the characteristics of the study participants, as well as a report of the results of the clinical trial.Trial registration numberNCT02092987, Pre-results.

Project description:It is estimated that global dementia rates will more than triple by 2050 and result in a staggering economic burden on families and societies. Dementia carries significant physical, psychological and social challenges for individuals and caregivers. Informal caregiving is common and increasing as more people with dementia are being cared for at home instead of in nursing homes. Caregiver burden is associated with lower perceived health, lower social coherence, and increased risk of morbidity and mortality. The aim of this trial is to evaluate the effects of information and communication technology (ICT) on caregiver burden among informal caregivers of people with dementia by reducing the need for supervision.This randomized controlled trial aims to recruit 320 dyads composed of people with dementia living in community settings and their primary informal caregivers. In the intervention group, people with dementia will have a home monitoring kit installed in their home while dyads in the control group will receive usual care. The ICT kit includes home-leaving sensors, smoke and water leak sensors, bed sensors, and automatic lights that monitor the individual's behavior. Alerts (text message and/or phone call) will be sent to the caregiver if anything unusual occurs. All study dyads will receive three home visits by project administrators who have received project-specific training in order to harmonize data collection. Home visits will take place at enrollment and 3 and 12 months following installation of the ICT kit. At every home visit, a standardized questionnaire will be administered to all dyads to assess their health, quality of life and resource utilization. The primary outcome of this trial is the amount of informal care support provided by primary informal caregivers to people with dementia.This is the first randomized controlled trial exploring the implementation of ICT for people with dementia in a large sample in Sweden and one of the first at the international level. Results hold the potential to inform regional and national policy-makers in Sweden and beyond about the cost-effectiveness of ICT and its impact on caregiver burden.ClinicalTrials.gov, NCT02733939 . Registered on 10 March 2016.

Project description:Background and Objectives:The number of persons living with dementia (PLWD) in the United States will reach 16 million by 2050. Behavioral and psychological symptoms of dementia challenge family caregivers and contribute to negative caregiver outcomes such as burden and depression. Available technology can support the delivery of effective interventions to families providing dementia care at home. The Supporting Family Caregivers with Technology for Dementia Home Care (FamTechCare) randomized controlled trial evaluated the effects of a telehealth intervention on caregiver outcomes. Research Design and Methods:The FamTechCare intervention provides tailored dementia-care strategies to in-home caregivers based on video recordings caregivers submit of challenging care situations. An expert team reviews the videos and provides individualized interventions weekly for the experimental group. In the telephone-support attention control group, caregivers receive feedback from an interventionist via the telephone based on caregiver retrospective recall of care challenges. Effects of the intervention on caregiver outcomes, including burden, depression, sleep disturbance, competence, desire to institutionalize the PLWD, and caregiver reaction to behavioral symptoms were evaluated by fitting linear mixed regression models to changes in the outcomes measured at 1 and 3 months. Results:FamTechCare caregivers (n = 42) had greater reductions in depression (p = .012) and gains in competence (p = .033) after 3 months compared to the attention control group (n = 41). Living in rural areas was associated with a reduction in depression for FamTechCare caregivers (p = .002). Higher level of education was associated with greater improvements or lesser declines in burden, competence, and reaction to behavioral symptoms for both the FamTechCare and attention control caregivers. Discussion and Implications:This research demonstrated benefits of using available technology to link families to dementia care experts using video-recording technology. It provides a foundation for future research testing telehealth interventions, tailored based on rich contextual data to support families, including those in rural or remote locations.

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A home-based exercise intervention for caregivers of persons with dementia: study protocol for a randomised controlled trial.

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A home-based exercise intervention for caregivers of persons with dementia: study protocol for a randomised controlled trial.

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