Dataset Information

The effectiveness and health-economic evaluation of "Partner in Balance," a blended self-management program for early-stage dementia caregivers: study protocol for a cluster-randomized controlled trial.

ABSTRACT:

Background

Informal caregivers of people with dementia are crucial in dementia care. However, they are insufficiently supported and report caregiver burdens, which urges the need for cost-effective interventions aimed at supporting caregivers. This paper presents the design of a study evaluating the effectiveness, cost-effectiveness, and cost-utility of a blended self-management program for early-stage dementia caregivers.

Methods/design

A pragmatic, cluster randomized controlled trial with a shared control group will be conducted. Participants will be informal caregivers of people with early-stage dementia and will be recruited by local care professionals. Randomization will be carried out at the level of the care professional level in a ratio of 35% to 65% (control arm vs. intervention arm). Participants in the control arm will receive care as usual and the intervention arm will receive the blended care self-management program "Partner in Balance" within a usual care setting in the Netherlands. Data will be collected at baseline and at 3-, 6-, 12-, and 24-month follow-ups. The primary outcome for effectiveness (part 1) is care management self-efficacy. For the health-economic evaluation (part 2) total care costs and the quality of life for individuals with dementia (cost-effectiveness) and quality-adjusted life years (cost-utility) will be the base case analysis. Secondary outcomes (parts 1 and 2) will include depression, anxiety, perceived informal caregiving stress, service-use self-efficacy, quality of life, caregivers' gain, and perseverance time. A process evaluation (part 3) will investigate the internal and external validity of the intervention.

Discussion

In this trial, we plan to evaluate the effectiveness, cost-effectiveness, and cost-utility of "Partner in Balance" among informal caregivers of people with dementia. We expect to find a significant increase in care management self-efficacy, and the program to be cost-effective, and provide valuable insights to stakeholders of "Partner in Balance."

Trial registration

ClinicalTrials.gov, NCT05450146. Registered on 4 November 2022.

SUBMITTER: Osstyn SL

PROVIDER: S-EPMC10288740 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

The effectiveness and health-economic evaluation of "Partner in Balance," a blended self-management program for early-stage dementia caregivers: study protocol for a cluster-randomized controlled trial.

Osstyn Sander L SL Handels Ron R Boots Lizzy M M LMM Balvert Sanne C E SCE Evers Silvia M A A SMAA de Vugt Marjolein E ME

Trials 20230622 1

<h4>Background</h4>Informal caregivers of people with dementia are crucial in dementia care. However, they are insufficiently supported and report caregiver burdens, which urges the need for cost-effective interventions aimed at supporting caregivers. This paper presents the design of a study evaluating the effectiveness, cost-effectiveness, and cost-utility of a blended self-management program for early-stage dementia caregivers.<h4>Methods/design</h4>A pragmatic, cluster randomized controlled ...[more]

PMID: 37349828

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Project description:BackgroundThe benefits of electronic health support for dementia caregivers are increasingly recognized. Reaching caregivers of people with early-stage dementia could prevent high levels of burden and psychological problems in the later stages.ObjectiveThe current study evaluates the effectiveness of the blended care self-management program, Partner in Balance, compared to a control group.MethodsA single-blind randomized controlled trial with 81 family caregivers of community-dwelling people with mild dementia was conducted. Participants were randomly assigned to either the 8-week, blended care self-management Partner in Balance program (N=41) or a waiting-list control group (N=40) receiving usual care (low-frequent counseling). The program combines face-to-face coaching with tailored Web-based modules. Data were collected at baseline and after 8 weeks in writing by an independent research assistant who was blinded to the treatment. The primary proximal outcome was self-efficacy (Caregiver Self-Efficacy Scale) and the primary distal outcome was symptoms of depression (Center for Epidemiological Studies Depression Scale). Secondary outcomes included mastery (Pearlin Mastery Scale), quality of life (Investigation Choice Experiments for the Preferences of Older People), and psychological complaints (Hospital Anxiety and Depression Scale-Anxiety and Perceived Stress Scale).ResultsA significant increase in favor of the intervention group was demonstrated for self-efficacy (care management, P=.002; service use P=.001), mastery (P=.001), and quality of life (P=.032). Effect sizes were medium for quality of life (d=0.58) and high for self-efficacy care management and service use (d=0.85 and d=0.93, respectively) and mastery (d=0.94). No significant differences between the groups were found on depressive symptoms, anxiety, and perceived stress.ConclusionsThis study evaluated the first blended-care intervention for caregivers of people with early-stage dementia and demonstrated a significant improvement in self-efficacy, mastery, and quality of life after receiving the Partner in Balance intervention, compared to a waiting-list control group receiving care as usual. Contrary to our expectations, the intervention did not decrease symptoms of depression, anxiety, or perceived stress. However, the levels of psychological complaints were relatively low in the study sample. Future studies including long-term follow up could clarify if an increase in self-efficacy results in a decrease or prevention of increased stress and depression. To conclude, the program can provide accessible preventative care to future generations of caregivers of people with early-stage dementia.Trial registrationNetherlands Trial Register NTR4748; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4748 (Archived by WebCite at http://www.webcitation.org/6vSb2t9Mg).

Project description:BackgroundCaring for a family member with dementia puts caregivers at risk of overburdening. Electronic health (eHealth) support for caregivers offers an opportunity for accessible tailored interventions. The blended care self-management program "Partner in Balance" (PiB) for early-stage dementia caregivers was executed in Dutch dementia care organizations. The program combines face-to-face coaching with tailored Web-based modules. Next to an evaluation of program effectiveness, an evaluation of sampling and intervention quality is essential for the generalizability and interpretation of results.ObjectiveThe aim of this study was to describe the process evaluation from the perspective of both family caregivers (participants) and professionals delivering the intervention (coaches) to determine internal and external validity before the effect analysis and aid future implementation.MethodsImplementation, sampling, and intervention quality were evaluated with quantitative and qualitative data from logistical research data, coach questionnaires (n=13), and interviews with coaches (n=10) and participants (n=49). Goal attainment scaling was used to measure treatment-induced change. Analyses were performed with descriptive statistics and deductive content analysis.ResultsThe participation rate of eligible caregivers was 51.9% (80/154). Recruitment barriers were lack of computer and lack of need for support. Young age and employment were considered recruitment facilitators. All coaches attended training and supervision in blended care self-management. Deviations from the structured protocol were reported on intervention time, structure, and feedback. Coaches described an intensified relationship with the caregiver post intervention. Caregivers appreciated the tailored content and positive feedback. The blended structure increased their openness. The discussion forum was appreciated less. Overall, personal goals were attained after the program (T>50). Implementation barriers included lack of financing, time, and deviating target population.ConclusionsParticipants and coaches were satisfied with the intervention, but adapting the content to specific subgroups, for example, younger caregivers, was recommended. Implementation of the program requires more awareness of the benefits of blended care self-management programs and training in tailored self-management skills.Trial registrationDutch Trial Register (NTR): NTR4748; http://www.trialregister.nl (Archived by WebCite at http://www.webcitation.org/6vSb2t9Mg).

Project description:BackgroundPeople with dementia increasingly depend on informal caregivers. Internet-based self-management interventions hold considerable promise for meeting the educational and support needs of early stage dementia caregivers (EDCs) at a reduced cost.ObjectiveThis study aimed to (1) develop an online self-management program for EDC to increase self-efficacy and goal attainment, and (2) evaluate the program's feasibility and report preliminary data on effectiveness.MethodsBased on the Medical Research Council (MRC) framework for the development and evaluation of complex interventions, a stepwise approach was adopted to explore potential user needs and develop and validate the content by means of (1) focus group discussions with dementia caregivers (N=28), (2) interviews with dementia care professionals (N=11), and (3) individual think-aloud usability tests with EDC (N=2) and experts (N=2). A pilot evaluation was conducted with EDC (N=17) to test the feasibility and establish preliminary effects. Self-report measures of feasibility were completed after the completion of intervention. Self-efficacy and goal attainment were evaluated before and after the intervention.ResultsThe different steps provided useful information about the needs of potential users regarding the content and delivery of the program. This resulted in the newly developed "Partner in Balance" program. At the start, system failures resulted in a high noncompleter rate (7/17, 41%), but at the end, an acceptable feasibility score of 209 (range 54-234) was found. The convenience of completing the program at home, the tailored content, and the guidance (face-to-face and online) were appraised positively. Preliminary effects on caregiver self-efficacy (P<.05) and goal attainment (T>50) were promising.ConclusionsAdaptations were made to the program to limit the amount of system failures and prevent high noncompleter rates. As recommended by the MRC framework, confirming the feasibility and preliminary effectiveness is a valuable step toward examining the effectiveness of this newly developed intervention.Trial registrationDutch Trial Register (NTR): NTR4217; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4217 (Archived by WebCite at http://www.webcitation.org/6f6B8lvRP).

Project description:BackgroundVery few evidence-based eHealth interventions for caregivers of people with dementia are implemented into practice. Municipalities are one promising context in which to implement these interventions due to their available policy and innovation incentives regarding (dementia) caregiving and prevention. In this study, two evidence-based eHealth interventions for caregivers of people with dementia (Partner in Balance and Myinlife) were implemented in 8 municipalities in the Euregion Meuse-Rhine. Partner in Balance is a blended care, 8-week, self-management intervention intervention designed to aid caregivers of people with dementia in adapting to their new roles that is delivered through coaches in participating health care organizations who are trained to use it to offer online support to their clients. Myinlife is an eHealth/mHealth intervention integrated into the Dutch Alzheimer's Association website and available from the App Store or Google Play, designed to help caregivers of people with dementia use their social network to better organize care and share positive (caregiving) experiences.ObjectiveThis study's objectives were to evaluate the success of the implementation of Myinlife and Partner in Balance and investigate determinants of their successful implementation in the municipality context.MethodsThis study collected eHealth use data, Partner in Balance coach evaluation questionnaires, and information on implementation determinants. This was done by conducting interviews with the municipality officials based on the measurement instrument for determinants of implementation (MIDI). These data from multiple sources and perspectives were integrated and analyzed to form a total picture of the determinants (barriers and facilitators to implementation in the municipality context).ResultsThe municipality implementation of Partner in Balance and Myinlife showed varying levels of success. In the end, 3 municipalities planned to continue the implementation of Partner in Balance, while none planned to continue the implementation of Myinlife. The 2 Partner in Balance municipalities that did not consider the implementation to be successful viewed the implementation as an external project. For Myinlife, it was clear that more face-to-face contact was needed to engage the implementing municipality and target groups. Successful implementations were linked to implementer self-efficacy and sense of ownership, which seemed to be absent in unsuccessful implementations.ConclusionsThe experiences of implementing these interventions suggested that this implementation context was feasible regarding the required budget and infrastructure. The need to foster sense of ownership and self-efficacy in implementers will be integrated into future implementation protocols as part of standard implementation materials for municipalities and organizations implementing Myinlife and Partner in Balance.

Project description:BackgroundGiven the increasing use of digital interventions in health care, understanding how best to implement them is crucial. However, evidence on how to implement new academically developed interventions in complex health care environments is lacking. This case study offers an example of how to develop a theory-based implementation plan for Partner in Balance, an electronic health (eHealth) intervention to support the caregivers of people with dementia.ObjectiveThe specific objectives of this study were to (1) formulate evidence-based implementation strategies, (2) develop a sustainable business model, and (3) integrate these elements into an implementation plan.MethodsThis case study concerns Partner in Balance, a blended care intervention to support the caregivers of people with dementia, which is effective in improving caregiver self-efficacy, quality of life, and experienced control. The large-scale implementation of Partner in Balance took place in local dementia case-management services, local care homes, dementia support groups, and municipalities. Experiences from real-life pilots (n=22) and qualitative interviews with national stakeholders (n=14) were used to establish an implementation plan consisting of implementation strategies and a business model.ResultsThe main finding was the need for a business model to facilitate decision-making from potential client organizations, who need reliable pricing information before they can commit to training coaches and implementing the intervention. Additionally, knowledge of the organizational context and a wider health care system are essential to ensure that the intervention meets the needs of its target users. Based on these findings, the research team formulated implementation strategies targeted at the engagement of organizations and staff, dissemination of the intervention, and facilitation of long-term project management in the future.ConclusionsThis study offers a theory-based example of implementing an evidence-based eHealth intervention in dementia health care. The findings help fill the knowledge gap on the eHealth implementation context for evidence-based eHealth interventions after the trial phase, and they can be used to inform individuals working to develop and sustainably implement eHealth.

Project description:BackgroundFrequent hospitalization and permanent nursing home placement not only affect the well-being of persons with dementia, but also place great financial strain on society. Therefore, it is important to create effective strategies to support informal caregivers so that they can continue to perform their demanding role. Preliminary qualitative evidence suggests that community-based respite services can actually be important for caregivers, and that the level of evidence should be further established in terms of effectiveness. Therefore, a comparative study to assess the effectiveness and cost-effectiveness of an in-home respite care program will be initiated.MethodsThis manuscript described a quasi-experimental study to assess (cost)-effectiveness of an in-home respite care program to support informal caregivers of persons with dementia.Study population124 informal caregivers and persons with dementia will be included in the intervention group and will receive an in-home respite care program by an organization called Baluchon Alzheimer. 248 dyads will be included in the control group and will receive standard dementia care. The primary outcome is caregiver burden. Secondary outcomes are: quality of life of caregivers, frequency of behavioral problems of persons with dementia and the reactions of caregivers to those problems, intention to institutionalize the care-recipient, time to nursing home placement, resource use of the care-recipient, and willingness to pay for in-home respite care. When the trial demonstrates a difference in outcomes between both groups, within-trial and modeled cost-effectiveness analyses will be conducted in a separate economic evaluation plan to evaluate possible cost-effectiveness of the in-home respite care program compared to the control group receiving standard dementia care. Finally, the model based cost-effectiveness analyses will allow to extrapolate effects over a longer time horizon than the duration of the trial.DiscussionThis study will have great added value because to date no studies measured effectiveness and cost-effectiveness of an in-home respite care program of the Baluchon type. Results of this trial can thus give much more insight in potential benefits and disadvantages of community-based respite care. Conclusions based on this trial can help policy-makers in elaborating future directions of dementia care.Trial registrationClinicaltrials.gov Identifier NCT02630446 .

Project description:IntroductionLimited research has examined the economic impact of vision difficulty (VD) and dementia on older adults and their caregivers. We aimed to determine whether older adults with VD and/or dementia, and their caregivers, face more economic hardships than their counterparts without VD or dementia.MethodsWe used cross-sectional data from the 2015 National Health and Aging Trends Study (NHATS), a population-based survey of Medicare beneficiaries, linked to their family/unpaid caregivers from the National Study of Caregiving (NSOC). Regression models characterized the association of VD (self-report), dementia (survey and cognitive assessments), and co-occurring VD and dementia with debt, receiving financial help from relatives, government-based Supplemental Nutrition Assistance Program (SNAP), other food assistance, utility assistance, and caregiver financial difficulty.ResultsThe NHATS sample included 6,879 community-dwelling older adults (5670 no VD/dementia, 494 VD-alone, 512 dementia-alone, 203 co-occurring VD and dementia). Adults with VD and dementia had higher odds of receiving SNAP benefits (OR = 2.6, 95%CI = 1.4-4.8) and other food assistance (OR = 4.1, 95%CI = 1.8-9.1) than adults without VD/dementia, while no differences were noted for debt, financial help, and utility assistance. Adults with VD-alone had higher odds of debt (OR = 2.1, 95%CI = 1.3-3.2), receiving financial help (OR = 1.7, 95%CI = 1.1-2.5) and other food assistance (OR = 2.7, 95%CI = 1.7-4.3); while adults with dementia-alone had higher odds of debt (OR = 2.8, 95%CI = 1.4-5.5). The NSOC sample included 1,759 caregivers (995 caring for adults without VD/dementia, 223 for VD-alone, 368 for dementia-alone, and 173 for co-occurring VD and dementia). Compared to caregivers of older adults without VD/dementia, caregivers of adults with VD and dementia had higher odds of financial difficulty (OR = 3.0, 95%CI = 1.7-5.3) while caregivers of adults with VD-alone or dementia-alone did not.DiscussionWhile older adults with VD- or dementia-alone experienced increased economic hardships, disparities in food assistance were amplified among older adults with co-occurring disease. Caregivers of adults with co-occurring disease experienced more financial difficulty than caregivers of adults with a single or no disease. This study highlights the need for interventions across clinical and social services to support the economic wellbeing of our aging population and their caregivers.

Dataset Information

The effectiveness and health-economic evaluation of "Partner in Balance," a blended self-management program for early-stage dementia caregivers: study protocol for a cluster-randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

The effectiveness and health-economic evaluation of "Partner in Balance," a blended self-management program for early-stage dementia caregivers: study protocol for a cluster-randomized controlled trial.

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