Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests an online training program called CuRB-IT, which helps family caregivers of people with dementia manage difficult behaviors. The program aims to boost caregivers' confidence and provide practical coping methods, making caregiving less stressful.
Is caregiver coaching for dementia safe for humans?
The available research on caregiver coaching for dementia, including programs like CuRB-IT, focuses on improving caregiver strategies and mental health without reporting any safety concerns, suggesting it is generally safe for participants.
157811How is the CuRB-IT treatment for dementia caregivers different from other treatments?
CuRB-IT is unique because it involves personalized online coaching sessions for family caregivers, focusing on education, communication, and individualized strategies to manage care-resistant behaviors in dementia patients. This approach emphasizes person-centered care and relationship-building, unlike traditional treatments that may not address the caregiver's role in managing resistance to care.
235610Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment CuRB-IT for dementia caregivers?
Research shows that coaching for dementia caregivers, like CuRB-IT, can improve caregiver communication, reduce stress, and help manage care-resistant behaviors. Similar programs have shown improvements in caregiver mental health and reduced strain, suggesting that CuRB-IT may also be effective.
14589Eligibility Criteria
This trial is for family caregivers over 18 years old who help a relative with mild cognitive impairment or dementia and face resistance when providing care. Caregivers must speak/read English, have internet access, and share living or cooking space with the care recipient.Inclusion Criteria
I need help with daily tasks like dressing or using the bathroom.
Exclusion Criteria
I cannot speak or read English.
Participant Groups
The study tests CuRB-IT, an intervention for caregivers dealing with care-resistant behavior in dementia patients. Participants are split into two groups: one starts CuRB-IT immediately and the other after a delay, both completing surveys and diaries to track progress.
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate InterventionExperimental Treatment1 Intervention
Complete baseline survey, complete 3 weeks of daily diaries and intermittent survey, receive 12 weeks of CurB-IT, then complete 3 rounds of 21-day daily diaries and intermittent surveys while receiving attention during the 12-week intervals between daily diaries.
Group II: Delayed interventionActive Control1 Intervention
Complete baseline survey, complete 3 weeks of daily diaries, receive 12 weeks of attention, complete 3 weeks of daily diaries and 1 intermittent survey, receive 12 weeks of CurB-IT, then complete 2 rounds of 21-day daily diaries and intermittent surveys while receiving attention during the 12-week intervals between daily diaries.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
References
Translating Evidence-Based Dementia Caregiving Interventions into Practice: State-of-the-Science and Next Steps. [2022]Over the past 3 decades, more than 200 dementia caregiver interventions have been tested in randomized clinical trials and found to be efficacious. Few programs have been translated for delivery in various service contexts, and they remain inaccessible to the 15+ million dementia family caregivers in the United States. This article examines translational efforts and offers a vision for more rapid advancement in this area. We summarize the evidence for caregiver interventions, review published translational efforts, and recommend future directions to bridge the research-practice fissure in this area. We suggest that as caregiver interventions are tested external to service contexts, a translational phase is required. Yet, this is hampered by evidentiary gaps, lack of theory to understand implementation challenges, insufficient funding and unsupportive payment structures for sustaining programs. We propose ways to advance translational activities and future research with practical applications.
Impact of caregivers' behaviors on resistiveness to care and collaboration in persons with dementia in the context of hygienic care: an interactional perspective. [2016]The role played by various physical and verbal behaviors of professional caregivers in the onset of resistiveness to care (RTC) and collaborative behaviors of nursing home residents with dementia was assessed in a daily hygienic care routine context.
The best evidence for minimizing resistance-to-care during assisted personal care for older adults with dementia in nursing homes: a systematic review. [2022]To determine the effectiveness of interventions in minimizing resistance-to-care behaviors during assisted personal care for nursing home residents with dementia.
Evaluation of a Telephone-Delivered, Community-Based Collaborative Care Management Program for Caregivers of Older Adults with Dementia. [2018]To evaluate whether a community-based, telephone-delivered, brief patient/caregiver-centered collaborative dementia care management intervention is associated with improved caregiver and care recipient (CR) outcomes.
Description of Process and Content of Online Dementia Coaching for Family Caregivers of Persons with Dementia. [2020]Family caregivers of persons with dementia encounter resistance to care behaviors (RCBs). The purpose of this methods paper was to describe the process and content of six weekly 60-min caregiver coaching sessions delivered synchronously through an online platform to 26 family caregivers of persons with dementia. All session notes were analyzed for process; two coaching sessions from five purposely-selected participants were transcribed and analyzed thematically for content. The six sessions followed an overall pattern. The first session included the most teaching and goal-setting; the coaches also queried the family caregiver about the premorbid personality, work history, and interpersonal attributes of the person with dementia. Sessions two through five were the most active coaching sessions; previously suggested strategies were evaluated and tailored; caregivers also role-played with the coaches and developed scripts designed to curtail RCB. The sixth session served as a review of successful caregiver strategies and concluded the coaching relationship. Four primary content themes emerged in the coaching process: (1) education; (2) caregiver communication; (3) affirmation of the caregiver; and (4) individualized strategies. These four content categories were used throughout the coaching process and were interwoven with each other so that the participant knew why the behavior was occurring, how to verbally address it, how to use a strategy effectively, and affirmation of the result. The coaching process and content demonstrated alignment with person-centered practices and relationship-centered care.
Findings From a Real-World Translation Study of the Evidence-Based "Partners in Dementia Care". [2022]Label="BACKGROUND AND OBJECTIVES" NlmCategory="OBJECTIVE">Numerous non-pharmacological programs for family caregivers and persons with dementia (PWDs) have been found efficacious in randomized controlled trials. Few programs have been tested in translation studies that assess feasibility and outcomes in less-controlled, real-world implementations. This translation study tested the impact of the partnership version of BRI Care Consultation, "Partners in Dementia Care (PDC)," on outcomes for PWDs and their family/friend caregivers. PDC was delivered via partnerships between the Louis Stokes Department of Veterans Affairs Medical Center and the Greater East Ohio Alzheimer's Association Chapter and the Western Reserve Area Agency on Aging. PDC is a personalized coaching program done by telephone, e-mail, and regular mail.
The association between informal caregiving and behavioral risk factors: a cross-sectional study. [2021]This study aimed to compare informal caregivers/dementia caregivers to non-caregivers regarding alcohol consumption, smoking behavior, obesity, and insufficient physical activity and to identify caregiving-related factors (caregiving intensity, length of caregiving, relationship to the care recipient, and type of caregiving task) which are associated with behavioral risk factors in caregivers/dementia caregivers.
Effectiveness of "Reducing Disability in Alzheimer's Disease" Among Dyads With Moderate Dementia. [2022]Replications of evidence-based dementia care receiver-caregiver dyad interventions in the community are scarce. We aimed to assess the effectiveness of the Kansas City implementation of Reducing Disability in Alzheimer's Disease (RDAD) among a convenience sample of dyads with moderate dementia, which addressed needs identified by nine participating community agencies. We hypothesized that dyads' mental health and physical activity outcomes would improve from baseline to end-of-treatment. The final analytic sample included 66 dyads. Outcomes improved (p < .01) from pre- to post-intervention: behavioral symptom severity (range 0-36) decreased from 11.3 to 8.6, physical activity increased from 125.0 to 190.0 min/week, caregiver unmet needs (range 0-34) decreased from 10.6 to 5.6, caregiver behavioral symptom distress (0-60) decreased from 15.5 to 10.4, and caregiver strain (0-26) decreased from 11.1 to 9.7. This adapted implementation of RDAD leads to clinically meaningful improvements and might inform scaling-up.
Caregiver outcomes of a dementia care program. [2022]The University of California, Los Angeles Alzheimer's and Dementia Care (ADC) program enrolls persons living with dementia (PLWD) and their family caregivers as dyads to work with nurse practitioner dementia care specialists to provide coordinated dementia care. At one year, despite disease progression, overall the PLWDs' behavioral and depressive symptoms improved. In addition, at one-year, overall caregiver depression, strain, and distress related to behavioral symptoms also improved. However, not all dyads enrolled in the ADC program showed improvement in these outcomes. We conducted a mixed qualitative-quantitative study to explore why some participants did not benefit and what could be changed in this and other similar dementia management programs to increase the percentage who benefit. Semi-structured interviews (N=12) or surveys (N=41) were completed with 53 caregivers by telephone, mail and online. Seven areas for potential program improvement were identified from the first 12 interviews. These included: recommendations that did not match caregivers' perceived care needs, barriers to accessing care and utilizing resources, differing care needs based on stage of dementia, needing services not offered by the ADC, needing more education or support, behavioral recommendations that the caregiver felt did not work, and poor rapport of the dementia expert with caregivers. Despite having been identified as having had no clinical benefit from participating in the program, most caregivers (85%) reported that the program was very beneficial or extremely beneficial. Respondents identified the close, longitudinal relationship and access to a dementia care expert as particularly beneficial. This dichotomy highlights that perceived benefit for most of the interviewed caregivers was not captured with the formal instruments used by the program.
Behaviors of care providers and resistiveness to oral care of persons living with dementia. [2021]Since care providers' behavior could be related to resistiveness to care (RTC) among persons living with dementia, developing care providers' behavioral strategies to reduce or prevent RTC is required. This study examined whether care providers' person-centered or task-centered behaviors were related to RTC. A secondary data analysis was conducted using 70 videos of 23 persons living with dementia who received routine oral care in long-term care settings. Data were analyzed using linear mixed models. Among task-centered behaviors, "physically controlling" significantly increased RTC. For person-centered behaviors, "cooperatively negotiating" increased RTC, while "assessing comfort" decreased RTC. Care providers need to consider the comfort or needs of persons living with dementia rather than physically controlling them in oral care situations. These findings may offer insight into the context of RTC occurrences to provide more comfortable oral care for persons living with dementia.
Caring for Informal Dementia Caregivers and Their Loved Ones Via the HOMeCARE Exercise and Mindfulness for Health Program (HOMeCARE): A Randomized, Single-Blind, Controlled Trial. [2023]Objective: To investigate the effects of a dyadic intervention of mindfulness-based stress reduction (MBSR) for informal dementia caregivers and home-based balance and progressive resistance training (PRT) for their loved ones. Methods: The study was a two arm, randomized, controlled, single-blinded, parallel-group trial. Dyads were randomized to an intervention group: an 8-week MBSR course (daily) and an 8-week PRT and balance training (3 days/week) for their loved ones or a waiting list control group. Results: Nine dyads were randomized [caregivers: median age 75 (40-81) years, loved ones: 77 (73-88) years]. The intervention significantly improved caregiver mindfulness [relative effect size (95% confidence interval) 1.35 (-0.10, 2.81); p = .009] and functional mobility in their loved ones [mean difference (95% confidence interval) 1.53 (-3.09, 6.14)] with no significant effects on caregiver burden [relative effect size (95% confidence interval) 0.22 (-1.09, 1.54); p = .622]. Conclusion: The study appeared feasible in the home environment and future large and longer trials should test the efficacy of a more abbreviated MBSR intervention and to optimize adoption and sustain adherence over time. Trial registry name: HOMeCare: Caring for the Dementia Caregiver and their Loved One via the HOMeCare Exercise and Mindfulness for Health Program Trial URL: https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12617000347369 Registration number: ACTRN12617000347369.