Caregiver Coaching for Dementia

(CuRB-IT Trial)

Overseen By Frank Puga, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Non-English speakers, No smartphone/internet

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

266 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support family caregivers of people with mild cognitive impairment or dementia. Participants will either begin the CuRB-IT coaching program immediately or after a delay. CuRB-IT helps caregivers manage daily challenges and stress. The trial seeks caregivers who live with or cook for someone with dementia and assist with daily tasks like bathing or cooking. Participants need access to a smartphone or the internet.

As an unphased trial, this study offers caregivers a unique opportunity to access supportive resources that can enhance their daily lives.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this coaching method is safe for caregivers?

Research shows that CuRB-IT, an online training program, helps caregivers manage difficult behaviors in people with dementia. Although specific safety data for CuRB-IT is unavailable, the program is non-invasive. It does not involve taking medicine or undergoing physical procedures, which usually reduces the risk of side effects.

Studies on similar training programs for caregivers generally find them safe and well-received. Participants often find these programs useful and safe because they focus on learning new skills and techniques online. This setup allows caregivers to learn at their own pace, enhancing safety. Participants should stay informed and ask any questions before joining a study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CuRB-IT program for caregivers of dementia patients because it offers a structured coaching approach that is not typically found in standard treatments, which often focus primarily on medication and direct patient care. Unlike traditional methods that center on pharmacological solutions, CuRB-IT emphasizes caregiver support through coaching, potentially improving the quality of life for both caregivers and patients. This innovative approach aims to equip caregivers with practical skills and emotional support, addressing a critical gap in current dementia care practices.

What evidence suggests that CuRB-IT is effective for dementia caregiving?

Research has shown that CuRB-IT, which stands for Care-Resistant Behavior Internet Training, might help caregivers of people with dementia. In this trial, participants will be divided into two groups: one receiving the CuRB-IT intervention immediately and the other after a delay. Studies have found that this training improves caregivers' problem-solving skills, making it easier to handle difficult behaviors. This can lead to less stress and better coping strategies for caregivers. The training also focuses on helping caregivers respond more effectively to dementia-related behaviors, potentially improving their quality of life. Although more research is needed, early results suggest that CuRB-IT could be a valuable tool for caregivers facing the daily challenges of dementia care. ^{1 3 4 6 7}

Who Is on the Research Team?

Rita A Jablonski, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 am over 18, care for a family member aged 60+ without pay, and we live together or share a kitchen.

Care recipient has mild cognitive impairment or dementia as identified using the Quick Dementia Rating System instrument

I refuse or struggle to accept help with daily tasks.

Exclusion Criteria

I cannot speak or read English.

Persons who do not have reliable access to a smart phone or internet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline surveys and 3 weeks of daily diaries

3 weeks

1 visit (in-person or virtual)

Immediate Intervention

Immediate intervention group receives 12 weeks of CuRB-IT and completes 3 rounds of 3-week daily diaries with intermittent surveys

12 weeks

Delayed Intervention

Delayed intervention group receives 12 weeks of attention, completes 1 round of 3-week daily diaries and 1 intermittent survey, then receives 12 weeks of CuRB-IT and completes 2 rounds of 3-week daily diaries with intermittent surveys

24 weeks

Follow-up

Participants are monitored for intervention decay and performance at 3- and 6-months post intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CuRB-IT

Trial Overview 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.

How Is the Trial Designed?

Group I: Immediate Intervention Experimental Treatment 1 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 intervention Active Control 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Task-centered behaviors, particularly 'physically controlling' actions by care providers, significantly increased resistiveness to care (RTC) among persons living with dementia during oral care.

In contrast, person-centered behaviors like 'assessing comfort' decreased RTC, suggesting that prioritizing the comfort and needs of individuals with dementia can lead to more effective and less resistive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviors of care providers and resistiveness to oral care of persons living with dementia. Kim, B., Lee, KH., Cho, E., et al.[2021]

Caregiver behaviors, including physical actions and verbal instructions, significantly influence the likelihood of resistiveness to care (RTC) in nursing home residents with dementia, with the relationship depending on the resident's prior behavior.

Positive instructions can encourage collaboration in residents with preserved language abilities, but may lead to RTC in those with severe language impairments, highlighting the importance of tailoring caregiver approaches to individual resident needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of caregivers' behaviors on resistiveness to care and collaboration in persons with dementia in the context of hygienic care: an interactional perspective. Belzil, G., Vézina, J.[2016]

A study involving 26 family caregivers of persons with dementia revealed that six weekly online coaching sessions effectively addressed resistance to care behaviors (RCBs) through education, communication strategies, and individualized approaches.

The coaching sessions emphasized person-centered practices, helping caregivers understand the reasons behind RCBs, develop effective communication scripts, and affirm their caregiving efforts, ultimately enhancing their ability to manage care challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description of Process and Content of Online Dementia Coaching for Family Caregivers of Persons with Dementia. Jablonski, RA., Winstead, V., Geldmacher, DS.[2020]

The Kansas City implementation of the Reducing Disability in Alzheimer's Disease (RDAD) intervention showed significant improvements in both mental health and physical activity for 66 caregiver-receiver dyads with moderate dementia, with behavioral symptom severity decreasing from 11.3 to 8.6 and physical activity increasing from 125 to 190 minutes per week.

Caregivers also reported reduced unmet needs and lower levels of distress and strain, indicating that the RDAD intervention not only benefits individuals with dementia but also supports their caregivers, suggesting potential for broader application in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of "Reducing Disability in Alzheimer's Disease" Among Dyads With Moderate Dementia. Perales-Puchalt, J., Barton, K., Ptomey, L., et al.[2022]

Over 200 dementia caregiver interventions have been proven effective in randomized clinical trials, but very few have been adapted for real-world use, leaving many of the 15+ million dementia family caregivers in the U.S. without access to these resources.

The article highlights the need for a translational phase to implement these interventions effectively, addressing challenges such as funding, payment structures, and gaps in evidence to ensure caregivers receive the support they need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating Evidence-Based Dementia Caregiving Interventions into Practice: State-of-the-Science and Next Steps. Gitlin, LN., Marx, K., Stanley, IH., et al.[2022]

Resistance-to-care behaviors are common among nursing home residents with dementia, affecting about 9% of residents, and can lead to serious health issues for both residents and caregivers, including malnutrition and emotional distress.

Effective interventions to manage these behaviors during personal care activities are crucial, as they can help reduce the frequency and intensity of resistance, ultimately improving care quality and safety for both residents and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The best evidence for minimizing resistance-to-care during assisted personal care for older adults with dementia in nursing homes: a systematic review. Konno, R., Kang, HS., Makimoto, K.[2022]

Caregivers, including those caring for individuals with dementia, are more likely to be overweight or obese and to smoke compared to non-caregivers, indicating a potential risk for health issues.

Interestingly, caregivers reported lower rates of binge drinking and insufficient physical activity, suggesting that caregiving may lead to both risky and health-promoting behaviors, although the overall effects are relatively modest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between informal caregiving and behavioral risk factors: a cross-sectional study. Gottschalk, S., König, HH., Brettschneider, C.[2021]

The 'Partners in Dementia Care' (PDC) program, implemented over 12 months with 148 caregivers and 84 persons with dementia, showed significant improvements in outcomes for both groups, including reduced caregiver isolation and increased confidence in caregiving.

The positive results of the PDC program in real-world settings were consistent with previous randomized controlled trials, demonstrating its effectiveness as a regular service for supporting caregivers and persons with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Findings From a Real-World Translation Study of the Evidence-Based "Partners in Dementia Care". Bass, DM., Hornick, T., Kunik, M., et al.[2022]

The dyadic intervention combining mindfulness-based stress reduction (MBSR) for caregivers and balance and progressive resistance training (PRT) for their loved ones significantly improved caregiver mindfulness and functional mobility in the loved ones, indicating potential benefits for both parties involved.

Despite these improvements, the intervention did not significantly reduce caregiver burden, suggesting that while mindfulness training is beneficial, additional strategies may be needed to address the challenges faced by caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Lang, T., Daniel, K., Inskip, M., et al.[2023]

A community-based, telephone-delivered dementia care management program significantly reduced caregiver burden over time compared to standard clinical evaluation, based on a study involving 440 caregivers of older adults with dementia.

Caregivers in the intervention group also reported fewer challenging behaviors from care recipients and less distress in response to these behaviors at the 3-month follow-up, indicating improved outcomes for both caregivers and care recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Telephone-Delivered, Community-Based Collaborative Care Management Program for Caregivers of Older Adults with Dementia. Mavandadi, S., Wray, LO., DiFilippo, S., et al.[2018]

The UCLA Alzheimer's and Dementia Care program showed overall improvements in behavioral and depressive symptoms for persons living with dementia and their caregivers after one year, despite disease progression.

A mixed-methods study identified seven areas for improvement in the program, highlighting that while some caregivers felt they did not benefit clinically, 85% still found the program very or extremely beneficial due to the supportive relationship with dementia care experts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver outcomes of a dementia care program. Evertson, LC., Jennings, LA., Reuben, DB., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11689855/

COACHING DEMENTIA CAREGIVERS TO MASTER CARE ... The purpose of this study is to test the efficacy of Care-Resistant Behavior Internet Training intervention, CuRB-IT, on caregiver problem-solving coping ...

2. ctv.veeva.com ctv.veeva.com/study/coaching-dementia-caregivers-to-master-care-resistant-behavior

Coaching Dementia Caregivers to Master Care-Resistant ... Complete baseline survey, complete 3 weeks of daily diaries and intermittent survey, receive 12 weeks of CurB-IT, then complete 3 rounds of 21- ...

3. heraldopenaccess.us heraldopenaccess.us/openaccess/telehealth-coaching-for-caregivers-of-persons-with-dementia-and-care-resistant-behaviors-an-exploratory-study

Telehealth Coaching for Caregivers of Persons with ... Behavioral and Psychiatric Symptoms of Dementia (BPSD) are major drivers of distress among caregivers, and negatively affect quality of life ...

4. researchgate.net researchgate.net/publication/387656652_COACHING_DEMENTIA_CAREGIVERS_TO_MASTER_CARE-RESISTANT_BEHAVIOR_CURB-IT

COACHING DEMENTIA CAREGIVERS TO MASTER CARE- ... The purpose of this study is to test the efficacy of Care-Resistant Behavior Internet Training intervention, CuRB-IT, on caregiver problem-solving coping skills ...

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/309249

Coaching Dementia Caregivers to Master Care-Resistant ... Outcome measure. Change in caregiver responses to dementia-related behaviors. Measure description. Experimental (immediate) and control (delayed intervention) ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/309249

Coaching Dementia Caregivers to Master Care-Resistant ... 266 family caregivers will be randomly assigned to either immediate intervention or delayed intervention groups.

7. clinconnect.io clinconnect.io/trials/NCT05098652

Coaching Dementia Caregivers to Master Care-Resistant The goal is to see if a coaching program called CuRB-IT can improve the caregivers' ability to manage challenging behaviors and provide better care. A total of ...