TASK III for Stroke Caregiver Support

Overseen By Tamilyn Bakas, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Pregnant, Terminal illness, Alzheimer's, others

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

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

296 Participants Needed

Trial Summary

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on caregiver support rather than medication use.

What data supports the effectiveness of the TASK III treatment for stroke caregiver support?

Research on the TASK program shows it helps stroke caregivers by providing information and skills they need, improving their ability to care for stroke patients after they leave the hospital. ^{1 2 3 4 5}

Is the TASK III intervention safe for stroke caregivers?

The available research does not specifically address safety concerns for the TASK III intervention, but it focuses on providing support and information to caregivers through telehealth technologies, which are generally considered safe. ^{1 6 7 8 9}

How is the TASK III treatment for stroke caregiver support different from other treatments?

The TASK III treatment is unique because it uses telehealth technology to provide a flexible, personalized support program for stroke caregivers, allowing them to choose from various formats like phone calls, interactive websites, and eBooks to best suit their needs. ^{1 2 4 5 6}

What is the purpose of this trial?

Caring for a family member after a stroke can be very difficult and worsen the physical and mental health of untrained caregivers. The TASK III intervention is a unique, comprehensive caregiver intervention program that enables caregivers to develop the necessary skills to manage care for the survivor, while also taking care of their own health.

Research Team

Tamilyn Bakas, PhD, RN

Principal Investigator

University of Cincinnati

Eligibility Criteria

This trial is for unpaid family caregivers of stroke survivors who can communicate in English and use a phone or computer. They must be willing to engage in 9 calls with a nurse and 5 interviews, have no severe cognitive impairments, and not care for someone in long-term facilities. Exclusions include caregivers or survivors with certain mental illnesses, substance abuse history, under age 18, incarcerated, pregnant, or terminally ill.

Inclusion Criteria

Access to telephone or computer

Primary caregiver (family member or significant other providing care for a stroke survivor at home)

Fluent in the English language (i.e., able to read, speak, and understand English)

Exclusion Criteria

Caregiver or survivor has a history of hospitalization for alcohol or drug abuse within the past 5 years

I am a caregiver or survivor with a terminal illness.

Survivor did not need help from the caregiver

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TASK III intervention or are assigned to the ISR group, focusing on skill-building and self-management strategies

8 weeks

Telephone, FaceTime, or online videoconferencing sessions

Follow-up

Participants are monitored for long-term efficacy of the intervention, including life changes and depressive symptoms

52 weeks

Periodic assessments at 12, 24, and 52 weeks

Treatment Details

Interventions

• Information Support and Referral (ISR) Group
• Telehealth Assessment and Skill-Building Kit (TASK III) Group

Trial Overview The TASK III study tests a caregiver support program against standard information support. Caregivers will either receive the TASK III intervention with skill-building resources and nurse calls or just general information and referrals to help them manage their caregiving responsibilities while maintaining their own health.

Participant Groups

Group I: TASK III Group Experimental Treatment 1 Intervention

The Telehealth Assessment and Skill-Building Kit (TASK III) group

Group II: ISR Group Active Control 1 Intervention

The Information, Support, and Referral (ISR) group

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

The Telephone Assessment and Skill-Building Kit (TASK) program significantly improved optimism among stroke caregivers over 12 weeks, with medium effect sizes compared to a control group of 19 caregivers.

Caregivers in the TASK program also reported reduced task difficulty and improved threat appraisal at various points during the study, indicating that the program effectively addresses caregiver needs in the early discharge period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke caregiver outcomes from the Telephone Assessment and Skill-Building Kit (TASK). Bakas, T., Farran, CJ., Austin, JK., et al.[2022]

The GETCare program, a 5-week remote training initiative for informal caregivers of stroke patients, was well-received, with 18 out of 28 participants reporting high satisfaction and finding the content helpful.

The program's structure, which included education, skills training, and weekly check-ins, was deemed appropriate by caregivers, highlighting its potential as a valuable resource for supporting caregivers in the critical early months following a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piloting GETCare: A Goal-Based Education and Skills Training Program for Caregivers. Einerson, J., Cardell, B., Majersik, JJ., et al.[2023]

In a study involving 254 stroke caregivers, the TASK II intervention demonstrated a protocol adherence rate of 80%, while the comparison group showed a higher adherence rate of 92%, indicating that both interventions were followed closely but with some differences in fidelity.

Caregivers in the TASK II group spent significantly more time engaging with the intervention materials and talking with nurses compared to those in the Information, Support, and Referral group, highlighting the greater dosage of the TASK II intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers. McLennon, SM., Hancock, RD., Redelman, K., et al.[2018]

The goal-setting tip sheet designed for stroke family caregivers was evaluated positively for its accuracy, feasibility, and acceptability, with average ratings between 3.25 and 5.00 from various stakeholders including caregivers and clinicians.

This tool aims to improve the health of caregivers, who often overlook their own well-being, highlighting the potential benefits of structured goal-setting in supporting caregiver health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing and Evaluating a Goal-Setting Tip Sheet for Stroke Family Caregiver Health. Bakas, T., Jones, H., Israel, J., et al.[2022]

The TASK II intervention, a nurse-led program for stroke caregivers, significantly reduced depressive symptoms and improved life changes for caregivers with mild to severe depression over 52 weeks, compared to a standard information and support group.

While the TASK II intervention initially decreased unhealthy days among all caregivers at 8 weeks, this improvement was not maintained in the long term, indicating a need for ongoing support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial. Bakas, T., Austin, JK., Habermann, B., et al.[2022]

Stroke family caregivers have diverse preferences for telehealth technologies, with telephone assessments receiving the highest average rating (M=4.36-5.00), indicating a strong preference for this method of communication.

The study highlights the need for multiple telehealth options, as caregivers rated various technologies differently, suggesting that tailored interventions could better meet their needs and improve support for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting the telephone assessment and skill-building kit to the telehealth technology preferences of stroke family caregivers. Bakas, T., McCarthy, MJ., Israel, J., et al.[2022]

Caregivers of stroke survivors using a web-based education and support intervention reported more rehabilitation-related healthcare visits, which may have led to increased musculoskeletal issues, highlighting the importance of targeted support for these caregivers.

Non-Web users experienced more emergency department visits and hospital admissions, particularly for cardiology and pulmonology issues, indicating a potential gap in care management that could be addressed through better education and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a web-based caregiver intervention on the reasons stroke survivors use health care services during the first year post treatment. Steiner, V., Pierce, LL., Windnagel, F., et al.[2018]

A pilot study involving 93 stroke caregivers showed that a 4-week telephone and web-based intervention significantly reduced caregiver depression and burden, with a completion rate of 77%.

The majority of caregivers found the intervention helpful, with 78% rating the sessions positively, indicating that such web-based programs can effectively support caregivers, although further research is needed to confirm long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The RESCUE problem solving intervention for stroke caregivers: A mixed-methods pilot study. Jordan, MM., Freytes, IM., Orozco, T., et al.[2023]

The RESCUE intervention, which provides Internet and telephone support for stroke caregivers, was found to be feasible and acceptable, with a high completion rate of 96% among participants in a pilot trial involving 53 caregivers.

Qualitative feedback indicated that caregivers valued the intervention, suggesting it could effectively address their needs, and the study supports the need for further testing of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a telephone and web-based stroke caregiver intervention: a pilot randomized controlled trial of the RESCUE intervention. LeLaurin, JH., Freytes, IM., Findley, KE., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Stroke caregiver outcomes from the Telephone Assessment and Skill-Building Kit (TASK). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Piloting GETCare: A Goal-Based Education and Skills Training Program for Caregivers. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Designing and Evaluating a Goal-Setting Tip Sheet for Stroke Family Caregiver Health. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adapting the telephone assessment and skill-building kit to the telehealth technology preferences of stroke family caregivers. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The impact of a web-based caregiver intervention on the reasons stroke survivors use health care services during the first year post treatment. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

The RESCUE problem solving intervention for stroke caregivers: A mixed-methods pilot study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a telephone and web-based stroke caregiver intervention: a pilot randomized controlled trial of the RESCUE intervention. [2022]