Telehealth Assessment and Skill-Building Intervention for Stroke Caregivers (TASK III)
2 other identifiers
interventional
332
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedStudy Start
First participant enrolled
November 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
February 27, 2026
February 1, 2026
3.8 years
March 10, 2022
February 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Life Changes
Life Changes (i.e., changes in social functioning, subjective well-being, and physical health as a result of providing care) measured by the Bakas Caregiving Outcomes Scale (BCOS). The BCOS consists of 15 items rated on a response scale ranging from -3 (changed for the worst) to +3 (Changed for the best). The items are recoded (-3 = 1) (-2 = 2) (-1 = 3) (0 = 4) (1 = 5) (2 = 6) (3 = 7) so that positive numbers can be obtained for analysis. The recoded responses to the 15 items are summed for a total score with a possible range of 15-105. Higher scores indicate more positive life changes as a result of providing care.
Baseline to 8 weeks (primary endpoint), long-term baseline to 12, 24, and 52 weeks
Secondary Outcomes (7)
Depressive Symptoms
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Other Symptoms
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Unhealthy Days
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Self-management of Steps
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Self-management of Exercise
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
- +2 more secondary outcomes
Other Outcomes (6)
Mediator: Task Difficulty
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Mediator: Threat Appraisal
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Mediator: Self-efficacy of Exercise
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
- +3 more other outcomes
Study Arms (2)
TASK III Group
EXPERIMENTALThe Telehealth Assessment and Skill-Building Kit (TASK III) group
ISR Group
ACTIVE COMPARATORThe Information, Support, and Referral (ISR) group
Interventions
The ISR group will receive an American Heart Association brochure about family caregiving and 8 weekly calls from a nurse, with a booster call a month later (telephone, videoconferencing, or FaceTime). The ISR nurse will provide information, support, and referral to community resources.
The TASK III group will receive a TASK III Resource Guide (mailed hard copy, USB drive, eBook, and Website access) and 8 weekly calls from a nurse, with a booster call a month later (telephone, videoconferencing, or FaceTime). The TASK III nurse will train caregivers how to assess their needs and concerns, and how to use the TASK III Resource Guide containing content and skill-building tip sheets to address their needs and concerns. Caregivers will also receive an American Heart Association brochure about family caregiving, as well as information, support, and referral to community resources.
Eligibility Criteria
You may qualify if:
- 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)
- Access to telephone or computer.
- No difficulties hearing or talking by telephone or computer.
- Score 4 or more on a 6-item cognitive impairment screener.
- Willing to participate in 9 calls from a nurse and 5 data collection interviews (Baseline, 8, 12, 24, 52).
You may not qualify if:
- Excluded if the survivor:
- Had not had a stroke.
- Did not need help from the caregiver.
- Resides in a nursing home or long-term care facility.
- Excluded if the caregiver or survivor is:
- Under the age of 18 years.
- Prisoner or on house arrest.
- Pregnant.
- Terminal illness (e.g., late stage cancer, end-of-life condition, renal failure requiring dialysis).
- History of Alzheimer's, dementia, or severe mental illness (e.g., suicidal tendencies, schizophrenia, severe untreated depression or manic-depressive disorder).
- History of hospitalization for alcohol or drug abuse within the past 5 years).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cincinnati College of Nursing
Cincinnati, Ohio, 45219, United States
Related Publications (1)
Bakas T, Miller E, Sucharew H, Kreitzer N, Israel J, Rota M, Harnett B, Dunning K, Jones H, McCarthy M, Brehm B, Austin JK, Mitchell PH. Examining the Efficacy of the Telehealth Assessment and Skill-Building Kit (TASK III) Intervention for Stroke Caregivers: Protocol for a Randomized Controlled Clinical Trial. JMIR Res Protoc. 2025 Mar 25;14:e67219. doi: 10.2196/67219.
PMID: 39937971BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tamilyn Bakas, PhD, RN
University of Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Jane E. Procter Endowed Chair
Study Record Dates
First Submitted
March 10, 2022
First Posted
March 31, 2022
Study Start
November 30, 2022
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
January 31, 2027
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
Qualified investigators may request access to de-identified data from the University of Cincinnati. Special measures will be taken to ensure that caregivers or stroke survivors are not identifiable by any data that are shared. Close collaboration with Dr. Bakas and her research team will be necessary for the use of shared data.