Telehealth Assessment and Skill-Building Intervention for Stroke Caregivers (TASK III)

NCT ID: NCT05304078

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2026-08-31

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.

Detailed Description

Stroke is a leading cause of serious, long-term disability, and has a very sudden onset. Families are often thrust into providing care without sufficient training from health care providers, having to learn on their own to provide care. Studies show that caregiving without proper training can be detrimental to caregiver's physical and mental health, which can impede survivor rehabilitation and lead to institutionalization and higher societal costs. Unlike existing stroke caregiver interventions, which require costly face-to-face interactions, and that focus primarily on the survivor's care, the nurse-led Telephone Assessment and Skill-Building Kit (TASK II) is delivered completely by telephone, and empowers caregivers to address both their own and the survivor's needs using innovative skill-building strategies. Aligned with current patient and caregiver guidelines, TASK II demonstrated evidence of content validity, treatment fidelity, caregiver satisfaction, and efficacy for reducing caregiver depressive symptoms; however, TASK II revealed a need for a stronger focus on self-management (SM) strategies to improve caregiver symptoms and health, along with enhanced use of other telehealth modes of delivery. In an NINR-funded R21, the Telehealth Assessment and Skill-building Kit (TASK III) was optimized through the innovative leveraging of technologies and SM strategies to improve stroke family caregiver symptoms and health. A new goal setting tip sheet promotes caregivers' self-management of their own symptoms and health through the use of novel skill-building strategies. caregivers now choose how they want to access the TASK III Resource Guide (mailed hard copy, eBook, USB drive, or interactive website (https://www.task3web.com/) and how they would like to interact with the nurse (telephone, FaceTime, or online videoconferencing). Preliminary TASK III data provided evidence for feasibility of recruitment, retention, treatment fidelity, high satisfaction, and positive data trends in 74 stroke family caregivers randomized to TASK III (n=36) or to an Information, Support, and Referral (ISR) group (n=38). The purpose of the proposed study is to test short-term (immediately post-intervention at 8 weeks) and long-term (12, 24, and 52 weeks) efficacy of the TASK III intervention, compared with the ISR group, in 296 stroke caregivers. The primary outcome is caregiver life changes (i.e., physical health, physical functioning, emotional well-being, general health) as a result of providing care. Secondary outcomes include depressive symptoms (in caregivers with mild to severe depressive symptoms), other symptoms (stress, fatigue, sleep, pain, shortness of breath), unhealthy days, SM of diet/exercise, and self-reported healthcare utilization. Theoretically-based mediators include task difficulty, threat appraisal, and self-efficacy. Program evaluation outcomes (satisfaction, technology ratings) will also be analyzed. If TASK III is shown to be efficacious in the proposed randomized controlled clinical trial, our next goal will be to translate TASK III into ongoing stroke systems of care; and to adapt it for use among caregivers with other debilitating/chronic conditions providing a tremendous public health impact.

Conditions

Family Caregivers; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

TASK III Group

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

Group Type: EXPERIMENTAL

Telehealth Assessment and Skill-Building Kit (TASK III) Group

Intervention Type: BEHAVIORAL

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.

ISR Group

The Information, Support, and Referral (ISR) group

Group Type: ACTIVE_COMPARATOR

Information Support and Referral (ISR) Group

Intervention Type: BEHAVIORAL

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.

Interventions

Telehealth Assessment and Skill-Building Kit (TASK III) Group

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.

Intervention Type: BEHAVIORAL

Information Support and Referral (ISR) Group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Tamilyn Bakas

Professor and Jane E. Procter Endowed Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamilyn Bakas, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati College of Nursing

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tamilyn Bakas, PhD, RN

Role: CONTACT

tamilyn.bakas@uc.edu

513-558-2254

Facility Contacts

Tamilyn Bakas, PhD, RN

Role: primary

Tamilyn.bakas@uc.edu

513-558-2254

References

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.

Reference Type: DERIVED

PMID: 39937971 (View on PubMed)

Other Identifiers

R01NR020184

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022-0180

Identifier Type: -

Identifier Source: org_study_id