Clinical trial NCT05304078: Telehealth Assessment and Skill-Building Intervention for Stroke Caregivers (TASK III)
Official title: Telehealth Assessment and Skill-Building Intervention for Stroke Caregivers (TASK III)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Family Caregivers
Stroke
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-03-31
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Life Changes
timeFrame: Baseline to 8 weeks (primary endpoint), long-term baseline to 12, 24, and 52 weeks
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
measure: Other Symptoms
timeFrame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
measure: Unhealthy Days
timeFrame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
measure: Self-management of Steps
timeFrame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
measure: Self-management of Exercise
timeFrame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
measure: Self-management of Diet
timeFrame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
measure: Healthcare Utilization
timeFrame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Other outcomes:
measure: Mediator: Task Difficulty
timeFrame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
measure: Mediator: Threat Appraisal
timeFrame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
measure: Mediator: Self-efficacy of Exercise
timeFrame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
measure: Mediator: Self-efficacy of Diet
timeFrame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
measure: Program Evaluation Outcomes: Satisfaction
timeFrame: 12 weeks
measure: Program Evaluation Outcomes: Technology
timeFrame: 12 weeks
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati College of Nursing
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Tamilyn Bakas, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: