Clinical trial NCT03635151: Caregiver Self-Management Needs Through Skill-Building
Official title: Caregiver Self-Management Needs Through Skill-Building
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Caregivers
Stroke
Keywords: Clinical trial
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-08-17
Enrollment: 74
Sex: ALL
Minimum age (years): 21
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 Telephone Assessment and Skill-Building Kit (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 themselves. The long-term goal of this study is to offer training and support for family caregivers through an efficacious, cost-effective program.

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 any training from health care providers. Studies have shown that caregiving without 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 that require costly face to face interactions, and that focus primarily on the survivor's care, the 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 has demonstrated evidence of content validity, treatment fidelity, caregiver satisfaction, and efficacy for reducing depressive symptoms; however, future development of TASK II requires a stronger focus on self-management strategies to improve caregiver health, and enhanced use of other telehealth modes of delivery prior to implementation into ongoing stroke systems of care. The purpose of this study is to optimize the TASK III intervention through the innovative leveraging of technologies and theoretically-based self-management strategies to improve caregiver health. Specific Aim 1 consists of focus groups and individual interviews with 40 experts (10 interdisciplinary researchers, 10 technology experts, 10 clinicians and clinical leaders, and 10 stroke family caregivers) to provide preferences about essential areas of new self-management content, proposed technologies (e.g., iBook, eBook, interactive website, FaceTime, Zoom), and future implementation strategies to inform a novel TASK III prototype. Specific Aim 2 will determine feasibility of the TASK III intervention with a pilot study of 74 stroke caregivers randomized to TASK III or an Information, Support, and Referral (ISR) group in preparation for a larger randomized controlled clinical trial. Recruitment, retention, treatment fidelity, satisfaction, and technology ratings will be obtained for both TASK III and ISR groups who will receive 8 weekly sessions with a booster session 4 weeks later. Outcome measures will be explored at baseline, 8 weeks (end of intervention), and 12 weeks (after booster). If TASK III is shown to be efficacious in a future randomized controlled clinical trial, our next goal will be to translate TASK III into ongoing stroke systems of care; and, someday to adapt it for use among caregivers with other debilitating/chronic conditions providing a tremendous public health impact.

Eligibility criteria: Inclusion Criteria:

* 21 years or older
* Primary caregiver (unpaid family member or significant other providing care for a stroke survivor)
* Must be providing care after discharge to the home setting (for Specific Aim 2)
* Fluent in the English language
* Access to telephone or computer
* No difficulties hearing or talking by telephone or computer
* (Specific Aim 1) Willing to participate in an online or telephone focus group or an online or telephone individual interview. Some interviews or focus groups may be offered face to face.
* (Specific Aim 2) Willing to participate in 9 calls from a nurse and 3 data collection interviews.

Exclusion Criteria:

Excluded if the survivor:

* Had not had a stroke
* Did not need help from the caregiver
* Was going to reside in a nursing home or long-term care facility

Excluded if the caregiver:

* Scores \<16 on the Oberst Caregiving Burden Scale Task Difficulty Subscale (for Specific Aim 2)
* Scores \< 4 on a 6-item cognitive impairment screener.

Excluded if the caregiver or survivor is:

* 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

Primary outcomes:
measure: Caregiver Satisfaction Ratings for Both TASK III and ISR Programs Measured by the Caregiver Satisfaction Scale (CSS).
timeFrame: 12 weeks
Secondary outcomes:
measure: Depressive Symptoms Measured by the Patient Health Questionnaire Depression Scale (PHQ-9).
timeFrame: Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.
measure: 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).
timeFrame: Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.
measure: Unhealthy Days Measured by the Number of Unhealthy Days in the Past 30 Days.
timeFrame: Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati College of Nursing
state: Ohio
Study officials:
affiliation: University of Cincinnati College of Nursing
name: Tamilyn Bakas, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakas T, McCarthy MJ, Israel J, Brehm BJ, Dunning K, Rota M, Turner M, Miller EL. Adapting the telephone assessment and skill-building kit to the telehealth technology preferences of stroke family caregivers. Res Nurs Health. 2021 Feb;44(1):81-91. doi: 10.1002/nur.22075. Epub 2020 Oct 19.
citation: Bakas T, Jones H, Israel J, Kum C, Miller EL. Designing and Evaluating a Goal-Setting Tip Sheet for Stroke Family Caregiver Health. Rehabil Nurs. 2021 Sep-Oct 01;46(5):279-288. doi: 10.1097/RNJ.0000000000000306.