Telephone Assessment and Skill-Building Intervention for Stroke Caregivers
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 254
- Locations
- 2
- Primary Endpoint
- Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS)
Study Overview
Brief Summary
The purpose of this study is to test the efficacy of the revised Telephone Assessment and Skill-Building Kit (TASK II) compared with an Information, Support, and Referral (ISR) intervention in family caregivers of stroke survivors. We will also test if TASK II intervention effects on primary outcomes (depressive symptoms, caregiving-related negative life changes, unhealthy days) are mediated through effects on secondary outcomes (task difficulty, optimism, threat appraisal). Comparative costs and outcomes for the TASK II and ISR interventions will also be explored.
Detailed Description
Stroke is the number one cause of disability in the United States, and over 4 million stroke survivors are alive today. Many stroke survivors need the help of a family caregiver. A family caregiver is a family member or close friend who helps the stroke survivor once they go home. Many caregivers need information and support during the first few months after the stroke survivor is discharged home. One group of caregivers will receive the TASK II intervention and another group of caregivers will receive existing educational materials about stroke and caregiving through an information, support, and referral (ISR) process. Both groups of caregivers will receive written materials about stroke and caregiving by mail and weekly telephone calls by a nurse for a total of 8 weeks, with an additional call at 12 weeks. A research assistant will also call by telephone at the beginning of the study, and at 8, 12, and 24 weeks after the beginning of the study, with a follow-up call at 1 year to interview both groups of caregivers about their caregiving activities and about their own health and well-being. If shown to be efficacious, our next goal will be to translate the TASK II intervention into practice settings to meet current recommendations and guidelines that emphasize follow up care for stroke survivors and their family caregivers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Primary caregiver (unpaid family member or significant other) of a stroke survivor
- •No more than 8 weeks after survivor discharged home
- •Plans to be providing care for 1 year or longer
- •Access to a telephone
- •Willingness to participate in 9 calls from a nurse and 5 data collection interviews at designated study time points
Exclusion Criteria
- •Caregiver or survivor age < 21 years
- •Caregiver denies that survivor has had a stroke
- •Caregiver does not consider him or herself a caregiver, stating that the survivor is not impaired or is the same as before the stroke
- •Caregiver has low task difficulty (OCBS task difficulty score < 16)
- •Caregiver communication difficulties (e.g., hearing loss)
- •Caregiver not fluent in the English language
- •Caregiver 6-item MMSE score less than 4
- •Survivor residing in a nursing home or long-term care facility
- •Survivor or caregiver has a terminal illness (e.g., cancer, end of life condition with decreased life expectancy, renal failure requiring dialysis)
- •Survivor or caregiver history of hospitalization for alcohol or drug abuse
- •Survivor or caregiver history of severe mental illness (e.g., Alzheimer's, dementia, suicidal tendencies, severe untreated depression or manic depressive disorder, schizophrenia)
- •Survivor or caregiver pregnancy
- •Survivor or caregiver is a prisoner or on house arrest
Outcomes
Primary Outcomes
Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS)
Time Frame: Change in caregiving-related negative life changes from baseline to 8 weeks
Caregivers randomized to the TASK II group will have a greater reduction in caregiving-related negative life changes compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Unhealthy days: Unhealthy Days (UD)
Time Frame: Change in unhealthy days from baseline to 8 weeks
Caregivers randomized to the TASK II group will have a greater reduction in unhealthy days compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9)
Time Frame: Change in depressive symptoms from baseline to 8 weeks
Among caregivers who screen positive for depressive symptoms at baseline, those randomized to the TASK II intervention will have a greater reduction in depressive symptoms compared to those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Secondary Outcomes
- Task difficulty: Oberst Caregiving Burden Scale Difficulty Subscale (OCBS)(Change in task difficulty from baseline to 8 weeks)
- Optimism: Revised Life Orientation Test (LOT-R)(Change in optimism from baseline to 8 weeks)
- Threat appraisal: Appraisal of Caregiving Threat Subscale (ACS)(Change in threat appraisal from baseline to 8 weeks)