Telephone Assessment and Skill-Building Intervention for Stroke Caregivers (NCT01275495) | Clinical Trial Compass
CompletedPhase 3
Telephone Assessment and Skill-Building Intervention for Stroke Caregivers
United States254 participantsStarted 2010-05
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9)
Timeframe: Change in depressive symptoms from baseline to 8 weeks
2
Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS)
Timeframe: Change in caregiving-related negative life changes from baseline to 8 weeks
3
Unhealthy days: Unhealthy Days (UD)
Timeframe: Change in unhealthy days from baseline to 8 weeks