Stroke Clinical Trial
— TASKIIOfficial title:
Telephone Assessment and Skill-Building Intervention for Stroke Caregivers
Verified date | March 2015 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 254 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Indiana University School of Nursing | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | National Institute of Nursing Research (NINR) |
United States,
Bakas T, Farran CJ, Austin JK, Given BA, Johnson EA, Williams LS. Content validity and satisfaction with a stroke caregiver intervention program. J Nurs Scholarsh. 2009;41(4):368-75. doi: 10.1111/j.1547-5069.2009.01282.x. — View Citation
Bakas T, Farran CJ, Austin JK, Given BA, Johnson EA, Williams LS. Stroke caregiver outcomes from the Telephone Assessment and Skill-Building Kit (TASK). Top Stroke Rehabil. 2009 Mar-Apr;16(2):105-21. doi: 10.1310/tsr1602-105. — View Citation
Bakas T, Li Y, Habermann B, McLennon SM, Weaver MT. Developing a cost template for a nurse-led stroke caregiver intervention program. Clin Nurse Spec. 2011 Jan-Feb;25(1):41-6. doi: 10.1097/NUR.0b013e318203cb92. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9) | 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. | Change in depressive symptoms from baseline to 8 weeks | No |
Primary | Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS) | 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. | Change in caregiving-related negative life changes from baseline to 8 weeks | No |
Primary | Unhealthy days: Unhealthy Days (UD) | 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. | Change in unhealthy days from baseline to 8 weeks | No |
Secondary | Task difficulty: Oberst Caregiving Burden Scale Difficulty Subscale (OCBS) | Caregivers randomized to the TASK II group will have a greater reduction in task difficulty 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. | Change in task difficulty from baseline to 8 weeks | No |
Secondary | Optimism: Revised Life Orientation Test (LOT-R) | Caregivers randomized to the TASK II group will have a greater increase in optimism 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. | Change in optimism from baseline to 8 weeks | No |
Secondary | Threat appraisal: Appraisal of Caregiving Threat Subscale (ACS) | Caregivers randomized to the TASK II group will have a greater reduction in threat appraisal 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. | Change in threat appraisal from baseline to 8 weeks | No |
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