Telephone Assessment and Skill-Building Intervention for Stroke Caregivers "TASKII"

Completed

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Telephone Assessment and Skill-Building Kit (TASK II) Behavioral
    ARM 1: Kind: Experimental
    Label: Telephone Assessment and Skill-Building Kit (TASK II)
    Description: The TASK II group will fill out a checklist about their needs and concerns, and will receive written tip sheets by mail that address the needs and concerns that they feel are most important. A nurse will call by telephone (lasting about 30 minutes or less) once a week for a total of 8 weeks, with another call at 12 weeks, to provide more information, answer questions, and to discuss more written tip sheets based on the caregiver's needs and concerns.
  • Information, Support, and Referral (ISR) Behavioral
    ARM 1: Kind: Experimental
    Label: Information, Support, and Referral (ISR)
    Description: The ISR group will receive existing educational materials about stroke and caregiving developed by the American Stroke Association and weekly telephone calls by a nurse (lasting about 30 minutes or less) for a total of 8 weeks, with another call at 12 weeks.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Supportive Care
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9) Change in depressive symptoms from baseline to 8 weeks No
Primary Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS) Change in caregiving-related negative life changes from baseline to 8 weeks No
Primary Unhealthy days: Unhealthy Days (UD) Change in unhealthy days from baseline to 8 weeks No
Secondary Task difficulty: Oberst Caregiving Burden Scale Difficulty Subscale (OCBS) Change in task difficulty from baseline to 8 weeks No
Secondary Optimism: Revised Life Orientation Test (LOT-R) Change in optimism from baseline to 8 weeks No
Secondary Threat appraisal: Appraisal of Caregiving Threat Subscale (ACS) Change in threat appraisal from baseline to 8 weeks No

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