Background: Stroke and traumatic brain injury (TBI) are leading causes of long-term disability among veterans who require the care of informal caregivers. There are very few evidence-based, easy-to-deliver programs to train caregivers in providing care, and only one intervention has been found that comprehensively addresses both caregiver and survivor needs through skill-building strategies. The Telephone Assessment and Skill-Building Kit (TASK I), an 8-week intervention program delivered by nurses to address the needs of stroke caregivers, has demonstrated feasibility and initial efficacy. This program has been recently revised (TASK II), and is currently being tested in a randomized controlled clinical trial of 220 caregivers of civilin stroke patients (R01 NR010388). The program has also been adapted for family caregivers of civilian TBI patients (TASK II- TBI) and is currently being tested for content validity and feasibility. Objectives: The objectives of this study are to evaluate (a) the efficacy of the revied Telephone Assessment and Skill-building Kit (TASK II) in informal caregivers of veterans with stroke and (b) estimate effect sizes for the TASK II-TBI intervention for informal caregivers of veterans with TBI. Both the TASK II and TASK II-TBI interventions will be compared with an Information Support, and Referral (ISR) intervention that will serve as an attention control group.
The specific aims of this study are: 1) to test the short-term and long-term efficacy of the TASK II intervention for improving the primary outcomes of stroke caregivers'depressive symptoms, caregiving-related negative life changes, and unhealthy days;2) to test the short-term and long-term efficacy of the Task II intervention for improving the primary outcome mediators of stroke caregivers'task difficulty, optimism, and threat appraisal;and 3) to evaluate program delivery costs for the TASK II and TASK II-TBI intervention and ISR procedures, and to assess the cost-effectiveness of the TASK II and TASK II-TBI interventions in terms of noncaregiving hours and unhealthy days in caregivers of veterans with both stroke and TBI. The exploratory aims of this study are: 1) to estimate effect sizes for TASK II-TBI intervention on (a) the primary outcomes for TBI caregivers'depressive symptoms, caregiving-related negative life changes, unhealthy days, and (b) the TBI caregivers'primary outcome mediators of task difficulty, optimism, and threat appraisal;and 2) to estimate intervention (TASK II and TASK II-TBI) effect sizes on the secondary outcomes of social participation, self-efficacy of caregiving, and the quality of the relationship between the caregiver of the veteran with stroke or TBI and the veteran survivors. Methods: We propose to conduct a randomized, controlled trial to evaluate the TASK II and TASK II-TBI interventions among caregivers of veterans with stroke or TBI. Informal caregivers of veterans with stroke (N = 222) or TBI (N = 108) who have received care at the Michael E. DeBakey VAMC in Houston or the Richard L. Roudebush VAMC in Indianapolis will be randomized to the TASK II or TASK II-TBI intervention or to the ISR control group. Both the intervention and control procedures involve 8 telephone sessions delivered over 8 weeks, with a booster session at 12 weeks. Data collections will occur at the baseline, 8 weeks, 12 weeks, 24 weeks, and 1 year after baseline. Linear mixed models will be applied to the repeated-measures data to test efficacy of the program in Stroke caregivers and to estimate effect sizes in TBI caregivers. An incremental cost-effectiveness ratio (ICER) will be employed to address the comparative costs and outcomes for the TASK II intervention and ISR groups. Impacts: Caring for a family member after a stroke or a TBI can be very challenging. The TASK II intervention enables caregivers to develop the necessary skills to manage care for the survivor, while also taking care of themselves. If effective, the long-term goal of this study is to implement this turnkey program for family caregivers of veterans with stroke and TBI across VHA by offering comprehensive training and support.
Stroke and traumatic brain injury are leading causes of disability among veterans who require the care of informal members in the home setting. Families are often thrust into providing care for veterans after a stroke or a TBI. This study compares the comprehensive nursing Telephone Assessment and Skill-building Kit (TASK) intervention for stroke caregivers (TASK-II) and for TBI caregivers (TASK-II TBI) to an Informal, Support and Referral intervention for enabling caregivers to develop the necessary skills to manage care for the survivors and care for themselves as caregivers. The significance of this program is the potential implementation of this turnkey program for family caregivers of veterans with stroke and TBI across VHA by offering comprehensive training and support through an efficacious, cost-effective program.