Depression Clinical Trial
Official title:
Internet and Telephone Support Intervention for Stroke Caregivers
This study will test a problem-solving and support intervention for caregivers of veterans with stroke. The investigators will assign caregivers to one for four groups: 4-session intervention, 8-session intervention, attention control (active listening), or standard care. The investigators will assess the impact of the intervention on caregiver outcomes (depression, burden, stress, problem-solving abilities, self-efficacy, and quality of life) and veteran outcomes (functional abilities).
Background: Caregiver depression and burden are common following a family member's stroke and
are major contributors of stroke survivors' functional recovery, resource use, and
institutionalization. Previous studies reveal that problem-solving interventions are
effective in improving caregiver and Veteran outcomes post-stroke. However, most of these
studies were burdensome for caregivers and labor intensive because they involved multiple,
face-to-face sessions. To overcome this shortcoming, the long-term goal is to implement
caregiver programs that involve low-cost, evidence-based interventions that can be sustained
in routine clinical practice. The investigators' immediate objective is to pilot test a
problem-solving intervention that uses telephone support plus the Internet (i.e., the team's
previously developed and nationally available RESCUE website) to improve the quality
caregiving and the rehabilitation of Veterans. This pilot randomized controlled trial (RCT)
simulates all aspects of a planned, future merit review proposal. This work builds on the
team's extensive experience in caregiver education.
Aim #1: To explore the impact of a 4-session and 8-session Internet and telephone support
intervention on stroke caregiver and Veteran outcomes when compared to an attention-control
condition and standard care. The investigators will obtain preliminary data on effect
estimates, group differences, and information on variability, correlations, and data ranges.
Data will inform a sample size calculation for the larger trial and provide preliminary
information on the impact of different doses of the intervention.
Aim #2: Determine caregivers' perceptions of the interventions and the attention control
condition: Acceptability, facilitators/barriers, credibility of the nurse interventionists.
The investigators will learn the strengths and weaknesses of the project, thereby helping to
make improvements in the investigators' future merit project.
Methods: The investigators will conduct a four-arm, randomized controlled trial with three
assessment points (baseline and two post-tests) and use mixed methods to determine
caregivers' perceptions of the intervention and the attention control condition. The
investigators will enroll 48 stroke caregivers whose Veterans receive care in VISN8. Eligible
caregivers will complete baseline measures and then will be randomized to four arms: 1)
4-session intervention, 2) 8-session intervention, 3) attention control condition, or 4)
standard care. Registered nurses will conduct the combined Internet and telephone
intervention and the attention-control condition. The intervention is based on the
relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The
investigators will modify the traditional, problem-solving intervention by adding web-based
training using interactive modules, factsheets, and tools on the national RESCUE Stroke
Caregiver website. (http://www.cidrr8.research.va.gov/rescue/). For the first post-test, a
research team member will telephone caregivers to answer questions on instruments with
established reliability and validity. A second post-test will be conducted approximately four
to five months after the first post-test assessment to evaluate longer-term effects.
Qualitative interviews will be conducted with 18 caregivers to obtain in-depth perceptions of
the credibility of nurses, and value, facilitators, and barriers of the intervention and the
attention control condition.
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