Internet and Telephone Support Intervention for Stroke Caregivers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- VA Office of Research and Development
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Change in Depressive Symptoms
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All non-paid caregivers of Veterans with a primary diagnosis of stroke, discharged to home from a medical or rehabilitation facility are eligible for participation if they meet the following criteria:
- •have caregiving responsibility for a Veteran who has a diagnosis of stroke (ICD9 codes for stroke: 430-438) within the last 2.5 years and who have at least one activity of daily living (ADL), cognitive, or speech deficit related to stroke
- •score 1 or greater on the Perceived Stress Scale
- •have Internet access and ability
- •are reachable by their cell or home phones
- •read English at a seventh-grade reading level or better
- •agree to random assignment to a study arm
Exclusion Criteria
- •The investigators will exclude caregivers who fail to meet one or more of the inclusion criteria and whose Veterans:
- •have a life expectancy of less than 6 months
- •are receiving hospice/palliative care or are residing in a community living center
- •Life expectancy will be determined by reviewing the electronic health record (EHR) and conferring with our physician and clinical team members
Outcomes
Primary Outcomes
Change in Depressive Symptoms
Time Frame: 25 weeks after baseline
Change in depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale. The CES-D is a 20-item, 4-point Likert scale ranging from never (0) to most of the time (3). Possible scores range from 0-60 with higher scores indicating more symptoms. It has been used in numerous studies with caregivers and has good reliability and validity.
Change in Caregiver Burden
Time Frame: 25 weeks after baseline
Changes in burden will be measured by the Short Version of the Zarit Burden Interview. This 12-item instrument was reduced from the original 29-item instrument. This instrument is scored on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). Possible scores range from 0-48 with higher scores indicating higher burden. The instrument was originally developed to measure dementia caregiver burden, but, the S-ZBI has been used in stroke caregiver studies and items are appropriate for other caregiver populations.
Secondary Outcomes
- Change in Health-Related Quality of Life - Physical Scale(25 weeks after baseline)
- Change in Perceived Stress(25 weeks after baseline)
- Change in Stroke Knowledge(25 weeks after baseline)
- Changes in Problem-Solving Abilities(9 weeks after baseline)
- Caregiving Self-efficacy(9 weeks after baseline)
- Change in Veteran Functional Abilities(25 weeks after baseline)
- Change in Problem-Solving Abilities(25 weeks after baseline)
- Change in Caregiving Self-Efficacy(25 weeks after baseline)
- Change in Health-Related Quality of Life - Mental Scale(25 weeks after baseline)