NCT04348851

Internet and Telephone Support Intervention for Stroke Caregivers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Depression
• Quality of Life
• Recovery of Function
• Self Efficacy
• Stress

Interventions

Type	Name	Description
BEHAVIORAL	Caregiver problem-solving	Registered nurses will conduct the combined Internet and telephone intervention 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 our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue
BEHAVIORAL	Attention Control	The RNs will only provide active listening and paraphrasing. The RNs will ask caregivers to talk about their caregiver experiences. The nurses will not provide advice, but rather direct caregivers to access information on the Caregiver Family Alliance website (www.caregiver.org) for managing problems or to contact their healthcare

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-09-19
• Completion: 2016-10-01
• First posted: 2020-04-16
• Last updated: 2020-06-02
• Results posted: 2020-05-18

Locations

1 site across 1 country: United States