Clinical trial NCT04348851: Internet and Telephone Support Intervention for Stroke Caregivers
Official title: Internet and Telephone Support Intervention for Stroke Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Quality of Life
Recovery of Function
Self Efficacy
Stress
Keywords: stroke
caregiving
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-04-16
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four-arm randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Depressive Symptoms
timeFrame: 9 weeks after baseline
measure: Change in Caregiver Burden
timeFrame: 9 weeks after baseline
measure: Change in Depressive Symptoms
timeFrame: 25 weeks after baseline
measure: Change in Caregiver Burden
timeFrame: 25 weeks after baseline
Secondary outcomes:
measure: Change in Health-Related Quality of Life - Physical Scale
timeFrame: 9 weeks after baseline
measure: Change in Perceived Stress
timeFrame: 9 weeks after baseline
measure: Change in Stroke Knowledge
timeFrame: 9 weeks after baseline
measure: Changes in Problem-Solving Abilities
timeFrame: 9 weeks after baseline
measure: Caregiving Self-efficacy
timeFrame: 9 weeks after baseline
measure: Change in Veteran Functional Abilities
timeFrame: 9 weeks after baseline
measure: Change in Health-Related Quality of Life - Physical Scale
timeFrame: 25 weeks after baseline
measure: Change in Perceived Stress
timeFrame: 25 weeks after baseline
measure: Change in Stroke Knowledge
timeFrame: 25 weeks after baseline
measure: Change in Problem-Solving Abilities
timeFrame: 25 weeks after baseline
measure: Change in Caregiving Self-Efficacy
timeFrame: 25 weeks after baseline
measure: Change in Veteran Functional Abilities
timeFrame: 25 weeks after baseline
measure: Change in Health-Related Quality of Life - Mental Scale
timeFrame: 9 weeks after baseline
measure: Change in Health-Related Quality of Life - Mental Scale
timeFrame: 25 weeks after baseline
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL
name: Constance R. Uphold, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: LeLaurin J, Schmitzberger M, Eliazar-Macke N, Freytes IM, Dang S, Uphold C. A commentary on methodological issues in stroke caregiver research: lessons learned from three RESCUE intervention studies. Top Stroke Rehabil. 2019 Jul;26(5):399-404. doi: 10.1080/10749357.2019.1607485. Epub 2019 Apr 30.