N/A Completed N=174 Randomized Double-blind Supportive Care

RESCUE Stroke Caregiver Website to Enhance Discharge Planning

Depression · quality of life · Self Efficacy · Recovery of Function

Source: ClinicalTrials.gov NCT01600131 ↗

Enrolled (actual)

174

Serious AEs

0.0%

Results posted

Jan 2023

Primary outcomePrimary: Change in Depressive Symptoms at 11 Weeks — -1.8; -1.6 score on a scale — p=0.693

Summary

Aims and Intervention: The long-term goal is to implement stroke caregiver programs that involve low-cost interventions that are sustainable in routine clinical practice. The immediate objective is to test, using a randomized controlled trial, a problem-solving intervention for stroke caregivers that can be delivered during the transitional care period (e.g., time which Veteran is discharged to home) followed by online, in-home sessions. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on previously developed and nationally available RESCUE Caregiver website (www.cidrr8.research.va.gov/rescue). The investigators will also provide on-line, skills training and application of the problem-solving approach via the RESCUE messaging center. The immediate, primary aim (#1) is to test the effect of the intervention on stroke caregivers' depressive symptoms at 11 and 19 weeks after baseline data collection. Aim #2 is to test the effect of the intervention on stroke caregivers' burden, positive aspects of caregiving, self-efficacy, health-related quality of life (HRQOL), and satisfaction with care at 11 and 19 weeks after baseline data collection. Aim #3 is to test the effect of the intervention on Veterans' outcomes: functional abilities and healthcare utilization (i.e., unintended hospital bed days of care, number of emergency room visits, number of unscheduled clinic visits) at 11 and 19 weeks after baseline data collection. Aim #4 is to determine the budgetary impact for implementing the intervention. Aim #5 is to determine the facilitators, barriers and best practices for implementing the intervention. Design and Methods: The investigators will conduct a two-group randomized controlled trial. The investigators will enroll 240 stroke caregivers at 8 study sites (North Florida/South Georgia Veterans Healthcare System, Miami VA Healthcare System, James A. Haley Veterans Hospital in Tampa, Michael E. Debakey VAMC in Houston, Hunter Holmes McGuire VAMC in Richmond, Central Arkansas Veterans Healthcare System, VA Tennessee Valley Healthcare System, and the VA Boston Healthcare System). Eligible caregivers will be interviewed, complete baseline measures, and then be randomized to two groups: 1) intervention group, or 2) standard care. A team member will telephone caregivers at 11 weeks and 19 weeks after baseline data collection to answer questions on instruments with established reliability and validity. Qualitative interviews will be conducted with selected caregivers to obtain in-depth perceptions of the value, facilitators, and barriers of the intervention. Impact: This is the first known study to test a transition-to-home intervention combined with technology to improve the quality of caregiving and the recovery of Veterans.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Depressive Symptoms at 11 Weeks	-1.8; -1.6	0.693
PRIMARY Change in Depressive Symptoms at 19 Weeks	-1.3; 0.2	0.693
PRIMARY Change in Caregiver Burden - Zarit	-0.6; 0.3	0.346
PRIMARY Change in Caregiver Burden - Time Required	-17.3; -14.5	0.688
PRIMARY Change in Caregiver Burden - Task Difficulty	-2.5; -0.6	0.180
SECONDARY Change in Perceived Stress	-0.6; -0.02	0.318
SECONDARY Change in Positive Perceptions of Caregiving	1.1; 0.0	0.305
SECONDARY Change in Stroke Knowledge	0.0; 0.2	—
SECONDARY Change in General Patient Satisfaction	-1.6; 0.1	0.090
SECONDARY Change in Veteran Functional Status	5.6; 1.7	0.225
SECONDARY Change in Self-efficacy - Obtaining Respite	4.5; -2.7	0.158
SECONDARY Change in Self-efficacy - Controlling Upsetting Thoughts	4.5; -1.2	0.149
SECONDARY Change in Health-Related Quality of Life - Physical	-1.2; -0.2	0.846
SECONDARY Change in Health-Related Quality of Life - Mental Health	2.0; 0.6	0.293

Eligibility Criteria

Inclusion Criteria

All caregivers of Veterans with a primary diagnosis of stroke are eligible for participation if they meet the following criteria:

are the primary caregiver and provide the majority of care for a Veteran who has a primary diagnosis of stroke (ICD9 codes for stroke: 430-438) and who has at least one activity of daily living (ADL) deficits or a new or worsening cognitive or physical functioning problem,
have Internet and email access and ability,
are reachable by cell or home phone,
read English at the sixth grade reading level or better,
score 1 or greater on the Perceived Stress Scale
Veteran has been discharged to home within the preceding four months or plans to be ultimately discharged to home
are agreeable to be randomized to the intervention or standard care group

Exclusion Criteria

Caregivers who fail to meet one or more of the inclusion criteria and whose Veterans

are terminally ill
have a life expectancy of less than 6 months
are a prisoner, or
are professional caregivers who had no preexisting relationship to the Veteran
are enrolled or have completed similar caregiving interventions (at PI discretion)

Life expectancy and service use will be determined by reviewing the CPRS records and conferring with the in-patient staff and with the investigators' clinical team members (MDs, RNs).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01600131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.