NCT01600131: RESCUE

RESCUE Stroke Caregiver Website to Enhance Discharge Planning

Completed NA Results posted Last updated 17 January 2023

What this trial tests

NA trial testing Caregiver problem-solving in Depression in 174 participants. Completed in 30 April 2021.

Timeline

22 June 2015

Primary endpoint
30 April 2021

30 April 2021

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	174
Start date	22 June 2015
Primary completion	30 April 2021
Estimated completion	30 April 2021
Sites	3 locations across United States

Drugs / interventions tested

• Caregiver problem-solving
• Standard Care — full drug profile →

Conditions studied

• Depression — all drugs for Depression →
• Quality of Life — all drugs for Quality of Life →
• Self Efficacy — all drugs for Self Efficacy →
• Recovery of Function — all drugs for Recovery of Function →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Depression or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Depressive Symptoms at 11 Weeks Primary · 11 weeks after baseline

Changes 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.

Group	Value	95% CI
Caregiver Education and Support	-1.8	± 9.4
Standard Care	-1.6	± 9.0

Change in Depressive Symptoms at 19 Weeks Primary · 19 weeks after baseline

Changes 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.

Group	Value	95% CI
Caregiver Education and Support	-1.3	± 11.4
Standard Care	0.2	± 11.0

Change in Caregiver Burden - Zarit Primary · 11 weeks after baseline

Changes in burden will be measured by the Short Version of the Zarit Burden Interview (S-ZBI). 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.

Group	Value	95% CI
Caregiver Education and Support	-0.7	± 5.7
Standard Care	1.3	± 5.7

Change in Caregiver Burden - Zarit Primary · 19 weeks after baseline

Changes in burden will be measured by the Short Version of the Zarit Burden Interview (S-ZBI). 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.

Group	Value	95% CI
Caregiver Education and Support	-0.6	± 6.7
Standard Care	0.3	± 5.6

Change in Caregiver Burden - Time Required Primary · 11 weeks after baseline

Changes in caregiver burden - time required will be measured by the Oberst Caregiving Burden Scale (OCBS). It contains 15 items that rate different types of caregiving tasks for stroke survivors based on perceived time and difficulty of the task. Each item is scored on a scale of 1 to 5 (total range from 15 to 75) with higher scores indicating greater time required or higher task difficulty.

Group	Value	95% CI
Caregiver Education and Support	-16.8	± 14.4
Standard Care	-14.7	± 12.9

Change in Caregiver Burden - Time Required Primary · 19 weeks after baseline

Changes in caregiver burden - time required will be measured by the Oberst Caregiving Burden Scale (OCBS). It contains 15 items that rate different types of caregiving tasks for stroke survivors based on perceived time and difficulty of the task. Each item is scored on a scale of 1 to 5 (total range from 15 to 75) with higher scores indicating greater time required or higher task difficulty.

Group	Value	95% CI
Caregiver Education and Support	-17.3	± 12.7
Standard Care	-14.5	± 13.7

Change in Caregiver Burden - Task Difficulty Primary · 11 weeks after baseline

Changes in caregiver burden - task difficulty will be measured by the Oberst Caregiving Burden Scale (OCBS). The OCBS contains 15 items that rate different types of caregiving tasks for stroke survivors based on perceived time and difficulty of the task. Each item is scored on a scale of 1 to 5 (total range from 15 to 75) with higher scores indicating greater time required or higher task difficulty.

Group	Value	95% CI
Caregiver Education and Support	-2.0	± 8.4
Standard Care	-0.5	± 8.2

Change in Caregiver Burden - Task Difficulty Primary · 19 weeks after baseline

Changes in caregiver burden - task difficulty will be measured by the Oberst Caregiving Burden Scale (OCBS). The OCBS contains 15 items that rate different types of caregiving tasks for stroke survivors based on perceived time and difficulty of the task. Each item is scored on a scale of 1 to 5 (total range from 15 to 75) with higher scores indicating greater time required or higher task difficulty.

Group	Value	95% CI
Caregiver Education and Support	-2.5	± 7.7
Standard Care	-0.6	± 8.3

Change in Perceived Stress Secondary · 11 weeks after baseline

Changes in perceived stress will be measured by the Perceived Stress Scale (PSS-4). The 4-item measure asses stress experienced in the last month on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores range from 0-16, with higher scores indicating more stress.

Group	Value	95% CI
Caregiver Education and Support	-0.5	± 3.4
Standard Care	-0.2	± 3.0

Change in Perceived Stress Secondary · 19 weeks after baseline

Changes in perceived stress will be measured by the Perceived Stress Scale (PSS-4). The 4-item measure asses stress experienced in the last month on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores range from 0-16, with higher scores indicating more stress.

Group	Value	95% CI
Caregiver Education and Support	-0.6	± 3.0
Standard Care	-0.02	± 3.2

Change in Positive Perceptions of Caregiving Secondary · 11 weeks after baseline

Changes in positive perceptions of caregiving will be measured by the Positive Aspects of Caregiving Scale. The scale contains 11 items scored from 1 (disagree a lot) to 5 (agree a lot). Total range from 11 to 55. Higher scores indicate more positive perceptions of caregiving.

Group	Value	95% CI
Caregiver Education and Support	2.1	± 7.2
Standard Care	0.1	± 6.7

Change in Positive Perceptions of Caregiving Secondary · 19 weeks after baseline

Changes in positive perceptions of caregiving will be measured by the Positive Aspects of Caregiving Scale. The scale contains 11 items scored from 1 (disagree a lot) to 5 (agree a lot). Total range from 11 to 55. Higher scores indicate more positive perceptions of caregiving.

Group	Value	95% CI
Caregiver Education and Support	1.1	± 8.4
Standard Care	0.0	± 7.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected during participation in study (19 weeks).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Caregiver Education and Support

Serious: 0/86 (0%)

Deaths: 0/86

Standard Care

Serious: 0/88 (0%)

Deaths: 0/88

Other adverse events (1 terms — click to expand)

Reaction	System	Caregiver Education and Su…	Standard Care
Diverticulitis	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT01600131 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Postdischarge Intervention for Stroke Caregivers: Protocol for a Randomized Controlled Trial.
   LeLaurin JH, Lamba AH, Eliazar-Macke ND, Schmitzberger MK, et al · · 2020 · cited 7× · PMID 33174856 · DOI 10.2196/21799