NCT03142841: RESCUE

Spanish Intervention for Caregivers of Veterans With Stroke

Completed NA Results posted Last updated 18 December 2025

What this trial tests

NA trial testing RESCUE Problem Solving Intervention in Depression in 210 participants. Completed in 4 March 2024.

Timeline

1 January 2018

Primary endpoint
4 March 2024

4 March 2024

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	210
Start date	1 January 2018
Primary completion	4 March 2024
Estimated completion	4 March 2024
Sites	4 locations across Puerto Rico, United States

Drugs / interventions tested

• RESCUE Problem Solving Intervention

Conditions studied

• Depression — all drugs for Depression →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Eligibility, any sex, with Depression. 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 Caregiver Depression at 9 Weeks Primary · 9 weeks after baseline

Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity.

Group	Value	95% CI
Standard Care Group	15.0	± 6.5
Intervention Group	10.2	± 5.4

Change in Caregiver Depression at 21 Weeks Primary · 21 weeks after baseline

Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity.

Group	Value	95% CI
Standard Care Group	14.3	± 7.7
Intervention Group	10.5	± 6.0

Change in Caregiver Burden-Zarit - 9 Weeks Secondary · 9 weeks

Changes in burden will be measured by the Zarit Burden Interview instrument. This 22 item instrument is scored on a 5-point Likert scale, ranging from 0 (Never) to 4 (Nearly Always). The minimum value is 0 and the maximum score is 88. Higher scores indicate higher burden.

Group	Value	95% CI
Standard Care	30.3	± 5.9
Problem Solving Intervention	24.5	± 6.6

Change in Caregiver Burden-Zarit - 21 Weeks Secondary · 21 weeks

Changes in burden will be measured by the Zarit Burden Interview instrument. This 22 item instrument is scored on a 5-point Likert scale, ranging from 0 (Never) to 4 (Nearly Always). The minimum value is 0 and the maximum score is 88. Higher scores indicate higher burden.

Group	Value	95% CI
Standard Care	30.8	± 6.7
Problem Solving Intervention	23.2	± 7.0

Change in Caregiver Self-Efficacy-Obtaining Respite - 9 Weeks Secondary · 9 weeks

Change in Self-Efficacy is measured by the Revised Scale for Caregiving Self-Efficacy- Obtaining Respite subscale. The subscale contains 5 items which asks caregivers to rate their level of confidence (from 0% to 100%) to ask for assistance. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.

Group	Value	95% CI
Standard Care Group	45.6	± 18.2
Intervention Group	54.2	± 18.9

Change in Caregiver Self-Efficacy-Obtaining Respite - 21 Weeks Secondary · 21 weeks

Change in Self-Efficacy is measured by the Revised Scale for Caregiving Self-Efficacy- Obtaining Respite subscale. The subscale contains 5 items which asks caregivers to rate their level of confidence (from 0% to 100%) to ask for assistance. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.

Group	Value	95% CI
Standard Care Group	41.0	± 17.3
Intervention Group	57.2	± 21.4

Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 9 Weeks Secondary · 9 weeks

Measured by Revised Scale for Caregiver Self Efficacy - Controlling Upsetting Thoughts subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.

Group	Value	95% CI
Standard Care Group	82.2	± 9.0
Intervention Group	84.8	± 10.8

Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 21 Weeks Secondary · 21 weeks

Measured by Revised Scale for Caregiver Self Efficacy - Controlling Upsetting Thoughts subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.

Group	Value	95% CI
Standard Care Group	79.9	± 10.6
Intervention Group	84.9	± 10.6

Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 9 Weeks Secondary · 9 weeks

Measured by Revised Scale for Caregiver Self Efficacy - Responding to Disruptive Behaviors subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.

Group	Value	95% CI
Standard Care Group	81.2	± 11.1
Intervention Group	80.2	± 11.1

Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 21 Weeks Secondary · 21 weeks

Measured by Revised Scale for Caregiver Self Efficacy - Responding to Disruptive Behaviors subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.

Group	Value	95% CI
Standard Care Group	78.6	± 9.2
Intervention Group	86.6	± 11.1

Change in Veteran's Functional Abilities- 9 Weeks Secondary · 9 weeks

Changes in Veteran functional abilities as measured by the Stroke Impact Scale-16 (SIS-16). The SIS-16 is a 16 item physical dimension instrument, developed as a brief standalone tool for measuring the physical aspects of stroke recovery. We modified this instrument to be administered to the caregiver about their evaluation of Veteran's functional ability. Scoring is based on a 5-point Likert scale, ranging from 16-80 points with 1 = an inability to complete the item \& 5 = no difficulty experienced at all. Total Scores are transformed scores which have been standardized on a scale of 0-100 wh

Group	Value	95% CI
Standard Care Group	43.8	± 6.0
Intervention Group	51.6	± 8.3

Change in Veteran's Functional Abilities- 21 Weeks Secondary · 21 weeks

Changes in Veteran functional abilities as measured by the Stroke Impact Scale-16 (SIS-16). The SIS-16 is a 16 item physical dimension instrument, developed as a brief standalone tool for measuring the physical aspects of stroke recovery. We modified this instrument to be administered to the caregiver about their evaluation of Veteran's functional ability. Scoring is based on a 5-point Likert scale, ranging from 16-80 points with 1 = an inability to complete the item \& 5 = no difficulty experienced at all. Total Scores are transformed scores which have been standardized on a scale of 0-100 wh

Group	Value	95% CI
Standard Care Group	43.3	± 7.8
Intervention Group	51.7	± 9.3

Sponsor's own description

This research study will test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. The investigators will adapt their previously pilot-tested problem-solving intervention and make it culturally-relevant for Hispanic caregivers. The investigators' main goal is to test the efficacy of a brief, telephone and online problem-solving intervention. The objectives are: 1) reduce caregiver burden and depression, 2) improve caregivers' problem-solving abilities, self-efficacy, and quality of life, 3) improve Veterans' functional abilities and determine the intervention's impact on Veterans' healthcare utilization, 4) determine budgetary impact, and 5) determine caregivers' perceptions of the intervention.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Telephone interventions, delivered by healthcare professionals, for providing education and psychosocial support for informal caregivers of adults with diagnosed illnesses.
   Corry M, Neenan K, Brabyn S, Sheaf G, et al · · 2019 · cited 28× · PMID 31087641 · DOI 10.1002/14651858.cd012533.pub2
2. Study protocol of a telephone problem-solving intervention for Spanish-speaking caregivers of veterans post-stroke: an 8-session investigator-blinded, two-arm parallel (intervention vs usual care), randomized clinical trial.
   Freytes IM, Schmitzberger MK, Rivera-Rivera N, Lopez J, et al · · 2023 · cited 1× · PMID 36932321 · DOI 10.1186/s12875-022-01929-y
3. The Impact of a Spanish Online and Telephone Intervention for Caregivers of Veterans Post-Stroke: Findings on Caregiver Burden.
   Lopez J, Snyder S, Orozco T, Foulke H, et al · · 2025 · PMID 41464271 · DOI 10.3390/healthcare13243202
4. A telephone problem-solving intervention for Spanish-speaking caregivers of veterans post-stroke: an 8-session investigator-blinded, two-arm parallel (intervention vs usual care), randomized clinical trial
   Freytes IM, Schmitzberger MK, Rivera-Rivera N, Lopez J, et al · · 2022 · DOI 10.21203/rs.3.rs-2039128/v1