N/A
Completed N=210
Spanish Intervention for Caregivers of Veterans With Stroke
Source: ClinicalTrials.gov NCT03142841 ↗Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: Change in Caregiver Depression at 9 Weeks — 15.0; 10.2 score on a scale — p=0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Caregiver Depression at 9 Weeks |
15.0; 10.2 | 0.001 sig |
| PRIMARY Change in Caregiver Depression at 21 Weeks |
14.3; 10.5 | 0.017 sig |
| SECONDARY Change in Caregiver Burden-Zarit - 9 Weeks |
30.3; 24.5 | 0.017 sig |
| SECONDARY Change in Caregiver Burden-Zarit - 21 Weeks |
30.8; 23.2 | 0.002 sig |
| SECONDARY Change in Caregiver Self-Efficacy-Obtaining Respite - 9 Weeks |
45.6; 54.2 | 0.152 |
| SECONDARY Change in Caregiver Self-Efficacy-Obtaining Respite - 21 Weeks |
41.0; 57.2 | 0.008 sig |
| SECONDARY Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 9 Weeks |
82.2; 84.8 | 0.812 |
| SECONDARY Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 21 Weeks |
79.9; 84.9 | 0.229 |
| SECONDARY Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 9 Weeks |
81.2; 80.2 | 0.968 |
| SECONDARY Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 21 Weeks |
78.6; 86.6 | 0.196 |
| SECONDARY Change in Veteran's Functional Abilities- 9 Weeks |
43.8; 51.6 | 0.067 |
| SECONDARY Change in Veteran's Functional Abilities- 21 Weeks |
43.3; 51.7 | 0.066 |
| SECONDARY Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 9 Weeks |
41.8; 42.8 | 0.225 |
| SECONDARY Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 21 Weeks |
40.3; 41.2 | 0.138 |
| SECONDARY Changes in Caregiver Health Related Quality of Life - Mental Health Component - 9 Weeks |
43.8; 49.9 | 0.002 sig |
| SECONDARY Changes in Caregiver Health Related Quality of Life - Mental Health Component - 21 Weeks |
44.4; 48.4 | 0.052 |
| SECONDARY Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 9 Weeks |
99.5; 98.0 | 0.981 |
| SECONDARY Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 21 Weeks |
98.2; 100.1 | 0.221 |
| SECONDARY Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 9 Weeks |
93.2; 92.1 | 0.159 |
| SECONDARY Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 21 Weeks |
92.5; 90.6 | 0.103 |
| SECONDARY Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 9 Weeks |
101.2; 105.0 | 0.247 |
| SECONDARY Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 21 Weeks |
100.5; 104.9 | 0.174 |
| SECONDARY Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 9 Weeks |
91.5; 92.4 | 0.408 |
| SECONDARY Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 21 Weeks |
91.7; 92.4 | 0.457 |
| SECONDARY Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 9 Weeks |
88.6; 87.7 | 0.187 |
| SECONDARY Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 21 Weeks |
87.4; 86.9 | 0.315 |
| SECONDARY Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 9 Weeks |
107.7; 108.7 | 0.289 |
| SECONDARY Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 21 Weeks |
107.5; 109.9 | 0.055 |
Eligibility Criteria
Inclusion Criteria: Hispanic caregivers of Veterans with a primary diagnosis of stroke are eligible for participation if they meet the following criteria: 1) are the primary caregiver and provide the majority of care for a Veteran who has a diagnosis of stroke (ICD9 codes for stroke: 430-438 or ICD 10 codes 160.0 through 169.998) within the last year and who has at least two activity of daily living (ADL) deficits or a new or worsening neurological problem, 2) have Internet access and ability, (either themselves or via a relative or friend) 3) are reachable by cell or home phone, 4) Spanish is their preferred language, 5) have moderate to severe stress, and 6) ) identify self as Hispanic, and 7) agree to random assignment to the intervention or standard care group.
Random assignment to the intervention or standard care group. The investigators will determine caregiver status.
Exclusion Criteria: The investigators will exclude caregivers who fail to meet one or more of the inclusion criteria or are managing end-of-life issues (stroke survivors are likely to die within five months following discharge).
Data sourced from ClinicalTrials.gov (NCT03142841). 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.