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NCT01600131 · ClinicalTrials.gov registry record · NA
RESCUE Stroke Caregiver Website to Enhance Discharge Planning
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 174
- Enrollment target
NCT01600131: Completed NA study, sponsored by VA Office of Research and Development.
NCT01600131 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 174 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01600131, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 174 participants
- Enrollment target
Study 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 Veteran
Primary Outcome
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.
Interventions
- OTHER Standard Care
- BEHAVIORAL Caregiver problem-solving
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2015-06-22 |
| Est. Completion | 2021-04-30 |
| Phase | NA |
What the finished NCT01600131 record still lists
NCT01600131 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT01600131 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01600131 about?
NCT01600131 is a clinical study titled "RESCUE Stroke Caregiver Website to Enhance Discharge Planning". 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 th...
What is the current status of trial NCT01600131?
This trial is currently completed. It is a NA study. The enrollment target is 174 participants. The study started on 2015-06-22. Estimated completion is 2021-04-30.
What interventions are being tested in trial NCT01600131?
The interventions under investigation include: Standard Care (OTHER), Caregiver problem-solving (BEHAVIORAL).
Who is sponsoring clinical trial NCT01600131?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01600131's enrollment target sits among peer trials
174 610th of 2000 higher than 1,390 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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