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NCT01275495 · ClinicalTrials.gov registry record · Phase 3
Telephone Assessment and Skill-Building Intervention for Stroke Caregivers
A Phase 3 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 3
- Development phase
- 254
- Enrollment target
NCT01275495: Completed Phase 3 study, sponsored by Indiana University.
NCT01275495 is a Phase 3 study that has completed, run by Indiana University. The registered enrollment target is 254 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01275495, a Phase 3 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 254 participants
- Enrollment target
Study Summary
The purpose of this study is to test the efficacy of the revised Telephone Assessment and Skill-Building Kit (TASK II) compared with an Information, Support, and Referral (ISR) intervention in family caregivers of stroke survivors. We will also test if TASK II intervention effects on primary outcomes (depressive symptoms, caregiving-related negative life changes, unhealthy days) are mediated through effects on secondary outcomes (task difficulty, optimism, threat appraisal). Comparative costs and outcomes for the TASK II and ISR interventions will also be explored.
Primary Outcome
Among caregivers who screen positive for depressive symptoms at baseline, those randomized to the TASK II intervention will have a greater reduction in depressive symptoms compared to those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Interventions
- BEHAVIORAL Telephone Assessment and Skill-Building Kit (TASK II)
- BEHAVIORAL Information, Support, and Referral (ISR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
What the finished NCT01275495 record still lists
NCT01275495 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Telephone Assessment and Skill-Building Kit (TASK II) is the first listed.
NCT01275495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01275495 about?
NCT01275495 is a clinical study titled "Telephone Assessment and Skill-Building Intervention for Stroke Caregivers". The purpose of this study is to test the efficacy of the revised Telephone Assessment and Skill-Building Kit (TASK II) compared with an Information, Support, and Referral (ISR) intervention in family caregivers of stroke survivors. We will also test if TASK II intervention effects on primary outcome...
What is the current status of trial NCT01275495?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 254 participants. The study started on 2010-05. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01275495?
The interventions under investigation include: Telephone Assessment and Skill-Building Kit (TASK II) (BEHAVIORAL), Information, Support, and Referral (ISR) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01275495?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01275495's enrollment target sits among peer trials
254 1245th of 2000 higher than 755 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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