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NCT01141738 · ClinicalTrials.gov registry record · NA
Problem-solving: A Stroke Caregiver Early Intervention
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 362
- Enrollment target
NCT01141738 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 362 participants.
The verdict
NCT01141738, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 362 participants
- Enrollment target
Study Summary
Intervention studies for stroke caregivers (CG's) during early caregiving are few and have met with limited success. The Post-Stroke Rehabilitation Clinical Practice Guidelines (1995) recommend sensitivity to the adverse effects of caregiving on family functioning and CG health. Breakdown of the informal care system can lead to premature introduction of formal services, excess disability, and decline in well-being for stroke survivor and CG alike. Thus, it is important to attempt to prevent the chronic distress of stroke CGs through an early intervention that prevents and remediates distress, coaches problem-solving and other coping skills, can affect multiple outcomes, has durable effects, and is non-threatening and accessible. The proposed intervention will incorporate these features and will be low cost and feasible for use in clinical practice; it will target outcomes important to stroke CGs, depression, anxiety, caregiver preparedness, perceptions of life changes, family functioning, and survivor functioning. The individual format will make it possible to address life stage needs and cultural issues. Given the prevalence of distress in chronic stroke CGs, early intervention to prevent and mediate negative outcomes is essential. The proposed study will, therefore test the efficacy of an early intervention for stroke survivor caregivers that provides structured information on problem-solving and resources, guided problem-solving in the context of a supportive relationship, and training in skills to cope with stress and emotions. The intervention will be tailored based on assessment data, will begin during acute rehabilitation and will extend through the most stressful caregiving phase. The study will use a two-group design (the experimental caregiver problem-solving intervention \[CPSI\] group and a wait-list control \[WLC\]) group to examine the effectiveness of the CPSI in reducing CG depressive symptoms and anxiety, improving caregiver preparedness, perception
Interventions
- BEHAVIORAL Wait List Control
- BEHAVIORAL Caregiver Problem-Solving Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2005-04 |
| Est. Completion | 2009-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01141738
The ClinicalTrials.gov registry entry for NCT01141738 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 362 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Wait List Control is the first listed.
NCT01141738 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01141738 about?
NCT01141738 is a clinical study titled "Problem-solving: A Stroke Caregiver Early Intervention". Intervention studies for stroke caregivers (CG's) during early caregiving are few and have met with limited success. The Post-Stroke Rehabilitation Clinical Practice Guidelines (1995) recommend sensitivity to the adverse effects of caregiving on family functioning and CG health. Breakdown of the inf...
What is the current status of trial NCT01141738?
This trial is currently completed. It is a NA study. The enrollment target is 362 participants. The study started on 2005-04. Estimated completion is 2009-12.
What interventions are being tested in trial NCT01141738?
The interventions under investigation include: Wait List Control (BEHAVIORAL), Caregiver Problem-Solving Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01141738?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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