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NCT00259480 · ClinicalTrials.gov registry record · Phase 3
Project ACT: Advancing Caregiving Techniques
A Phase 3 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 3
- Development phase
- 272
- Enrollment target
NCT00259480 is a Phase 3 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 272 participants.
The verdict
NCT00259480, a Phase 3 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 272 participants
- Enrollment target
Study Summary
The specific aims of this study are to: 1. Test the immediate effectiveness of the intervention to reduce caregiver upset with targeted disruptive behaviors (primary outcome). Hypothesis: Caregivers in the intervention group will report less upset with target behaviors at 4-months in comparison to caregivers in the control group. 2. Test the immediate effectiveness of the intervention to reduce caregiver burden (secondary outcome). Hypothesis: Caregivers in the intervention group will report less burden at 4-months in comparison to caregivers in the control group. 3. Test the immediate effectiveness of the intervention to reduce the frequency of occurrence of targeted disruptive behaviors in persons with dementia (secondary outcome). Hypothesis: Caregivers in the intervention group will report a decrease in the frequency of occurrence of targeted behaviors at 4-months in comparison to caregivers in the control group. 4. Test the maintenance effect of intervention at 6-months on caregiver upset and burden and targeted disruptive behaviors. Hypothesis: Compared to usual care, caregivers in intervention will maintain reduced upset and burden and report less occurrences of targeted behaviors from 4 to 6-months. 5. Assess the cost of the intervention and its cost effectiveness. We have also received funding to conduct a supplementary study to evaluate the effect of the nurse intervention on behavior reduction and caregiver distress. The specific aims of this supplementary study arm are to: 1) describe the prevalence and type of medical conditions among control group participants who receive the nurse intervention, 2) describe for those with a detected medical condition/problem, the number of caregivers who follow-up with physicians and the type of physician follow-up/treatment that occurs; 3) evaluate whether control group participants who receive the nurse intervention report reduced disruptive behaviors and caregiver upset at 6 weeks (pre-post comparison); and 4) for
Interventions
- BEHAVIORAL Home Based Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2001-08 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00259480
The ClinicalTrials.gov registry entry for NCT00259480 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 272 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Home Based Intervention is the first listed.
NCT00259480 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00259480 about?
NCT00259480 is a clinical study titled "Project ACT: Advancing Caregiving Techniques". The specific aims of this study are to: 1. Test the immediate effectiveness of the intervention to reduce caregiver upset with targeted disruptive behaviors (primary outcome). Hypothesis: Caregivers in the intervention group will report less upset with target behaviors at 4-months in comparison to ...
What is the current status of trial NCT00259480?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 272 participants. The study started on 2001-08. Estimated completion is 2015-03.
What interventions are being tested in trial NCT00259480?
The interventions under investigation include: Home Based Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT00259480?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
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