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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: Completed Phase 3 study, sponsored by Thomas Jefferson University.

NCT00259480 is a Phase 3 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 272 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 272 participants
Start Date 2001-08
Est. Completion 2015-03
Phase Phase 3
Thomas Jefferson University

292 total trials

What the finished NCT00259480 record still lists

NCT00259480 is an interventional study that assigns participants to a tested intervention. The registered 272 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 (65% lower).

The record links to 0 conditions, and to 1 intervention - of which Home Based Intervention is the first listed.

NCT00259480 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00259480's enrollment target sits among peer trials

272 1214th of 2000 higher than 785 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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Source: ClinicalTrials.gov NCT00259480, the US trial registry maintained by the National Library of Medicine. NCT00259480 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.