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Completed Phase 3 Interventional Accepts healthy volunteers

Project ACT: Advancing Caregiving Techniques

ClinicalTrials.gov ID: NCT00259480

Public ClinicalTrials.gov record NCT00259480. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 28, 2026, 1:31 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Reducing Family Caregiver Upset With Disruptive Behavior

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 control group participants who receive the nurse intervention, compare the level of disruptive behaviors and caregiver upset 4 months from entry into this study arm with the results in the Project ACT experimental group (who received the multi-component intervention).

Study identification

NCT ID
NCT00259480
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
272 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
21 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2001
Primary completion
Feb 28, 2014
Completion
Feb 28, 2015
Last update posted
May 12, 2015

2001 – 2015

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Laura N. Gitlin,Ph.D Philadelphia Pennsylvania 19107 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00259480, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 12, 2015 · Synced Sep 28, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00259480 live on ClinicalTrials.gov.

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