Trials / Completed
CompletedNCT00259480
Project ACT: Advancing Caregiving Techniques
Reducing Family Caregiver Upset With Disruptive Behavior
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 272 (actual)
- Sponsor
- Thomas Jefferson University · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
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 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Home Based Intervention | occupational therapy |
Timeline
- Start date
- 2001-08-01
- Primary completion
- 2014-03-01
- Completion
- 2015-03-01
- First posted
- 2005-11-29
- Last updated
- 2015-05-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00259480. Inclusion in this directory is not an endorsement.