Project ACT: Advancing Caregiving Techniques
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|ClinicalTrials.gov Identifier: NCT00259480|
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : May 13, 2015
The specific aims of this study are to:
- 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.
- 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.
- 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.
- 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.
- 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).
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Behavioral: Home Based Intervention||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||272 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Reducing Family Caregiver Upset With Disruptive Behavior|
|Study Start Date :||August 2001|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2015|
Behavioral: Home Based Intervention
- Caregiver upset [ Time Frame: Baseline, t2, t3 ]
- Care recipient behaviors [ Time Frame: Baseline, t2, t3 ]
- Caregiver self-efficacy [ Time Frame: Baseline, t2, t3 ]
- Nursing home placement [ Time Frame: When needed ]
- Caregiver depression [ Time Frame: Baseline, t2, t3 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259480
|United States, Pennsylvania|
|Laura N. Gitlin,Ph.D|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Laura N Gitlin, Ph.D||Thomas Jefferson University|