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Sponsored by: |
Thomas Jefferson University |
Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00259480 |
The specific aims of this study are to:
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 | Intervention | Phase |
Alzheimer's Disease |
Behavioral: Home Based Intervention |
Phase III |
Genetics Home Reference related topics: | Alzheimer disease |
MedlinePlus related topics: | Alzheimer's Caregivers Alzheimer's Disease Caregivers |
Study Type: | Interventional |
Study Design: | Other, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment |
Official Title: | Reducing Family Caregiver Upset With Disruptive Behavior |
Estimated Enrollment: | 272 |
Study Start Date: | August 2001 |
Estimated Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Caregivers are eligible for study participation if they:
Caregivers will be considered eligible if they obtain a total summed score of "3" or higher using the following algorithm:
Thus, caregivers with only scores of "1" ( a little upset) with three or more behavioral occurrences will not be considered eligible for this study. That is, this criteria excludes caregivers with no upset or a little upset. We will also require that the care recipient: 1) has a NINCDS-ADRDA diagnosis (physician generated) of dementia or a Mini-mental State Examination (MMSE) score of <23.
Exclusion Criteria:
A caregiver is excluded if the caregiver or care recipient:
Caregivers will also be excluded if:
Care-recipients will also be excluded if:
These criteria exclude caregivers of ADRD patients at the severe stage of the disease process who may not benefit from the proposed intervention.
United States, Pennsylvania | |||||
Laura N. Gitlin,Ph.D | |||||
Philadelphia, Pennsylvania, United States, 19107 |
Thomas Jefferson University |
Principal Investigator: | Laura N Gitlin, Ph.D | Thomas Jefferson University |
Responsible Party: | Thomas Jeffferson University- Center for Applied Research on Aging and Health ( Laura N. Gitlin, Ph.D ) |
Study ID Numbers: | RO1 AG22254 |
First Received: | November 28, 2005 |
Last Updated: | January 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00259480 |
Health Authority: | United States: Institutional Review Board |
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