Expired Study
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Washington, District of Columbia 22057


Purpose:

The point of this research is to improve the communicative relationship between the caregiver and care receiver. It is input from the caregiver on these communicative behaviors that will inform the process of understanding how to reduce the caregiver burden that comes from this communicative relationship.


Study summary:

This research study is developing a new checklist to measure communicative coping behaviors of persons with Alzheimer's Disease in the home environment. The Communicative Coping Behavior Checklist (CCBC) is an observation checklist to be completed by the caregiver or knowledgeable informant. The current version includes 23 behaviors to be rated for frequency and effectiveness. The behaviors that will be observed cover management of memory loss within three broad categories: humor, explanations, and general coping behaviors. Two kinds of couples will participate in this study. One includes a person with Alzheimer's Disease and their caregiver. The second includes a cognitively intact participant and study partner, both over the age of 60, to serve as controls. Study Visit 1 (3 hours long) During the first visit, the person with Alzheimer's Disease/control participant can expect to be asked questions about their memory, thinking and concentration, demographics, quality of life, and mood. The caregiver/study partner will be asked about their quality of life, mood, and daily activities. At the end of the visit the caregiver/study partner will be given a copy of the CCBC and asked to take it home. S/he will be instructed to rate the person with Alzheimer's Disease/ control participant's communicative coping behavior over the course of the next two weeks. At the end of that time, a research assistant will call the caregiver/study partner and administer the CCBC over the telephone. Study Visit 2 (3 hours long) The second visit will occur in the clinic approximately 12 months from the date of the first visit. As with the first study visit, again both the person with Alzheimer's Disease/control participant and the caregiver/study partner will answer questions about their memory, quality of life, mood, and daily activities. Once again, the caregiver/study partner will be given a copy of the CCBC and asked to take it home and complete. Both visits will take about three hours for the caregiver/study partner and about two hours for the person with dementia or control subject.


Criteria:

*Note* Currently enrolling participants for control group only Inclusion Criteria: - Couples including spouse or family member who spend at least 2-3 hours per day together - Both must be cognitively intact Exclusion Criteria: - Cognitive impairment


Study is Available At:


Original ID:

IA0082


NCT ID:

NCT00182988


Secondary ID:

1RO3AG022627


Study Acronym:


Brief Title:

Alzheimer's Caregiver Communication Study


Official Title:

Alzheimer's Caregiver Ratings of Communication & Coping Behavior


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Aging (NIA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Time Perspective: Prospective


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

140


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Pamela Saunders, PhD
Principal Investigator
Georgetown University

Study Dates

Start Date:October 2004
Completion Date:December 2007
Completion Type:Actual
Verification Date:November 2009
Last Changed Date:November 24, 2009
First Received Date:September 13, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Aging (NIA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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