Alzheimer's Caregiver Communication Study
|First Received Date ICMJE||September 13, 2005|
|Last Updated Date||November 24, 2009|
|Start Date ICMJE||October 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00182988 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Alzheimer's Caregiver Communication Study|
|Official Title ICMJE||Alzheimer's Caregiver Ratings of Communication & Coping Behavior|
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Alzheimer's Disease|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||140|
|Completion Date||December 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
*Note* Currently enrolling participants for control group only
|Ages||60 Years and older|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00182988|
|Other Study ID Numbers ICMJE||IA0082, 1RO3AG022627|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Pamela A. Saunders, Ph.D., Georgetown University|
|Study Sponsor ICMJE||National Institute on Aging (NIA)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institute on Aging (NIA)|
|Verification Date||November 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP