Alzheimer's Family Research
Tracking Information | |||||
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First Received Date ICMJE | March 16, 2009 | ||||
Last Updated Date | May 13, 2011 | ||||
Start Date ICMJE | July 2008 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00878059 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Alzheimer's Family Research | ||||
Official Title ICMJE | Proxy Decision Making for Alzheimer Disease Research | ||||
Brief Summary | This is a research study about how family members make research participation decisions for a relative with Alzheimer's or a related dementia. The purpose of this study is to learn more about how proxies (the family member who makes decisions for that relative), would think through decisions about whether to enroll their relative in studies for not-yet-approved medications for Alzheimer's Disease. The long-term goal of the study is to improve the way researchers inform families about clinical research studies and opportunities for participation. This study is being sponsored by the National Institute on Aging. Study participants will be interviewed by a research staff member about research enrollment decisions for their relative. A number of standardized questionnaires will be administered. There is only one visit required. The interview lasts about three hours. The investigators will try to make it as convenient as possible for your schedule. This is a non-intervention study. UCSF CHR # H58055-31168-02 v.1 Date: 012709 |
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Detailed Description |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Time Perspective: Cross-Sectional | ||||
Biospecimen | |||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Subjects will be adult men and women who, under California law (AB2328), would be legally eligible to serve as proxy decision makers for Alzheimer's Disease patients for research. These will be spouses or adult children of people with Alzheimer's Disease. |
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Condition ICMJE | Decision Making | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) | Proxies
A family member-caregiver (the medical decision-maker) for someone with Alzheimer's Disease. Must be the person who would be able to make decisions for someone with Alzheimer's disease about being in medical research. |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 200 | ||||
Estimated Completion Date | July 2011 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 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 | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00878059 | ||||
Other Study ID Numbers ICMJE | AD R01 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Laura B. Dunn, MD / Principal Investigator, Associate Professor, UCSF | ||||
Study Sponsor ICMJE | University of California, San Francisco | ||||
Collaborators ICMJE | National Institute on Aging (NIA) | ||||
Investigators ICMJE |
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Information Provided By | University of California, San Francisco | ||||
Verification Date | May 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |