Home-Based Assessment for Alzheimer Disease Prevention (HBA)
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|ClinicalTrials.gov Identifier: NCT00546767|
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : September 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment Alzheimer's Disease||Behavioral: Mail and Live Phone Behavioral: Interactive Voice Response (IVR) Behavioral: Home-based Computer Kiosk Behavioral: Traditional Evaluation Instruments||Not Applicable|
There is an unmet need for effective, efficient, and economical methods for conducting AD prevention trials. Traditional in-person visits to clinical assessment sites are time consuming and costly and may exclude some people from participation, such as those who are older, or are less mobile or with significant medical illnesses. These may be the people who are at greatest risk for cognitive decline, and also may be without financial resources for services such as transportation to a study site. Prevention trials require long observation periods and these same issues of health, resources, and transportation may cause significant drop out. These obstacles increase expense of clinical trials which require large sample sizes, costly clinical staff and long observation periods. Thus, home-based assessments may lead to more representative recruitment of those most at risk for decline, as well as better retention and reduced study costs.
This is a randomized study of 600 participants, comparing three methods of test administration and data collection. Each enrolled participant will have an In-person (Standard) assessment (in the clinic or at home) prior to baseline.
Participants will be classified as either normal or MCI (Mild Cognitive Impairment) and randomly assigned to an assessment method and to a frequency of assessment. Cognitive performance, self-rated cognitive complaint, functioning in daily life, affective symptoms, global change, quality of life and resource use will all be assessed in each method at each visit. The total time for the at-home assessments will be approximately 45 minutes. In addition, all participants will be provided a multi-vitamin to be taken twice a day, and a measure of medication adherence will be collected for each assessment method.
Changes in certain cognitive measures may "trigger" an in-person assessment, in which participants may change from a categorization of normal or amnestic MCI, to non-amnestic MCI, impaired not MCI, or dementia (i.e., specifically Alzheimer's Disease or another dementia). We estimate that 12% of the study population will trigger over the 4 years of the study and will progress to a more impaired diagnostic category. In addition, a random sample of non-triggered cases (25%) will be selected for an in-person re-assessment during the 4 years of the protocol as a comparison for the trigger group. At the end of the 4-year study period all participants will undergo an in-person evaluation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||640 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease Prevention Research in People Over 75 Years Old|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
|Experimental: Mail and Live Phone||
Behavioral: Mail and Live Phone
This group will receive assessments of all domains by mail, except for the cognitive performance assessment which will be administered via phone by a live, trained evaluator. Medication compliance will be monitored by a written medication log which will be returned by mail with the other mail-in assessments.
Behavioral: Interactive Voice Response (IVR)
In this group, participants will be asked to answer questions via an automated phone system using interactive voice recognition (IVR) and key-pad response entry. Medication compliance will be monitored by the same method. A standard large-key telephone and training in the use of the interactive phone system will be provided to all participants.
|Experimental: Computer Kiosk||
Behavioral: Home-based Computer Kiosk
Participants at entry will receive a special Kiosk-like device for collecting assessment information and will be taught to use this device. The user interface will consist of a monitor with a touch screen and a telephone handset, similar to what is often used in museum displays. Pre-recorded instructions will be delivered through the handset as well as displayed visually on the screen. Data will be collected using the handset's high-quality microphone. Daily activity assessments of timed medication use will be obtained via an automated medication tracking device.
|Active Comparator: Traditional||
Behavioral: Traditional Evaluation Instruments
Evaluation methods typically used in clinical trials
- Feasibility Data -- the number of subjects recruited, screened, enrolled, and retained [ Time Frame: 4 years ]
- Efficiency Data -- staff time required to successfully complete data collection [ Time Frame: Each experimental visit ]
- Transition from cognitive health to impairment [ Time Frame: 4 years ]
- Method-Specific Adherence, including medication adherence [ Time Frame: 4 years ]
- Rate of change in domains of assessment [ Time Frame: 4 years ]
- Research blood samples [ Time Frame: 4 years ]
- Safety Assessments: symptom checklist and adverse event checklist [ Time Frame: 4 years ]
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): NCT00546767
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|Principal Investigator:||Mary Sano, PhD||Mount Sinai Medical School|