Dementia Clinical Trial
— R2D2Official title:
Reducing Risk of Dementia Through Deprescribing (R2D2)
A cluster-randomized controlled trial (RCT) called "Reducing Risk of Dementia through Deprescribing" (R2D2) to evaluate the impact of a deprescribing intervention on important cognitive and safety outcomes.
Status | Recruiting |
Enrollment | 344 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria for Participants: - Age 65 and older; - At least one office visit to their primary care physician within the previous 12 months; - Use of a target anticholinergic medication within the last two weeks OR medical record evidence of exposure to target anticholinergic medications at or above a cognitive risk threshold in the prior 12 months - Able to communicate in English; - Access to a telephone Exclusion Criteria for Participants: - Permanent resident of an extended care facility (nursing home) - Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined by International Classification of Diseases (ICD) version 9/10 codes - Diagnosis of Alzheimer's Disease or Related Dementia as determined by (a), (b), or (c) below: 1. ICD-9/10 codes, or 2. Current use of a medication for Alzheimer's Disease or a Related Dementia, or 3. A pattern of responses to the Functional Activities Questionnaire (FAQ) that indicate dementia (i.e., = 3 FAQ items are scored at "requires assistance," or if = 1 FAQ item is scored at "dependent"). |
Country | Name | City | State |
---|---|---|---|
United States | Community Health Network Foundation, Inc. | Indianapolis | Indiana |
United States | Eskenazi Health | Indianapolis | Indiana |
United States | Indiana University Health | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Cognitive Composite Score | Cognitive composite scores will be collected from participants at baseline, 6, 12, 18 and 24 months and changes in the composite scores over time will be compared between the intervention and usual care groups. An overall cognitive composite score including measures of information processing speed, memory, and executive function will be conducted at each time point from the average of each measure's z-score, constructed by subtracting the mean baseline scores and dividing by the baseline standard deviation. The z-score transformation of the cognitive composite score will have a mean of 0 and standard deviation of 1 at baseline, with higher scores representing improvement in cognition. | Baseline, 6, 12, 18, and 24 months | |
Primary | Change in Patient Reported Outcome Measurement Information System (PROMIS) | Participant self-reported, 4-item scales evaluating depression, anxiety, pain, and insomnia will be collected for each participant at each time point. Each PROMIS measure raw score can be converted to a T-score where 50 represents the general population norm for that symptom and each 10-point deviation represents one standard deviation (SD) from the population norm. Changes in the T-scores over time will be compared between the intervention and usual care groups. | Baseline, 6, 12, 18, and 24 months | |
Primary | Change in Health Utilities Index (HUI) | Participant self-reported measure of health-related quality of life, evaluating domains including vision, hearing, speech, ambulation, dexterity, emotion, cognitive function and pain. These attributes produce a single score on a standardized utility measure with individual health domain scores ranging from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI) scores ranging from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health. HUI scores will be collected at each outcome assessment and change in HUI scores over time will be compared between the intervention and usual care groups. | Baseline, 6, 12, 18, and 24 months |
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