Behavioral Interventions to Prevent or Delay Dementia
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About
This study will compare the effectiveness of different combinations of 5 types of behavioral interventions across patient-centered outcomes. It will also evaluate which outcomes (e.g. quality of life, cognition, function, mood) matter most to people at risk for dementia and their care partners. The results of this study have the potential to direct patients, families, and health care providers as to which combinations of behavioral interventions provide the greatest potential impact on which dementia prevention outcomes. Greater use of behavioral strategies that are targeted to the outcomes of most important to the patient will likely improve patient compliance and treatment adherence. This, in turn, can lessen the need for medication, health care, and long term care utilization.
Full description
Traditional randomized controlled trials (RCTs) can be thought of as 'additive' trials where randomization leads to the addition of treatments beyond placebo. Participants are confronted with the probability of receiving placebo (no treatment). This leads many potential participants to not consent or to withdraw if they believe they are receiving no treatment. In contrast, the proposed trial will be 'subtractive'. This innovative approach to randomization will involve suppression of just 1 of the 5 treatment components. Thus, all participants will receive at least 80% of the menu of interventions offered in this trial.
Enrollment
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Inclusion criteria
A candidate for the HABIT program with a diagnosis of amnestic MCI (confirmed at eligibility visit by a Clinical Dementia Rating (CDR) scale of 0.5).
A cognitively normal care partner who has at least twice-weekly contact with the participant.
Either not taking or stable on memory medicine(s) (e.g. donepezil) for at least 3 months.
Fluent in English. (Expanding the program to communities of Spanish- speakers will be a high priority in subsequent dissemination work).
Exclusion criteria
Inclusion in another clinical trial that would exclude participation. Subject will be considered for participation at the end of such a trial or as appropriate.
Medically unable to participate in all arms by virtue of visual or auditory impairments or non-ambulatory status.
Trial design
Primary purpose
Allocation
Interventional model
Masking
272 participants in 5 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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