Behavioral Interventions to Prevent or Delay Dementia
- Conditions
- Mild Cognitive ImpairmentMild DementiaImpaired CognitionMild Cognitive DisorderAmnestic DisorderDementia and Amnestic ConditionsMemory ImpairmentMemory DisordersPoor Short-term Memory
- Interventions
- Behavioral: Computer Brain Fitness TrainingBehavioral: Cognitive RehabilitationBehavioral: Wellness EducationBehavioral: Support Group (patient and partner)Behavioral: Physical Exercise
- Registration Number
- NCT02265757
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 272
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).
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description No Cognitive Rehabilitation Computer Brain Fitness Training Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise. No Cognitive Rehabilitation Wellness Education Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise. No Support Group Computer Brain Fitness Training Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Wellness Education and Physical Exercise No Wellness Education Computer Brain Fitness Training Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Physical Exercise No Physical Exercise Computer Brain Fitness Training Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education No Physical Exercise Support Group (patient and partner) Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education No Cognitive Rehabilitation Support Group (patient and partner) Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise. No Cognitive Rehabilitation Physical Exercise Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise. No Support Group Physical Exercise Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Wellness Education and Physical Exercise No Wellness Education Cognitive Rehabilitation Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Physical Exercise No Computer Brain Fitness Training Cognitive Rehabilitation Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and Physical Exercise No Computer Brain Fitness Training Support Group (patient and partner) Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and Physical Exercise No Computer Brain Fitness Training Wellness Education Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and Physical Exercise No Computer Brain Fitness Training Physical Exercise Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and Physical Exercise No Support Group Cognitive Rehabilitation Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Wellness Education and Physical Exercise No Wellness Education Physical Exercise Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Physical Exercise No Physical Exercise Cognitive Rehabilitation Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education No Support Group Wellness Education Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Wellness Education and Physical Exercise No Wellness Education Support Group (patient and partner) Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Physical Exercise No Physical Exercise Wellness Education Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education
- Primary Outcome Measures
Name Time Method Improvement in patient quality of life baseline to 18 months quality of life measured by the QOL-AD scale
- Secondary Outcome Measures
Name Time Method improvement in caregiver mood and sense of burden baseline to 18 months measured by the Caregiver Burden questionnaire and the Center for Epidemiological Studies Depression scale (CESD)
improvement in patient memory based everyday functioning baseline to 18 months measured by the Everyday Cognitive Functioning scale (ECOG)
Trial Locations
- Locations (3)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States