Behavioral Interventions to Prevent or Delay Dementia
Comparative Effectiveness of Behavioral Interventions to Prevent or Delay Dementia (CEBIPODD)
1 other identifier
interventional
272
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 10, 2014
CompletedFirst Posted
Study publicly available on registry
October 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedFebruary 22, 2019
February 1, 2019
3.8 years
October 10, 2014
February 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in patient quality of life
quality of life measured by the QOL-AD scale
baseline to 18 months
Secondary Outcomes (2)
improvement in patient memory based everyday functioning
baseline to 18 months
improvement in caregiver mood and sense of burden
baseline to 18 months
Study Arms (5)
No Cognitive Rehabilitation
EXPERIMENTALWill receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise.
No Computer Brain Fitness Training
EXPERIMENTALWill receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and Physical Exercise
No Support Group
EXPERIMENTALWill 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
EXPERIMENTALWill 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
EXPERIMENTALWill receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education
Interventions
Will provide each couple with memory compensation training 5 days per week for 2 weeks, with initial and ending adherence sessions. All sessions will involve 45- 60 minutes of training. The curriculum is described briefly here. Learning phases. three training stages from learning theory: 1) an acquisition phase in which use of the memory compensation system is learned, 2) an application phase in which a participant is taught to apply to his/her daily life, and 3) an adaptation phase in which a participant practices incorporating into his/her daily life so as to make its use habitual.
Will use the commercially available Posit Science product BrainHQ™ (www.brainhq.com) on tablets (e.g. iPads). Participants will complete 45-60 minutes of training daily in the program and will be encouraged to maintain 250 minutes of computerized brain training per week for 18 months post program. Each participant's adherence and progress will be tracked through the clinician portal provided by Posit Science both during HABIT and for 18 months post-program.
Patient: The patient support group will meet for 45-60 minutes daily. It will use the LifeBio Memory Journal© as a basis for reminiscence-focused group sessions. Partner: The care partner support group meets separately from the patient group for 45-60 minutes daily.
The education component will involve daily 60-minute group sessions with topics including Introduction to the Program, Living with MCI, Changes in Roles, Communication and Relationships, Sleep Hygiene, Steps to Healthy Brain Aging, Preventing Dementia, MCI and Depression, Nutrition and Exercise, Safety and Assistive Technologies, and Participating in Research, Community Resources, Meaning and Purpose, and Joy.
The HABIT physical exercise intervention is intended to initiate and sustain a schedule rather than a type of physical activity. HABIT will provide a customized DVD as a supplement for continued use and practice after the program to those that opt to continue yoga. Will use an activity log completed by the partner to track activity level of the participants during the 18 month follow-up period.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Medically unable to participate in all arms by virtue of visual or auditory impairments or non-ambulatory status.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (3)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Publications (3)
Levy SA, Smith G, De Wit L, DeFeis B, Ying G, Amofa P, Locke D, Shandera-Ochsner A, McAlister C, Phatak V, Chandler M. Behavioral Interventions in Mild Cognitive Impairment (MCI): Lessons from a Multicomponent Program. Neurotherapeutics. 2022 Jan;19(1):117-131. doi: 10.1007/s13311-022-01225-8. Epub 2022 Apr 12.
PMID: 35415779DERIVEDChandler MJ, Locke DE, Crook JE, Fields JA, Ball CT, Phatak VS, Dean PM, Morris M, Smith GE. Comparative Effectiveness of Behavioral Interventions on Quality of Life for Older Adults With Mild Cognitive Impairment: A Randomized Clinical Trial. JAMA Netw Open. 2019 May 3;2(5):e193016. doi: 10.1001/jamanetworkopen.2019.3016.
PMID: 31099860DERIVEDSmith G, Chandler M, Locke DE, Fields J, Phatak V, Crook J, Hanna S, Lunde A, Morris M, Graff-Radford M, Hughes CA, Lepore S, Cuc A, Caselli M, Hurst D, Wethe J, Francone A, Eilertsen J, Lucas P, Hoffman Snyder C, Kuang L, Becker M, Dean P, Diehl N, Lofquist M, Vanderhook S, Myles D, Cochran D. Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study. JMIR Res Protoc. 2017 Nov 27;6(11):e223. doi: 10.2196/resprot.8103.
PMID: 29180344DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie Fields, PhD, LP
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
October 10, 2014
First Posted
October 16, 2014
Study Start
June 1, 2014
Primary Completion
March 31, 2018
Study Completion
March 31, 2018
Last Updated
February 22, 2019
Record last verified: 2019-02