Back to resultsBehavioral Interventions to Prevent or Delay Dementia
Primary Purpose
Mild Cognitive Impairment, Memory Disorders, Mild Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Rehabilitation
Computer Brain Fitness Training
Support Group (patient and partner)
Wellness Education
Physical Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Behavioral Intervention, Mild Cognitive Impairment, HABIT, Cognitive Rehabilitation, Multi-Component Intervention
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Arizona
- Mayo Clinic in Florida
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
No Cognitive Rehabilitation
No Computer Brain Fitness Training
No Support Group
No Wellness Education
No Physical Exercise
Arm Description
Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise.
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and 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
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Physical Exercise
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education
Outcomes
Primary Outcome Measures
Improvement in patient quality of life
quality of life measured by the QOL-AD scale
Secondary Outcome Measures
improvement in patient memory based everyday functioning
measured by the Everyday Cognitive Functioning scale (ECOG)
improvement in caregiver mood and sense of burden
measured by the Caregiver Burden questionnaire and the Center for Epidemiological Studies Depression scale (CESD)
Full Information
NCT ID
NCT02265757
First Posted
October 10, 2014
Last Updated
February 21, 2019
Sponsor
Mayo Clinic
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02265757
Brief Title
Behavioral Interventions to Prevent or Delay Dementia
Official Title
Comparative Effectiveness of Behavioral Interventions to Prevent or Delay Dementia (CEBIPODD)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Memory Disorders, Mild Dementia, Impaired Cognition, Mild Cognitive Disorder, Amnestic Disorder, Dementia and Amnestic Conditions, Poor Short-term Memory, Memory Impairment
Keywords
Behavioral Intervention, Mild Cognitive Impairment, HABIT, Cognitive Rehabilitation, Multi-Component Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
272 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Cognitive Rehabilitation
Arm Type
Experimental
Arm Description
Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise.
Arm Title
No Computer Brain Fitness Training
Arm Type
Experimental
Arm Description
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and Physical Exercise
Arm Title
No Support Group
Arm Type
Experimental
Arm Description
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Wellness Education and Physical Exercise
Arm Title
No Wellness Education
Arm Type
Experimental
Arm Description
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Physical Exercise
Arm Title
No Physical Exercise
Arm Type
Experimental
Arm Description
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Rehabilitation
Other Intervention Name(s)
Memory Compensation Training, Memory Support System
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computer Brain Fitness Training
Other Intervention Name(s)
Brain Fitness
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Support Group (patient and partner)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wellness Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Exercise
Other Intervention Name(s)
Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in patient quality of life
Description
quality of life measured by the QOL-AD scale
Time Frame
baseline to 18 months
Secondary Outcome Measure Information:
Title
improvement in patient memory based everyday functioning
Description
measured by the Everyday Cognitive Functioning scale (ECOG)
Time Frame
baseline to 18 months
Title
improvement in caregiver mood and sense of burden
Description
measured by the Caregiver Burden questionnaire and the Center for Epidemiological Studies Depression scale (CESD)
Time Frame
baseline to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Fields, PhD, LP
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35415779
Citation
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.
Results Reference
derived
PubMed Identifier
31099860
Citation
Chandler 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.
Results Reference
derived
PubMed Identifier
29180344
Citation
Smith 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.
Results Reference
derived
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Behavioral Interventions to Prevent or Delay Dementia
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