The Brain Health Champion Study (BHC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03772977|
Recruitment Status : Enrolling by invitation
First Posted : December 12, 2018
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment Dementia, Mild Subjective Cognitive Decline At Risk for Cognitive Decline||Behavioral: Brain Health Champion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Brain Health Champion Study: Promoting Non-pharmacological Interventions in Cognitive Disorders and Those at Risk|
|Actual Study Start Date :||May 8, 2017|
|Actual Primary Completion Date :||October 31, 2018|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Brain Health Champion (BHC)
A "health coach" intervention with weekly phone calls and in-person visits
Behavioral: Brain Health Champion
A health coach embedded within an existing clinical care team
No Intervention: Standard of Care (SOC)
The current physician/provider counseling on brain health to reduce cognitive decline or incidence of cognitive impairment that occurs, per providers' own practice
- Self-report adherence to Mediterranean diet [ Time Frame: 6 months ]
Goulet Mediterranean Diet Score (questionnaire).
Measured adherence to the Mediterranean Diet. Likert Scale 0-44, with higher values indicating stronger adherence to the dietary pattern.
- Self-report participation in cognitive and socially stimulating activities [ Time Frame: 6 months ]
Florida Cognitive Activities Scale (questionnaire).
Measures participation in socially and cognitively stimulating activities. Likert Scale 0-180, with higher values indicating greater participation.
- Self-report exercise and physical activity [ Time Frame: 6 months ]
Physical Activity Scale for the Elderly (questionnaire).
Measures walking, moderate, and vigorous activity. Zero lower limit, no upper limit. Higher values indicate more physical activity.
- Quality of Life Self-Report [ Time Frame: 6 months ]
Flanagan Quality of Life Scale (questionnaire).
Measures quality of life. Likert scale 0-112, higher values indicate higher quality of life.
- Neuropsychiatric status [ Time Frame: 6 months ]
Neuropsychiatric Inventory Questionnaire.
Measures caregiver report of 12 neuropsychiatric symptoms, severity (1-3) and distress (0-5) with higher values indicating more neuropsychiatric symptoms.
- Cognitive function [ Time Frame: 6 months ]
Mini Mental Status Examination: Multidomain cognitive test, scored 0-30.
PACC-BHC: Neurosychological test battery including: 1) Free and Cued Selective Reminding Test (FCSRT); 2) Logical Memory, immediate and delayed Story Recall; 3) Visual Paired Associates; 4) Digit-Symbol Substitution Test; 5) Trail Making Test, Part A; 6) Trail Making, Part B; 7) Number Span, 8) Category Fluency (animals, fruits, vegetables); and 9) Phonemic Fluency.
- Sleep [ Time Frame: 6 months ]
Medical Outcomes Study Sleep Scale
Likert scale measuring sleep quality and sleep problems index. 0-60 with greater values representing higher sleep quality and lower sleep problems.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772977
|United States, Massachusetts|
|Brigham and Women's Hospital, Department of Neurology|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Seth A Gale, MD||Brigham and Women's Hospital|