Brigham and Women's Hospital, Department of Neurology
Boston, Massachusetts, 02115, United States
NCT Number: NCT03772977
6-month, randomized, controlled investigation measuring the effect of increased clinical contact and personalization compared to standard physician counseling on adherence to consensus-based, brain health recommendations for patients with subjective cognitive decline, mild cognitive impairment, and early dementia or patients who are at risk for developing these conditions.
This study is active but is not currently recruiting participants.
Notify Me60 year–79 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
This is a 6-month, randomized, controlled investigation measuring the effect of increased clinical contact and personalized recommendations from a health coach, compared to standard physician counseling on adherence to consensus-based, brain health recommendations, including 80 patients with either subjective cognitive decline, MCI, or early dementia enrolled from a hospital-based memory disorders clinic, or, with risk factors for dementia enrolled from a hospital-based primary care clinic. Participants and caregivers in the health coach arm work with a health coach within their respective practice, called the a "brain health champion" (BHC), through weekly motivational phone calls every 6 weeks. In the encounters and visits, BHCs and patients/caregivers work together to establish, update, and achieve personalized, attainable lifestyle goals. Participants in the control arm receive standard counseling and education from providers during routine clinic visits. Changes in physical activity, dietary pattern, and social and cognitive activities are measured using questionnaires validated in cognitively impaired and normal populations. Other outcomes include measures of quality of life (QOL), cognitive function, neuropsychiatric status, sleep quality, and behavior. Follow-up assessments are also completed at 6 months post-intervention, with some patients receiving "booster" encounters to assess the maintenance of behaviors.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A health coach embedded within an existing clinical care team
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.
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.
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.
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.
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.
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.
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.
Brigham and Women's Hospital
Other
The Brain Health Champion Study: Promoting Non-pharmacological Interventions in Cognitive Disorders and Those at Risk
Acronym: BHC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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