Brain Health Together: A Live-Streaming Group-Based Digital Program

University of California San Francisco (UCSF)

Status: Completed

Conditions: Mild Cognitive Impairment; Cognitive Decline; Cognitive Deterioration; Cognitive Impairment, Mild; Cognitive Deficits, Mild

Treatments: Behavioral: Maintain Brain Health Together; Behavioral: Brain Health Together; Behavioral: Brain Health Academy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05818423

R44AG074727 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to develop and test a comprehensive Brain Health Together program for older adults living with cognitive decline.

Full description

Older adults with cognitive decline (including either mild cognitive impairment [MCI] or subjective cognitive decline [SCD]) represent a large market with important unmet needs. Approximately one in three older adults (18 million Americans) are currently living with cognitive decline, which places them at increased risk of developing Alzheimer's disease and related dementias (ADRD). There are no medications that can prevent development of dementia in people with cognitive decline; however, there is growing evidence that behavioral interventions targeting modifiable dementia risk factors-such as increasing physical activity and reducing social isolation-may help improve cognitive function and could potentially delay dementia onset. Preliminary results suggest that Moving TogetherTM program is associated with significant improvements in cognitive function, physical function, social isolation, and self-regulation as well as increased default mode network connectivity on pre/post resting state functional magnetic resonance imaging scans in people with cognitive decline. The investigators believe that these benefits would be even greater if Moving Together were combined with a comprehensive brain health coaching program.

Enrollment: 208 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English language fluency;*
• live in U.S.;
• cognitive decline (subjective cognitive decline OR diagnosis of mild cognitive impairment in the past 12 months)
• ready to make lifestyle changes to improve brain health;
• have 2 or more brain health risk factors (e.g., low physical activity, depression, hypertension, diabetes, etc)
• have a desktop or laptop computer or iPad/tablet with a video camera;
• have broadband internet access;
• able to participate in online, live-streaming classes with two-way video

Exclusion criteria

Candidates meeting any of the exclusion criteria will not be eligible to participate.

Alzheimer's disease or dementia

• Major neurological disorder (e.g., Parkinson's disease, Multiple Sclerosis, amyotrophic Lateral Sclerosis)

• Schizophrenia or other psychotic disorder
• Autism or autism spectrum disorder
• Major mood or anxiety disorder that is not well-controlled (e.g., symptoms of depression or anxiety that made it hard to do daily tasks in past 6 months)
• Fracture of spine ("compression fracture") in the past 12 months
• Vertigo or severe dizziness in the past 12 months
• Severe vision or hearing impairment (e.g., unable to see and hear well enough to watch a movie on TV);
• Stroke or heart attack in the past 12 months
• Physical limitation that would restrict ability to participate (e.g., use wheelchair or walker to get around home, unable to stand up from sitting without assistance)
• Currently in another research study that could confound results of this study (e.g., drug study or other study to improve brain health)
• Previous participation in Moving Together or Brain Health Together
• Limited life expectancy (e.g., enrolled in hospice, undergoing cancer treatment)

If participants are not sure about certain conditions, they will be asked to describe their condition, and the research team will determine whether they meet eligibility criteria or not.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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208 participants in 3 patient groups

Brain Health Academy

Experimental group

Description:

Participant in this arm will watch expert videos on a wide range of brain health topics and will complete quizzes for 2.5 hours a week for 12 weeks (30 hours total)

Treatment:

Behavioral: Brain Health Academy

Brain Health Together

Experimental group

Description:

Participants in this arm will participate in online, live-streaming Moving Together classes (1 hour a week) and group brain health classes (1 hour a week) and will work 1-on-1 with a brain health coach to set personalized risk reduction goals (0.5 hours a week) for 12 weeks (30 hours total)

Treatment:

Behavioral: Brain Health Together

Maintain Brain Health Together

Experimental group

Description:

Participants in this arm will participate in the full Brain Health Together program for 12 weeks (30 hours) followed by weekly group classes and six 1-on-1 coaching sessions for another 12 weeks (additional 15 hours; 45 hours total)

Treatment:

Behavioral: Maintain Brain Health Together