Counseling for Cognitive Decline

(BHC Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Other interventions, Exercise inability, Health concerns

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if regular, personalized support helps individuals follow brain health advice more effectively than standard doctor visits. Participants will either receive weekly phone calls from a "health coach" (the Brain Health Champion) or standard counseling from their doctor. The trial targets individuals with early signs of memory issues or risk factors for dementia. Ideal participants include patients at Brigham Health who already see a doctor there and have early signs of cognitive decline or a family history of dementia. As an unphased trial, this study offers a unique opportunity to contribute to understanding how personalized support can enhance brain health management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for patients with cognitive decline?

Research has shown that the Brain Health Champion treatment is generally well-tolerated. In earlier studies, participants received regular support through health coaching, which encourages healthy habits to potentially slow or prevent memory and thinking problems.

These studies did not identify any major side effects from the health coaching itself. Participants managed the weekly phone calls and personalized support without significant issues, suggesting the treatment is safe for those at risk of memory problems or with early signs of dementia.

Overall, focusing on lifestyle changes through coaching appears to be a low-risk approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brain Health Champion (BHC) because it offers a fresh approach to tackling cognitive decline. Unlike the standard of care, which typically involves in-person counseling sessions with healthcare providers, BHC introduces a "health coach" who provides guidance through weekly phone calls. This new delivery method makes the intervention more accessible and convenient for patients, potentially leading to better adherence and outcomes. By emphasizing regular, personalized support, BHC aims to enhance patients' brain health in a way that is both innovative and user-friendly.

What evidence suggests that the Brain Health Champion intervention could be effective for cognitive decline?

Research has shown that health coaching, such as the Brain Health Champion program available to participants in this trial, might help slow or prevent memory and thinking problems. Studies have found that adopting brain-healthy habits can lower the risk of dementia. Early results from similar programs demonstrated improvements in overall thinking skills, planning, and spatial understanding. This method emphasizes changing health habits, which can be particularly beneficial for those with memory or thinking challenges. Overall, these findings suggest that personalized health coaching could be a promising approach to supporting brain health. ^{1 6 7 8 9}

Who Is on the Research Team?

Seth Gale

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 55 to 85 who are patients at Brigham Health system, fluent in English, and have cognitive issues like mild dementia or are at risk. Neurology patients must have specific diagnoses with certain MMSE scores, while primary care participants need a high CAIDE score or diabetes.

Inclusion Criteria

I am between 55 and 85 years old.

Existing patient at Brigham Health system with at least one prior visit with providers and plans to establish/continue longitudinal care

Be sufficiently fluent in the English language to understand instructions and perform the cognitive and functional tests

Exclusion Criteria

Be enrolled in another health behavior or non-pharmacologic intervention for a neurocognitive disorder

I cannot or do not want to exercise regularly.

Be not recommended to participate by their Internist/Primary Care Provider due to health-related concerns.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized recommendations from a health coach or standard physician counseling over 6 months

6 months

Weekly motivational phone calls for the health coach arm; routine clinic visits for the control arm

Follow-up

Participants are monitored for maintenance of behaviors and outcomes 6 months post-intervention

6 months

Follow-up assessments and booster encounters

What Are the Treatments Tested in This Trial?

Interventions

• Brain Health Champion

Trial Overview

The study tests the 'Brain Health Champion' program over six months. It compares personalized clinical contact and advice on brain health against standard counseling for people with cognitive decline or those at risk of developing such conditions.

How Is the Trial Designed?

Group I: Brain Health Champion (BHC) Experimental Treatment 1 Intervention

A "health coach" intervention with weekly phone calls

Group II: Standard of Care (SOC) Active Control 1 Intervention

The current physician/provider counseling on brain health to reduce cognitive decline or incidence of cognitive impairment that occurs, per providers' own practice

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

The pilot study involving 19 older adults with mild cognitive impairment (MCI) showed that combining cognitive training, mind-body exercise, and nurse-led risk factor modification (CPR) was feasible and had preliminary benefits, particularly in reducing cognitive decline and improving quality of life.

The nurse-led risk factor modification (RFM) group demonstrated significant improvements in cognitive scores, while the CPR group showed reductions in health service costs, indicating that both interventions could be effective strategies for managing MCI in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot feasibility randomized controlled trial on combining mind-body physical exercise, cognitive training, and nurse-led risk factor modification to reduce cognitive decline among older adults with mild cognitive impairment in primary care. Xu, Z., Zhang, D., Lee, ATC., et al.[2022]

In a 12-week intervention trial involving 127 elderly patients with Mild Cognitive Impairment (MCI), 84% showed significant improvements in cognitive function after participating in a personalized Brain Fitness Program.

Among a subset of 17 patients who underwent MRI scans, 12 exhibited either no hippocampal atrophy or an increase in hippocampal volume, suggesting potential for reversing cognitive decline associated with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Personalized 12-week "Brain Fitness Program" for Improving Cognitive Function and Increasing the Volume of Hippocampus in Elderly with Mild Cognitive Impairment. Fotuhi, M., Lubinski, B., Trullinger, M., et al.[2022]

A review of 12 dietary supplements marketed for brain health revealed that 67% had ingredients listed on their labels that were not detected in the actual product, indicating potential misbranding.

Additionally, 83% of the products contained compounds that were not reported on the labels, and many scientific claims made by these products lacked scientific support, highlighting the need for consumer education and regulatory improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Public Health Issue: Dietary Supplements Promoted for Brain Health and Cognitive Performance. Crawford, C., Boyd, C., Avula, B., et al.[2021]

Citations

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The Brain Health Champion Study

There is growing evidence that adherence to brain-healthy behaviors can reduce the cognitive decline and risk of dementia.

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researchgate.net

researchgate.net/publication/337202061_The_Brain_Health_Champion_study_Health_coaching_changes_behaviors_in_patients_with_cognitive_impairment

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PDF | Introduction: Converging evidence suggests that increasing healthy behaviors may slow or prevent cognitive decline.

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Compensatory and Lifestyle-Based Brain Health Program ...

Our pilot study demonstrates preliminary feasibility of a cognitive compensatory and lifestyle-based brain health program.

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NCT05934136 | Brain Health Program for Older Adults with ...

The investigators will compare two brain health programs in older adults with subjective cognitive decline and lifestyle risk factors for dementia.