A Pilot Study for the Brain Health Support Program

Study Overview
=================
Brief Summary
-----------------
Prior studies have shown that programs that focus on promoting brain health and managing lifestyle risks (such as poor diet, obesity, physical inactivity, sleep issues, loneliness) may help in preventing or lowering the risk of dementia. To address this, investigators have developed the CAN-THUMBS UP program to conduct studies that target lifestyle risk and focus on dementia prevention. An online Brain Health Support Program (BHSP) has been developed. The BHSP is an educational program designed to teach about dementia. Before the full BHSP is offered to a large group, we are conducting an initial pilot study to help assess the usability of the program.

Official Title
-----------------
A Pilot Study for the Brain Health Support Program (BHSP) Intervention of the Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia

Conditions
-----------------
Dementia, Mild Cognitive Impairment, Subjective Cognitive Impairment, Pre-dementia, Dementia Prevention

Intervention / Treatment
-----------------
* Behavioral: Brain Health PRO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for No Dementia and one of the following (according to CCNA criteria): Cognitively Intact (CI) Cognitively Intact plus Subjective Cognitive Impairment (CI + SCI) Mild Cognitive Impairment (MCI) • AND Classified as being at increased risk of dementia based on at least one of the following: First-degree family history of dementia Self-Reported or documented current and/or history at midlife (45-60) on any of the following risk factors: Hypertension (documented Systolic Blood Pressure > 140 mm Hg; OR physician diagnosis of hypertension; OR treatment for hypertension; OR other approaches to treatment (e.g. diet, exercise)) Hypercholesterolemia (documented total cholesterol > 6.5 mmol/L; OR physician diagnosis of hypercholesterolemia; OR treatment for hypercholesterolemia; OR other approaches to treatment (e.g. diet, exercise)) Body Mass Index > 30 kg/m2 (derived from NIH Metric BMI Calculator) Physical Inactivity (active is defined as engaging in a minimum of 20- 30 min of physical activity causing sweating and breathlessness, at least 2 times a week)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Dementia<br> | Behavioral: Brain Health PRO<br>* The BHSP is an educational program designed to teach about dementia. It aims to provide best available evidence for lifestyle changes that can help lower dementia risk, and to provide specific recommendations for positive lifestyle changes (e.g., physical exercises to try at home, healthy recipes). The program was developed as a collaborative effort by Canadian investigators who have expertise in the different areas of dementia prevention, along with input from older-adult citizen advisors.<br>* Other names: Brain Health Support Program;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functionality of the BHSP | Functionality of the web-based components of the BHSP measured in the pilot and qualitative focus group(s) questions | Nov 2021-Mar 2022 | 
| User acceptance of the BHSP | User adherence and engagement using the online program during the pilot including dates and times of use, duration of use and completion of program assessments | Nov 2021-Mar 2022 | 
| Usability of the BHSP | User satisfaction and evaluation of usability and acceptability of BHSP measured during the pilot and focus group(s) | Nov 2021-Mar 2022 | 
| To assess participant satisfaction with the organization, presentation and personalization of the BHSP content | Qualitative evaluation of participant responses during the focus group discussion | Nov 2021-Mar 2022 | 
| To evaluate the feasibility of remote data collection | User data, feedback and adherence to remote measures, such as: Screening evaluation by tele/video-conference, Neuropsychological Test Battery, Burst cognitive testing with the MyCogHealth app, online version of the Cogstate Brief Battery, Assessments of lifestyle risk factors (sleep, diet, mood, cognition, physical activity, vascular health, social and psychological health, vision and hearing), Actigraphy and EEG wearables as measures of total daily physical activity and sleep fragmentation, and Saliva sample collection for genomics testing (Polygenic Hazard Score) | Nov 2021-Mar 2022 |