Clinical trial NCT05167045: A Pilot Study for the Brain Health Support 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Mild Cognitive Impairment
Subjective Cognitive Impairment
Pre-dementia
Dementia Prevention
Lead sponsor: Baycrest
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit it's cohort from various locations around Canada.

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.


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)

Primary outcomes:
measure: Functionality of the BHSP
timeFrame: Nov 2021-Mar 2022
measure: User acceptance of the BHSP
timeFrame: Nov 2021-Mar 2022
measure: Usability of the BHSP
timeFrame: Nov 2021-Mar 2022
measure: To assess participant satisfaction with the organization, presentation and personalization of the BHSP content
timeFrame: Nov 2021-Mar 2022
measure: To evaluate the feasibility of remote data collection
timeFrame: Nov 2021-Mar 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Fredericton
country: Canada
facility: University of New Brunswick
state: New Brunswick
city: Toronto
country: Canada
facility: Baycrest
state: Ontario
Study officials:
References: