Dementia risk reduction in the general practice: a tailored approach

Completed

Conditions: cognitive decline
dementia
10012272

Registration Number: NL-OMON56196

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

• Registered with a participating general practice
• Age 40-60 years old on date of consent
• Medically stable
• Proficient in Dutch language
• Access to internet in order to use the smartphone application
• Owns a smartphone
• Presence of any one (or more) of the following risk factors:
o Depression - previous history or active episode of minor depression as
recorded on medical record - if general practitioner deems patient fit to
participate
o Diabetes type 2 (diagnosis e.g. on a diabetes disease register)
o Hypertension
o Obesity (BMI >= 30)
o Current smoker
o Hyperlipidemia
o More than moderate consumption of alcohol (>1 standard unit per day)
o Coronary heart disease
o Chronic kidney disease
o Inactive to moderately inactive lifestyle
o Lack of cognitive activity
o Unhealthy diet

Exclusion Criteria

• ¬Active episode of major depression, if general practitioner deems patient
too severely ill to participate, recorded in medical record or assessed by a
validated instrument
• People who are unable to give informed consent
• People who have dementia
• People with certain conditions because of which they cannot make the
suggested lifestyle changes by default (e.g. special dietary requirements due
to e.g. bariatric surgery or coeliac disease); movement constraints (e.g. due
to cerebral palsy or hemiparesis)
• People who have previously used the MijnBreincoach app

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility will be evaluated on the basis of: (1) difference in change in<br /><br>LIBRA scores between groups; (2) use of the health app (percentage of<br /><br>completers, access to and time spent on app); (3) the number of excluded<br /><br>individuals and dropouts; (4) participants* understandings, attitudes and views<br /><br>towards their LIBRA profile and the health app, including their role when<br /><br>embedding behavior change into everyday life; and (5) perspectives of involved<br /><br>primary care practitioners on the LIBRA profile and health app in terms of<br /><br>acceptability, demand, integration and implementation.<br /><br>Usability of ESM technology will be evaluated based on ESM-derived data points,<br /><br>response rates and participants* subjective experiences regarding the method<br /><br>and its feedback.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A secondary study endpoint is the frequency and severity of the 12 individual<br /><br>LIBRA factors present within study participants at baseline and at follow-up. </p><br>