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Dementia risk reduction in the general practice: a tailored approach

Dementia risk reduction in the general practice: a tailored approach - Dementia risk reduction in the general practice

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56196
Enrollment
200
Registered
2021-05-25
Start date
2021-12-10
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cognitive decline dementia

Interventions

In the PoC trial, both the intervention (n=90) and control group (n=90) will get one session of personal face-to-face general practitioner (GP) guidance about living a brain-healthy lifestyle (based
a validated risk score that assesses how brain-healthy one*s current lifestyle is, based on 12 modifiable risk and protective factors for dementia). The intervention group will additionally get acc

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
A secondary study endpoint is the frequency and severity of the 12 individual LIBRA factors present within study participants at baseline and at follow-up.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)