Dementia / cognitive decline
Conditions
Interventions
The intervention that will be tested in both the PoC trial and pilot study consists of the following:
• One session of personalized GP guidance concerning dementia risk reduction
• Access to a smartp
Sponsors
Maastricht University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: • Registered with a participating general practice • Age 40 – 60 on date of consent • Presence of one (or more) of the following risk factors: - Depression – previous history or active episode of minor depression as recorded on medical record – if GP deems patient fit to participate - Diabetes type 2 (diagnosis e.g. on a diabetes disease register) o Hypertension - Obesity (BMI = 30) - Current smoker - Hyperlipidemia - More than moderate consumption of alcohol (>1 standard drink per day) - Coronary heart disease - Chronic kidney disease - Inactive to moderately inactive lifestyle (assessed using the European Prospective Investigation into Cancer and Nutrition (EPIC) Physical activity questionnaire) - Unhealthy diet (defined as non-adherence to the Mediterranean diet, assessed using the Mediterranean Diet Adherence Screener (MEDAS)) - Lack of cognitive activity (assessed using the Cognitive Reserve Index questionnaire (CRIq)) • Proficient in Dutch language • Access to internet in order to use the smartphone application • Owns a smartphone
Exclusion criteria
Exclusion criteria: Active episode of major depression, while GP deems patient unfit to participate, recorded in medical record or assessed by a validated instrument • People unable to give IC • People with 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
| Measure | Time frame |
|---|---|
| The main endpoint of the PoC trial is the feasibility of the intervention. It will be evaluated on the basis of the following endpoints: 1. The difference in total LIBRA score change between the intervention and control group. 2. Use of the app 3. Participants’ awareness of modifiable dementia risk and protective factors at baseline and after 3 months 4. Participants’ understandings of and attitudes towards their health profile and the MijnBreincoach app 5. Participants views regarding supports and barriers to embed behavior changes into everyday life and, and whether the MijnBreincoach app helps or hinders participants make and maintain changes to individual health-related behaviors 6. Perspectives of involved primary care practitioners on the LIBRA score, and the MijnBreincoach app in terms of acceptability, demand, integration and implementation. 7. Further, the number of excluded individuals, and the number of dropouts will be recorded. The main endpoint of the embedded pilot study will be the usability of ESM-based questionnaires and feedback. This will be evaluated based on: 1. The obtained data points coming from the ESM-questionnaires will be examined in an exploratory manner. These will include measures of: - Context (time, location, social context) - Current activity - (Social cognitive) determinants of behavior - Positive and negative affect 2. The subjective experiences of the participants on the ESM-questionnaires and the ESM-feedback | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary study endpoint is the frequency and severity of individual LIBRA factors present within study participants at baseline and at follow-up. All LIBRA factors will be assessed: - Low/moderate alcohol intake (self-reported) - Coronary heart disease (self-reported or patient dossier) - Physical activity level (assessed with the European Prospective Investigation into Cancer and Nutrition (EPIC) Physical activity questionnaire) - Chronic kidney disease (self-reported or patient dossier) - Diabetes (self-reported or patient dossier) - Hyperlipidemia (self-reported or patient dossier) - Smoking (self-reported) - Obesity (self-reported height and weight) - Hypertension (measured) - Mediterranean diet adherence (assessed with the MEditerranean Diet Adherence Screener (MEDAS)) - Depression (assessed with the Patient Health Questionnaire 9 (PHQ-9)) - Cognitive activity (assessed with the Cognitive Reserve Index Questionnaire (CRIq)) | — |
Contacts
Public ContactStephanie Van Asbroeck
Maastricht University Medical Center
Outcome results
None listed