unhealthy behavior, unhealthy lifestyle
Conditions
Interventions
Participants randomized to the intervention arm will have access to an app that
facilitates self-management of dementia risk factors (obesity, physical
inactivity, hypertension, hypercholesterolemia
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 50 years under 75 years; - Basic level of literacy in Dutch; - Possession of a smartphone; - Migration background; OR Dutch background with low SES background, operationalised using educational level and occupational status. - Increased risk of dementia based on: 1. >= 1 dementia risk factors defined as: hypertension, dyslipidaemia, Diabetes Mellitus, Active smoking, Overweight, Lack of physical exercise, Depression 2. OR Manifest cardiovascular disease, as diagnosed by specialist or general practitioner
Exclusion criteria
Exclusion criteria: - Previously diagnosed with dementia by a specialist or general practitioner - A score below the cut-off score of 21 on the Rowland Universal Dementia Assessment Scale (RUDAS), a validated dementia screening method specifically developed to be less susceptible to cultural, linguistic, and educational biases. The RUDAS is available in multiple languages, including Dutch and Turkish. - Any condition expected to limit 12 months compliance and follow-up, including metastasised malignancy or other terminal illness - Any impairment interfering with operation of a smartphone - Participating in another RCT on lifestyle behavioural change
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is a type 2 hybrid implementation-effectiveness randomised controlled clinical trial. There is a primary effectiveness outcome and there are several implementation outcomes. - Effectiveness: composite score of systolic blood pressure, non HDL-cholesterol and BMI. We will use the z-score of the difference between baseline and 12 months follow-up values to be analyzed as continuous variables, as previously done in the HATICE trial. - Implementation of the mHealth application: Since the different implementation outcomes will have to be weighed against each other, we will measure multiple aspects of implementation using mixed methods. o Acceptability: user-friendliness and credibility (qualitative research methods). o Adoption: quantitative analysis of the utilisation, usage and uptake of the mHealth intervention. o Appropriateness: qualitative analysis of the perceived fit or relevance of the mHealth intervention in the target population. o Feasibility: qualitative analysis to what extent the mHealth application can be carried out in a low socio-economic setting and in a population with a migration background. o Fidelity: qualitative evaluation of the degree to which the mHealth application is implemented compared to the original design. o Implementation cost: analysis of the implementation costs will be part of a health economic analysis. o Sustainability: quantitative evaluation of the extent to which the mHealth application is being used during the 12 months of the implementation trial. For the groups with a Dutch, Turkish and Surinamese Hindustan background, the study will be extended to 36 months to study long term effectiveness and implementation outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in CAIDE and LIBRA dementia risk score - Change in individual modifiable components of the CAIDE and LIBRA risk score (i.e. blood pressure, BMI, total cholesterol, physical activity) - Disability (questionnaire: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0, 12-item)) - Depressive symptoms (questionnaire: Geriatric Depression Scale 15-item (GDS-15)) - Self-efficacy (questionnaire: Partners In Health (PIH)) - Cost-effectiveness - Intervention costs - Cognitive functioning, assessed with culturally-sensitive short cognitive test battery - Digital measures for social daily functioning measured by BeHapp (remote behavioural monitoring app). Only in a subgroup of participants willing to install the BeHapp app; separate consent will be asked on the informed consent form. | — |
Countries
Netherlands
Contacts
Public ContactMP Hoevenaar-Blom
Amsterdam UMC
Outcome results
None listed