Lowering dementia risk factors in people with elevated dementia risk Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 19/06/2024:
Randomization will take place in the app using a computer algorithm in a 1:1 manner. Participants will be informed that random allocation will be to one of two
Sponsors
Amsterdam University Medical Centers
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 05/06/2024: 1. Age =50 years =75 years 2. Basic level of literacy in Dutch 3. Possession of a smartphone 4. Turkish or South-Asian Surinamese background; OR Dutch background with low SES, operationalised using educational level and occupational status 5. Increased risk of dementia based on = one dementia risk factor defined as: 5.1. Hypertension, defined by any of the following: 5.1.1. Diagnosis by specialist or general practitioner. 5.1.2. Currently on anti-hypertensive drugs. 5.1.3. Baseline blood pressure: =140/90 mmHg; 5.2. Dyslipidaemia, defined by any of the following: 5.2.1. Diagnosis by specialist or general practitioner 5.2.2. Use of lipid-lowering drugs 5.2.3. Baseline total cholesterol =5.0 mmol/L 5.3. Diabetes mellitus, defined by any of the following: 5.3.1. Diagnosis by specialist or general practitioner 5.3.2. Use of any blood glucose-lowering medication 5.4. Active smoking (use of any sort of tobacco in any quantity) 5.5. Overweight, defined by any of the following: 5.5.1. Body mass index (BMI) =30 kg/m² 5.5.2. Waist circumference men =102 cm, women =88 cm 5.6. Lack of physical exercise, defined as below the World Health Organization (WHO) norm (five times a week 30 minutes or a total of 150 minutes per week of intermediate exercise) 5.7. Depression 5.7.1. Currently on anti-depressive medication or receiving psychotherapy for depression 5.7.2. History of treatment (i.e. drug therapy or psychotherapy) for depression OR Manifest cardiovascular disease, as diagnosed by specialist or general practitioner _____ Previous inclusion criteria: 1. Age =50 years =75 years 2. Basic level of literacy in Dutch 3. Possession of a smartphone 4. Turkish or South-Asian Surinamese background; OR Dutch background with low SES, operationalised using educational level and occupational status 5. Increased risk of dementia based on = one dementia risk factor defined as: 5.1. Hypertension, defined by any of the following: 5.1.1. Diagnosis by specialist or general practitioner. 5.1.2. Currently on anti-hypertensive drugs. 5.1.3. Baseline blood pressure: =140/90 mmHg; 5.2. Dyslipidaemia, defined by any of the following: 5.2.1. Diagnosis by specialist or general practitioner 5.2.2. Use of lipid-lowering drugs 5.2.3. Baseline total cholesterol =5.0 mmol/L 5.3. Diabetes mellitus, defined by any of the following: 5.3.1. Diagnosis by specialist or general practitioner 5.3.2. Use of any blood glucose-lowering medication 5.4. Active smoking (use of any sort of tobacco in any quantity) 5.5. Overweight, defined by any of the following: 5.5.1. Body mass index (BMI) =25 kg/m² 5.5.2. Waist circumference men =102 cm, women =88 cm 5.6. Lack of physical exercise, defined as below the World Health Organization (WHO) norm (five times a week 30 minutes or a total of 150 minutes per week of intermediate exercise) 5.7. Depression 5.7.1. Current depression 5.7.2. Currently on anti-depressive medication or receiving psychotherapy for depression 5.7.3. History of treatment (i.e. drug therapy or psychotherapy) for depression OR Manifest cardiovascular disease, as diagnosed by specialist or general practitioner
Exclusion criteria
Exclusion criteria: 1. Diagnosed with dementia by a specialist or general practitioner 2. A score below 21 on the Rowland Universal Dementia Assessment Scale (RUDAS) validated dementia screening method specifically developed to be less susceptible to cultural, linguistic, and educational biases 3. Any condition expected to limit 12 months of compliance and follow-up, including metastasised malignancy or other terminal illness 4. Any impairment interfering with the operation of a smartphone 5. Participating in another RCT on lifestyle behavioural change 6. Present alcohol or illicit drug abuse impairing study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 05/06/2024: All effectiveness outcomes are measured at baseline and at the study end after 12 months. 1. The primary effectiveness outcome will be a composite score of the objectively measurable dementia risk factors: 1.1. Systolic blood pressure measured twice with a calibrated automated blood pressure device 1.2. non-HDL cholesterol measured using a capillary blood sample 1.3. BMI (kg/m2) calculated using weight and height measured with a calibrated scale Implementation outcomes: Quantitative: 2.1. Coverage: (non)response rates, comparison characteristics participants with eligible/source population measured at baseline 2.2. Adoption: quantitative analysis of the utilisation, usage and uptake, e.g. logins, goals setting, sending messages measured after 1 month (data features) 2.3. Appropriateness measured using a short questionnaire of perceived fit or relevance after 6 months and at study end 2.4. Acceptability measured using a short questionnaire of agreeability, user-friendliness, credibility, complexity, content* after 6 months and at study end 2.5. Sustainability: adherence, dropout measured after 6 months and at the end of the study, data features throughout the study 2.6. Implementation cost estimated by platform price and coach full-time equivalent at the end of the study Qualitative: 2.7. Feasibility: the extent to which the mHealth intervention can be carried out, practical and social barriers/facilitators measured after 6 months 2.8. Appropriateness: perceived fit or relevance in the target population measured after 6 months 2.9. Acceptability: agreeability, user-friendliness, credibility, complexity, content measured after 6 months 2.10. Fidelity: the degree to which the mHealth application is implemented compared to the original protocol, measured after 6 months 2.11. Adoption: initial utilisation, usage and uptake measured after 6 months 2.12. Sustainability: adherence, dropout measured after 6 months _____ | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/06/2024: All effectiveness outcomes are measured at baseline and at study end after 12 months: 1. Physical exercise measured using the self-administered short International Physical Activity Questionnaire - Short Form (IPAQ-SF) 2. Disability measured using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0, 12-item) 3. Depressive symptoms measured using the Geriatric Depression Scale 15-item (GDS-15) 5. Dementia risk score measured using Cardiovascular Risk Factors, Aging and Dementia (CAIDE) 6. Individual modifiable components of the CAIDE risk score 7. Intervention costs measured using costs of coaches and intervention development by Interactive Studios 8. Cost-effectiveness analyses using health-economic decision-analytic model 9. Cognitive functioning measured using the Rowland Universal Dementia Assessment Scale (RUDAS) and Box task 10. Daily distance moved, measured usingBehapp, a remote behavioural monitoring app, in a subgroup of participants willing to install the BeHapp app _____ Previous secondary outcome measures: All effectiveness outcomes are measured at baseline and at study end after 12 months: 1. Physical exercise measured using the self-administered short International Physical Activity Questionnaire - Short Form (IPAQ-SF) 2. Disability measured using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0, 12-item) 3. Depressive symptoms measured using the Geriatric Depression Scale 15-item (GDS-15) 5. Dementia risk score measured using Cardiovascular Risk Factors, Aging and Dementia (CAIDE) 6. Individual modifiable components of the CAIDE risk score 7. Intervention costs measured using costs of coaches and intervention development by Interactive Studios 8. Cost-effectiveness analyses using health-economic decision-analytic model 9. Cognitive functioning measured using the Rowland Universal Dementia Assessment Scale (RUDAS) 10. Daily distance moved, measured usingBehapp, a remote behavioural mon | — |
Countries
Netherlands
Contacts
Public ContactEdo Richard
Outcome results
None listed