Elderly persons at risk of dementia Mental and Behavioural Disorders Dementia
Conditions
Interventions
Intervention group: coach-supported mobile health platform
Participants randomised to the intervention arm of the study will have access to an interactive mHealth platform that facilitates self-manage
Sponsors
AMC
Eligibility
Sex/Gender
All
Age
55 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age =55 years - 75 years 2. Good proficiency of the national language (English in UK, Mandarin in China) 3. Possession of a smartphone 4. Persons who currently don’t have good access to preventive health care, including Low SES in the UK (Sussex and Greater Cambridge areas), operationalised as living in a postal code area ranked as equal to or less than the 3rd decile of the index of multiple deprivation (IMD) OR inhabitant of the Greater Beijing area irrespective of SES. 5. = Two dementia risk factors defined as: 5.1. Manifest cardiovascular disease, as diagnosed by specialist or general practitioner 5.2. Lack of physical exercise (self-reported), 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) 5.3. Active smoking (self-reported use of any sort of tobacco in any quantity) 5.4. Hypertension, defined by any of the following: 5.4.1. Diagnosis by specialist or general practitioner. 5.4.2. Currently on anti-hypertensive drugs. 5.4.3. Baseline blood pressure: = 140/90 mmHg; 5.5. Overweight, defined by any of the following: 5.5.1. Body mass index (BMI) = 30 (UK) or 28 (China) 5.5.2. Waist circumference men = 102 cm (UK) or 90 cm (China), women = 88 cm or 85 cm (China) 5.6. Diabetes mellitus, defined by any of the following: 5.6.1. Diagnosis by specialist or general practitioner 5.6.2. Use of insulin or other blood glucose-lowering medication 5.7. Depression 5.7.1. Currently on anti-depressive medication or receiving psychotherapy 5.7.2. History of treatment (i.e. drug therapy, psychotherapy etc.) for depression 5.8. Dyslipidaemia, defined by any of the following: 5.8.1. Diagnosis by specialist or general practitioner 5.8.2. Use of lipid-lowering drugs 5.8.3. Baseline low density lipoprotein (LDL-C) = 3.0 mmol/L and/or total cholesterol = 5.0 mmol/L.
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed with dementia by a specialist or general practitioner 2. Mini Mental State Examination (MMSE) < 24 3. Any condition expected to limit 18-months compliance and follow-up, including metastasised malignancy or other terminal illness 4. Smartphone illiteracy, defined as not able to send a message from a smartphone 5. Visual impairment interfering with operation of a smartphone 6. Participating in another RCT 7. Present alcohol or illicit drug abuse; binge drinking is not an exclusion criterion – this is a potential target for behaviour change
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effectiveness of the mHealth intervention measured by the difference in dementia risk as measured with the CAIDE risk score between baseline and follow-up. 2. Implementation of the mHealth application. 2.1 Acceptability: through qualitative research analysing the perceptions of different stakeholders (i.e. end-users, professionals, insurance companies and policy makers) whether the mHealth intervention is agreeable. Factors related to acceptability are user-friendliness and credibility. 2.2 Adoption: quantitative analysis of the utilisation, usage and uptake of the mHealth intervention 2.3 Appropriateness: qualitative analysis of the perceived fit or relevance of the mHealth intervention in the target population 2.4 Feasibility: qualitative analysis to what extent the mHealth application can be carried out in a low socio-economic setting and a middle-income setting. 2.5 Fidelity: qualitative evaluation of the degree to which the mHealth application is implemented compared to the original design 2.6 Implementation cost: analysis of the implementation costs will be part of the health economic analysis 2.7 Coverage: quantitative analysis of the degree to which the population with low socio-economic status and the population in a middle-income setting actually receives the mHealth application. 2.8 Sustainability: quantitative evaluation of the extent to which the mHealth application is being used during 18 months of the implementation trial and whether the dementia risk is sustainably reduced after this period. | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline and follow-up: 1. Individual modifiable components of the CAIDE risk score 1.1 Blood pressure 1.2 BMI 1.3 Total cholesterol 1.4 Physical activity (Questionnaire: International Physical Activity Questionnaire (IPAQ short)) 2. Estimated 10-year cardiovascular disease risk (estimated from a validated prediction score) 3. LIfestyle for BRAin health (LIBRA) score (estimated) 4. Number of uncontrolled risk factors 5. Incident dementia (obtained from questionnaires and validated) 6. Incident cardiovascular disease (stroke, TIA, myocardial infarction, angina pectoris) (obtained from questionnaires and verified from medical records) 7. Mortality (obtained from questionnaires and validated) 8. Diet (Questionnaire: Cleghorn short form food frequency questionnaire) 9. Disability (Questionnaire: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0, 12-item)) 10. Anxiety (Questionnaire: Hospital Anxiety and Depression Scale (HADS, anxiety only)) 11. Self-management (Questionnaire: Partners In Health (PIH)) 12. Depressive symptoms (Questionnaire: Geriatric Depression Scale 15-item (GDS-15)) 13. Cost-effectiveness (questionnaire EQ5D) | — |
Countries
China, England, United Kingdom
Outcome results
None listed