A blended app and coach support programme to improve brain health

Feasibility trial outcome measures:
1. Sociodemographic measures: deprivation- measured using the Index of Multiple Deprivation (IMD) of the participant postcode, ethnicity as per ONS classification, age and gender, and education, questionnaire at baseline
2. Recruitment, acceptability of trial randomisation, intervention adherence, attrition: data log at 3 months
3. Availability of a designated practice nurse, health care assistant or CRN research delivery staff within participating GP practices: data log at baseline
4. Primary and secondary outcomes completion:
4.1. Cognition (80% follow-up): NIH Toolbox at 3 months
4.2. Use of app: data log at 3 months
4.3. BP (measured using blood pressure monitor): baseline and 3 months
4.4. BMI: (measurement of height and weight): baseline and 3 months
4.5. HbA1c(blood test):baseline and 3 months
4.6. Dementia Risk Score (PHQ-9): baseline and 3 months
4.7. Use of hearing devices: data log at 3 months
4.8. Social contact (Lubben Social Network Scale): questionnaire at baseline and 3 months
4.9. Quality of life (EQ-5D-5L): questionnaire at baseline and 3 months
4.10. Resource use (Client Service Receipt Inventory - CSRI): questionnaire at baseline and 3 months
5. Process evaluation: think-aloud interviews, individual interviews and if needed, focus groups, considering active elements, acceptability: Qualitative work at 3 months
6. The number of people identified as potentially eligible from GP lists: data log at baseline
7. The number of people who have been sent an invite to participate: data log at baseline
8. Number who agreed to contact about participation by responding to the invitation from the practice: data log at baseline
9. Number consenting to be included in the study: data log at baseline
10. Number recruited who meet eligibility criteria after baseline assessment: data log at baseline
11. Number randomised after baseline assessment from those eligible: data log at baseline
12. From those randomised, the number and proportion of people from deprived backgrounds (postcode in lower 4 deciles of the Index of Multiple Deprivation): data log at baseline
13. From those randomised, the number and proportion of people with formal education ending before 14 years of age: questionnaire at baseline
14. From those randomised, the number and proportion of people from minority ethnic backgrounds, measured according to Office for National Statistics guidance: questionnaire at baseline
15. The number and proportion randomised to the intervention arm who start the intervention (at least one intervention coaching session): data log at baseline
16. The number and proportion of participants randomised to the intervention arm who are adherent to the intervention, operationalised as logging into the intervention at least once a week, for at least two-thirds of weeks: data log at 3 months
17. The number and proportion of participants, by arm, who remain in the study until the final follow-up:
data log at 3 months
18. The number and proportion of participants, by arm, completing the envisaged primary outcome (NIH Toolbox) and each outcome measure at baseline and 3 months follow-up: questionnaire at baseline and 3 months
19. The intervention’s acceptability assessed during the process evaluation: data log at 3 months
20. The costs of delivering the intervention: data log at 3 months
21. Barriers and facilitators of using the prototype ENHANCE App as determined by qualitative interviews: Qualitative work at 3 months

Randomised controlled trial:
Between randomisation group differences at 12 months in individual Z-scores of the NIH Toolbox, comprising of 4 subtests: Pattern Comparison, Flanker, Picture Sequence, and Dimensional Card Sorting.

Randomised controlled trial:
1. Changes in each one of the NIH Toolbox four cognitive tests (Pattern Comparison, Flanker, Picture Sequence, Dimensional Card Sorting)
2. Between group change in dementia risk factors at follow-up:
2.1. Systolic/diastolic blood pressure measured using BP monitor at baseline, 6 months and 12 months
2.2. BMI (measurement of height and weight) at baseline, 6 months and 12 months
2.3. HBA1c (blood test) at baseline, 6 months and 12 months
2.4. Self-reported smoking (cigarettes/week) questionnaire at baseline, 6 months and 12 months
2.6. Self-reported alcohol use (units/week measured using the Audit-C) questionnaire at baseline, 6 months and 12 months.
2.7. Hearing device use: self-reported yes/no use and if a user, self-reported daily use (in hours): Measured using 1 item of the International Outcome Inventory for Hearing Aids (IOI-HA) “Over the past 2 weeks, estimate the average daily duration of hearing aid use”: questionnaire at baseline
2.8. Hearing disability: change in self-reported hearing disability (when using hearing devices, if hearing device user), measured by validated Hearing Handicap Inventory for the Elderly – Screening version (HHIE-S) questionnaire at baseline, 6 months and 12 months.
2.9. Social contact: self-reported weekly contact using the 6-item Lubben Social Network Scale questionnaire at baseline, 6 months and 12 months
2.10. Mood: PHQ-9 questionnaire at baseline, 6 months and 12 months
2.11. Engagement in weekly physical activities measured by validated Rapid Assessment of Physical Activity (RAPA) questionnaire at baseline, 6 months and 12 months
2.12. Composite dementia risk score using an adapted LIBRA score, incorporating all 10 risk factors of interest and modified from risk scores found to be sensitive and responsive for use as surrogate outcomes in dementia prevention trials: questionnaire at baseline, 6 months and 12 months
3. App login (system usage) data on engagement: data log at 6 months and 12 months:
3.1. Number, frequency, and duration of participant logs into the app, per week, over the 24 weeks of the intervention: data log at 6 months and 12 months
3.2. Number, frequency, and duration of logs in each risk-specific component and in cognitive training activities
4. EuroQol EQ-5D-5L, a preference-based measure of health-related quality of life for calculation of quality-adjusted life years (QALYs): Questionnaire at baseline 6 months and 12 months
5. Adapted version of the Client Service Receipt Inventory (CSRI) questionnaire at baseline 6 months and 12 months