A blended app and coach support programme to improve brain health

Eligibility criteria

Inclusion Criteria:
1. Age >=60 and <=80 years
2. Living in the community (not admitted to hospital or in a care home)
3. Registered with a GP practice
4. Able and willing to give informed consent
5. Participants should in principle be available for data collection at trial follow-up
6. Has access to a phone (does not have to own a phone but needs access to receive login code)
7. Has >=3 of the following risk factors:
7.1. Untreated or undertreated hypertension at a level increasing dementia risk measured as per NHS recommendations for blood pressure monitoring at a GP surgery (>=140/90 mmHg)
7.2 Untreated or undertreated diabetes mellitus (baseline HbA1c >= 48 mmol/mol)
7.3. Obesity (BMI >30 kg/m²) in those aged 60-75 years; high BMI will not be considered a risk factor in those over 75 years because the evidence suggests that losing weight after that age may increase dementia risk
7.4. Current smoker (smoking at least 7 cigarettes in the past week)
7.5. Drinking above level increasing dementia risk (>21 U/week)
7.6. Low level of physical activity (RAPA <150 min/week)
7.7. Formal education stopped before age 14
7.8. Depression (PHQ-9->=9)
 7.9. Infrequent social contact as measured using the 6-item version of the Lubben Social Network Scale
7.10. Untreated or undertreated hearing loss as determined by the following:
7.10.1. Untreated hearing loss: The participant has never been prescribed hearing aids and a Hearing screening test using the HearWHO app as tested during baseline is positive for hearing loss.
7.10.2. Undertreated hearing loss: The participant has been prescribed hearing aids at some point but is currently using them for less than 1 h per day on average, as determined by the International Outcome Inventory for Hearing Aids (IOI-HA).
7.10.3. If the person has treated hearing loss with current average daily use above 1 h a day they do not meet this criterion. People who have ever been prescribed hearing aids are assumed to have hearing loss and do not need to have their hearing tested.
The inclusion criteria for the main RCT will be refined following the feasibility trial.
Exclusion Criteria:
1. Participants already enrolled in another intervention trial.
2.  Dementia - either existing recorded diagnosis, taking acetylcholinesterase inhibitor, memantine or other dementia-specific medication. We will also monitor low cognitive score at baseline in the NIH Toolbox, and scores lower than 2 SD below the mean according to published norms will be discussed with clinical researchers to consider dementia adjudication for exclusion. (When this happens, the clinician making the adjudication will contact the participant to discuss the results and the reasons for exclusion and encourage them to visit their GP about this).
3. Active alcohol (AUDIT-C ≥8) or known substance dependence as identified by the practice team.
4. If question No. 9 on PHQ-9 ≥1, the participant will be excluded from ENHANCE due to suicidal thoughts.
5. Medical conditions preventing trial completion, including end-of-life care as determined by a practice GP, patients on the severe mental illness register, and blindness.
6. If in the opinion of the practitioner taking consent, the person is unable to provide informed consent.
7. Another member of the household has been recruited into the ENHANCE trial.
The inclusion and exclusion criteria for the main RCT will be refined accordingly following the feasibility trial.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-05-21