Dementia Nervous System Diseases
Conditions
Interventions
Intervention Arm (Feasibility Trial):
Participants with at least three dementia risk factors as specified in the eligibility criteria, are randomised (2:1
n = 40) to receive a 12-week ENHANCE intervention. This includes a prototype app that delivers weekly activities focused on selected risk factors and personalised support from a coach. The coach meets
n = 20), receive a letter containing their risk profile and encouragement to share this with their GP practice for follow-up, without additional coaching or app support.
Intervention Arm (Main RCT):
n = 294) to receive the intervention over 12 months. Baseline assessments—including questionnaires, clinical evaluations, blood sample analysis, and measurement of the 10 specified risk factors—are co
Sponsors
North London NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >=60 and =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 =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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 p | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed