Dementia Nervous System Diseases Unspecified dementia
Conditions
Interventions
Timetable: Training of interviewers will be conducted in April 2018. Once governance processes (DBS, Research letters of access etc), are in place the trialists will begin approaching participants in
Sponsors
University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Past participants in the Cognitive Function and Ageing Study II who have not refused further contact with the study 2. Must report at least 1 of the following: 2.1. Hypertension, angina, intermittent claudication or heart attack 2.2. Stroke or transient ischaemic attacks 2.3. Current or recent smoker (within last five years) 2.4. Diabetes 2.5. Physically inactive 3. Participants must have capacity to provide informed consent 4. Must have access to a computer (library if not at home)
Exclusion criteria
Exclusion criteria: 1. Non participants of the Cognitive Function and Ageing Study II or those study participants who have refused further contact from the study 2. Dementia or cognitive impairment (study diagnosis using CFAS algorithm) or MMSE< 21 3. Computer illiteracy (defined as unable to send email) 4. Severe visual impairment (interferes with computer operation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| From 25/06/2018: This trial is not powered to investigate health outcomes. The primary aim of the study is to conduct the preparatory work necessary to design a large-scale randomised controlled trial of an internet based intervention in the older population by resolving key uncertainties for trials in this population of older age adults (75-90 years) with an increased cardiovascular risk. Prior to 25/06/2018: The proportion of people with pre-existing eligibility criteria from the CFAS II cohort who remain eligible for approach From 25/06/2018: 1. The acceptability of the intervention to the target population of people aged 75-90 years, measured at baseline 2. The proportion of the older population who have access to and use the internet, measured at baseline 3. A primary health outcome measure of treatment will be a change in the Australian National University - Alzheimer Disease Risk Index (ANU-ADRI) score conducted at baseline and 12-week follow-up interviews 4. The number of those randomised to the ‘active intervention’ group who agree to accept the intervention 5. The proportion of those randomised to the ‘control intervention’ group who agree to take part 6. The retention rate post randomisation at baseline for all groups 7. The adherence rate during the internet intervention period of 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| From 25/06/2018: 1. The variability between baseline and 12 weeks in the main outcome measure (ANU-ADRI), a validated self-reported tool to identify those at risk of Alzheimer’s disease (AD) and dementia in later life 2. Composite scores of systolic blood pressure, total cholesterol, body mass index and MMSE at baseline and 12-week follow-up interviews 3. The EuroQol 5-Dimension (EQ-5D), a health-related quality of life questionnaire, will be measured and tested for suitability as an assessment of cost-effectiveness for the main trial 4. Alternative health outcome measures such as brief dementia screening index, and the UK based dementia risk score, will be measured for comparison purposes at 12 weeks 5. At baseline the trialists will determine the impact of the trial discussion on study retention 6. The extent to which informed consent has modified behaviour at 12 weeks 7. The potential for changes in outcomes in intervention and control groups at 12 weeks | — |
Countries
United Kingdom
Outcome results
None listed