Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2018
INTERVENTION: 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 May 2018. They will conduct the interviews and 12 week follow up interviews over a period of 15 months. Qualitative interviewing will begin July 2018 until August 2019 with focus groups being held between January and July 2019. The study will end in June 2020. Recruitment: All potential participants were recruited into the Cognitive Function and Ageing Study II (CFAS II) between 2008 and 2011. Over 7700 people were initially recruited to the study from three centres of the UK – Cambridge, Newcastle and Nottingham. All participants have conducted a baseline and two year follow‐up interview. All participants have given their consent for the study to approach them in the future for further interviews. Interviews will take place in participants own homes or a place of their choosing which provides a level of privacy. The trialists will approach 336 CFAS II participants aged over 75 years in each centre and invite them to take part in a further wave of interviewing. The interview is administered using assisted computer direct entry and has the following sections: demographics (marital status, education, residential status and intellectual activity) Lifestyle (smoking and alcohol), brief measure of physical activity. Health status including self‐perceived health, self‐reported chronic diseases including heart disease, angina, diabetes, stroke, Parkinson’s disease, epilepsy and meningitis. Rose angina questionnaire, medication history, activities of daily living and cognition. We will also include new proposed outcome measures: Australian National University Alzheimer Disease Risk Index (ANU ADRI), EQ‐5D ‐ a health related quality of life questionnaire, blood pressure, cholesterol measurement and body mass index. At the end of the computer based interview participan CONDITION: Specialty: Public Health, Primary sub‐specialty: Public Health; UKCRC code/ Disease: Neurological/ Other degenerative diseases of the nervous system ; Nervous System Diseases 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) PRIMARY OUTCOME: 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 OUTCOME: 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
Epistemonikos ID: 6e63c53c210b3df5eb8f21cd455639eb7f0d0f02
First added on: Aug 24, 2024