Feasibility RCT: In-MINDD Profiler & Supportive Environment

Not Applicable

Completed

• Conditions: Dementia; Mental and Behavioural Disorders; Demetia

• Registration Number: ISRCTN98553005
• Lead Sponsor: HS Greater Glasgow and Clyde (UK)

Brief Summary

2015 protocol in: http://www.pilotfeasibilitystudies.com/content/1/1/40 2016 results summary in: https://cordis.europa.eu/project/rcn/105501/reporting/en

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-07
• Study Completion: 2015-11-30
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Registered with a participating practice
2. Age 40 ? 60 on date of consent
3. Presence of any one (or more) of the following risk factors
3.1. Depression ? previous history OR active episode of minor depression as recorded on medical record ? IF GP deems patient fit to participate
3.2. Diabetes (diagnosis e.g. on a diabetes disease register)
3.3. Hypertension (as per national guidelines)
3.4. Obesity (BMI of 30.0 or above)
3.5. Current smoker
3.6. High cholesterol (as per national guidelines)
3.7. Coronary heart disease (diagnosis e.g. on a CHD disease register)
3.8. Self reported sedentary lifestyle
3.9. Self reported lack of cognitive stimulation
4. Medically stable
5. Literate in language of the partner country where patient is recruited (English/Dutch/French as appropriate).
6. Access to the internet in order to communicate by email and access information online

Exclusion Criteria

1. Active episode of major depression, if GP deems patient too severely ill to participate, recorded in medical record or assessed using a validated assessment score e.g. HADS
2. People who are unable to give informed consent
3. People who have dementia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Global risk score, calculated on the basis of a basket of individual risk factors identified from work package 1 of In-MINDD. These will include physical and cognitive activity; presence of depression, diabetes and/or cardiovascular disease; high cholesterol; smoking status; hypertension; and obesity.<br><br> dementia risk score will be measured by a dementia risk questionnaire. The questionnaire will be completed at baseline and at study completion (six months) and will be comprised of information on participants' mood, physical activity, cognitive activity and diet via four validated instruments which have been carefully selected and adapted where necessary.<br>

Secondary Outcome Measures

Name	Time	Method
Changes in individual risk factors