Demin: Design and baseline results of a cluster randomized controlled trial investigating the uptake and effectiveness of a dementia risk reduction program in middle‐aged descendants of people with recently diagnosed Alzheimer disease or vascular dementia
Authors: Vrijsen Joyce , Maeckelberghe Els , Abu‐Hanna Ameen , De Deyn Peter Paul , de Winter Andrea , Reesink Fransje E , Voshaar Richard C Oude , Buskens Erik , De Rooij Sophia , Smidt Nynke 
Published: December 2020

Background

As no curative treatments for dementia are yet available, prevention is a key element to counteract the dementia epidemic. Our aim is to investigate the uptake and effectiveness of a tailor‐made online‐lifestyle‐program for dementia‐risk‐reduction targeting risk and protective factors for dementia among middle‐aged descendants of people with recently diagnosed late‐onset‐dementia.

Method

Demin is a cluster‐randomized‐controlled‐trial(RCT) with one‐year follow‐up, including 21 memory clinics which are randomized to a passive or active recruitment‐strategy (poster and flyer in waiting room of memory clinic; or with additional personal invitation by the medical doctor). We aim to recruit 378 participants, aged 40‐ 60 years, with a parent who is recently diagnosed with Vascular Dementia or Alzheimer’s Disease at one of the participating memory clinics. All participants will receive the tailor‐made online‐lifestyle‐program for dementia‐risk‐reduction, consisting of a dementia‐risk‐assessment (online questionnaire, physical examination and a fasting blood sample) and a tailor‐made online‐lifestyle‐advice for dementia‐risk‐reduction targeting protective (Mediterranean‐diet, low/moderate alcohol use, cognitive activity) and risk‐factors (physical inactivity, smoking, loneliness, cardiovascular diseases, hypertension, high cholesterol, diabetes, obesity, renal dysfunction, depression) for dementia. Dementia‐risk‐assessment will be repeated four times (3, 6, 9 and 12 months after baseline) during follow‐up. The primary outcome is the difference in uptake (proportion that signed online‐informed‐consent(IC)‐form of all potential eligible participants that received the patient‐information‐form) between the passive and active recruitment‐strategy. Secondary outcomes include change in 1) the Lifestyle‐for‐Brain‐Health(LIBRA)‐score, 2) individual health‐behaviors, 3) beliefs‐and‐attitudes with regard to dementia‐risk‐reduction and 4) compliance to the online‐health‐advice and that of the general‐practitioner.

Result

Setting up a multicenter cluster‐RCT is a challenge. Twenty out of 79 approached memory clinics in the Netherlands participate in the Demin‐study. The participant recruitment started in December,2018 and will continue until July 1st,2020. Within one year, 436(60%) of the 729 potential eligible participants received a patient‐information‐form of which 69(16%) signed the online IC‐form using SMS‐tan.

Conclusion

The primary outcome(uptake) and baseline results will be presented at the conference. In addition, we will pay attention to the challenges of setting up a multicenter cluster‐RCT pertaining to the required approval of the Dutch ministry of Health, Welfare and Sport according to the population‐screening‐act was needed.