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Innovative, Midlife Intervention for Dementia Deterrence: Feasibility Randomized Controlled Trial

Innovative, Midlife Intervention for Dementia Deterrence: Feasibility Randomized Controlled Trial - In-MINDD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42204
Enrollment
150
Registered
2014-08-18
Start date
2014-11-28
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Interventions

The online In-MINDD intervention and support environment consists of the following (note: all webpages will be in Dutch): •The In-MINDD Profiler, the study website that is used to gather the baselin

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Registered with a participating general practice -Age 40 - 60 on date of consent -Presence of any one (or more) of the following risk factors: o Depression - previous history or active episode of minor depression as recorded on medical record - if GP deems patient fit to participate o Diabetes (diagnosis e.g. on a diabetes disease register) o Hypertension o Obesity (BMI >= 30) o Current smoker o High cholesterol o Coronary heart disease (diagnosis e.g. on a coronary heart disease register) o Self-reported sedentary lifestyle o Self-reported lack of cognitive stimulation - Medically stable -Proficient in Dutch language -Access to internet in order to communicate by email and access information online

Exclusion criteria

Exclusion criteria: -Active episode of major depression, if GP deems patient too severely ill to participate, recorded in medical record or assessed by a validated instrument -People who are unable to give informed consent -People who have dementia

Design outcomes

Primary

MeasureTime frame
Feasibility will be evaluated on the basis of: •The number of participants that accomplish the online intervention. In addition, the number of excluded subjects, and the number of dropouts will be recorded. The researchers will try to contact withdrawn subjects, in order to clarify, the reason of the premature withdrawal (e.g. whether his or her reason were related to experimental set up). Mainly because this is part of the primary endpoint. Subjects will be informed that they are not obligated to give the reason why he or she has stopped with the experiment. These outcome measurements can give us crucial information about the applied intervention •Use of the online support environment in terms of access to and time spent on the support environment •Participants understanding of and attitudes towards their health profile and cognitive health score •Participants views regarding supports and barriers to embed behavior changes into everyday life •Perspectives of involved primary care practitioners on the cognitive health score, health profile, online intervention, and online support environment in terms of utility

Secondary

MeasureTime frame
The secondary outcome (surrogate endpoint) will be the change in LIfestyle for BRAin health (LIBRA) score, showing the gain in terms of brain health (room for improvement) someone can achieve by adopting a healthy lifestyle and adherence to disease management programs. The weight of each risk factor is based on an algorithm consisting of risk estimates retrieved from current meta-analyses and systematic reviews. Previous studies have used similar calculation of dementia risk. It consists of calculating the natural logarithm of a given risk factor, and using the factor with the lowest value (closest to zero) as the reference value. Each other factor*s weight is standardized against this reference value. In Table 1 of the rsearch protocol, the effect was lowest for low/moderate alcohol intake (relative risk (RR) = 0.74 --> ln (RR) = -0.30), so it was given a weight of one (i.e 0.30/0.30) and other risk factors were standardized by dividing them through 0.30. Summation of the weights for endorsed risk factors will yield a person*s In-MINDD dementia risk score. These following risk factors are included in the algorithm: low/moderate alcohol intake, coronary heart disease, physical inactivity, chronic kidney disease, diabetes, cholesterol, smoking, midlife obesity, midlife hypertension, healthy diet/Mediterranean diet, depression and cognitive activity

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)