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

Dementia is an important public health problem in our ageing society. Despite
recent advances in the epidemiology of dementia, there is a profound lack of
public awareness that dementia risk may depend to some extent on modifiable
lifestyle factors. This lack of awareness is a major issue with important
consequences: persons-at-risk do not seek help, they receive insufficient and
inaccurate care as well as support from their social environment, and dementia
is stigmatized. In addition, most people are unaware that health and life style
adaptations, especially at midlife, might improve their cognitive health profile

The present feasibility study is part of the FP-7 funded In-MINDD (Innovative
Midlife Intervention for Dementia Deterrence; http://inmindd.eu) project, which
aims to decrease dementia risk and/or delay its onset through lifestyle
interventions in midlife. The overall aims of In-MINDD are to: (1) develop a
robust dementia risk model based on modifiable risk factors; (2) implement this
risk model in collaboration with patients and practitioners, by designing and
supporting an on-line user environment; and (3) test the feasibility and
effectiveness of the In-MINDD system through a primary care-based feasibility
RCT (present study). In addition, In-MINDD tries to communicate the message
that dementia risk can and should be modified to a wide audience, including the
general public, doctors, primary care nurses.

Primary Objective:
Our primary objective is to test the feasibility of the online In-MINDD
intervention through a primary care-based feasibility RCT. We hypothesize, that
providing persons with information on their health profile and access to
supportive on-line support environment is feasible.

By answering the following objectives we can largely explain whether the
In-MINDD RCT is successful in achieving the primary objective:
-Comparison of the effectiveness of the online In-MINDD intervention in
promoting cognitive health and lowering the prevalence/severity of individual
dementia risk factors with care as usual
-Exploration of the usage of the online In-MINDD intervention by participants
in terms of access to and time spent on the support environment
-Exploration of the feasibility of using the online In-MINDD intervention and
support environment from the perspective of participants
-Exploration of participants understanding of and attitudes towards their
health profile
-Exploration of the supports and barriers to embedding behavior changes into
everyday life, and whether the online In-MINDD intervention helps or hinders
participants make and maintain changes to individual health-related behaviors
-Exploration of the feasibility of using the online In-MINDD intervention from
the perspective of primary care practitioners
-Understanding the primary care practitioners view of the utility of the health
profile and how they relate that information to participants


Secondary Objective(s):
Our secondary objective (surrogate endpoint) is to test the effectiveness of
the online In-MINDD intervention for behavioural change that might justify a
large effectiveness RCT on dementia risk reduction. We hypothesize that
providing persons with information on their health profile and access to
supportive on-line support environment will influence their risk factor profile
and as a result will reduce their overall dementia risk score within a six
month period.

The study is a randomized feasibility RCT. Participants will be randomly
assigned to the experimental group (In-MINDD arm) and the control group
(control arm) after eligibility criteria are checked and after participants
signed informed consent (see Figure 4). Participants, GPs, practice nurses, and
the research team will know the arm to which participants are allocated.
Participants can follow the online In-MINDD intervention from home.

Duration of participation
The total duration of the study participation will be six months. This
six-months period is based on an estimation of time necessary to assess a
behavioral intervention like the In-MINDD intervention (sufficient time to
observe or to detect behavioral changes). Inclusion will start from July 2014.

Setting
The In-MINDD feasibility RCT will be based in four different primary care
systems in Europe, namely: Netherlands (Maastricht University), Scotland
(University of Glasgow), Ireland (Dublin City University) and France
(Université Nice Sophia Antipolis). Within each country, the work will be
located in general practices/family practices. A total of 6 general practices
will be recruited in each country; within each practice, a total of 25 patients
will be recruited, giving a total study population of 600 patients across the
four countries. For the present study conducted in the Netherlands, we will
recruit 150 participants. We will contact two GP associations within South
Limburg (ZIO = Zorg In Ontwikkeling, Maastricht en Heuvelland; HOZL =
Huisartsen Oostelijk Zuid-Limburg) to facilitate recruitment of general
practices (preferably three practices in the Eastern and three in the Western
region of South Limburg) based on their previous involvement in scientific
research, their expertise in elderly and mental health care, and their interest
in taking part in this particular study.

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 baseline
collection, is based on an online self-administered questionnaire for
individuals in midlife and takes approximately 15-25 minutes to complete (see
Figure 1 for an example of a profiler screen). The questions included in the
In-MINDD profiler were designed to collect the information from respondents in
relation to those risk and protective factors for dementia that it has been
decided to target in the In-MINDD intervention. Background information about
participants and family medical history is also collected. The following
provides a more detailed description of information collected via the In-MINDD
profiler:
- Back ground (socio-demographic) information about users (i.e. age, sex,
country of birth, marital status, employment status, educational attainment
(localized to each country) level of occupational attainment, and living
arrangements
- Information about the user*s health including height and weight (to calculate
body mass index), total cholesterol level, blood pressure, diagnosis of
cardiovascular disease, diabetes and chronic kidney disease.
- Information about family medical history (i.e. dementia, cardiovascular
disease and diabetes)
- Information about alcohol consumption.

•Personalized information about the participant*s health profile (LIBRA score)
and individual risk factor scores. The personal LIBRA profile will be presented
using an *exploded doughnut* style chart, as shown in Figure 2 below. The LIBRA
score ranges from 0-100, with a score of 100 indicating that an individual has
no risk across all dementia risk factors that are included in the In-MINDD
inventory. The adoption of a brain healthy lifestyle across all risk factors
means that this person is at a reduced risk of developing dementia. The
opposite holds for a score of 0. The LIBRA profile comprises three parts: (1)
*Keep this up* - the sum of dementia risk factors for which the individual has
no risk; (2) *Remember to manage well* - the sum of manageable risk factors for
which the individual has risk. Note that three risk factors within the dementia
risk model (i.e. cardiovascular disease, diabetes and chronic kidney disease),
whilst not amenable to modification by way of active lifestyle change once a
user has developed the condition, are important factors for chronic disease
management; and (3) *Room for improvement* - the sum of the risk factors for
which the individual has risk that can be modified through lifestyle change. As
well as their overall LIBRA profile and score, more detailed textual
information about individual risk factors that make up each segment of the
personal LIBRA profile will also be presented. For example, with respect to the
segment on room for improvement, individuals will be presented with a more
detailed breakdown of the risk factors that can be modified by way of lifestyle
changes, referred to as their LIBRA improvement space (Figure 3). See section
8.1.2 for the algorithm of the LIBRA score.

•A suite of information (self-help materials) about each of the modifiable risk
factors for dementia. This will include information on links between the risk
factor and dementia, guidelines related to each risk factor (e.g.
guidelines/recommendations around physical activity, alcohol consumption),
suggestions for actions that can be taken to reduce the risk, and carefully
selected localized websites

•Online personalized support, in which participants will be informed of
personally most relevant risk factor(s) and invited to select one (or two or
three at most) area(s) in which to make lifestyle changes. This selection of
target factors will take place in consultation with the involved GP who remains
medically responsible for the advice. Participants will be given suggestions
about how to make lifestyle changes in this area. They will be invited via a
reminder (by email) every month to review their health progress. This will
ensure that advice is ongoing and tailored and in keeping with current best
practice in health promotion i.e. not trying to get them to change everything
at once. The support environment of each risk factor consists of the following
sections/subpages: background/introduction, relation of risk factor with brain
health, what can you do?, personalized plan, goals, and supportive weblinks.

•In-MINDD Forum, whereby participants can *Ask the Experts*. Experts are
involved medical doctors/researchers in the field of health promotion/dementia
prevention who are able to answers questions given their background/expertise.
Participants will be invited to submit opinions, thoughts and questions about
cognitive health promotion and experiences of participating in the study.
Experts will review and respond directly to the participant. In addition, the
most commonly asked questions will be used to inform the development of a
(moderated) Frequently Asked Questions (FAQ) Page

•Blogs Page, whereby participants and In-MINDD researchers will be invited to
start a Blog about their thoughts on cognitive health promotion, experience of
participating in the study and an account of the lifestyle changes they have
made to improve their cognitive health. The blog is moderated to ensure that
the online In-MINDD community is constructive and beneficial to the readers of
the blog. The In-MINDD research team and participants in the In-MINDD arm of
the trial will be able to comment on the blog. There will be a set of rules
outlining what is appropriate and inappropriate ti post and what should or
shouldn*t be in posts and comments: (1) the In-MINDD blog is restricted to the
In-MINDD research team and to participants allocated to the In-MINDD arm of the
trial; (2) posts and comments shall cover topics that are relevant for the
readers (research team, participants in the In-MINDD arm); (3) posts and
comments shall be respectful to other people and their viewpoints; (4)
profanity is not allowed on the blog page; (5) the blog moderators (a member of
the research team in each of the four partner countries) have the ability to
edit and delete posts and comments if they are not considered with the
interests of the online In-MINDD community or do not comply with the In-MINDD
blog rules and guidelines.

Participating in this study is without any foreseeable risk. Similar
interventions have been conducted in the past. People can participate in the
online In-MINDD intervention from their own home or workplace. The baseline
measurement and follow-up measures are composed of demographics and
questionnaires which are not considered burdensome or stressful. Those who take
part in face-to-face interviews can stop the interview at any time and are free
to ask the researcher to move on to another topic. We do not expect any
negative effects through participating in the online programme. At the end of
the online programme participants receive a message (disclaimer) stated that if
they, after participating in the programme, are still worried about their
cognitive health they should contact their GP. Participating in the study has
an additional advantage to the participants. The intervention programme will
increase knowledge about dementia risk factors, give people insight in their
individual health profile, and provide them tools (strategies and tips) in
order to improve their cognitive health.