Diabetes and WELLbeing

Diabetes is a long term non-communicable disease with high costs to patients,
health services and society, and for which there is currently no standardised
approach to self-management. Diabetes is an increasing problem, even more so it
is starting to become an worldwide epidemic. This emphasizes that type 2
diabetes is an ever increasing problem, and this has led to a cross-border
initiative (United Kingdom, Belgium, France and the Netherlands) under the name
of the DWELL project (Diabetes WELLbeing). The overall aim of DWELL is to
enhance self-management of type 2 diabetes through a co-produced 12 week
educational programme, and improve health and wellbeing measures. The
co-production entails using input from current patients and health care staff
in order to create a programme that will appeal to all diabetics. In addition a
specific staff training programme will be produced, to ensure all staff can be
of the best service to participants, and, even more importantly, staff will be
able to prolong the DWELL education programme after the project ends. The
ultimate goal of the DWELL project is to create a programme with elements that
apply to everyone, which will allow participants to pick the elements that best
suit their needs, and will provide a solid support system to ensure the best
results for each individual. In addition to a certain set of elements that will
be identical in all delivery countries, each country will add additional
elements based on their expertise.
Healthy diet, regular physical activity, and maintaining a normal body weight
are ways to prevent or delay the onset of diabetes type 2. Based on this fact,
it seems necessary to evaluate physical (in)activity in diabetes patients.
Physical inactivity has been identified as the fourth leading risk factor for
global mortality, meaning extreme sedentary behaviour can actually be deadly.
This emphasizes the importance of physical activity in the entire health care
system. The importance of improving physical activity and physical performance
in diabetes patients is clear, however how this can be accomplished is another
story. There are several interventions possible, and multiple interventions
have been proven effective in the past, however their effects were only short
term. Each country contributing to the DWELL project will find his own way in
delivering the intervention. However, what they all have in common is the
emphasis on self-management. Patients must be motivated to take matters into
their own hands.
Motivational interviewing is a directive, patient-centred form of counselling
designed to evoke changes in behaviour by assisting people explore, clarify and
resolve ambivalence regarding behaviour change. Using motivational interviewing
the advantages and disadvantages of the current and intended behaviour can be
identified, thereby motivating the patient to take control of the situation and
identify barriers that keep the patient from changing his behaviour. From this
point onwards, the patient will be assisted in setting realistic goals
regarding behaviour change, which can be used to increase intrinsic-motivation,
which will ultimately positively affect lifestyle changes long term. Previous
studies that have implemented motivational interviewing in the diabetes
population have shown some positive results. Given the fact that motivational
interviewing increases intrinsic motivation, combined with the successes in
previous studies, it is hypothesized that motivational interviewing can have a
massive effect on the ability to self-manage diabetes.
In conclusion, we believe it is in the best interest of diabetes patients
worldwide to create a new innovative treatment programme, which involves
monitoring movement and offering motivational interviewing, to create the most
personal and specified support for patients, that should and could massively
increase the success-rate of self-management.

Decrease disease-burden in the diabetes type 2 population, by improving quality
of life, physical activity levels, physical performance and the overall quality
of diabetes care. Thereby empowering the diabetes population to better
self-manage their condition, through the use of movement monitors and
motivational interviewing.

The study will be set up as a randomized controlled trial, consisting of 3
groups, one control group that will receive standard care and two intervention
groups. It has been chosen to make the control group slightly smaller, to be
able to receive significant results, but at the same time provide as many
participants as possible with the intervention. The participants of both
intervention groups will receive a move monitor, which they will wear for a
week at baseline and at the end of the 12 week intervention period. A long term
check-up will be performed after 6 and 12 months, which falls in line with
usual care check-ups, at the one year follow-up point the participants will be
asked to wear the move monitor again for a week. The participants in one of
the intervention groups will receive motivational interviews (for 12 weeks) in
addition to wearing the move monitor, the appointment to each group will be
blinded as CASTOR will be used to randomly assign participants to either of the
groups.

Patients in the intervention groups, will be asked to wear a McRoberts movement
monitor for 24 hours on 7 consecutive days. The movement monitor will be worn
for a week at baseline and at the end of the 12 week intervention period. To be
able to investigate the long term effects, the move monitor will be worn for
one week at one year follow-up again. In addition the IPAQ questionnaire will
be used, as a simple means of getting additional information on physical
activity. Participants will be asked to fill out this questionnaire at
baseline, after the 12 week intervention, and at 6 and 12 month follow-up. To
gain insight in the physical performance levels, the iSPPB will be conducted
at baseline, after the 12 week intervention and at 6-, 9-, and 12 months
follow-up. The questionnaires, EQ5D and IPQ-R, will be conducted at baseline,
at the end of the 12 week intervention and at 6-, 9- and 12 months follow-up
as well. Blood values are measured as form of standard care, and will be
analysed for this study as well.

The motivational interviewing will be used as an extra form of support in the
process to decreasing disease burden in one of the intervention groups.
Motivational interviews will be conducted more frequently, namely 3 to 12 times
in the 12 week intervention period. The first meeting will take place in the
first week, the second meeting will be initiated by the patients themselves.
During this meeting it will be estimated how many meetings are desirable based
on the individual needs and characteristics of the patient. By complying to the
patient*s needs, the motivational interviewing will increase motivation and
coherence to treatment. Its effect will be measured using physical parameters,
wellbeing and quality of life (QoL) questionnaires and blood values.

Patients in the control group will receive the standard diabetes care, and will
be asked to complete all questionnaires, IPAQ, EQ5D, IPQ-R and the quality of
care questionnaire at baseline, after the 12 week intervention period and at
6-, 9-, and 12 months follow-up. They will also be asked to complete the iSPPB
at baseline, after the 12 week intervention and at 6-, 9-, and 12 months
follow-up, and their bloodwork will be analyzed.

It is the aim of the DWELL project to involve patients in the development of
several modules that can be added to the intervention. Building on that, the
DWELL project is hoping to get some motivated participants and train them to
become patient ambassadors. They will then receive training as well and will
become a factor of support for new patients. Since they have been through the
process themselves, it is expected that these patient ambassadors have a better
understanding of the patients and will be able to provide support from
experience and create group relatedness, which can be beneficial for both old
and new patients. The old patients will form a beacon of information and
support for the new patients, whereas the new patients will provide a constant
flow of motivation for the old patients.

All tests will be performed by educated and specifically trained personnel in
controlled environments, using standardised protocols that guarantee patient
safety. Therefore, it is expected that significant risks will not occur.
In addition, a risk classification has been performed, using the NFU risk
classification list and table. Based on these tables, it is safe to conclude
that the participants is this study are at no risk.