The primary aim of this study is to examine the feasibility, usability, and acceptability of the educational care pathway for both patients and healthcare professionals. The secondary aim is to investigate the preliminary effects on patients*…
ID
Source
Brief title
Condition
- Diabetic complications
- Glucose metabolism disorders (incl diabetes mellitus)
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are usability, feasibility and acceptability of the
educational care pathway.
Secondary outcome
Secondary endpoints include perceived learning about diabetes and its relevant
lifestyle factors, patient activation towards diabetes self-management, and
glucose regulation.
Background summary
Type 2 diabetes (T2D) reduces the quality of life and life expectancy
significantly. Furthermore, as the prevalence of T2D increases, both the impact
on our healthcare system and the economic burden grow. Lifestyle changes can be
effective in achieving partial or complete remission of T2D; however, long-term
maintenance of health behaviour can be challenging. Knowledge about the disease
and about the influence of lifestyle on health is crucial for optimal disease
(self-)management. We have developed a novel educational care pathway, aiming
to increase patients* knowledge about T2D and its related lifestyle factors, to
empower patients in managing their disease, and to improve glucose regulation.
Study objective
The primary aim of this study is to examine the feasibility, usability, and
acceptability of the educational care pathway for both patients and healthcare
professionals. The secondary aim is to investigate the preliminary effects on
patients* perceived learning about diabetes and its associated factors,
activation towards disease management, and glucose regulation.
Study design
The study entails a mixed methods sequential explanatory design and will be
conducted in the endocrinology department of the Leiden University Medical
Center in The Netherlands. The quantitative research consists of questionnaires
administered at baseline (T0) and at the end of the eight-week educational care
pathway (T1). The qualitative part is conducted at T1 and consists of focus
groups with patients, and in-depth interviews with healthcare professionals.
Intervention
The intervention is an eight-week care pathway that combines education,
self-monitoring and a smartphone application. The education will be provided in
both individual and group consultations, plus online videos that explain the
pathogenesis of diabetes, as well as the effect of food, activity, sleep and
stress on glucose regulation. The pathway will be supported by a so-called
*diabetes box* that includes self-monitoring devices and a smartphone
application. This allows the participants to monitor blood glucose, physical
activity, sleep, stress, and their diet. The smartphone application provides a
platform where all the measurements are visualized and combined, and where
teaching material can be accessed.
Study burden and risks
The information included in the educational care pathway is in line with
information provided to the patient in current regular care. We do not expect
any health risks to be associated with the use of self-monitoring and
smartphone application. The time investment for the pathway is approximately
six to nine hours for the five consultations, 60 minutes for the video*s and 60
minutes for the self-monitoring. The time investment is thus larger compared to
regular care that generally includes two appointments of 10 and 45min. In
addition, participants will spend 20 minutes to complete the questionnaires
and, for a small subgroup, 90 minutes for focus groups. Potential benefits of
the new educational care pathway are increased knowledge and activation, and
improved glucose regulation. To conclude, the potential benefits are expected
to outweigh the burden of the study.
Pieter Bothstraat 24
LEIDEN 2315 AP
NL
Pieter Bothstraat 24
LEIDEN 2315 AP
NL
Listed location countries
Age
Inclusion criteria
Type 2 diabetes mellitus or post transplantation diabetes as diagnosed by a
medical specialist or a general practitioner
Aged 18 years or older
Own a smartphone
Have wireless Internet access at home
Exclusion criteria
Disabling (near) deafness and/or blindness without means to compensate
When patients are deemed to be unfit to participate in group consultations;
this decision is left to the discretion of the responsible healthcare
professional
Total pancreatectomy in medical history or during the study
Received solid organ transplant less than one year ago
Pregnancy
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL76573.058.21 |