To investigate the effectiveness of text-messages sent via a smartphone app (app-triggers) regarding dietary habits, physical activity, prevention of hypoglycaemic events and glycaemic variability on HbA1c, body weight, diabetes self-management and…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoints are 1) the percentage of patients who achieve an
HbA1c level *7% (53 mmol/mol) without hypoglycaemia (plasma glucose <3.5 mmol/L
(63 mg/dL) and 2) the HbA1c level as a continuous outcome variable after a
follow-up duration of 6 months.
Secondary outcome
Change between baseline and 6 months (end of intervention period) in:
- Clinical parameters (body weight, BMI, waist circumference, lipid profile,
blood pressure, insulin dose, number of hypoglycaemic events, glycaemic
variability)
- Self-management (SDSQ)
- Food habits (FFQ)
- Physical activity (IPAQ)
- Health status (EQ-5D, SF36)
- Diabetes related quality of life (ADDQoL)
- Patients satisfaction (DTSQ).
The cost-effectiveness of the intervention after 6 months.
In the intervention group only: satisfaction with the app; the sustainability
of the effect of the intervention with regard to the primary outcome, body
weight and EQ-5D, after three months of non-use compared to three months
prolonged use, both after six months of initial use of the app; determinants of
success for the primary outcome; such as gender, age, social economic status,
diabetes duration, short or prolonged intervention.
Background summary
Self-management is one of the cornerstones of diabetes treatment, especially in
insulin treatment. Attainment to lifestyle interventions, e.g. dietary habits
and physical activity, will help to prevent both micro- and macrovascular
complications. Insulin dose adjustments to changes in physical activity and
diet may prevent hypoglycaemic episodes and limit glycaemic variability. These
self-management activities are necessary but difficult to maintain. Physicians,
diabetes nurses and practice nurses aim to stimulate self-management.
In the Netherlands 85-90% of the 700.000 type 2 diabetes patients are treated
in the primary care setting; among them, 15-20% are treated with insulin. With
the growing number of diabetes patients, the expected shortage of practice
nurses and the increasing workload of general practitioners, innovative and
(cost-)effective solutions to promote self-management in the primary care are
needed.
Study objective
To investigate the effectiveness of text-messages sent via a smartphone app
(app-triggers) regarding dietary habits, physical activity, prevention of
hypoglycaemic events and glycaemic variability on HbA1c, body weight, diabetes
self-management and to assess determinants of success in type 2 diabetes
patients treated with insulin therapy.
Study design
Non-blinded randomised controlled trial (RCT), with parallel-groups and
randomisation ratio 1:1 intervention versus control.
Intervention
Receiving of app-triggers to support diabetes self-management regarding dietary
habits, physical activity, hypoglycaemia, and glucose regulation (including
glycaemic variability). The app-triggers are clear messages containing specific
goals which can quickly be achieved (based on Health Belief Model), information
or short questions to promote diabetes education and to motivate patients to
adhere to lifestyle advices. Messages are positively framed (based on positive
framing theory) with the content according to (inter-)national guidelines.
Messages are sent between 9.30 a.m. and 8.00 p.m.. Patient will determine their
preferred frequency (2 or 6 times weekly, with a maximum of one message daily),
and preferred topics (receiving messages with regard to hypoglycaemia is
obligated, patients will choose 2-3 extra topics).
Study burden and risks
Participants are asked to complete questionnaires on food habits, physical
activity, health status, diabetes related quality of life, diabetes
self-management and patient satisfaction at baseline and follow-up (6 months
later). Filling out these forms may be confronting and is time consuming
(approximately half an hour). In the intervention group, participants are asked
to fill out a questionnaire on health status after a follow-up duration of 9
months. Depending on regular clinical controls, an extra blood sample is taken
at one to three measurement occasions. Patients are used to give blood samples
in order to determine their HbA1c and lipid profile. Complications of taking a
blood sample may be a hematoma or an infection. Participants in the
intervention group receive app-triggers over a period of 6-9 months with a
personalised frequency of twice or six times a week. We do not expect any
adverse effects from receiving app-triggers. Patients in both the intervention
as in the control group are familiar with self-management. In theory,
stimulating healthy food choices and physical activity may result in
hypoglycaemic events. However, receiving app-triggers with regard to preventing
and managing hypoglycaemia is obligatory. Some patients may find receiving
app-triggers at random times, e.g. at work, stigmatising. The study population
does not involve minors or incapacitated. The privacy of the participants will
be assured.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Type 2 diabetes patients who are on insulin treatment since at least 3 months, with a baseline HbA1c level >7% (53 mmol/mol) aged 40-70 years. Logistic requirements are the possession of an e-mail address and a smartphone.
Exclusion criteria
Insulin naïve type 2 diabetes patients, patients with a history of alcoholism, drug abuse, dementia or major psychiatric disorder that is likely to invalidate informed consent, or limit the ability of the individual to comply with the protocol requirements.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53125.041.15 |