Condition category
Nutritional, Metabolic, Endocrine
Date applied
01/04/2019
Date assigned
18/04/2019
Last edited
11/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims:
Changing lifestyle is the first line of treatment in the management of type 2 diabetes. Lifestyle factors mainly include eating behavior, physical activity and mental health. In order to help newly diagnosed type 2 diabetics with the needed lifestyle modifications, outpatient clinics offer special group training courses. Unfortunately, group training courses are limited by time and resource constraints. Therefore, a smartphone app has been developed which makes use of the time between the individual group training sessions. The app provides tasks that encourage the patients to think about their lifestyle. After the final session of the group training course, the app additionally delivers diabetes-relevant tips. These tips repeat the contents discussed in the group training courses over a period of 4 weeks. The aim of this study is to evaluate whether the usage of the app increases the effects of the group training courses, especially on changes in diabetes self-management ability.

Who can participate?
Adults over the age of 18 who attend group training courses for type 2 diabetes at one of the three study centres (outpatient diabetes clinics) in Austria.

What does the study involve?
Participants are asked to join this study during the first session of a group training course for type 2 diabetes. Participants are allocated to one of two groups according to the time of participation. Those in the first group (control group) are asked to monthly complete questionnaires on their smartphones – using a specifically developed smartphone app – regarding their diabetes self-management as well as their perceived burden caused by the disease. During the study period of 3 months, the participants of the first group are additionally asked each month to give a small finger-prick blood sample to test their long-term blood sugar level. Those in the second group (intervention group) are asked to complete the same programme as the first group. In addition, they are asked to complete tasks using the specifically developed smartphone app in the time between the individual sessions of the group training courses and to rate tips on diabetes-related topics that are received over a period of 4 weeks after their last group training course session.
This allows an evaluation whether or not mHealth supported group training sessions have a positive effect on the diabetes self-management and long-term blood sugar level of type 2 diabetics.

What are the possible benefits and risks of participating?
All participants receive additional measurements of their long-term blood sugar levels. This may be perceived as a burden, on the other hand, there is the benefit of closely monitored blood sugar levels. Participants who are assigned to the intervention group will receive prompts to considertheir diabetes-relevant behaviour. Information obtained from this study may help type 2 diabetics in adapting to a healthier lifestyle in the future. By taking part in this study there are no risks of physical injury or harm.

Where is the study run from?
The DM2CUA-pilot study is being run by the University of Applied Sciences Salzburg, Austria, and takes place in three outpatient diabetes clinics across the federal state of Salzburg, Austria (Privat-klinik Wehrle Diakonissen GmbH, Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft mbH, Gemeinnützige Oberndorfer Krankenhausbetriebsgesellschaft mbH).

When is the study starting and how long is it expected to run for?
February 2019 to August 2019

Who is funding the study?
Federal State of Salzburg, Austria

Who is the main contact?
Mag.a Melanie Roth, BSc
Researcher
Department of Nursing
University of Applied Sciences Salzburg, Austria
Melanie.roth@fh-salzburg.ac.at

Trial website

https://dm2cua.multimediatechnology.at/

Contact information

Type

Scientific

Primary contact

Ms Melanie Roth

ORCID ID

Contact details

Urstein Sued 1
Puch/Salzburg
5412
Austria
+43 (0)50 2211-1471
melanie.roth@fh-salzburg.ac.at

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

DM2CUA-pilot-V2

Study information

Scientific title

Effects of an mHealth support-programme within and beyond the scope of group training courses for type 2 diabetes in an open case-control cluster pilot study

Acronym

DM2CUA-pilot

Study hypothesis

Timepoint 0: start of group training course
Timepoint 1: end of group training course
Timepoint 2: 4 weeks after end of group training course
Timepoint 3: 8 weeks after end of group training course

Primary hypothesis:
The diabetes self-management competence (measured by means of the DSMQ questionnaire) is greater at least at one timepoint (timepoint 1, 2 or 3) in persons with type 2 diabetes mellitus who, in addition to receiving standard-of-care group training courses, are provided with a mHealth support-programme consisting of tasks administered via smartphone-app that encourage critical reflection on diabetes-relevant topics and that are discussed within the group training courses (duration: 4-5 weeks) and information on diabetes-relevant topics delivered via smartphone-app over a period of 4 weeks subsequent to the completed group training course (intervention group), than in persons with type 2 diabetes mellitus who participate in standard-of-care group training courses (control group).

Secondary hypotheses:
1. The (clinically positive) change from timepoint 0 to timepoint 2 in diabetes self-management competence is greater in the intervention group than in the control group.
2. The diabetes self-management competence in the intervention group is sustainably higher (timepoint 2 to timepoint 3) than in the control group.
3. The (clinically positive) change from timepoint 0 to timepoint 3 in the long-term blood sugar level (HbA1c) is greater in the intervention group than in the control group.
4. There is a measurable correlation between smartphone usage data and smartphone sensor data and the subjective rating of information value by intervention group participants.

Ethics approval

Approved 24/01/2019, Province Ethics Committee of Salzburg [Ethikkommission für das Bundesland Salzburg] (Michael-Pacher-Str 36, Postfach 427, 5010 Salzburg; +43 662 8042-2375; ethikkommission@salzburg.gv.at), ref: 415-E/2438/5-2019

Study design

Open-label case-controlled cluster-randomised multicentre pilot study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Type 2 diabetes mellitus

Intervention

Intervention: participation in standard-of-care group training courses supplemented with a mHealth support programme consisting of:
1. Tasks administered via smartphone app that encourage critical reflection on diabetes-relevant topics and that are discussed within the group training courses (duration: 4-5 weeks)
2. Information on diabetes-relevant topics delivered via smartphone app over a period of 4 weeks subsequent to the completed group training course
Control: participation in standard-of-care group training courses
Cluster-randomization: allocation to intervention or control group as well as study centre (cluster) according to time and location of participation in group training courses.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Self-care relevant to glycaemic control assessed using the Diabetes Self Management Questionnaire (DSMQ) at T0 (start of group training course), T1 (end of group training course), T2 (4 weeks after end of group training course) and T3 (8 weeks after end of group training course)

Secondary outcome measures

1. Diabetes-related emotional distress assessed using the Diabetes Distress Scale (DDS) T0 (start of group training course), T1 (end of group training course), T2 (4 weeks after end of group training course) and T3 (8 weeks after end of group training course)
2. Impact of health education assessed using the Health Education Impact Questionnaire (heiQ) at T0 and T1
3. Long-term blood glucose concentration assessed by HbA1c measurement at T0, T1, T2 and T3
4. Personal environmental factors assessed using smartphone background data between T1 and T2
5. Subjective rating of information value of intervention between T1 and T2

Overall trial start date

01/10/2018

Overall trial end date

30/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Any gender
3. Diagnosed with type 2 diabetes mellitus
4. Able to use a smartphone independently
5. Knowledge of the German language in speaking and writing (independent use of language)
6. Able and willing to participate in a group training course for type 2 diabetes mellitus at one of the three study centres

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

73 (3 clusters; 20-27 participants per cluster)

Participant exclusion criteria

1. Diagnosed with type 1 diabetes mellitus
2. Diagnosed with gestational diabetes mellitus
3. Visual impairments that adversely affect the use of the smartphone application

Recruitment start date

01/02/2019

Recruitment end date

30/06/2019

Locations

Countries of recruitment

Austria

Trial participating centre

Gemeinnützige Oberndorfer Krankenhausbetriebsgesellschaft m.b.H.
Paracelsusstraße 37
Oberndorf bei Salzburg
5110
Austria

Trial participating centre

Diakonissen & Wehrle Privatklinik GmbH
Guggenbichlerstraße 20
Salzburg
5026
Austria

Trial participating centre

Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft mbH
Müllner Hauptstraße 48
Salzburg
5020
Austria

Sponsor information

Organisation

Salzburg University of Applied Sciences (Fachhochschule Salzburg)

Sponsor details

Campus Urstein Süd 1
Puch/Salzburg
5412
Austria
+43-(0)50-2211-2000
office@fh-salzburg.ac.at

Sponsor type

University/education

Website

https://www.fh-salzburg.ac.at/en/

Funders

Funder type

Government

Funder name

Federal State of Salzburg, Austria

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The investigators plan to publish all results from the study distributed over approximately four publications in relevant discipline-specific (e.g. diabetic medicine, mobile health, health education) peer-reviewed journals until 12/2020.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available because the approved ethics committee proposal and corresponding informed consent letters for the participants, which also correspond to the data protection strategy of the Salzburg University of Applied Sciences for this study, do not allow the publication of participant level data.

Intention to publish date

31/12/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/04/2019: Trial's existence confirmed by Ethikkommission für das Bundesland Salzburg.