Clinical trial NCT01315756: Self-management in Type 2 Diabetes Patients Using the Few Touch Application
Official title: The Norwegian Study in Renewing Health: Stimulating Self-management in Patients With Type 2 Diabetes Mellitus Through Telecare With the Few Touch Application and Health Counseling - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Oslo University College
name: European Commission
name: The Research Council of Norway
First posted: 2011-03-15
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is hypothesized that the use of the mobile phone-based self-help system FTA, and with the patients as active players, will improve diabetes self-management reflected by improved glycemic control and lipids, self-care behaviours and lifestyle changes such as improved dietary habits and increased physical activity, compared with usual care. Following this; it is also hypothesized that this will also lead to a reduction in overall risk for diabetes complications (expressed by reduction in e.g., 5 year absolute risk for coronary artery disease as calculated using the Swedish National Diabetes Register's risk calculator) and in the prevalence of the metabolic syndrome (e.g., as defined by the International Diabetes Federation). It also hypothesized that health counselling based on TTM and CBT by a diabetes nurse, and with individualized feedback via sms from the diabetes nurse, may have an important function as a supplement to the self-help system (FTA). In addition, it is hypothesized that the patients' health status and diabetes-related quality of life (HRQL) will improve. The results of this study may show that a commonly used tool like the mobile phone, and also mobile phone together with health counselling, fitted into the patients' daily life, is more effective and cost-effective than standard care.

Detailed description: The purpose of this study is to examine the effectiveness of mobile phone-based lifestyle tools, and health counseling using tailored SMS and individual phone-calls to the patients, for self-management of T2DM. Maintaining daily symptom diaries (described below) by an easy way of self-monitoring appear to offer a valid and reliable way of assessing behaviours. In addition, the patients are able to view their own registrations on the Smartphone, i.e. a programmable mobile phone with a touch sensitive screen. The self-help system, called the "Few Touch application", recently tested on 12 people with T2DM at NST, University Hospital of North Norway (UNN), will form the basis for the patients' mobile interaction system.

Eligibility criteria: Inclusion Criteria:

Age \>18; diagnosed T2DM \> 3 months prior to study inclusion; in case the patient is receiving one or more glucose lowering drug (e.g., metformin, sulphonylurea, glinide, α-glucosidase inhibitor, DPP-IV inhibitor, GLP-1 analogue, glitazone, insulin) the treatment should be stabilized (i.e., no change in dosage the last three months prior to inclusion except for insulin treated patients who are allowed ±15% dose adjustment; HbA1c \>7%; capability of understanding and filling in Norwegian questionnaires; be able to use the system provided; be cognitive able to participate.

Primary outcomes:
measure: Improved glycemic control, HbA1c
timeFrame: One year
Secondary outcomes:
measure: Lipids, self-care, lifestyle changes, complications, quality of life.
timeFrame: One year
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Norwegian Centre for Integrated Care and Telemedicine (NST ), University Hospital of North- Norway
state: Troms
city: Oslo
country: Norway
facility: Oslo University College
Study officials:
affiliation: Norwegian Centre for Integrated Care and Telemedicine (NST ), University Hospital of North- Norway
name: Bjørn Engum, M.Sc. / M.HA
role: STUDY_CHAIR
References:
citation: Arsand E, Tatara N, Ostengen G, Hartvigsen G. Mobile phone-based self-management tools for type 2 diabetes: the few touch application. J Diabetes Sci Technol. 2010 Mar 1;4(2):328-36. doi: 10.1177/193229681000400213.
citation: Arsand E, Tufano JT, Ralston JD, Hjortdahl P. Designing mobile dietary management support technologies for people with diabetes. J Telemed Telecare. 2008;14(7):329-32. doi: 10.1258/jtt.2008.007001.
citation: Arsand E, Demiris G. User-centered methods for designing patient-centric self-help tools. Inform Health Soc Care. 2008 Sep;33(3):158-69. doi: 10.1080/17538150802457562.
citation: Wangberg SC, Arsand E, Andersson N. Diabetes education via mobile text messaging. J Telemed Telecare. 2006;12 Suppl 1:55-6. doi: 10.1258/135763306777978515.
citation: Gammon D, Arsand E, Walseth OA, Andersson N, Jenssen M, Taylor T. Parent-child interaction using a mobile and wireless system for blood glucose monitoring. J Med Internet Res. 2005 Nov 21;7(5):e57. doi: 10.2196/jmir.7.5.e57.
citation: Torbjornsen A, Ribu L, Ronnevig M, Grottland A, Helseth S. Users' acceptability of a mobile application for persons with type 2 diabetes: a qualitative study. BMC Health Serv Res. 2019 Sep 6;19(1):641. doi: 10.1186/s12913-019-4486-2.
citation: Torbjornsen A, Smastuen MC, Jenum AK, Arsand E, Ribu L. Acceptability of an mHealth App Intervention for Persons With Type 2 Diabetes and its Associations With Initial Self-Management: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 May 21;6(5):e125. doi: 10.2196/mhealth.8824.
citation: Holmen H, Wahl A, Torbjornsen A, Jenum AK, Smastuen MC, Ribu L. Stages of change for physical activity and dietary habits in persons with type 2 diabetes included in a mobile health intervention: the Norwegian study in RENEWING HEALTH. BMJ Open Diabetes Res Care. 2016 May 12;4(1):e000193. doi: 10.1136/bmjdrc-2016-000193. eCollection 2016.
citation: Ribu L, Holmen H, Torbjornsen A, Wahl AK, Grottland A, Smastuen MC, Elind E, Bergmo TS, Breivik E, Arsand E. Low-intensity self-management intervention for persons with type 2 diabetes using a mobile phone-based diabetes diary, with and without health counseling and motivational interviewing: protocol for a randomized controlled trial. JMIR Res Protoc. 2013 Aug 26;2(2):e34. doi: 10.2196/resprot.2768.