Self-management in Type 2 Diabetes Patients Using the Few Touch Application

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315756
• Other study ID #: Renewing Health Norway
• Status: Completed
• Phase: Phase 0
• First received: March 14, 2011
• Last updated: December 11, 2014
• Start date: March 2011
• Est. completion date: October 2013

Study information

• Verified date: December 2014
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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, a-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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• Use of Few Touch Application (FTA)
The users will receive a Smartphone with the diabetes diary application ("the Few Touch application"), a self-help tool that consists of five main elements accessible to the user. The five elements are the food habits registration, blood glucose data management system, physical activity registration, personal goals setting and general information. While blood glucose data is automatically transferred to the phone from the blood glucose meter when the user has performed a measurement, activity data and food habits have to be entered manually by the user.
• Use of FTA and health counseling based on TTM and CBT
The users will additionally receive health counseling based on TTM and CBT by a diabetes nurse with individualized feedback via SMS from the diabetes nurse which is based on the patient's initiative (via SMS). In addition, the diabetes nurse will call the patients three times during this period and discuss progress. Both the SMS-messages and the calls will be based on CBT according to the TTM-level. The intervention allows information to be given both in an individualized and tailored manner for each particular patient by the nurse, but also in a general way via SMS. The patients need to understand the relationship between areas such as glucose levels, diet, exercises and medicine, in the context of their own lifestyle needs.

Locations

Country	Name	City	State
Norway	Oslo University College	Oslo
Norway	Norwegian Centre for Integrated Care and Telemedicine (NST ), University Hospital of North- Norway	Tromsø	Troms

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital of North Norway	European Commission, Oslo University College, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (5)

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. — View Citation

Arsand E, Tatara N, Østengen 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. — View 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. — View 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. — View Citation

Wangberg SC, Arsand E, Andersson N. Diabetes education via mobile text messaging. J Telemed Telecare. 2006;12 Suppl 1:55-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved glycemic control, HbA1c	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.	One year	No
Secondary	Lipids, self-care, lifestyle changes, complications, quality of life.	It is hypothesized that the use of the mobile phone-based self-help system FTA will improve diabetes self-management, reflected by improved lipids values, self-care behaviors and lifestyle changes compared with usual care, that this will also lead to a reduction in overall risk for diabetes complications, that health counseling based on TTM and CBT by a diabetes nurse and with individualized feedback via SMS may have an important function as a supplement to the self-help system, and that the patients' health status and diabetes-related quality of life will improve.	One year	No