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

NCT01315756 | Completed Early Phase 1

• 1 other identifier: Renewing Health Norway
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Lipids, self-care, lifestyle changes, complications, quality of life.

  One year

Study Arms (3)

Control group

NO INTERVENTION

Treatment as usual.

Few Touch Application (FTA)

EXPERIMENTAL

This arm 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.

Device: Use of Few Touch Application (FTA)

FTA and health counseling

EXPERIMENTAL

This arm 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.

Device: Use of FTA and health counseling based on TTM and CBT

Interventions

Use of Few Touch Application (FTA) DEVICE

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.

Also known as: Use of Diabetesdagbok

Few Touch Application (FTA)

Use of FTA and health counseling based on TTM and CBT DEVICE

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.

Also known as: Use of Few Touch Application with Health Counseling

FTA and health counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University Hospital of North Norway: lead
• Oslo University College: collaborator
• European Commission: collaborator
• The Research Council of Norway: collaborator

Study Sites (2)

Oslo University College

Oslo, Oslo County, 0167, Norway

Location

Norwegian Centre for Integrated Care and Telemedicine (NST ), University Hospital of North- Norway

Tromsø, Troms, 9038, Norway

Location

Related Publications (9)

• 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.

  PMID: 20307393 BACKGROUND

• 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.

  PMID: 18852310 BACKGROUND

• 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.

  PMID: 18850399 BACKGROUND

• 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.

  PMID: 16884582 BACKGROUND

• 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.

  PMID: 16403721 BACKGROUND

• 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.

  PMID: 31492176 DERIVED

• 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.

  PMID: 29784635 DERIVED

• 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.

  PMID: 27239317 DERIVED

• 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.

  PMID: 23978690 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bjørn Engum, M.Sc. / M.HA

  Norwegian Centre for Integrated Care and Telemedicine (NST ), University Hospital of North- Norway

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 15, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

NO (2)