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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University Hospital of North Norway.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Oslo University College
European Commission
The Research Council of Norway
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01315756
First received: March 14, 2011
Last updated: May 11, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Device: Use of Few Touch Application (FTA)
Device: Use of FTA and health counseling based on TTM and CBT
Phase 0

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

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Improved glycemic control, HbA1c [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Lipids, self-care, lifestyle changes, complications, quality of life. [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Treatment as usual.
Experimental: Few Touch Application (FTA)
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)
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.
Other Name: Use of Diabetesdagbok
Experimental: FTA and health counseling
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
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.
Other Name: Use of Few Touch Application with Health Counseling

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315756

Contacts
Contact: Astrid Grøttland +47 976 95 111 astrid.grottland@telemed.no
Contact: Gerd Ersdal, M.D. +47 915 71 915 gerd.ersdal@telemed.no

Locations
Norway
Norwegian Centre for Integrated Care and Telemedicine (NST ), University Hospital of North- Norway Recruiting
Tromsø, Troms, Norway, 9038
Contact: Astrid Grøttland    +47 976 95 111    astrid.grottland@telemed.no   
Contact: Gerd Ersdal, M.D.    +47 915 71 915    gerd.ersdal@telemed.no   
Principal Investigator: Eirik Årsand, PhD         
Oslo University College Recruiting
Oslo, Norway, 0167
Contact: Lis Ribu, PhD    +4792206229    Lis.Ribu@su.hio.no   
Principal Investigator: Lis Ribu, PhD         
Sponsors and Collaborators
University Hospital of North Norway
Oslo University College
European Commission
The Research Council of Norway
Investigators
Study Chair: Bjørn Engum, M.Sc. / M.HA Norwegian Centre for Integrated Care and Telemedicine (NST ), University Hospital of North- Norway