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

U

University Hospital of North Norway

Status and phase

Completed
Early Phase 1

Conditions

Type 2 Diabetes

Treatments

Device: Use of FTA and health counseling based on TTM and CBT
Device: Use of Few Touch Application (FTA)

Study type

Interventional

Funder types

Other

Identifiers

NCT01315756
Renewing Health Norway

Details and patient eligibility

About

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.

Full 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.

Enrollment

151 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

151 participants in 3 patient groups

Control group
No Intervention group
Description:
Treatment as usual.
Few Touch Application (FTA)
Experimental group
Description:
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.
Treatment:
Device: Use of Few Touch Application (FTA)
FTA and health counseling
Experimental group
Description:
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.
Treatment:
Device: Use of FTA and health counseling based on TTM and CBT

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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