"Information Technology Methodology for Patient Motivation in Diabetes Management."

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-04-30

Brief Summary

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Type 2 diabetes is a chronic metabolic disorder requiring lifestyle modification and medicines, adherence to which has to be practised on a daily basis.

Motivation of patients to adhere to treatment is difficult in clinical practice. It is well documented that majority of patients do not reach the glycaemic targets even in the centres of excellence. Regular short service messages (SMS) through cell phones could have a positive effect on behaviour and adherence to life style changes and compliance to drugs. It may be practical and feasible to use information technology as an effective and simple tool for motivating patients to adhere to the prescribed treatment regimen.

In diabetic patients, frequent reminders regarding the need for adherence to LSM and drugs by the medical professionals will improve the compliance.

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Detailed Description

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In diabetic patients, frequent reminders by the medical professionals on the need for adherence to Life Style Modification (LSM) and drugs will improve the compliance. SMS may be an effective and cheap tool of communication. Improved compliance is likely to result in better glycaemic control.

Out of total number of 200, consecutive randomization of 100 patients each to SMS or usual care arms will be done. Patients in the SMS group will get SMS once in 3 days as a reminder. Patients will be reviewed at 3, 6, 9 and 12 months from the date of randomization

Fasting and 2hr postprandial glucose and HbA1c will be tested during each visit.

At baseline and at the end of the study, lipids, and renal function test will also be done. A validated questionnaire will be used to assess physical activity, diet habits, adherence to drug prescriptions and frequency of monitoring of blood glucose. . Body weight, blood pressure, biochemical variables, scores for diet and physical activity and compliance to drugs, will be compared using students 't' test or chi-square test as relevant.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1 is experimental with SMS

Arm 1 is experimental with SMS intervention

Group Type EXPERIMENTAL

Pre-coded messages

Intervention Type BEHAVIORAL

Earlier life style modification and existing drug therapy was used and now SMS is added as a tool for reminder

2 is (active comparator) standard care

Arm 2 is the usual care arm (standard care)

Group Type ACTIVE_COMPARATOR

Diabetes Treatment

Intervention Type DRUG

Life style modification and drug therapy

Interventions

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Pre-coded messages

Earlier life style modification and existing drug therapy was used and now SMS is added as a tool for reminder

Intervention Type BEHAVIORAL

Diabetes Treatment

Life style modification and drug therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, 30-65 yrs of age at the time of entry and have type 2 diabetes for a minimum period of 5 years.
* HbA1C ranging 8.0-10.0%
* Patients either receiving OHA and / or insulin