Information Technology Methodology for Patient Motivation in Diabetes Management.

Study Overview
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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.

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.

Official Title
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Reinforcement of Adherence to Prescription Recommendations in Diabetic Patients Using Short Message Service (SMS)- A Pilot Study

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Pre-coded messages
* Drug: Diabetes Treatment


Participation Criteria
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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 Exclusion Criteria: Type 1 diabetes Patients with history of blindness, decreased vision Serious vascular complications : Cancer

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 is experimental with SMS<br>Arm 1 is experimental with SMS intervention | Behavioral: Pre-coded messages<br>* Earlier life style modification and existing drug therapy was used and now SMS is added as a tool for reminder<br>|
| Active Comparator: 2 is (active comparator) standard care<br>Arm 2 is the usual care arm (standard care) | Drug: Diabetes Treatment<br>* Life style modification and drug therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioural changes resulting in diet, better adherence to treatment. |  | At intervals of three months for one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in HbA1c, other glycemic measures and improvement in blood lipid parameters |  | Annual | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Life style modification,, Type 2 diabetes,, SMS,, Patient adherence