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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Pre-coded messages; Drug: Diabetes Treatment

• Registration Number: NCT00727896
• Lead Sponsor: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-07-31
• Study Start: 2008-08
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-04
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-03
• Last Update Submitted: 2011-06-24
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 is experimental with SMS	Pre-coded messages	Arm 1 is experimental with SMS intervention
2 is (active comparator) standard care	Diabetes Treatment	Arm 2 is the usual care arm (standard care)

Primary Outcome Measures

Name	Time	Method
Behavioural changes resulting in diet, better adherence to treatment.	At intervals of three months for one year

Secondary Outcome Measures

Name	Time	Method
Reduction in HbA1c, other glycemic measures and improvement in blood lipid parameters	Annual

Trial Locations

Locations (1)

India Diabetes Research Foundation and Dr.A.Ramachandran's Diabetes Hospitals; 🇮🇳 Chennai, Tamil nadu, India