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OpenTrials
Completed

NCT Number: NCT00727896

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

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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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

India Diabetes Research Foundation and Dr.A.Ramachandran's Diabetes Hospitals

Chennai, Tamil Nadu, 600 008, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-coded messages

Behavioral

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

Diabetes Treatment

Drug

Life style modification and drug therapy

Primary outcomes

  1. Behavioural changes resulting in diet, better adherence to treatment.

    Time frame: At intervals of three months for one year

Secondary outcomes

  1. Reduction in HbA1c, other glycemic measures and improvement in blood lipid parameters

    Time frame: Annual

Sponsors and collaborators

Lead sponsor

India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 4, 2008
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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