"Information Technology Methodology for Patient Motivation in Diabetes Management."
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|ClinicalTrials.gov Identifier: NCT00727896|
Recruitment Status : Completed
First Posted : August 4, 2008
Last Update Posted : June 27, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Pre-coded messages Drug: Diabetes Treatment||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||"Reinforcement of Adherence to Prescription Recommendations in Diabetic Patients Using Short Message Service (SMS)- A Pilot Study"|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Experimental: 1 is experimental with SMS
Arm 1 is experimental with SMS intervention
Behavioral: Pre-coded messages
Earlier life style modification and existing drug therapy was used and now SMS is added as a tool for reminder
Active Comparator: 2 is (active comparator) standard care
Arm 2 is the usual care arm (standard care)
Drug: Diabetes Treatment
Life style modification and drug therapy
- Behavioural changes resulting in diet, better adherence to treatment. [ Time Frame: At intervals of three months for one year ]
- Reduction in HbA1c, other glycemic measures and improvement in blood lipid parameters [ Time Frame: Annual ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727896
|India Diabetes Research Foundation and Dr.A.Ramachandran's Diabetes Hospitals|
|Chennai, Tamil nadu, India, 600 008|
|Principal Investigator:||Samith A Shetty, M.B.B.S, MDRC||India Diabetes Research Foundation (IDRF) and Dr.A.Ramachandran's Diabetes Hospitals|