Clinical trial NCT00727896: "Information Technology Methodology for Patient Motivation in Diabetes Management."
Official title: "Reinforcement of Adherence to Prescription Recommendations in Diabetic Patients Using Short Message Service (SMS)- A Pilot Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Life style modification,
Type 2 diabetes,
SMS,
Patient adherence
Lead sponsor: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Sponsor class: OTHER
First posted: 2008-08-04
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Behavioural changes resulting in diet, better adherence to treatment.
timeFrame: At intervals of three months for one year
Secondary outcomes:
measure: Reduction in HbA1c, other glycemic measures and improvement in blood lipid parameters
timeFrame: Annual
Other outcomes:
Locations:
city: Chennai
country: India
facility: India Diabetes Research Foundation and Dr.A.Ramachandran's Diabetes Hospitals
state: Tamil nadu
Study officials:
affiliation: India Diabetes Research Foundation (IDRF) and Dr.A.Ramachandran's Diabetes Hospitals
name: Samith A Shetty, M.B.B.S, MDRC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006 Feb;49(2):289-97. doi: 10.1007/s00125-005-0097-z. Epub 2006 Jan 4.