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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727896
• Other study ID #: SMS001IDRF
• Status: Completed
• Phase: Phase 1
• First received: July 31, 2008
• Last updated: June 24, 2011
• Start date: August 2008
• Est. completion date: April 2010

Study information

• Verified date: March 2011
• Source: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

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

Drug:
• Diabetes Treatment
Life style modification and drug therapy

Locations

Country	Name	City	State
India	India Diabetes Research Foundation and Dr.A.Ramachandran's Diabetes Hospitals	Chennai	Tamil nadu

Sponsors (1)

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

Country where clinical trial is conducted

India, 

References & Publications (1)

1) Ramachandran A; Snehalatha C; Mary S; Mukesh B; Bhaskar AD; Vijay V. 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 49: 289-297, 2006. 2) Murugesan N; Snehalatha C; Shobana R; Roglic G; Ramachandran A. Awareness about diabetes and its complications in the general and diabetic population in a city in Southern India. DRCP 77 : 433-7, 2007. 3) Ramachandran A; Shobana R; Snehalatha C; Augustine C; Murugesan N; Viswanathan V; Kapur A; Williams R. Increasing expenditure on health care incurred by diabetic subjects in a developing country: a study from India. Diabetes Care 30 : 252-6, 2007. 4)Ramachandran A, Mary S, Yamuna A, Murugesan N,Snehalatha C. High Prevalence of Diabetes and Cardiovascular Risk Factors Associated with urbanization in India. DOI:10.2337/dc07-1207

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioural changes resulting in diet, better adherence to treatment.		At intervals of three months for one year	Yes
Secondary	Reduction in HbA1c, other glycemic measures and improvement in blood lipid parameters		Annual	Yes

External Links

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