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

This study has been completed.
Sponsor:
Information provided by:
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
ClinicalTrials.gov Identifier:
NCT00727896
First received: July 31, 2008
Last updated: June 24, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Type 2 Diabetes
Behavioral: Pre-coded messages
Drug: Diabetes Treatment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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"

Resource links provided by NLM:


Further study details as provided by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals:

Primary Outcome Measures:
  • Behavioural changes resulting in diet, better adherence to treatment. [ Time Frame: At intervals of three months for one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction in HbA1c, other glycemic measures and improvement in blood lipid parameters [ Time Frame: Annual ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: August 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727896

Locations
India
India Diabetes Research Foundation and Dr.A.Ramachandran's Diabetes Hospitals
Chennai, Tamil nadu, India, 600 008
Sponsors and Collaborators
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Investigators
Principal Investigator: Samith A Shetty, M.B.B.S, MDRC India Diabetes Research Foundation (IDRF) and Dr.A.Ramachandran's Diabetes Hospitals
  More Information

Additional Information:
NA  This link exits the ClinicalTrials.gov site

Publications:
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

Responsible Party: Dr. Samith A Shetty/Consultant Diabetologist, INDIA DIABETES RESEARCH FOUNDATION (IDRF) and Dr. A. Ramachandran's Diabetes Hospitals (ARH)
ClinicalTrials.gov Identifier: NCT00727896     History of Changes
Other Study ID Numbers: SMS001IDRF
Study First Received: July 31, 2008
Last Updated: June 24, 2011
Health Authority: India: Institutional Review Board

Keywords provided by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals:
Life style modification,
Type 2 diabetes,
SMS,
Patient adherence

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014