"Information Technology Methodology for Patient Motivation in Diabetes Management." - Full Text View

Sponsored by:	India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Information provided by:	India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
ClinicalTrials.gov Identifier:	NCT00727896

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 I

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	"Reinforcement of Adherence to Prescription Recommendations in Diabetic Patients Using Short Message Service (SMS)- A Pilot Study"

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
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 is experimental with SMS: Experimental 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
2 is (active comparator) standard care: Active Comparator 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

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

Contacts

Contact: Samith A Shetty, MBBS, MDRC	+91-44-28582003/04/05 ext 233	ramachandran@ardiabetes.org
Contact: Chamukuttan Snehalatha, M.Sc,D.Phil, D.Sc	+91-44-28582003/04/05 ext 233	snehalatha@vsnl.com

Locations

India, Tamil nadu
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

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:	INDIA DIABETES RESEARCH FOUNDATION (IDRF) and Dr. A. Ramachandran's Diabetes Hospitals (ARH) ( Dr. Samith A Shetty/Consultant Diabetologist )
Study ID Numbers:	SMS001IDRF
Study First Received:	July 31, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00727896
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

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009