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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Pre-coded messages
Diabetes Treatment
Sponsored by
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Life style modification,, Type 2 diabetes,, SMS,, Patient adherence

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • India Diabetes Research Foundation and Dr.A.Ramachandran's Diabetes Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 is experimental with SMS

2 is (active comparator) standard care

Arm Description

Arm 1 is experimental with SMS intervention

Arm 2 is the usual care arm (standard care)

Outcomes

Primary Outcome Measures

Behavioural changes resulting in diet, better adherence to treatment.

Secondary Outcome Measures

Reduction in HbA1c, other glycemic measures and improvement in blood lipid parameters

Full Information

First Posted
July 31, 2008
Last Updated
June 24, 2011
Sponsor
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00727896
Brief Title
"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

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Life style modification,, Type 2 diabetes,, SMS,, Patient adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 is experimental with SMS
Arm Type
Experimental
Arm Description
Arm 1 is experimental with SMS intervention
Arm Title
2 is (active comparator) standard care
Arm Type
Active Comparator
Arm Description
Arm 2 is the usual care arm (standard care)
Intervention Type
Behavioral
Intervention Name(s)
Pre-coded messages
Intervention Description
Earlier life style modification and existing drug therapy was used and now SMS is added as a tool for reminder
Intervention Type
Drug
Intervention Name(s)
Diabetes Treatment
Intervention Description
Life style modification and drug therapy
Primary Outcome Measure Information:
Title
Behavioural changes resulting in diet, better adherence to treatment.
Time Frame
At intervals of three months for one year
Secondary Outcome Measure Information:
Title
Reduction in HbA1c, other glycemic measures and improvement in blood lipid parameters
Time Frame
Annual

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samith A Shetty, M.B.B.S, MDRC
Organizational Affiliation
India Diabetes Research Foundation (IDRF) and Dr.A.Ramachandran's Diabetes Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
India Diabetes Research Foundation and Dr.A.Ramachandran's Diabetes Hospitals
City
Chennai
State/Province
Tamil nadu
ZIP/Postal Code
600 008
Country
India

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
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"Information Technology Methodology for Patient Motivation in Diabetes Management."

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