"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

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
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
NCT ID
NCT00727896
First Posted
July 31, 2008
Last Updated
June 24, 2011
Sponsor
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
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
background
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"Information Technology Methodology for Patient Motivation in Diabetes Management."
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