- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00727896
"Information Technology Methodology for Patient Motivation in Diabetes Management."
"Reinforcement of Adherence to Prescription Recommendations in Diabetic Patients Using Short Message Service (SMS)- A Pilot Study"
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Tamil nadu
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Chennai, Tamil nadu, Indië, 600 008
- India Diabetes Research Foundation and Dr.A.Ramachandran's Diabetes Hospitals
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 1 is experimental with SMS
Arm 1 is experimental with SMS intervention
|
Earlier life style modification and existing drug therapy was used and now SMS is added as a tool for reminder
|
Actieve vergelijker: 2 is (active comparator) standard care
Arm 2 is the usual care arm (standard care)
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Life style modification and drug therapy
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Behavioural changes resulting in diet, better adherence to treatment.
Tijdsspanne: At intervals of three months for one year
|
At intervals of three months for one year
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Reduction in HbA1c, other glycemic measures and improvement in blood lipid parameters
Tijdsspanne: Annual
|
Annual
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Samith A Shetty, M.B.B.S, MDRC, India Diabetes Research Foundation (IDRF) and Dr.A.Ramachandran's Diabetes Hospitals
Publicaties en nuttige links
Algemene publicaties
- 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
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SMS001IDRF
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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