| CTRI Number |
CTRI/2024/10/075038 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Telemedicine follow up in uncontrolled Diabetes Mellitus Type 2 |
|
Scientific Title of Study
|
A pilot randomised controlled trial comparing telephonic message based follow up versus standard of care in patients with uncontrolled Type 2 Diabetes Mellitus in Medicine OPD |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krupa Devakumar |
| Designation |
PG registrar |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Medicine II office,
Room No. 202, Radiotherapy block,
Christian Medical College, Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9905641929 |
| Fax |
|
| Email |
krupadevakumar1995@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vignesh Kumar Chandiraseharan |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Medicine II office,
Room 202, Radiotherapy Block,
Christian Medical College, Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
8778879558 |
| Fax |
|
| Email |
vigneshmmc02@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Krupa Devakumar |
| Designation |
PG registrar |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Medicine II office,
Room 202, Radiotherapy block,
Christian Medical College, Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9905641929 |
| Fax |
|
| Email |
krupadevakumar1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Thesis Research Fund
Christian Medical College, Vellore |
|
|
Primary Sponsor
|
| Name |
Christian Medical College, Vellore |
| Address |
Christian Medical College, Vellore
Pin 632004 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krupa Devakumar |
Christian Medical College, Vellore |
Department of Medicine,
Christian Medical College, Ida Scudder Road, Vellore 632004 Vellore TAMIL NADU |
9905641929
krupadevakumar1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD (IRB), OFFICE OF RESEARCH, CHRISTIAN MEDICAL COLLEGE, VELLORE, INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard of care |
The comparator arm will receive the current standard of care which includes dietary advice provided by the physician and/or dietician, diabetes education provided by the physician and/or diabetic nurse educator, pharmacological therapy including biguanides, sulphonylureas, DPP IV inhibitors, SGLT 2 inhibitors, Thiazolidinediones, GLP 1 analogues depending on patient’s profile, comorbidities, allergies and adverse effects.
|
| Intervention |
Telephonic message follow up |
The intervention group will receive telephonic message based follow up (upto 2 messages a week for 12 weeks) in addition to standard care. The messages will be in one of the following languages:
Tamil
English
Hindi
Malayalam
Telugu
Bengali
It will be based on the patient’s preference.
This is based on the transtheoretical model of behavioural change
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Pragmatic trial |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in HbA1c |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hba1c at 6 months
Patient satisfaction at 3 months
quality of life at 3 months
Knowledge, attitude and practices at 3 months
Depression rates at 3 months |
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="128" Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes mellitus is a complex metabolic illness marked by elevated blood sugar levels due to issues with insulin secretion or action. It affects around 422 million people worldwide, particularly impacting low- and middle-income countries and causing 1.5 million deaths annually. The cases of Diabetes in India have been steadily increasing and rural Tamil Nadu experiencing a nearly threefold increase.
Studies indicate that digital tools for health coaching and education can help improve diabetes control measures, such as HbA1c, weight loss, and blood glucose levels. One effective intervention is telephone follow-up after a hospital visit, as phones are widely used and do not require additional equipment. This method involves health-related messages and motivational calls to encourage medication adherence and lifestyle changes. The study aims to show that such telephonic follow-up interventions can improve HbA1c levels and reduce LDL cholesterol, blood pressure, and depression within three months. The study focuses on general medicine outpatients in Tamil Nadu with HbA1c levels exceeding 8, comparing the effectiveness of standard treatment alone versus standard treatment supplemented with telephonic follow-up. The intervention group receives six weekly messages and a phone call at six weeks from the principal investigator, with messages provided in Tamil or English based on patient preference. Patients must be over 18, easily reachable by phone, and consent to participate. Exclusion criteria are not specified. The comparator group receives standard treatment following department practices.
The main goal of this study is to see if telemedicine follow-up for patients is as effective as standard care in managing HbA1c levels (a measure of blood sugar) at 3 months. Secondary goals include comparing HbA1c levels at 6 months, assessing patient satisfaction with telemedicine at 3 months, quality of life and comparing the prevalence of depression at 3 months between the telemedicine and standard care groups.
|