| CTRI Number |
CTRI/2026/02/102956 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Telehealth] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Telehealth versus regular hospital visits for improving medication use in diabetes patients |
|
Scientific Title of Study
|
Effect of Telehealth on medication adherence in Type 2 Diabetes Mellitus patients in comparison to traditional tertiary hospital OPD follow-up: A prospective Randomized parallel arm study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAGHU RAM G |
| Designation |
Postgraduate Resident |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Junior Resident, Department of pharmacology, AIIMS Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
6360363880 |
| Fax |
|
| Email |
raaghuramg28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAGHU RAM G |
| Designation |
Postgraduate Resident |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Junior Resident, Department of pharmacology, AIIMS Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
6360363880 |
| Fax |
|
| Email |
raaghuramg28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAGHU RAM G |
| Designation |
Postgraduate Resident |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Junior Resident, Department of pharmacology, AIIMS Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
6360363880 |
| Fax |
|
| Email |
raaghuramg28@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr RAGHU RAM G |
| Address |
Department of Pharmacology, AIIMS RISHIKESH, Shivaji Nagar, Rishikesh |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| RAGHU RAM G |
AIIMS Rishikesh |
Diabetes clinic, Department of General medicine and Department of Pharmacology, AIIMS Rishikesh.
Dehradun
UTTARANCHAL |
6360363880
raaghuramg28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Doctor-led routine/standard patient care |
1. OPD visits with doctor-led routine/standard patient care policy.
2. Patient will be counselled to store the empty medication strips/ bottles.
3. Phone call to each patient on completion of 2 months 3 weeks from randomization as a follow-up reminder and reminder to bring empty medication strips/ bottles.
4. Medication adherence measured and blood sample taken for HbA1c and FBG measurement at the end of 3 months.
5. Processing of any Adverse drug reaction reported voluntarily by the patient and actively questioning about any Adverse drug reactions. |
| Intervention |
Telehealth |
1. Random, weekly phone calls to each patient preferably as per their selected time-slots.
2. Video call/consultations to each patient at the end of second, sixth and tenth week from randomization.
3. Medication adherence measured and blood sample taken for HbA1c and FBG measurement at the end of 3 months.
4. Processing of any Adverse drug reaction reported voluntarily by the patient and actively questioning about any Adverse drug reactions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged between 18-60 years with Type 2 Diabetes Mellitus CURRENTLY on antidiabetic medication:
a. With HbA1c currently within normal limits.
b. Willing for OPD follow-up at predefined frequency.
c. Able to speak and read either English or Hindi or both.
d. Owns and operates or has accompanying attendant(s) willing to give access to a smartphone or device for telehealth consultations at predefined frequency.
e. Willing and able to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients requiring insulin therapy or emergency management during three months starting from enrolment day.
2. Patients with learning difficulties, vision and/or hearing impairments, or any disease that impairs ability to complete the study or follow-up protocol.
3. Pregnant female or females planning to conceive |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Measure changes in Medication adherence within each group using MMAS-8 scale and comparing the scores between groups |
At 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of the Morisky Medication Adherence Scale (MMAS-8) scores in each arm with its respective pill-count method scores at the end of 3 months |
At 3 months |
| Change in HbA1c and fasting blood glucose levels in each study arm, and its correlation with changes in adherence to antidiabetic medications |
At 3 months |
| Cost effectiveness of both approaches will be compared using Incremental Cost Effectiveness Ratio (ICER) formula |
At 3 months |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [raaghuramg28@gmail.com].
- For how long will this data be available start date provided 01-07-2028 and end date provided 01-07-2048?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Type 2 diabetes mellitus requires long-term pharmacotherapy, and medication adherence plays a critical role in achieving optimal glycemic control and preventing complications. However, poor adherence remains a major barrier to effective disease management, particularly in resource-constrained settings. Telehealth has emerged as a promising strategy to improve continuity of care, enhance patient engagement, and potentially improve treatment adherence. This prospective randomized parallel-arm study aims to compare the effectiveness of telehealth-based follow-up with traditional in-person outpatient department (OPD) follow-up in improving medication adherence among adults with type 2 diabetes mellitus attending a tertiary care center in Uttarakhand, India. A total of 124 eligible participants will be randomized into two groups: one receiving telehealth follow-up and the other receiving standard in-person follow-up. Medication adherence will be assessed using the Morisky Medication Adherence Scale (MMAS-8), and supported by the pill count method. Clinical outcomes will be evaluated using glycated hemoglobin (HbA1c) and fasting blood glucose levels. Additionally, a cost-effectiveness analysis will be performed using the Incremental Cost-Effectiveness Ratio (ICER) to compare both follow-up approaches. The findings of this study are expected to provide evidence on whether telehealth can serve as an effective alternative to conventional follow-up for improving adherence and clinical outcomes in patients with type 2 diabetes mellitus. |