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临床试验/CTRI/2026/02/102956
CTRI/2026/02/102956尚未招募不适用

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

Dr RAGHU RAM G1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2026年2月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
124
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adults aged between 18-60 years with Type 2 Diabetes Mellitus CURRENTLY on antidiabetic medication: a.
  • With HbA1c currently within normal limits.
  • Willing for OPD follow-up at predefined frequency.
  • Able to speak and read either English or Hindi or both.
  • Owns and operates or has accompanying attendant(s) willing to give access to a smartphone or device for telehealth consultations at predefined frequency.
  • Willing and able to provide written informed consent.

排除标准

  • Patients requiring insulin therapy or emergency management during three months starting from enrolment day.
  • Patients with learning difficulties, vision and/or hearing impairments, or any disease that impairs ability to complete the study or follow-up protocol.
  • Pregnant female or females planning to conceive.

研究者

发起方
Dr RAGHU RAM G
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

RAGHU RAM G

AIIMS RISHIKESH

研究点 (1)

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