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
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
RAGHU RAM G
AIIMS RISHIKESH
