Comparison of Telemedicine vs Standard OPD follow up in flares of ulcerative colitis - A patient preference randomised control trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cost of care inclusive of system and patient costs
研究概览
简要总结
We plan to study the difference in manner of follow up of patients with a flare of ulcerative colitis. In this patient preference randomized trial patients diagnosed with a flare of ulcerative colitis on basis of complete Mayo Score will be offered a follow up either through outpatients department physical visits or teleconsults using the e Sanjeevani platform. Patients without a distinct preference for either of these modes of follow up will be randomized to one of the two arms. At end of 14 weeks comparison will be made in respect to costs of care, quality of life and medication adherence and disease activity.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of ulcerative colitis as per standard criteria (ECCO definition) -Flares of ulcerative colitis diagnosed on basis of a modified Mayo Score of 5 or more including an endoscopy score of 2 or more -Planned for induction therapy with steroids or advanced therapy.
- •Age between 18-75 years.
排除标准
- •Crohn’s disease.
- •Pregnant women.
- •Severe comorbidity requiring follow-up.
- •Toxic megacolon.
- •Inability to comply with the study protocol or not willing to participate
- •Previous intestinal surgery.
结局指标
主要结局
Cost of care inclusive of system and patient costs
时间窗: Completion of 14 week
次要结局
- Quality of life score using EQ5D5L(14 week)
- Disease related quality of life using SIBDQ(14 week)
- Medication adherence using MARS5(14 week)
- Disease status active versus remission using partial Mayo Score(14 week)
- Health care utilisation including hospitalisation or emergency visit or surgery(14 weeks)
研究者
Vishal Sharma
Postgraduate Institute of Medical Education and Research