Digital Health Interventions for IBS- A longitudinal analysis of patient outcomes using an App (DailyBloomâ„¢ IBS) based approach
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Effectiveness
研究概览
简要总结
The consented subjects would be assigned to medical treatment by a Gastroenterologist and all 3 additional interventions through DailyBloomTM IBS product as recommended by the Gastroenterologist based on individual IBS patient need, of dietary plan based on FODMAP principles, mental wellness - Gut Directed Psychotherapy (Cognitive Behavioural Therapy), Physical wellness - Exercises, Yoga, Relaxation techniques digitally delivered through DailyBloomâ„¢ IBS [program, call and chat support]. Phase 1: Onboarding Phase (1 week), Phase 2: Elimination phase (4 weeks), Phase 3: Reintroduction phase (6 weeks), Phase 4: Sustenance phase (3 weeks) Medical History as per the eligibility criteria
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients from eighteen years of age to fifty years of age of either gender
- •Diagnosed with IBS (Using ROME III, ROME IV or Maning’s Criteria based on the treating physician discretion)
- •Ongoing medical treatment as per standard of care (SoC) under supervision of Gastroenterologist
- •Comfortable for using smartphone for management and agreeing to follow study related procedures
- •Subscribed to program -based management (Daily BloomTM IBS) pertaining to dietary, psychological and physical interventions
- •Provides written informed consent for participation in the study.
排除标准
- •Patients with co-existing medically significant conditions affecting the participation as mentioned below: Patients with IBS who have alarm signs (haematochezia, melena, unintentional weight loss, older age of onset of symptoms, family history of IBD, colon cancer, or other significant GI disease.
- •[IBS ACG Guideline]).
- •Patients with untreated/uncontrolled coexisting diseases (e.g. intestinal parasites, malignancy, psychiatric disorders, diabetes mellitus cardiovascular, pulmonary, hepatic, or renal disorder).
- •Patients with (irritable bowel syndrome on inflammatory bowel disease) IBD-IBS
- •In the opinion of the treating physician any other condition that may interfere the study participation.
结局指标
主要结局
Effectiveness
时间窗: Baseline, Week 5, 11 & 14
1. To evaluate the change from the baseline in IBS-SSS score at each of the study specific time points 2. To evaluate the change from the baseline in IBS specific QoL score at each of the study specific time points 3. Hospital Anxiety and Depression Scale from baseline to week 14
时间窗: Baseline, Week 5, 11 & 14
Safety
时间窗: Baseline, Week 5, 11 & 14
1. Safety Monitoring
时间窗: Baseline, Week 5, 11 & 14
Average number of flare-ups of the IBS symptoms during the study period
时间窗: Baseline, Week 5, 11 & 14
次要结局
- Effectiveness(Adherence will be based on the following 1.Nutritionists:)
研究者
Dr Rakesh Kalapala
AIG Hospitals (A unit of Asian Institute of Gastroenterology)