Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients
Not applicable · Testing education ,psycological support and social support · 4 sites · Second Affiliated Hospital, Zhejiang University, School of Medicine
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing education ,psycological support and social support as supportive care (to help with symptoms or quality of life). Condition(s) listed: Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 1.Clinically diagnosed IBD patients,according to the criteria of the Inflammatory Bowel Group of the Gastroenterology Branch of the Chinese Medical Association in 2018;
- 2.Aged 18 to 75 years old;
- 3.Understand and comply with the requirements of the program and sign informed consent.
Plus 3 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- Start date: 2023-04-01 (planned).
- Main results expected around 2027-01-01 (estimate from the record).
- 4 study sites listed in China.
Main thing being measured
- Improved score of Quality of Life after three months (three months)
In the researchers’ words
This study aims to prospectively explore the effect of incentive-integrated E-IBD (electronic inflammatory bowel disease) chronic disease management model on the improvement of IBD quality of life, and provide a more effective chronic disease management model for improving the quality of life and social participation of IBD patients.The investigators firstly identify the IBD patients in need of empowerment disease…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis |
| Lead sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Enrollment | 200 (estimated) |
| Start date | 2023-04-01 |
| Primary completion (est.) | 2027-01-01 |
| First posted | 2023-02-09 |
| Last updated | 2023-02-21 |
| Official title | Perspective Study on How Can the Incentive Integrated E-IBD Chronic Disease Management Model Improve the Quality of Life in IBD Patients |
| ClinicalTrials.gov ID | NCT05719766 |
Interventions
- education ,psycological support and social support (Other)
we would give targeted-education according to our patients' need(reflected via questionnaire; we would provide psycological and social support to patients based on their need reflected by questionnaire
Full eligibility criteria (from the record)
Inclusion Criteria: * 1.Clinically diagnosed IBD patients,according to the criteria of the Inflammatory Bowel Group of the Gastroenterology Branch of the Chinese Medical Association in 2018; * 2.Aged 18 to 75 years old; * 3.Understand and comply with the requirements of the program and sign informed consent. * 4.Identified as need intervention according to the patient identification questionnaire screening; * 5.Patients with the ability to complete all course training and/or follow-up work; * 6.Enrolled at least one year ahead of end of this study(for garantee of enough folllow-up time). Exclusion Criteria: * 1.Unable or unwilling to sign the consent form, or unable to follow the research procedure; * 2.Patients who have had a stoma or ileorectal anastomosis (partial scales are not available); * 3.Patients who do not complete training on time or do not complete follow-up assessments in their entirety; * 4.Patients with other malignancies or life-threatening complications； * 5.Pregnancy or lactation； * 6.Patients whose remaining follow-up time less than one year before the end of this study.
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | China | |
| Department of Gastroenterology, Huzhou Central Hospital | Huzhou | China | |
| Department of Gastroenterology, Ruijin Hospital | Shanghai | China | |
| Department of Gastroenterology, Shaoxing Central Hospital | Shaoxing | China |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.