Inflammatory Bowel DiseasesNCT05719766
Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients
A study testing education ,psycological support and social support in people with Inflammatory Bowel Diseases and Crohn Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 4 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- education ,psycological support and social support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesChina
- Study dates
- 1 Apr 2023to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, 310009
Yan chen, PhD,MD, +8613757118653, chenyan72_72@zju.edu.cn
Department of Gastroenterology, Huzhou Central Hospital
Huzhou
Jiang Liu, PhD
Department of Gastroenterology, Ruijin Hospital
Shanghai
Jie Zhong, PhD,MD, jimmyzj64@medmail.com.cn
Department of Gastroenterology, Shaoxing Central Hospital
Shaoxing
Yazhen Zhan, MD
About this study
Official title: Perspective Study on How Can the Incentive Integrated E-IBD Chronic Disease Management Model Improve the Quality of Life in IBD Patients
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 activities through the questionnaire .Then, the investigators feedback the patients' education content according to their needs found.Based on the social support network of patient organization and the medical support network of tertiary medical institutions, the investigators complete the empowerment process of IBD patients' self-management initiative and self-management ability, through the internet. Finally ,the investigators evaluate the quality of life(QoL), social participation,disease self-management level via questionnaire . The primary outcome is the improvement of QoL score after three months' intervention.
- Being tested
- education ,psycological support and social support
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education ,psycological support and social supportOther
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
| Study group | Role | What they receive |
|---|---|---|
| Routine follow-up group | No intervention | Not described |
| IBD Disease Management Research Group | Experimental | Not described Receives: Other: education ,psycological support and social support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved score of Quality of Life after three months
Improvement score of quality of life via short inflammatory bowel disease questionnaire(SIBDQ, score scale:0~70 points) after intervention for three months,higher scores mean better quality of life.
Measured: three months
Secondary outcomes (3)
Decreased score of Socially activity limited rating
Improvement score of socially activity limited rating after intervention for three months, or one year.
Measured: three months,one year
Decreased score of Hospital Anxiety and Depression Scale
improvement score of anxiety or depression via Hospital Anxiety and Depression Scale after intervention for three months, or one year. Lower scores mean the less anxiety or depression of the patients.
Measured: three months,one year
Increasion of disease kownledge
improvement of disease kownledge via Crohn's and Colitis Knowledge Score(CCKOWN， score scale: 0~24 points) after intervention for three months, or one year. Higher scores mean better knowledge.
Measured: three months,one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan chen, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719766
- Sponsor's protocol ID
- 20230049
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 20230049
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 activities through the questionnaire .Then, the investigators feedback the patients' education content according to their needs found.Based on the social support network of patient organization and the medical support network of tertiary medical institutions, the investigators complete the empowerment process of IBD patients' self-management initiative and self-management ability, through the internet. Finally ,the investigators evaluate the quality of life(QoL), social participation,disease self-management level via questionnaire . The primary outcome is the improvement of QoL score after three months' intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine follow-up group | No intervention | – |
| IBD Disease Management Research Group | Experimental | Other: education ,psycological support and social support |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| education ,psycological support and social supportwe 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 | Other | IBD Disease Management Research Group |
Primary outcome
Improved score of Quality of Life after three months
Time frame: three months
Improvement score of quality of life via short inflammatory bowel disease questionnaire(SIBDQ, score scale:0~70 points) after intervention for three months,higher scores mean better quality of life.
3 secondary outcomes
Decreased score of Socially activity limited rating
Time frame: three months,one year
Decreased score of Hospital Anxiety and Depression Scale
Time frame: three months,one year
Increasion of disease kownledge
Time frame: three months,one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan chen study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education ,psycological support and social support in people with Inflammatory Bowel Diseases and Crohn Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan chen, PhD, MD (+8613757118653, chenyan72_72@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved score of Quality of Life after three months (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05719766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.