Inflammatory Bowel DiseasesNCT06512792
Mobile App-Based Remote Management Model for IBD Patient
A study testing Telemedicine management through Mobile APP in people with Inflammatory Bowel Diseases, run by Changhai Hospital at 1 site in China.
Trial summary
Inflammatory Bowel Disease (IBD) is a chronic inflammatory condition of the intestines, with its incidence showing a significant year-on-year increase in China. Self-management is becoming increasingly important in the treatment and follow-up of IBD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Telemedicine management through Mobile APP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients will be diagnosed with IBD based on the diagnostic criteria outlined in the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing)". The diagnosis will be established by combining clinical symptoms, endoscopic examination results, imaging findings, and histological examination results.
- Participants must be between the ages of 18 and 75 and provide signed informed consent for the project.
- Within the two years prior to enrollment, medical records must show at least one instance assessed as an inflammatory active phase (Mayo score ≥ 3 or CDAI score ≥ 150).
Who cannot join
- Participants deemed unable to adhere to the study protocol as determined by the investigators.
- Individuals with a history of surgical treatment for IBD or those scheduled to undergo surgery.
- Uncontrolled internal medicine or psychiatric disorders.
- Pregnant individuals or those planning to become pregnant during the enrollment and follow-up period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Xuanming Fan, M.D., +86-18301972695, fan18301972695@163.com
Yu Bai, professor, +86-13564665324, md.baiyu@foxmail.com
About this study
Official title: Mobile App-Based Remote Management Model for IBD Patients: A Multi-Center Randomized Controlled Study
Inflammatory Bowel Disease (IBD) is a chronic inflammatory condition of the intestines, with its incidence showing a significant year-on-year increase in China. Self-management is becoming increasingly important in the treatment and follow-up of IBD. Numerous studies from Europe and North America have demonstrated that telemedicine can effectively manage disease activity, monitor symptoms, provide education, and improve prognosis. However, its application in China is limited, and there is a lack of high-quality clinical research. This study aims to explore the following objectives:
- Investigate the level of disease awareness among Chinese IBD patients and their needs related to telemedicine;
- Develop and preliminarily establish a telemedicine management system and operational process for IBD patients based on a mobile application platform;
- Clarify the impact of telemedicine on disease activity, quality of life, and healthcare resource utilization among Chinese IBD patients.
Read the detailed description
To investigate the level of awareness among Chinese IBD (Inflammatory Bowel Disease) patients about their condition and their needs regarding telemedicine, a survey questionnaire has been designed. The questionnaire includes sections on basic knowledge of IBD, treatment methods, daily management, and telemedicine needs. The content of the questionnaire will be discussed and finalized by a team of experts, and then distributed through the Wenjuanxing platform via the WeChat app across multiple centers nationwide, with an expected participation of over 1,000 patients. Additionally, researchers will conduct semi-structured interviews with 50 IBD patients from Changhai Hospital to understand their most concerning symptoms and issues. The results of these interviews will be used to create educational materials for patients.
To construct and operate a telemedicine management system for IBD patients based on the WeChat platform, the following steps will be taken:
- Establishing Electronic Health Records (EHRs): Each enrolled patient will have an EHR containing personal information, disease history, disease behavior, and treatment details.
- Health Management Monitoring: Researchers will provide personalized medication and follow-up reminders based on the EHRs. Patients will be encouraged to monitor their health at home, regularly record clinical symptoms, medication, diet, and exercise, and upload this information to the WeChat platform. Self-assessment questionnaires will be distributed periodically via Wenjuanxing to evaluate disease activity, quality of life, sleep, and psychological status, with results recorded in the EHRs.
- Personalized Recommendations and Interventions: Researchers will assess potential disease risks based on clinical symptoms, self-assessment questionnaires, and medical test results, sending alerts and providing targeted information and interventions.
- Health Education and Communication: Using results from semi-structured interviews, a health education resource library will be developed, including IBD knowledge, treatment, and daily management in various formats. Weekly personalized education sessions will be provided, and doctor-patient WeChat groups will be established for ongoing interaction, health consultations, and patient discussions.
This section outlines a 12-month, multicenter, randomized controlled clinical trial involving 500 IBD patients across five centers in China. The study aims to explore the impact of WeChat-based telemedicine on disease activity, quality of life, and healthcare resource utilization among IBD patients. Eligible patients will be randomly assigned to either an intervention group or a control group. The intervention group will receive telemedicine management via WeChat, including the establishment of electronic health records, health monitoring, risk alerts, and education, while the control group will receive standard traditional care without additional guidance. All participants will undergo research visits at baseline, 6 months, and 12 months, with colonoscopies required at baseline and 12 months for endoscopic evaluation. Monthly follow-ups via Wenjuanxing will assess healthcare resource utilization. Disease activity (primary endpoint), quality of life, and healthcare resource utilization (secondary endpoints) will be evaluated at baseline, 6 months, and 12 months.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Telemedicine management through Mobile APP
- Keywords
- Telemedicine, Mobile APP, Inflammatory Bowel Disease, Daily Management, Disease Activity, Randomized controlled
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine management through Mobile APPBehavioural
According to the patient's electronic health records, each participating center researcher conducts personalized medication reminders and follow-up reminders for enrolled patients on a one-on-one basis. Simultaneously, patients are advised to monitor their health at home, regularly record and upload changes in clinical symptoms, medication, diet, exercise, etc., on the Mobile APP platform. Periodically, self-assessment scales are distributed through the Questionnaire Star platform to assess and record the patient's disease activity, quality of life, sleep, psychological status, etc., and update the information in the electronic health records.Based on the patient's clinical symptoms, self-assessment scales, and feedback from medical institution tests and examinations, each participating center researcher will promptly assess potential health risks, send warning alerts, and provide targeted informational support and interventions.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing telemedicine interventions | Experimental | Participants in the intervention group received telemedicine management from researchers through the mobile app platform (establishing electronic health records, health management monitoring, risk warning and intervention, health education). Receives: Behavioral: Telemedicine management through Mobile APP |
| IBD patients receiving traditional medical care | No intervention | The control group received no guidance and only standard traditional care services (i.e., prescribed medication and regular outpatient follow-up). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity
Changes in disease activity scores at six months and one year of follow-up after enrollment were assessed. For UC patients, the modified Mayo score (total score 0-12, with higher scores indicating more severe intestinal lesions) was used. For CD patients, the SES-CD score (total score 0-60, with higher scores indicating more severe intestinal lesions) was utilized.
Measured: Six months after enrollment，1 year after enrollment
Secondary outcomes (4)
Quality of life assessment
A multidimensional assessment will be conducted using the widely validated and extensively used patient self-assessment scale, the Simple Quality of Life Questionnaire (IBDQ). This scale consists of 32 selected health-related questions (total score 32-224, with higher scores indicating better quality of life).
Measured: Six months after enrollment，1 year after enrollment
Psychological assessment
The assessment is conducted using the Hospital Anxiety and Depression Scale (HADS), which consists of 14 emotional questions. The total score ranges from 0 to 42, with higher scores indicating more severe psychological distress in patients.
Measured: Six months after enrollment，1 year after enrollment
Utilization rate of medical resources
The assessment of healthcare resource utilization will be conducted through a self-administered questionnaire. Follow-up questionnaires will be administered via the WeChat Questionnaire Star platform in the 1st, 2nd, 3rd, 4th, 5th, 7th, 8th, 9th, 10th, and 11th months to evaluate healthcare resource utilization patterns. This questionnaire has been developed through an extensive review of the literature and discussions with relevant experts. Its key components include total number of medical visits, IBD-related hospitalizations, emergency room visits, outpatient visits, endoscopic examinations, and telemedicine consultations.（The more frequently the relevant information is filled out, the lower the utilization of medical resources.）
Measured: Each month within the 1 year of enrollment
Ratio of reduced IBD flare-up episodes
The proportion of patients with reduced IBD flare-ups (one year before and after enrollment). IBD patients in a flare-up phase within one month after enrollment were excluded.
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Jan 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Model description
- IBD patients meeting the inclusion criteria will be stratified and randomly assigned to either the intervention group or the control group. Participants in the intervention group will undergo remote healthcare management by the researchers through the WeChat platform, including the establishment of electronic health records, health management monitoring, risk warning and intervention, and health education. On the other hand, participants in the control group will receive no specific guidance and will only receive standard traditional treatment services (i.e., medication according to prescription and routine outpatient follow-ups).Colonoscopy will be required for endoscopic assessment at baseline and at the 12-month follow-up. Additionally, participants will be surveyed monthly for one year to assess the utilization of healthcare resources. At the baseline, 6-month, and 12-month visits, researchers will evaluate disease activity, quality of life , and healthcare resource utilization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, Professor, Study director, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512792
- Sponsor's protocol ID
- CHEC2024-210
- Status last verified
- Jul 2024
- First submitted
- 18 Feb 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seyed Tabib NS, Madgwick M, Sudhakar P, Verstockt B, Korcsmaros T, Vermeire S. Big data in IBD: big progress for clinical practice. Gut. 2020 Aug;69(8):1520-1532. doi: 10.1136/gutjnl-2019-320065. Epub 2020 Feb 28.
PubMed 32111636Mak WY, Zhao M, Ng SC, Burisch J. The epidemiology of inflammatory bowel disease: East meets west. J Gastroenterol Hepatol. 2020 Mar;35(3):380-389. doi: 10.1111/jgh.14872. Epub 2019 Nov 24.
PubMed 31596960Burisch J, Zhao M, Odes S, De Cruz P, Vermeire S, Bernstein CN, Kaplan GG, Duricova D, Greenberg D, Melberg HO, Watanabe M, Ahn HS, Targownik L, Pittet VEH, Annese V, Park KT, Katsanos KH, Hoivik ML, Krznaric Z, Chaparro M, Loftus EV Jr, Lakatos PL, Gisbert JP, Bemelman W, Moum B, Gearry RB, Kappelman MD, Hart A, Pierik MJ, Andrews JM, Ng SC, D'Inca R, Munkholm P. The cost of inflammatory bowel disease in high-income settings: a Lancet Gastroenterology & Hepatology Commission. Lancet Gastroenterol Hepatol. 2023 May;8(5):458-492. doi: 10.1016/S2468-1253(23)00003-1. Epub 2023 Mar 2.
PubMed 36871566Hulme JB, Bain B, Hardin M, McKinnon A, Waldron D. The influence of adaptive seating devices on vocalization. J Commun Disord. 1989 Apr;22(2):137-45. doi: 10.1016/0021-9924(89)90030-0.
PubMed 2723144Singh A, Koenen B, Kirby DF. Bariatric Surgery and Its Complications in Inflammatory Bowel Disease Patients. Inflamm Bowel Dis. 2020 Jul 17;26(8):1155-1165. doi: 10.1093/ibd/izz246.
PubMed 31626698Gold SL, Rabinowitz LG, Manning L, Keefer L, Rivera-Carrero W, Stanley S, Sherman A, Castillo A, Tse S, Hyne A, Matos K, Cohen B, Grinspan A, Colombel JF, Sands BE, Dubinsky MC, Ungaro RC. High Prevalence of Malnutrition and Micronutrient Deficiencies in Patients With Inflammatory Bowel Disease Early in Disease Course. Inflamm Bowel Dis. 2023 Mar 1;29(3):423-429. doi: 10.1093/ibd/izac102.
PubMed 35590456Bai Y, Peng J, Gao J, Zou DW, Li ZS. Epidemiology of lower gastrointestinal bleeding in China: single-center series and systematic analysis of Chinese literature with 53,951 patients. J Gastroenterol Hepatol. 2011 Apr;26(4):678-82. doi: 10.1111/j.1440-1746.2010.06586.x.
PubMed 21083610Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Scholmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19.
PubMed 33359090Colombel JF, Narula N, Peyrin-Biroulet L. Management Strategies to Improve Outcomes of Patients With Inflammatory Bowel Diseases. Gastroenterology. 2017 Feb;152(2):351-361.e5. doi: 10.1053/j.gastro.2016.09.046. Epub 2016 Oct 5.
PubMed 27720840Yu Q, Zhu C, Feng S, Xu L, Hu S, Chen H, Chen H, Yao S, Wang X, Chen Y. Economic Burden and Health Care Access for Patients With Inflammatory Bowel Diseases in China: Web-Based Survey Study. J Med Internet Res. 2021 Jan 5;23(1):e20629. doi: 10.2196/20629.
PubMed 33399540Szigethy EM, Allen JI, Reiss M, Cohen W, Perera LP, Brillstein L, Cross RK, Schwartz DA, Kosinski LR, Colton JB, LaRusso E, Atreja A, Regueiro MD. White Paper AGA: The Impact of Mental and Psychosocial Factors on the Care of Patients With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2017 Jul;15(7):986-997. doi: 10.1016/j.cgh.2017.02.037. Epub 2017 Mar 12.
PubMed 28300693Colombel JF, Panaccione R, Bossuyt P, Lukas M, Baert F, Vanasek T, Danalioglu A, Novacek G, Armuzzi A, Hebuterne X, Travis S, Danese S, Reinisch W, Sandborn WJ, Rutgeerts P, Hommes D, Schreiber S, Neimark E, Huang B, Zhou Q, Mendez P, Petersson J, Wallace K, Robinson AM, Thakkar RB, D'Haens G. Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet. 2017 Dec 23;390(10114):2779-2789. doi: 10.1016/S0140-6736(17)32641-7. Epub 2017 Oct 31.
PubMed 29096949Kane SV, Cohen RD, Aikens JE, Hanauer SB. Prevalence of nonadherence with maintenance mesalamine in quiescent ulcerative colitis. Am J Gastroenterol. 2001 Oct;96(10):2929-33. doi: 10.1111/j.1572-0241.2001.04683.x.
PubMed 11693328Levine A, Rhodes JM, Lindsay JO, Abreu MT, Kamm MA, Gibson PR, Gasche C, Silverberg MS, Mahadevan U, Boneh RS, Wine E, Damas OM, Syme G, Trakman GL, Yao CK, Stockhamer S, Hammami MB, Garces LC, Rogler G, Koutroubakis IE, Ananthakrishnan AN, McKeever L, Lewis JD. Dietary Guidance From the International Organization for the Study of Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2020 May;18(6):1381-1392. doi: 10.1016/j.cgh.2020.01.046. Epub 2020 Feb 15.
PubMed 32068150Mikocka-Walus A, Knowles SR, Keefer L, Graff L. Controversies Revisited: A Systematic Review of the Comorbidity of Depression and Anxiety with Inflammatory Bowel Diseases. Inflamm Bowel Dis. 2016 Mar;22(3):752-62. doi: 10.1097/MIB.0000000000000620.
PubMed 26841224
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile App-Based Remote Management Model for IBD Patients: A Multi-Center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06512792
- Acronym / sponsor ID
- CHEC2024-210
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Telemedicine, Mobile APP, Inflammatory Bowel Disease, Daily Management, Disease Activity, Randomized controlled
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Jul 2024 (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.
Inflammatory Bowel Disease (IBD) is a chronic inflammatory condition of the intestines, with its incidence showing a significant year-on-year increase in China. Self-management is becoming increasingly important in the treatment and follow-up of IBD. Numerous studies from Europe and North America have demonstrated that telemedicine can effectively manage disease activity, monitor symptoms, provide education, and improve prognosis. However, its application in China is limited, and there is a lack of high-quality clinical research. This study aims to explore the following objectives:
- Investigate the level of disease awareness among Chinese IBD patients and their needs related to telemedicine;
- Develop and preliminarily establish a telemedicine management system and operational process for IBD patients based on a mobile application platform;
- Clarify the impact of telemedicine on disease activity, quality of life, and healthcare resource utilization among Chinese IBD patients.
Detailed description
To investigate the level of awareness among Chinese IBD (Inflammatory Bowel Disease) patients about their condition and their needs regarding telemedicine, a survey questionnaire has been designed. The questionnaire includes sections on basic knowledge of IBD, treatment methods, daily management, and telemedicine needs. The content of the questionnaire will be discussed and finalized by a team of experts, and then distributed through the Wenjuanxing platform via the WeChat app across multiple centers nationwide, with an expected participation of over 1,000 patients. Additionally, researchers will conduct semi-structured interviews with 50 IBD patients from Changhai Hospital to understand their most concerning symptoms and issues. The results of these interviews will be used to create educational materials for patients.
To construct and operate a telemedicine management system for IBD patients based on the WeChat platform, the following steps will be taken:
- Establishing Electronic Health Records (EHRs): Each enrolled patient will have an EHR containing personal information, disease history, disease behavior, and treatment details.
- Health Management Monitoring: Researchers will provide personalized medication and follow-up reminders based on the EHRs. Patients will be encouraged to monitor their health at home, regularly record clinical symptoms, medication, diet, and exercise, and upload this information to the WeChat platform. Self-assessment questionnaires will be distributed periodically via Wenjuanxing to evaluate disease activity, quality of life, sleep, and psychological status, with results recorded in the EHRs.
- Personalized Recommendations and Interventions: Researchers will assess potential disease risks based on clinical symptoms, self-assessment questionnaires, and medical test results, sending alerts and providing targeted information and interventions.
- Health Education and Communication: Using results from semi-structured interviews, a health education resource library will be developed, including IBD knowledge, treatment, and daily management in various formats. Weekly personalized education sessions will be provided, and doctor-patient WeChat groups will be established for ongoing interaction, health consultations, and patient discussions.
This section outlines a 12-month, multicenter, randomized controlled clinical trial involving 500 IBD patients across five centers in China. The study aims to explore the impact of WeChat-based telemedicine on disease activity, quality of life, and healthcare resource utilization among IBD patients. Eligible patients will be randomly assigned to either an intervention group or a control group. The intervention group will receive telemedicine management via WeChat, including the establishment of electronic health records, health monitoring, risk alerts, and education, while the control group will receive standard traditional care without additional guidance. All participants will undergo research visits at baseline, 6 months, and 12 months, with colonoscopies required at baseline and 12 months for endoscopic evaluation. Monthly follow-ups via Wenjuanxing will assess healthcare resource utilization. Disease activity (primary endpoint), quality of life, and healthcare resource utilization (secondary endpoints) will be evaluated at baseline, 6 months, and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- IBD patients meeting the inclusion criteria will be stratified and randomly assigned to either the intervention group or the control group. Participants in the intervention group will undergo remote healthcare management by the researchers through the WeChat platform, including the establishment of electronic health records, health management monitoring, risk warning and intervention, and health education. On the other hand, participants in the control group will receive no specific guidance and will only receive standard traditional treatment services (i.e., medication according to prescription and routine outpatient follow-ups).Colonoscopy will be required for endoscopic assessment at baseline and at the 12-month follow-up. Additionally, participants will be surveyed monthly for one year to assess the utilization of healthcare resources. At the baseline, 6-month, and 12-month visits, researchers will evaluate disease activity, quality of life , and healthcare resource utilization.
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing telemedicine interventions | Experimental | Behavioral: Telemedicine management through Mobile APPParticipants in the intervention group received telemedicine management from researchers through the mobile app platform (establishing electronic health records, health management monitoring, risk warning and intervention, health education). |
| IBD patients receiving traditional medical care | No intervention | –The control group received no guidance and only standard traditional care services (i.e., prescribed medication and regular outpatient follow-up). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients will be diagnosed with IBD based on the diagnostic criteria outlined in the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing)". The diagnosis will be established by combining clinical symptoms, endoscopic examination results, imaging findings, and histological examination results.
- Participants must be between the ages of 18 and 75 and provide signed informed consent for the project.
- Within the two years prior to enrollment, medical records must show at least one instance assessed as an inflammatory active phase (Mayo score ≥ 3 or CDAI score ≥ 150).
Key exclusion criteria (4 listed)
- Participants deemed unable to adhere to the study protocol as determined by the investigators.
- Individuals with a history of surgical treatment for IBD or those scheduled to undergo surgery.
- Uncontrolled internal medicine or psychiatric disorders.
- Pregnant individuals or those planning to become pregnant during the enrollment and follow-up period.
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 |
|---|---|---|
| Telemedicine management through Mobile APPAccording to the patient's electronic health records, each participating center researcher conducts personalized medication reminders and follow-up reminders for enrolled patients on a one-on-one basis. Simultaneously, patients are advised to monitor their health at home, regularly record and upload changes in clinical symptoms, medication, diet, exercise, etc., on the Mobile APP platform. Periodically, self-assessment scales are distributed through the Questionnaire Star platform to assess and record the patient's disease activity, quality of life, sleep, psychological status, etc., and update the information in the electronic health records.Based on the patient's clinical symptoms, self-assessment scales, and feedback from medical institution tests and examinations, each participating center researcher will promptly assess potential health risks, send warning alerts, and provide targeted informational support and interventions. | Behavioural | Patients undergoing telemedicine interventions |
Primary outcome
Disease activity
Time frame: Six months after enrollment，1 year after enrollment
Changes in disease activity scores at six months and one year of follow-up after enrollment were assessed. For UC patients, the modified Mayo score (total score 0-12, with higher scores indicating more severe intestinal lesions) was used. For CD patients, the SES-CD score (total score 0-60, with higher scores indicating more severe intestinal lesions) was utilized.
4 secondary outcomes
Quality of life assessment
Time frame: Six months after enrollment，1 year after enrollment
Psychological assessment
Time frame: Six months after enrollment，1 year after enrollment
Utilization rate of medical resources
Time frame: Each month within the 1 year of enrollment
Ratio of reduced IBD flare-up episodes
Time frame: 1 year after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Background: PubMed 32111636Seyed Tabib NS, Madgwick M, Sudhakar P, Verstockt B, Korcsmaros T, Vermeire S. Big data in IBD: big progress for clinical practice. Gut. 2020 Aug;69(8):1520-1532. doi: 10.1136/gutjnl-2019-320065. Epub 2020 Feb 28.
- Background: PubMed 31596960Mak WY, Zhao M, Ng SC, Burisch J. The epidemiology of inflammatory bowel disease: East meets west. J Gastroenterol Hepatol. 2020 Mar;35(3):380-389. doi: 10.1111/jgh.14872. Epub 2019 Nov 24.
- Background: PubMed 36871566Burisch J, Zhao M, Odes S, De Cruz P, Vermeire S, Bernstein CN, Kaplan GG, Duricova D, Greenberg D, Melberg HO, Watanabe M, Ahn HS, Targownik L, Pittet VEH, Annese V, Park KT, Katsanos KH, Hoivik ML, Krznaric Z, Chaparro M, Loftus EV Jr, Lakatos PL, Gisbert JP, Bemelman W, Moum B, Gearry RB, Kappelman MD, Hart A, Pierik MJ, Andrews JM, Ng SC, D'Inca R, Munkholm P. The cost of inflammatory bowel disease in high-income settings: a Lancet Gastroenterology & Hepatology Commission. Lancet Gastroenterol Hepatol. 2023 May;8(5):458-492. doi: 10.1016/S2468-1253(23)00003-1. Epub 2023 Mar 2.
- Background: PubMed 2723144Hulme JB, Bain B, Hardin M, McKinnon A, Waldron D. The influence of adaptive seating devices on vocalization. J Commun Disord. 1989 Apr;22(2):137-45. doi: 10.1016/0021-9924(89)90030-0.
- Background: PubMed 31626698Singh A, Koenen B, Kirby DF. Bariatric Surgery and Its Complications in Inflammatory Bowel Disease Patients. Inflamm Bowel Dis. 2020 Jul 17;26(8):1155-1165. doi: 10.1093/ibd/izz246.
- Background: PubMed 35590456Gold SL, Rabinowitz LG, Manning L, Keefer L, Rivera-Carrero W, Stanley S, Sherman A, Castillo A, Tse S, Hyne A, Matos K, Cohen B, Grinspan A, Colombel JF, Sands BE, Dubinsky MC, Ungaro RC. High Prevalence of Malnutrition and Micronutrient Deficiencies in Patients With Inflammatory Bowel Disease Early in Disease Course. Inflamm Bowel Dis. 2023 Mar 1;29(3):423-429. doi: 10.1093/ibd/izac102.
- Background: PubMed 21083610Bai Y, Peng J, Gao J, Zou DW, Li ZS. Epidemiology of lower gastrointestinal bleeding in China: single-center series and systematic analysis of Chinese literature with 53,951 patients. J Gastroenterol Hepatol. 2011 Apr;26(4):678-82. doi: 10.1111/j.1440-1746.2010.06586.x.
- Background: PubMed 33359090Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Scholmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19.
- Background: PubMed 27720840Colombel JF, Narula N, Peyrin-Biroulet L. Management Strategies to Improve Outcomes of Patients With Inflammatory Bowel Diseases. Gastroenterology. 2017 Feb;152(2):351-361.e5. doi: 10.1053/j.gastro.2016.09.046. Epub 2016 Oct 5.
- Background: PubMed 33399540Yu Q, Zhu C, Feng S, Xu L, Hu S, Chen H, Chen H, Yao S, Wang X, Chen Y. Economic Burden and Health Care Access for Patients With Inflammatory Bowel Diseases in China: Web-Based Survey Study. J Med Internet Res. 2021 Jan 5;23(1):e20629. doi: 10.2196/20629.
- Background: PubMed 28300693Szigethy EM, Allen JI, Reiss M, Cohen W, Perera LP, Brillstein L, Cross RK, Schwartz DA, Kosinski LR, Colton JB, LaRusso E, Atreja A, Regueiro MD. White Paper AGA: The Impact of Mental and Psychosocial Factors on the Care of Patients With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2017 Jul;15(7):986-997. doi: 10.1016/j.cgh.2017.02.037. Epub 2017 Mar 12.
- Background: PubMed 29096949Colombel JF, Panaccione R, Bossuyt P, Lukas M, Baert F, Vanasek T, Danalioglu A, Novacek G, Armuzzi A, Hebuterne X, Travis S, Danese S, Reinisch W, Sandborn WJ, Rutgeerts P, Hommes D, Schreiber S, Neimark E, Huang B, Zhou Q, Mendez P, Petersson J, Wallace K, Robinson AM, Thakkar RB, D'Haens G. Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet. 2017 Dec 23;390(10114):2779-2789. doi: 10.1016/S0140-6736(17)32641-7. Epub 2017 Oct 31.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Zhaoshen Li, Professor study director
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine management through Mobile APP in people with Inflammatory Bowel Diseases, run by Changhai Hospital at 1 site 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuanming Fan, M.D. (+86-18301972695, fan18301972695@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity (time frame: Six months after enrollment，1 year after enrollment). 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 NCT06512792, which also lists 36 linked publications.
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 22 Jul 2024.