Telehealth Monitoring in Inflammatory Bowel Disease: Effects on Medication Compliance, Self-Efficacy, and Quality of Life
NCT ID: NCT06971627
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
120 participants
INTERVENTIONAL
2024-04-20
2025-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chronic Care Model on Symptom Status, Stress and Quality of Life in Individuals With Inflammatory Bowel Disease
NCT06757231
A Qualitative Study on Patients' (un)Ability and (un)Willingness to Use Telemonitoring in Inflammatory Bowel Diseases
NCT06123052
Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients
NCT05719766
Mobile App-Based Remote Management Model for IBD Patient
NCT06512792
Nutrition, Meal Regularity and Quality of Life in Inflammatory Bowel Disease
NCT07179965
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants will be randomly assigned to either an intervention or control group. The intervention group will receive a 12-week structured telehealth program including an educational booklet, video content, a Zoom-based group session, biweekly phone calls, and reminder messages. The control group will receive only standard care and the educational booklet, with no additional intervention.
Assessments will be conducted at baseline (Week 0) and at the end of the intervention (Week 12) using validated tools: Harvey-Bradshaw Index (HBI), Simple Clinical Colitis Activity Index (SCCAI), Medication Adherence Report Scale (MARS), MedTake Test, IBD Self-Efficacy Scale, IBD Quality of Life Questionnaire, and IBD Distress Scale.
The effectiveness of the intervention will be determined by comparing pre- and post-intervention outcomes between the two groups.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Group
Participants in the intervention group will be included in a structured telehealth monitoring program led by a nurse for 12 weeks.
Nurse-led Telehealth Monitoring Program
Participants in the intervention group will be included in a structured telehealth monitoring program led by a nurse for 12 weeks.
Control group
Participants in the control group will only receive standard care. No additional interventions will be implemented during the 12-week period.
No intervention
Participants in the control group will only receive standard care. No additional interventions will be implemented during the 12-week period.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nurse-led Telehealth Monitoring Program
Participants in the intervention group will be included in a structured telehealth monitoring program led by a nurse for 12 weeks.
No intervention
Participants in the control group will only receive standard care. No additional interventions will be implemented during the 12-week period.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Individuals aged 18 years or older
* Able to read and write in Turkish
* Diagnosed with inflammatory bowel disease (IBD) for at least 6 months
* In clinical remission (Harvey-Bradshaw Index score \< 5 or Simple Clinical Colitis Activity Index score \< 3)
* Able to use a smartphone
* Have access to an online messaging application (e.g., WhatsApp) and a valid e-mail address
* Capable of downloading and using a mobile or computer-based video conferencing application (e.g., Zoom)
* Willing to participate in the study voluntarily
Exclusion Criteria
* Having any condition that impairs communication
* Pregnant women
* Patients receiving infusion-based treatment
* Having an advanced chronic disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istanbul University - Cerrahpasa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zeliha Tülek
RN, MSc, PhD, Prof.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kimya Kılıçaslan, PhD Candidate
Role: PRINCIPAL_INVESTIGATOR
Istanbul University - Cerrahpasa Institute of Graudate Studies
Zeliha Tulek, PhD, Prof.
Role: STUDY_DIRECTOR
Istanbul University - Cerrahpasa, Florence Nightingale Faculty of Nursing
Aykut Ferhat Çelik, MD, Prof.
Role: STUDY_CHAIR
Istanbul University - Cerrahpasa Cerrahpaşa Faculty of Medicine Department of Gastroenterology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Istanbul University - Cerrahpasa Cerrahpaşa Faculty of Medicine Department of Gastroenterology
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Gordon M, Sinopoulou V, Lakunina S, Gjuladin-Hellon T, Bracewell K, Akobeng AK. Remote care through telehealth for people with inflammatory bowel disease. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014821. doi: 10.1002/14651858.CD014821.pub2.
Pang L, Liu H, Liu Z, Tan J, Zhou LY, Qiu Y, Lin X, He J, Li X, Lin S, Ghosh S, Mao R, Chen M. Role of Telemedicine in Inflammatory Bowel Disease: Systematic Review and Meta-analysis of Randomized Controlled Trials. J Med Internet Res. 2022 Mar 24;24(3):e28978. doi: 10.2196/28978.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Inflammatory Bowel Disease
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.