Clinical trial NCT06971627: Telehealth Monitoring in Inflammatory Bowel Disease: Effects on Medication Compliance, Self-Efficacy, and Quality of Life
Official title: The Effect of Telehealth Monitoring on Medication Compliance, Self-Efficacy and Quality of Life in Patients With İnflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Disease (IBD)
Medication Compliance
Quality of Life
Telehealth Monitoring
Keywords: Inflammatory Bowel Disease
Medication Compliance
Self-Efficacy
Quality of Life
Telehealth Monitoring
Crohn&amp;#39;s Disease
Ulcerative colitis
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is designed as a randomized controlled trial with a pretest-posttest design, consisting of two groups: an intervention group and a control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled trial aims to evaluate the effect of nurse-led telehealth monitoring on medication adherence, self-efficacy, and quality of life in individuals with inflammatory bowel disease (IBD). The study will be conducted at the IBD Outpatient Clinic of Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty. Participants will be randomly assigned to either an intervention group receiving a 3-month structured telehealth program (including education, counseling, phone calls, and reminders) or a control group receiving only standard care and an educational booklet. Outcomes will be assessed at baseline and after 12 weeks.

Detailed description: This randomized controlled trial aims to assess the impact of a nurse-led telehealth monitoring program on medication adherence, self-efficacy, and quality of life in patients with inflammatory bowel disease (IBD). The study will be conducted at the IBD Outpatient Clinic, Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty Hospital.

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.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 18 years or older
* 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:

* Diagnosed with any psychiatric or cognitive disorder
* Having any condition that impairs communication
* Pregnant women
* Patients receiving infusion-based treatment
* Having an advanced chronic disease

Primary outcomes:
measure: Change in Medication Adherence Report Scale (MARS) scores
timeFrame: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
Secondary outcomes:
measure: Change in MedTake Test scores
timeFrame: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
measure: Change in Harvey-Bradshaw Index scores (for Crohn's Disease) and Change in Simple Clinical Colitis Activity Index scores (for Ulcerative Colitis)
timeFrame: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring
measure: Change in Inflammatory Bowel Disease (IBD) Self-Efficacy Scale scores
timeFrame: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
measure: Change in Inflammatory Bowel Disease Questionnaire scores
timeFrame: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University - Cerrahpasa Cerrahpaşa Faculty of Medicine Department of Gastroenterology
Study officials:
affiliation: Istanbul University - Cerrahpasa Institute of Graudate Studies
name: Kimya Kılıçaslan, PhD Candidate
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa, Florence Nightingale Faculty of Nursing
name: Zeliha Tulek, PhD, Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa Cerrahpaşa Faculty of Medicine Department of Gastroenterology
name: Aykut Ferhat Çelik, MD, Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.