Telehealth Monitoring in Inflammatory Bowel Disease: Effects on Medication Compliance, Self-Efficacy, and Quality of Life

Last updated: May 7, 2025
Sponsor: Istanbul University - Cerrahpasa
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Bowel Dysfunction

Ulcerative Colitis (Pediatric)

Treatment

Nurse-led Telehealth Monitoring Program

No intervention

Clinical Study ID

NCT06971627
Inflammatory Bowel Disease
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ColitisActivity Index score < 3)

  • Able to use a smartphone

  • Have access to an online messaging application (e.g., WhatsApp) and a valid e-mailaddress

  • Capable of downloading and using a mobile or computer-based video conferencingapplication (e.g., Zoom)

  • Willing to participate in the study voluntarily

Exclusion

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

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Nurse-led Telehealth Monitoring Program
Phase:
Study Start date:
April 20, 2024
Estimated Completion Date:
May 30, 2025

Study 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.

Connect with a study center

  • Istanbul University - Cerrahpasa Cerrahpaşa Faculty of Medicine Department of Gastroenterology

    Istanbul, 34098
    Turkey

    Active - Recruiting

+−

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.