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

NCT06971627 | Recruiting

• 1 other identifier: Inflammatory Bowel Disease
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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's Disease; Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Change in Medication Adherence Report Scale (MARS) scores

  This scale assesses self-reported medication adherence behavior. The outcome will evaluate the change in MARS scores from baseline to week 12 to determine the impact of the telehealth intervention on adherence.

  Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.

Secondary Outcomes (4)

• Change in MedTake Test scores

  Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.

• Change in Harvey-Bradshaw Index scores (for Crohn's Disease) and Change in Simple Clinical Colitis Activity Index scores (for Ulcerative Colitis)

  Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring

• Change in Inflammatory Bowel Disease (IBD) Self-Efficacy Scale scores

  Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.

• Change in Inflammatory Bowel Disease Questionnaire scores

  Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group will be included in a structured telehealth monitoring program led by a nurse for 12 weeks.

Behavioral: Nurse-led Telehealth Monitoring Program

Control group

OTHER

Participants in the control group will only receive standard care. No additional interventions will be implemented during the 12-week period.

Other: No intervention

Interventions

Nurse-led Telehealth Monitoring Program BEHAVIORAL

Participants in the intervention group will be included in a structured telehealth monitoring program led by a nurse for 12 weeks.

Intervention Group

No intervention OTHER

Participants in the control group will only receive standard care. No additional interventions will be implemented during the 12-week period.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University - Cerrahpasa Cerrahpaşa Faculty of Medicine Department of Gastroenterology

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 37140025 BACKGROUND

• 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.

  PMID: 35323120 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Medication Adherence; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Colitis; Colonic Diseases

Study Officials

• Kimya Kılıçaslan, PhD Candidate

  Istanbul University - Cerrahpasa Institute of Graudate Studies

  PRINCIPAL INVESTIGATOR

• Zeliha Tulek, PhD, Prof.

  Istanbul University - Cerrahpasa, Florence Nightingale Faculty of Nursing

  STUDY DIRECTOR

• Aykut Ferhat Çelik, MD, Prof.

  Istanbul University - Cerrahpasa Cerrahpaşa Faculty of Medicine Department of Gastroenterology

  STUDY CHAIR

Central Study Contacts

Kimya Kılıçaslan, PhD Candidate

CONTACT

+90 535 083 45 53; kimya.kilicaslan@iuc.edu.tr

Zeliha Tulek, PhD, Prof.

CONTACT

+90 532 776 29 93; ztulek@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, MSc, PhD, Prof.

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 14, 2025
• Study Start: April 20, 2024
• Primary Completion: July 20, 2024
• Study Completion: May 30, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)