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NCT Number: NCT06971627

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

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.

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Key information

Conditions

Inflammatory Bowel Disease (IBD) Behavior Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Health Behavior Inflammatory Bowel Diseases Intestinal Diseases Medication Adherence Medication Compliance Patient Acceptance of Health Care Patient Compliance Quality of Life Telehealth Monitoring Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University - Cerrahpasa Cerrahpaşa Faculty of Medicine Department of Gastroenterology

Istanbul, 34098, Turkey (Türkiye)

Location status: Recruiting

Location contact

Kimya Kılıçaslan, RN, PhD Candidate

CONTACT

[email protected]

+90 535 083 45 53

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

No intervention

Other

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

Primary outcomes

  1. Change in Medication Adherence Report Scale (MARS) scores

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

    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.

Secondary outcomes

  1. Change in MedTake Test scores

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

    The MedTake test evaluates patients' ability to understand and manage their oral medication regimen. This outcome will examine improvements in medication-taking skills from baseline to the end of the 12-week intervention.

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

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

    These indices measure disease activity in Crohn's Disease and Ulcerative Colitis, respectively. The outcome will track changes in disease activity from baseline to week 12 following the telehealth monitoring.

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

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

    This scale measures a patient's confidence in managing their IBD-related health challenges. The outcome will assess changes in self-efficacy levels between baseline and week 12.

  4. Change in Inflammatory Bowel Disease Questionnaire scores

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

    This questionnaire evaluates the quality of life in patients with IBD. The outcome will assess the effect of the intervention on quality of life by comparing scores at baseline and after 12 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Kimya Kılıçaslan, PhD Candidate

CONTACT

[email protected]

+90 535 083 45 53

Zeliha Tulek, PhD, Prof.

CONTACT

[email protected]

+90 532 776 29 93

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

The Effect of Telehealth Monitoring on Medication Compliance, Self-Efficacy and Quality of Life in Patients With İnflammatory Bowel Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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