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

Istanbul University - Cerrahpasa

Status: Enrolling

Conditions: Quality of Life; Telehealth Monitoring; Inflammatory Bowel Disease (IBD); Medication Compliance

Treatments: Other: No intervention; Behavioral: Nurse-led Telehealth Monitoring Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06971627

Inflammatory Bowel Disease

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

Behavioral: Nurse-led Telehealth Monitoring Program

Control group

Other group

Description:

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

Treatment:

Other: No intervention