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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Diagnosed with any psychiatric or cognitive disorder

Having any condition that impairs communication

Pregnant women

Patients receiving infusion-based treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Change in MedTake Test scores

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.

Time frame
Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
2

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

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.

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

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

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.

Time frame
Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
4

Change in Inflammatory Bowel Disease Questionnaire scores

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.

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

Other outcomes

Sponsors and contacts

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