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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Nurse-led Telehealth Monitoring Program
BehavioralParticipants in the intervention group will be included in a structured telehealth monitoring program led by a nurse for 12 weeks.
No intervention
Other interventionParticipants in the control group will only receive standard care. No additional interventions will be implemented during the 12-week period.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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