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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
120
Participants in the intervention group will be included in a structured telehealth monitoring program led by a nurse for 12 weeks.
Participants in the control group will only receive standard care. No additional interventions will be implemented during the 12-week period.
Istanbul University - Cerrahpasa Cerrahpaşa Faculty of Medicine Department of Gastroenterology
Istanbul, Turkey (Türkiye)
RECRUITINGChange 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.
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.
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
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.
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.
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