Trials / Recruiting
RecruitingNCT06971627
Telehealth Monitoring in Inflammatory Bowel Disease: Effects on Medication Compliance, Self-Efficacy, and Quality of Life
The Effect of Telehealth Monitoring on Medication Compliance, Self-Efficacy and Quality of Life in Patients With İnflammatory Bowel Disease
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Istanbul University - Cerrahpasa · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Nurse-led Telehealth Monitoring Program | Participants in the intervention group will be included in a structured telehealth monitoring program led by a nurse for 12 weeks. |
| OTHER | No intervention | Participants in the control group will only receive standard care. No additional interventions will be implemented during the 12-week period. |
Timeline
- Start date
- 2024-04-20
- Primary completion
- 2024-07-20
- Completion
- 2025-05-30
- First posted
- 2025-05-14
- Last updated
- 2025-05-14
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT06971627. Inclusion in this directory is not an endorsement.