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

Официальное название

The Effect of Telehealth Monitoring on Medication Compliance, Self-Efficacy and Quality of Life in Patients With İnflammatory Bowel Disease

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change in Medication Adherence Report Scale (MARS) scores [Срок оценки: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.]

Вторичные конечные точки (4)

• Change in MedTake Test scores [Срок оценки: 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) [Срок оценки: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring]
• Change in Inflammatory Bowel Disease (IBD) Self-Efficacy Scale scores [Срок оценки: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.]
• Change in Inflammatory Bowel Disease Questionnaire scores [Срок оценки: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul University - Cerrahpasa Cerrahpaşa Faculty of Medicine Department of Gastroentero — Istanbul

Публикации

• Gordon M, Sinopoulou V, Lakunina S, Gjuladin-Hellon T, Bracewell K, Akobeng AK. Remote care through telehealth for people with inflammatory bowel disease. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014821. doi: 10.1002/14651858.CD014821.pub2. PMID 37140025
• Pang L, Liu H, Liu Z, Tan J, Zhou LY, Qiu Y, Lin X, He J, Li X, Lin S, Ghosh S, Mao R, Chen M. Role of Telemedicine in Inflammatory Bowel Disease: Systematic Review and Meta-analysis of Randomized Controlled Trials. J Med Internet Res. 2022 Mar 24;24(3):e28978. doi: 10.2196/28978. PMID 35323120

Идентификаторы

NCT: NCT06971627 · Inflammatory Bowel Disease

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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