The Effect of Telehealth Monitoring on Medication Compliance, Self-Efficacy and Quality of Life in Patients With İnflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Medication Adherence Report Scale (MARS) scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention Group
Participants in the intervention group will be included in a structured telehealth monitoring program led by a nurse for 12 weeks.
干预措施: Nurse-led Telehealth Monitoring Program (Behavioral)
Control group
Participants in the control group will only receive standard care. No additional interventions will be implemented during the 12-week period.
干预措施: No intervention (Other)
结局指标
主要结局
Change in Medication Adherence Report Scale (MARS) scores
时间窗: Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.
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.
次要结局
- Change in MedTake Test scores(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)(Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring)
- Change in Inflammatory Bowel Disease (IBD) Self-Efficacy Scale scores(Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.)
- Change in Inflammatory Bowel Disease Questionnaire scores(Baseline (Week 0) and 12 weeks (3 months) following telehealth monitoring.)
研究者
Zeliha Tülek
RN, MSc, PhD, Prof.
Istanbul University - Cerrahpasa