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临床试验/NCT07429552
NCT07429552已完成不适用

The Effect of a Dynamic Blended Learning Module on Symptom Management in Patients Diagnosed With Pulmonary Hypertension

Acibadem University1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2022年1月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
1
主要终点
EmPHasis-10 Questionnaire

研究概览

简要总结

This study was conducted to evaluate the effect of the Dynamic Blended Learning Module developed for patients diagnosed with pulmonary hypertension (PH) on symptom management.

Pulmonary hypertension is a chronic disease that can cause symptoms that make daily life difficult, such as shortness of breath, fatigue, chest pain, dizziness, fainting, anxiety, body pain, edema, and sleep problems. These symptoms can negatively affect patients' daily lives and treatment process.

This study examined whether a structured program involving education and regular follow-up helped patients better manage their symptoms.

As part of the program, patients received face-to-face education and regular phone calls were made throughout the nine-month follow-up period. The education sessions provided information about the course of the disease, the correct use of medications, and possible side effects. Patients were instructed on how to manage side effects such as muscle and jaw pain, facial redness, nausea, and abdominal bloating. Additionally, they were informed about when and how to contact the healthcare team if any issues arose.

In one part of the program, a video showing the experiences of a patient who effectively managed their illness was shown to participants in the intervention group.

Patients were monitored for nine months and their symptoms were assessed at regular intervals. The program's effect on symptom management was evaluated by comparing it with patients receiving standard care.

详细描述

This study evaluated the effects of the Dynamic Blended Education Module (DBEM) on symptom management in patients diagnosed with pulmonary hypertension (PH). The study aimed to improve participants' ability to manage core PH symptoms-including dyspnea, chest pain, syncope, fatigue/weakness, anxiety/worry, edema, pain, and nausea-vomiting-both due to the disease process and the side effects of medications used. Written informed consent was obtained from all participants prior to enrollment.

The sample size was calculated using the G*Power program. An expected effect size of d=0.4 for the intervention group was considered, and it was determined that a total of 46 patients were required to achieve 85% power and a 5% alpha error. Initially, 46 patients were enrolled and assigned via stratified randomization by age, sex, and PH classification into the intervention (n=23) and control (n=23) groups. Baseline assessments included the Patient Identification Data Form, as well as validated and reliable instruments: EmPHasis-10 Scale, Hospital Anxiety and Depression Scale (HAD), and Richards-Campbell Sleep Questionnaire (RCUQ). Functional capacity was assessed using the Modified Borg Dyspnea Scale, Verbal Category Scale, and 6-Minute Walk Test (6MWT). Patients rested for 10 minutes before the 6MWT. At the start of the test, dyspnea, blood pressure, heart rate, and oxygen saturation were recorded. Participants walked for 6 minutes along a 30-meter corridor at their usual walking pace, with rest breaks as needed. The total walking distance was recorded, and symptoms were monitored during the test. At the end of the test, distance walked was calculated, and dyspnea, blood pressure, heart rate, and oxygen saturation were re-measured.

In the intervention group, symptom management was monitored by telephone during the first month. In the third month, the first intervention, which included face-to-face symptom management training during outpatient visits, was performed. This training covered the recognition and daily management of symptoms such as shortness of breath, chest pain, syncope, fatigue/weakness, anxiety/worry, edema, pain, and nausea-vomiting. After the initial intervention, 2 patients were excluded (ex), and new patients were enrolled according to randomization and inclusion criteria to maintain the sample size. Telephone follow-up continued between the 3rd and 6th months to monitor treatment adherence and symptom management.

In the sixth month, an educational video describing the experience of a patient who effectively managed their own symptoms was shown face-to-face during outpatient visits, and peer support was provided to participants to facilitate symptom management; follow-up of patients continued by telephone between the 6th and 9th months, and data analysis was completed by repeating the outcome assessments in the 9th month.

All participants completed the planned education and follow-up processes in both the intervention and control 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
None

盲法说明

Masking Description

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of pulmonary hypertension.
  • Functional class I-IV.
  • Confirmed diagnosis of pulmonary hypertension for at least 6 months.
  • Native Turkish speaker.
  • Age ≥18 years
  • Voluntary willingness to participate in the study

排除标准

  • Individuals with cognitive impairments or communication difficulties that would interfere with study participation
  • Patients who have previously undergone pulmonary endarterectomy and currently exhibit normal pulmonary artery pressures
  • Individuals who decline to provide informed consent for participation
  • Patients with an unstable or acute clinical condition

研究组 & 干预措施

Arm1

Experimental

In the experimental group, the symptoms experienced by each patient were identified, and the Dynamic Mixed Education Module (DBEM) was implemented to support effective symptom management. Process monitoring and support were provided via telephone calls. An educational video was recorded sharing the experiences and management strategies of a patient who effectively managed their process, and this was shared with participants to support symptom management processes. Training sessions and outcome assessments were conducted at 3, 6, and 9 months, consistent with patients' routine outpatient visits.

干预措施: Symptom Management (Other)

Arm2

No Intervention

No intervention was performed on the patients. Follow-ups were conducted according to the hospital's standard care protocols.

结局指标

主要结局

EmPHasis-10 Questionnaire

时间窗: Start of study , 3 months, 6 months, and 9 months

Quality of life was assessed using the EmPHasis-10 Questionnaire, a disease-specific tool developed for patients with pulmonary hypertension. The questionnaire has a score range of 0-50, with higher scores indicating worse quality of life and lower scores indicating better quality of life.

次要结局

  • Hospital Anxiety and Depression Scale (HADS)(Study start, 3 months, 6 months, and 9 months)
  • 6-Minute Walk Test, 6MWT(Study start, 3 months, 6 months, and 9 months)
  • Modified Borg Dyspnea Scale(Study start, 3 months, 6 months, and 9 months)
  • Richards-Campbell Sleep Questionnaire (RCSQ)(Study start, 3 months, 6 months, and 9 months)
  • Verbal Rating Scale (VRS)(Study start, 3 months, 6 months, and 9 months)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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