imprOving Adherence to Pulmonary artErial hyperteNsion Treatment With teLemedicIne and patieNt guidaNce - A Multicenter Pre- and Post-intervention Evaluation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Medication Adherence (Martín-Bayarre-Grau Scale - MBG)
研究概览
简要总结
Pulmonary arterial hypertension (PAH) is a progressive condition with high morbidity, frequent hospitalizations, and risk of right heart failure. Despite advances in treatment, poor adherence remains a major challenge. This randomized controlled study assesses whether remote monitoring can improve treatment adherence, clinical outcomes, and side effect management in PAH patients on oral therapy.
详细描述
Pulmonary arterial hypertension (PAH) is a severe, progressive condition requiring strict adherence to complex treatment regimens to improve outcomes. Despite advances in pharmacological therapy, non-adherence remains a significant challenge, impacting disease progression and increasing healthcare burden.
The OPENLINE study is a randomized, multicenter clinical trial designed to evaluate the impact of a structured telemedicine intervention on treatment adherence in PAH patients receiving stable oral therapy. Participants in the intervention group will receive biweekly teleconsultations for six months, focusing on patient education, adherence monitoring, and side effect management. The control group will follow standard clinical care without additional remote support.
The primary outcome is medication adherence, assessed using the Martín-Bayarre-Grau (MBG) scale. Secondary outcomes include changes in functional class, six-minute walk test distance, brain natriuretic peptide (BNP) levels, risk stratification (COMPERA 2.0 and REVEAL Lite), hospitalizations, mortality, and quality of life measured by the CAMPHOR questionnaire.
This study aims to determine whether a telemedicine-based intervention can enhance medication adherence and improve clinical outcomes in PAH patients, potentially informing future care strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults aged ≥18 years diagnosed with pulmonary arterial hypertension (PAH) (Group 1 of the WHO classification).
- •Stable oral PAH therapy (including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin pathway agents) for at least four weeks prior to enrollment.
- •Ability to participate in remote teleconsultations (access to a phone or internet).
- •Signed informed consent agreeing to study participation.
排除标准
- •Severe cognitive impairment or psychiatric disorders that could affect adherence or study participation.
- •Inability to communicate via phone or telemedicine due to technical or personal constraints.
- •Concurrent participation in another interventional clinical trial that could interfere with outcomes.
- •Life expectancy <6 months due to any condition unrelated to PAH.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Telemedicine-Based Intervention to Improve Adherence in PAH Patients on Oral Therapy
Participants will receive biweekly teleconsultations over 24 weeks, as part of a structured telemedicine intervention to support medication adherence in patients with pulmonary arterial hypertension (PAH) on stable oral therapy. Each teleconsultation is delivered by a trained healthcare professional and includes adherence assessment, identification of barriers, guidance on side effects, educational reinforcement, and motivational support. The intervention does not change the medical regimen but aims to optimize adherence and clinical outcomes through remote follow-up. Data will be collected at baseline and at 24 weeks to evaluate changes in adherence (Martín-Bayarre-Grau scale), functional class, 6-minute walk distance, BNP levels, risk stratification (COMPERA 2.0, REVEAL Lite), hospitalizations, mortality, and quality of life (CAMPHOR).
干预措施: Telemedicine-Based Adherence Support (Behavioral)
结局指标
主要结局
Medication Adherence (Martín-Bayarre-Grau Scale - MBG)
时间窗: 24 weeks (end of study period)
Adherence to oral pulmonary arterial hypertension (PAH) therapy will be evaluated using the Martín-Bayarre-Grau (MBG) scale, a validated questionnaire assessing adherence behaviors such as medication timing, dose compliance, and integration into daily routines. The scale generates a quantitative score ranging from 0 to 100, with higher values reflecting better adherence. The study will compare MBG scores obtained at baseline and after 24 weeks of biweekly teleconsultations to assess the impact of the telemedicine intervention on treatment adherence in a pre-post design.
次要结局
- Six-Minute Walk Test (6MWT) Distance(24 weeks)
- Brain Natriuretic Peptide (BNP) Levels(24 weeks)
- Risk Stratification (REVEAL Lite)(24 weeks)
- Functional Class (WHO/NYHA Classification)(24 weeks)
- Quality of Life (CAMPHOR Questionnaire)(24 weeks)
- Risk Stratification (COMPERA 2.0)(24 weeks)
- Hospitalizations and Mortality(24 weeks)
研究者
Caio Júlio César dos Santos Fernandes
Principal Investigator
University of Sao Paulo General Hospital