imprOving Adherence to Pulmonary artErial hyperteNsion Treatment With teLemedicIne and patieNt guidaNce

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH); Pulmonary Arterial Hypertension (PAH); Pulmonary Arterial Hypertension

• Registration Number: NCT06850792
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-02-22
• Study First Submitted QC: 2025-02-22
• Study First Posted: 2025-02-27
• Status Verified: 2025-04
• Study Start: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-20
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Medication Adherence (Martín-Bayarre-Grau Scale - MBG)	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, 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.

Secondary Outcome Measures

Name	Time	Method
Six-Minute Walk Test (6MWT) Distance	24 weeks	Distance walked during the six-minute walk test (6MWT) will be measured to evaluate functional capacity and exercise tolerance in patients with pulmonary arterial hypertension (PAH). The test will be conducted at baseline and after 24 weeks of telemedicine follow-up. Changes in the distance walked (in meters) will be analyzed to assess the impact of the intervention on physical performance.
Brain Natriuretic Peptide (BNP) Levels	24 weeks	BNP levels, a biomarker for right ventricular function and PAH severity, will be measured at baseline and at 24 weeks to assess changes in cardiac strain.
Risk Stratification (REVEAL Lite)	24 weeks	PAH risk stratification scores using REVEAL LITE will be calculated at baseline and at 24 weeks to assess changes in disease severity.
Functional Class (WHO/NYHA Classification)	24 weeks	Functional class will be assessed using the World Health Organization (WHO)/New York Heart Association (NYHA) classification, which categorizes the severity of symptoms and physical activity limitations in patients with pulmonary arterial hypertension (PAH). The classification ranges from Class I (no symptoms) to Class IV (symptoms at rest). Changes in functional class will be evaluated by comparing baseline and 24-week assessments to determine the impact of the telemedicine intervention on clinical status.
Quality of Life (CAMPHOR Questionnaire)	24 weeks	Quality of life will be evaluated using the CAMPHOR questionnaire, a validated tool assessing symptoms, activity limitations, and emotional well-being in PAH patients. Changes in scores from baseline to 24 weeks will be analyzed.
Risk Stratification (COMPERA 2.0)	24 weeks	PAH risk stratification scores using COMPERA 2.0 will be calculated at baseline and at 24 weeks to assess changes in disease severity.
Hospitalizations and Mortality	24 weeks	The number of hospitalizations due to PAH-related complications and all-cause mortality will be recorded throughout the 24-week study

Trial Locations

Locations (1)

InCor - Universidade de São Paulo; 🇧🇷 São Paulo, SP, Brazil