NCT06850792

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

imprOving Adherence to Pulmonary artErial hyperteNsion Treatment With teLemedicIne and patieNt guidaNce - A Multicenter Pre- and Post-intervention Evaluation Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
• Pulmonary Arterial Hypertension (PAH)
• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Telemedicine-Based Adherence Support	The intervention consists of biweekly teleconsultations for six months, conducted by healthcare professionals, focusing on medication adherence, patient education, side effect management, and remote support for individuals with pulmonary arterial hypertension (PAH). Patients will receive structured guidance on treatment adherence, tailored counseling, and real-time problem-solving strategies. The goal is to improve adherence to oral PAH therapy and enhance clinical outcomes compared to standard care.

Timeline

• Start date: 2025-05-07
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2025-02-27
• Last updated: 2025-06-10

Locations

1 site across 1 country: Brazil