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

NCT ID: NCT06850792

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-07
• Study Completion Date: 2028-04-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Telemedicine-Based Adherence Support

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Caio Júlio César dos Santos Fernandes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

InCor - Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Caio Fernandes, PhD

Role: CONTACT

caio.cesar@hc.fm.usp.br

+55 11 2661-1548

Facility Contacts

Caio Fernandes, PhD

Role: primary

caio.cesar@hc.fm.usp.br

+55 11 2661-1548

Other Identifiers

86868325.7.1001

Identifier Type: -

Identifier Source: org_study_id