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NCT Number: NCT06850792

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

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.

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Key information

Conditions

Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) Behavior Health Behavior Hypertension, Pulmonary Lung Diseases Medication Adherence Patient Acceptance of Health Care Patient Compliance Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension (PAH) Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

InCor - Universidade de São Paulo

São Paulo, 05048000, Brazil

Location status: Recruiting

Location contact

Caio Fernandes, PhD

CONTACT

[email protected]

+55 11 2661-1548

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine-Based Adherence Support

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.

Primary outcomes

  1. Medication Adherence (Martín-Bayarre-Grau Scale - MBG)

    Time frame: 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.

Secondary outcomes

  1. Functional Class (WHO/NYHA Classification)

    Time frame: 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.

  2. Six-Minute Walk Test (6MWT) Distance

    Time frame: 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.

  3. Brain Natriuretic Peptide (BNP) Levels

    Time frame: 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.

  4. Risk Stratification (COMPERA 2.0)

    Time frame: 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.

  5. Hospitalizations and Mortality

    Time frame: 24 weeks

    The number of hospitalizations due to PAH-related complications and all-cause mortality will be recorded throughout the 24-week study

  6. Quality of Life (CAMPHOR Questionnaire)

    Time frame: 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.

  7. Risk Stratification (REVEAL Lite)

    Time frame: 24 weeks

    PAH risk stratification scores using REVEAL LITE will be calculated at baseline and at 24 weeks to assess changes in disease severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Caio Fernandes, PhD

CONTACT

[email protected]

+55 11 2661-1548

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Acronym: OPENLINE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 27, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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