imprOving Adherence to Pulmonary artErial hyperteNsion Treatment With teLemedicIne and patieNt guidaNce
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telemedicine-Based Adherence Support.
- Who it may be relevant to
- Registry conditions: Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), Pulmonary Arterial Hypertension (PAH), Pulmonary Arterial Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
imprOving Adherence to Pulmonary artErial hyperteNsion Treatment With teLemedicIne and patieNt guidaNce - A Multicenter Pre- and Post-intervention Evaluation Study
Overview
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.
Interventions
- 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
Primary outcome measures
- Medication Adherence (Martín-Bayarre-Grau Scale - MBG) [Time frame: 24 weeks (end of study period)]
Secondary outcome measures (7)
- Functional Class (WHO/NYHA Classification) [Time frame: 24 weeks]
- Six-Minute Walk Test (6MWT) Distance [Time frame: 24 weeks]
- Brain Natriuretic Peptide (BNP) Levels [Time frame: 24 weeks]
- Risk Stratification (COMPERA 2.0) [Time frame: 24 weeks]
- Hospitalizations and Mortality [Time frame: 24 weeks]
- Quality of Life (CAMPHOR Questionnaire) [Time frame: 24 weeks]
- Risk Stratification (REVEAL Lite) [Time frame: 24 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- InCor - Universidade de São Paulo — São Paulo
Identifiers
NCT: NCT06850792 · 86868325.7.1001