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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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 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.
Trial sites (1)
Facility
City
Region
Status
InCor - Universidade de São Paulo
São Paulo
São Paulo
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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