RecruitingNot ApplicableNCT06850792

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

Sponsor

University of Sao Paulo General Hospital

Enrollment

61 participants

Start Date

May 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria5

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.

Interventions

BEHAVIORALTelemedicine-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.