Clinical trial NCT06850792: imprOving Adherence to Pulmonary artErial hyperteNsion Treatment With teLemedicIne and patieNt guidaNce
Official title: imprOving Adherence to Pulmonary artErial hyperteNsion Treatment With teLemedicIne and patieNt guidaNce - A Multicenter Pre- and Post-intervention Evaluation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
Pulmonary Arterial Hypertension (PAH)
Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension (PAH)
Medication Adherence
Telemedicine
Patient Education
Remote Monitoring
Digital Health Intervention
Randomized Controlled Trial (RCT)
Multicenter Study
COMPERA 2.0
REVEAL Lite
Six-Minute Walk Test (6MWT)
Quality of Life
CAMPHOR Questionnaire
Martín-Bayarre-Grau (MBG) Scale
Oral Therapy for PAH
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a multicenter, pre-post interventional study evaluating the impact of telemedicine on medication adherence in patients with pulmonary arterial hypertension (PAH) on stable oral therapy. Participants will receive biweekly teleconsultations over 24 weeks, focused on adherence support, education, and symptom management. The primary outcome is change in adherence measured by the Martín-Bayarre-Grau scale. Secondary outcomes include changes in functional class, 6-minute walk distance, BNP levels, risk stratification (COMPERA 2.0, REVEAL Lite), hospitalizations, mortality, and quality of life assessed by the CAMPHOR questionnaire. The study aims to determine whether a structured remote follow-up can enhance adherence and improve clinical outcomes in PAH.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Medication Adherence (Martín-Bayarre-Grau Scale - MBG)
timeFrame: 24 weeks (end of study period)
Secondary outcomes:
measure: Functional Class (WHO/NYHA Classification)
timeFrame: 24 weeks
measure: Six-Minute Walk Test (6MWT) Distance
timeFrame: 24 weeks
measure: Brain Natriuretic Peptide (BNP) Levels
timeFrame: 24 weeks
measure: Risk Stratification (COMPERA 2.0)
timeFrame: 24 weeks
measure: Hospitalizations and Mortality
timeFrame: 24 weeks
measure: Quality of Life (CAMPHOR Questionnaire)
timeFrame: 24 weeks
measure: Risk Stratification (REVEAL Lite)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: InCor - Universidade de São Paulo
state: SP
Study officials:
References: