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

NCT06850792 | Recruiting

• 1 other identifier: 86868325.7.1001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Medication Adherence (Martín-Bayarre-Grau Scale - MBG)

  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.

  24 weeks (end of study period)

Secondary Outcomes (7)

• Functional Class (WHO/NYHA Classification)

  24 weeks

• Six-Minute Walk Test (6MWT) Distance

  24 weeks

• Brain Natriuretic Peptide (BNP) Levels

  24 weeks

• Risk Stratification (COMPERA 2.0)

  24 weeks

• Hospitalizations and Mortality

  24 weeks

Study Arms (1)

Telemedicine-Based Intervention to Improve Adherence in PAH Patients on Oral Therapy

EXPERIMENTAL

Participants will receive biweekly teleconsultations over 24 weeks, as part of a structured telemedicine intervention to support medication adherence in patients with pulmonary arterial hypertension (PAH) on stable oral therapy. Each teleconsultation is delivered by a trained healthcare professional and includes adherence assessment, identification of barriers, guidance on side effects, educational reinforcement, and motivational support. The intervention does not change the medical regimen but aims to optimize adherence and clinical outcomes through remote follow-up. Data will be collected at baseline and at 24 weeks to evaluate changes in adherence (Martín-Bayarre-Grau scale), functional class, 6-minute walk distance, BNP levels, risk stratification (COMPERA 2.0, REVEAL Lite), hospitalizations, mortality, and quality of life (CAMPHOR).

Behavioral: Telemedicine-Based Adherence Support

Interventions

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.

Telemedicine-Based Intervention to Improve Adherence in PAH Patients on Oral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

InCor - Universidade de São Paulo

São Paulo, São Paulo, 05048000, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Caio Fernandes, PhD

CONTACT

+55 11 2661-1548; caio.cesar@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: February 27, 2025
• Study Start: May 7, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)