Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06850792

Improving Adherence to Pulmonary Arterial Hypertension Treatment With Telemedicine and Patient Guidance A Multicenter Pre- and Post-intervention Evaluation Study

Led by University of Sao Paulo General Hospital · Updated on 2025-06-10

61

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Pulmonary arterial hypertension (PAH) is a serious and progressive condition that often leads to high rates of hospitalization and right heart failure. This research aims to evaluate whether a structured telemedicine program can improve medication adherence and overall clinical outcomes in patients with PAH who are on stable oral therapies. The study focuses on addressing the ongoing challenge of poor treatment adherence despite advances in available medications. Participants in this randomized clinical trial will be divided into two groups: one receiving biweekly teleconsultations for six months and the other receiving standard clinical care without additional remote support. The telemedicine intervention includes patient education, monitoring of medication adherence, side effect management, and motivational support, all delivered by trained healthcare professionals without changing the prescribed medication regimen. During the study, participants will be monitored through baseline and 24-week assessments, including medication adherence measured by the Martín-Bayarre-Grau scale, functional classification, six-minute walk test, brain natriuretic peptide levels, risk stratification using COMPERA 2.0 and REVEAL Lite tools, hospitalizations, mortality, and quality of life via the CAMPHOR questionnaire. The total study duration for each participant is 24 weeks, with close follow-up to assess the impact of the telemedicine support on treatment adherence and health outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 65 years diagnosed with pulmonary arterial hypertension (PAH) classified as Group 1 by WHO
  • On stable oral PAH therapy (such as endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin pathway agents) for at least four weeks before joining
  • Able to participate in remote teleconsultations using phone or internet
  • Provided signed informed consent agreeing to participate in the study
Not Eligible

You will not qualify if you...

  • Severe cognitive or psychiatric conditions that might affect ability to follow treatment or participate
  • Unable to communicate via phone or telemedicine due to technical or personal reasons
  • Taking part in another interventional clinical trial that could affect study results
  • Life expectancy less than six months from any cause unrelated to PAH
  • Pregnant or breastfeeding

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Outpatient Treatment

Duration - 24 weeks

Participants receive biweekly teleconsultations over 24 weeks focusing on medication adherence, patient education, side effect management, and remote support for pulmonary arterial hypertension.

Biweekly teleconsultations for 24 weeks

Trial Site Locations

Total: 1 location

1

InCor - Universidade de São Paulo

São Paulo, São Paulo, Brazil, 05048000

Actively Recruiting

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Research Team

C

Caio Fernandes, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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