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Идёт набор NCT06850792

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

Без фазы С лечением Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Telemedicine-Based Adherence Support.
Кому может быть актуально
Состояния в реестре: Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), Pulmonary Arterial Hypertension (PAH), Pulmonary Arterial Hypertension. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
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Официальное название

imprOving Adherence to Pulmonary artErial hyperteNsion Treatment With teLemedicIne and patieNt guidaNce - A Multicenter Pre- and Post-intervention Evaluation Study

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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

Первичные конечные точки

  • Medication Adherence (Martín-Bayarre-Grau Scale - MBG) [Срок оценки: 24 weeks (end of study period)]
Вторичные конечные точки (7)
  • Functional Class (WHO/NYHA Classification) [Срок оценки: 24 weeks]
  • Six-Minute Walk Test (6MWT) Distance [Срок оценки: 24 weeks]
  • Brain Natriuretic Peptide (BNP) Levels [Срок оценки: 24 weeks]
  • Risk Stratification (COMPERA 2.0) [Срок оценки: 24 weeks]
  • Hospitalizations and Mortality [Срок оценки: 24 weeks]
  • Quality of Life (CAMPHOR Questionnaire) [Срок оценки: 24 weeks]
  • Risk Stratification (REVEAL Lite) [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Бразилия · 1 центр
  • InCor - Universidade de São Paulo — São Paulo

Идентификаторы

NCT: NCT06850792 · 86868325.7.1001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗