Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)OPENLINENCT06850792
imprOving Adherence to Pulmonary artErial hyperteNsion Treatment With teLemedicIne and patieNt guidaNce
A study testing Telemedicine-Based Adherence Support in people with Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) and Pulmonary Arterial Hypertension (PAH), run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), Pulmonary Arterial Hypertension (PAH), Pulmonary Arterial Hypertension
- What is being tested?
- Telemedicine-Based Adherence Support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteBrazil
- Study dates
- 7 May 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
InCor - Universidade de São Paulo
São Paulo, São Paulo, 05048000
Caio Fernandes, PhD, +55 11 2661-1548, caio.cesar@hc.fm.usp.br
About this study
Official title: imprOving Adherence to Pulmonary artErial hyperteNsion Treatment With teLemedicIne and patieNt guidaNce - A Multicenter Pre- and Post-intervention Evaluation Study
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.
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), Pulmonary Arterial Hypertension (PAH), Pulmonary Arterial Hypertension
- Being tested
- Telemedicine-Based Adherence Support
- 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
- Medical subject headings
- Pulmonary Arterial Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine-Based Adherence SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Telemedicine-Based Adherence Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks (end of study period)
Secondary outcomes (7)
Functional Class (WHO/NYHA Classification)
Functional class will be assessed using the World Health Organization (WHO)/New York Heart Association (NYHA) classification, which categorizes the severity of symptoms and physical activity limitations in patients with pulmonary arterial hypertension (PAH). The classification ranges from Class I (no symptoms) to Class IV (symptoms at rest). Changes in functional class will be evaluated by comparing baseline and 24-week assessments to determine the impact of the telemedicine intervention on clinical status.
Measured: 24 weeks
Six-Minute Walk Test (6MWT) Distance
Distance walked during the six-minute walk test (6MWT) will be measured to evaluate functional capacity and exercise tolerance in patients with pulmonary arterial hypertension (PAH). The test will be conducted at baseline and after 24 weeks of telemedicine follow-up. Changes in the distance walked (in meters) will be analyzed to assess the impact of the intervention on physical performance.
Measured: 24 weeks
Brain Natriuretic Peptide (BNP) Levels
BNP levels, a biomarker for right ventricular function and PAH severity, will be measured at baseline and at 24 weeks to assess changes in cardiac strain.
Measured: 24 weeks
Risk Stratification (COMPERA 2.0)
PAH risk stratification scores using COMPERA 2.0 will be calculated at baseline and at 24 weeks to assess changes in disease severity.
Measured: 24 weeks
Hospitalizations and Mortality
The number of hospitalizations due to PAH-related complications and all-cause mortality will be recorded throughout the 24-week study
Measured: 24 weeks
Quality of Life (CAMPHOR Questionnaire)
Quality of life will be evaluated using the CAMPHOR questionnaire, a validated tool assessing symptoms, activity limitations, and emotional well-being in PAH patients. Changes in scores from baseline to 24 weeks will be analyzed.
Measured: 24 weeks
Risk Stratification (REVEAL Lite)
PAH risk stratification scores using REVEAL LITE will be calculated at baseline and at 24 weeks to assess changes in disease severity.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start7 May 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)Studies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caio Júlio César dos Santos Fernandes, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850792
- Sponsor's protocol ID
- 86868325.7.1001
- Acronym
- OPENLINE
- Status last verified
- Apr 2025
- First submitted
- 22 Feb 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- imprOving Adherence to Pulmonary artErial hyperteNsion Treatment With teLemedicIne and patieNt guidaNce - A Multicenter Pre- and Post-intervention Evaluation Study
- ClinicalTrials.gov ID
- NCT06850792
- Acronym / sponsor ID
- OPENLINE / 86868325.7.1001
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telemedicine-Based Intervention to Improve Adherence in PAH Patients on Oral Therapy | Experimental | Behavioral: Telemedicine-Based Adherence SupportParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine-Based Adherence SupportThe 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. | Behavioural | Telemedicine-Based Intervention to Improve Adherence in PAH Patients on Oral Therapy |
Primary outcome
Medication Adherence (Martín-Bayarre-Grau Scale - MBG)
Time frame: 24 weeks (end of study period)
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.
7 secondary outcomes
Functional Class (WHO/NYHA Classification)
Time frame: 24 weeks
Six-Minute Walk Test (6MWT) Distance
Time frame: 24 weeks
Brain Natriuretic Peptide (BNP) Levels
Time frame: 24 weeks
Risk Stratification (COMPERA 2.0)
Time frame: 24 weeks
Hospitalizations and Mortality
Time frame: 24 weeks
Quality of Life (CAMPHOR Questionnaire)
Time frame: 24 weeks
Risk Stratification (REVEAL Lite)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine-Based Adherence Support in people with Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) and Pulmonary Arterial Hypertension (PAH), run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caio Fernandes, PhD (+55 11 2661-1548, caio.cesar@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (Martín-Bayarre-Grau Scale - MBG) (time frame: 24 weeks (end of study period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.