Improving adherence to PAH 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
Run by University of Sao Paulo General Hospital · NCT06850792 · Data updated 2026-11-12
This study will try whether regular telemedicine check-ins and guided education help people with PAH stick to their oral medications and manage side effects.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 61 (estimated) |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | May 7, 2025 |
| Main results expected | April 2028 |
| Study ends | April 2028 |
| Registry record updated | June 10, 2025 |
| Trial ID | NCT06850792 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with WHO Group 1 PAH who have been on stable oral PAH therapy for at least four weeks, can use phone or internet for teleconsultations, and can give informed consent.
✕Probably not a fit
Patients unlikely to receive benefit include those with severe cognitive or psychiatric disorders, inability to use telemedicine, participation in conflicting interventional trials, limited life expectancy (<6 months), pregnancy or breastfeeding, or those not on stable oral therapy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
OPENLINE is a randomized, multicenter trial testing a structured telemedicine intervention to improve medication adherence in adults with Group 1 PAH on stable oral therapy. Participants randomized to the intervention receive biweekly teleconsultations for six months focused on patient education, adherence monitoring, and side-effect management, while the control group receives standard clinical care. The primary outcome is medication adherence measured by the Martín-Bayarre-Grau (MBG) scale, and secondary outcomes include WHO functional class, six-minute walk distance, BNP levels, COMPERA 2.0 and REVEAL Lite risk scores, hospitalizations, mortality, and quality of life by CAMPHOR. The study is conducted at InCor - Universidade de São Paulo and requires participants to have access to a phone or internet for remote visits.
Why it matters
Potential benefit: If successful, this approach could increase medication adherence, reduce hospital admissions, and improve quality of life for people with PAH.
How similar studies have gone: Telemedicine and remote-monitoring programs have shown mixed but often positive effects on medication adherence in chronic diseases, though randomized data specific to PAH are limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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InCor - Universidade de São Paulo
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Caio Fernandes, PhD
- Email: caio.cesar@hc.fm.usp.br
- Phone: +55 11 2661-1548
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.