Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
The goal of this observational pilot trial is to evaluate the feasibility of home monitoring for patients with systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH). The study will assess home-based measures that may help detect disease progression earlier and will also evaluate patient satisfaction, usability, and the impact on health-related quality of life.
The study aims to answer:
* How feasible is home monitoring in SSc-PAH patients in terms of adherence, technical feasibility, and validity of home-based measures? * How do home-based assessments compare to hospital-based assessments in detecting disease progression? * How do patients experience digital home monitoring?
Participants will:
* Use a digital platform (Zeen Health) for biweekly self-reporting of symptoms and physiological measurements. * Perform functional tests at home, including the 1-minute sit-to-stand test (1MSTS). * Wear the ECG247 Smart Heart Sensor for one week to monitor heart rhythm. * Collect and submit home blood samples every two weeks. * Attend two hospital visits (baseline and week 12) for clinical assessments, functional testing, pulmonary function tests, echocardiography, and routine blood sampling for clinical assessments.
This 12-week study will assess the feasibility of home monitoring, as well as the validity and reliability of home-based measures. The findings will help design a future study aimed at integrating home-based assessments into routine clinical care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fulfilment of the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) SSc classification criteria
Fulfilment of the 2022 hemodynamic definition of PAH (mean pulmonary arterial pressure (mPAP) >20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg, and pulmonary vascular resistance (PVR) >2 WU) in the absence of other causes of pre-capillary PH (no significant ILD and no clinical suspicion of pulmonary or left sided heart disease as the predominant cause of PH), independent of diagnostic period and previous treatment
Participants must be able to understand and follow trial procedures including completion of questionnaires regarding Patient Reported Outcome measures
Participants must have access to the internet, and experience in using smartphones or other electronic devices with internet access.
Disqualifiers
Severe end organ disease
Severe heart failure with EF < 30%
End stage kidney disease with eGFR < 30 mL/min
End stage lung disease with FVC < 50% or coexisting severe lung diseases (e.g., COPD (including emphysema), GOLD grade 3-4 with FEV1 <50%)
Trial population
The study will include adult patients diagnosed with systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH). Participants will be identified primarily through the Norwegian Systemic Connective Tissue Disease and Vasculitis Registry (NOSVAR) and routine in- and outpatient consultations. Additional recruitment will occur via the national rheumatic association, the OUH clinical studies webpage, and Helsenorge. Participants will attend two study visits at Oslo University Hospital (baseline and week 12). Given the rarity of SSc-PAH, broad recruitment is necessary to obtain feasibility data. The target enrollment is \~20 patients.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 1 trial groupGroup A: SSc-PAH
Trial outcomes
Primary outcomes
1
Feasibility of Home Monitoring: Patient Adherence and Compliance
Adherence and compliance will be assessed by tracking the frequency and completeness of data entries in the digital platform. This includes biweekly symptom reporting, completion of the 1-minute sit-to-stand test (1MSTS), and compliance with ECG monitoring.
Time frame
From enrollment to the end of the study at 12 weeks2
Feasibility of Home Monitoring: Technical Feasibility
Technical feasibility will be evaluated based on the occurrence of technical failures, data loss, and missing entries in the home monitoring system. The frequency of reported technical issues and the ability of participants to successfully complete monitoring tasks will be recorded.
Time frame
From enrollment to the end of the study at 12 weeks3
Feasibility of Home Monitoring: Agreement Between Home-Based 1MSTS and Hospital-Based 6MWD for Exercise Capacity Assessment
Agreement between home-based 1-minute sit-to-stand test (1MSTS) and hospital-based 6-minute walk distance (6MWD) in assessing exercise capacity will be evaluated using correlation analysis (e.g., Pearson or Spearman correlation) and Bland-Altman plots to assess agreement. A regression model may be applied to explore the predictive relationship between 1MSTS (number of repetitions) and 6MWD (distance in meters). Unit of Measure: * Primary Unit: Agreement (correlation coefficient) * Secondary Units: 1MSTS (number of repetitions), 6MWD (meters)
Time frame
From enrollment to 12 weeks4
Feasibility of Home Monitoring: Agreement Between Home-Based and Hospital-Based Peripheral Oxygen Saturation (SpO₂) at Rest and Nadir During Exercise
Agreement between home-based and hospital-based peripheral oxygen saturation (SpO₂) at rest and the lowest (nadir) value during the tests. Unit of Measure: Percentage (%)
Time frame
From enrollment to 12 weeksSecondary outcomes
1
Patient Satisfaction with Home Monitoring
Patient satisfaction with home monitoring will be assessed using the Client Satisfaction Questionnaire (CSQ-8), which evaluates overall satisfaction with the home monitoring system. The CSQ-8 consists of eight items, each rated on a 4-point scale, with a total score range of 8 to 32. Higher scores indicate greater satisfaction. Unit of Measure: CSQ-8 total score (range: 8-32)
Time frame
12 weeks2
Patient Usability, Feasibility and Impact of Home Monitoring
Usability, feasibility, and perceived impact of home monitoring will be assessed using a custom-designed questionnaire. This questionnaire evaluates: * Usability (ease of use, technical difficulties, and disease-related limitations affecting use) * Feasibility (time commitment, disruption to daily life, need for additional guidance) * Impact (perceived usefulness for disease management, confidence in self-care, and emotional responses such as anxiety) Responses will be recorded on Likert scales (1-5 or 1-4, depending on the item). Unit of Measure: Individual questionnaire item scores (Likert scale 1-5 or 1-4)
Time frame
12 weeks3
Patient Engagement with Healthcare Providers
The frequency and reasons for interactions between participants and healthcare providers related to home monitoring will be tracked. These interactions may include technical difficulties, concerns about home-monitoring results, and symptom-related consultations.
Time frame
From enrollment to the end of the study at 12 weeks4
Impact of home monitoring on disease burden (EmPHasis-10 Score)
The EmPHasis-10 questionnaire will be used to assess changes in disease burden and health-related quality of life (HRQoL) for patients with pulmonary arterial hypertension. The total score ranges from 0 to 50, with higher scores indicating worse HRQoL. Unit of Measure: EmPHasis-10 total score (range: 0-50)
Time frame
Baseline and 12 weeksSponsors and contacts
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Source ClinicalTrials.gov