The Nor-SSCardioCare Pilot Trial: Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of Home Monitoring: Patient Adherence and Compliance
研究概览
简要总结
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.
详细描述
Study Overview The Nor-SSCardioCare Pilot Trial is a prospective, observational, single-arm feasibility study evaluating the implementation of home monitoring in patients with systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH).
The primary objective is to assess the feasibility of home monitoring in terms of patient adherence, technical feasibility, and the validity and reliability of home-based measures compared to hospital-based assessments.
Additionally, the study will evaluate patient satisfaction, usability of digital home monitoring, and its impact on health-related quality of life (HRQoL).
This 12-week study will generate feasibility data to inform the design of a larger trial aimed at integrating home monitoring into clinical care for earlier detection of disease progression and cardiac complications.
Background and Rationale SSc-PAH is a life-threatening complication of systemic sclerosis (SSc), with a high mortality rate and limited treatment response if diagnosed late.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Capable of giving signed informed consent
排除标准
- •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%)
- •In the opinion of the investigator, other clinically significant pulmonary abnormalities
- •Active treatment for cancer or non-curable cancer
- •Contraindications for functional assessment (6MWD and 1MSTS):
- •Uncontrolled systemic hypertension (systolic >220 mmHg or diastolic >120 mmHg) or hypotension (systolic <90 mmHg), resting tachycardia (>130 beats per minute).
- •Surgery, myocardial infarction/unstable angina, pneumothorax or stroke within the past 8 weeks.
- •Severe musculoskeletal or neurological limitations preventing safe ambulation or any acute illness which might impair performance or safety in the opinion of the investigator.
- •Unable to speak, write and read Norwegian
- •Pregnancy or planned pregnancy
结局指标
主要结局
Feasibility of Home Monitoring: Patient Adherence and Compliance
时间窗: From enrollment to the end of the study at 12 weeks
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.
Feasibility of Home Monitoring: Technical Feasibility
时间窗: From enrollment to the end of the study at 12 weeks
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.
Feasibility of Home Monitoring: Agreement Between Home-Based 1MSTS and Hospital-Based 6MWD for Exercise Capacity Assessment
时间窗: From enrollment to 12 weeks
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)
Feasibility of Home Monitoring: Agreement Between Home-Based and Hospital-Based Peripheral Oxygen Saturation (SpO₂) at Rest and Nadir During Exercise
时间窗: From enrollment to 12 weeks
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 (%)
Feasibility of Home Monitoring: Agreement Between Home-Based and Hospital-Based Heart Rate Measurements at Rest, Peak Exercise, and Recovery
时间窗: From enrollment to 12 weeks
Agreement between home-based and hospital-based heart rate measurements at rest, at maximum during the tests, and one minute after the tests. Unit of Measure: Beats per minute (bpm)
Feasibility of Home Monitoring: Agreement Between Home-Based and Hospital-Based Borg Dyspnea Scale Scores During Exercise
时间窗: From enrollment to 12 weeks
Agreement between home-based and hospital-based Borg dyspnea scale scores during the tests. Unit of Measure: Borg dyspnea scale score
Feasibility of Home Monitoring: Agreement Between Home-Based and Hospital-Based Visual Analogue Scale (VAS) Scores for Dizziness and Palpitations
时间窗: From enrollment to 12 weeks
Agreement between home-based and hospital-based Visual Analogue Scale (VAS) scores for dizziness and palpitations from 0 - 10 cm with higher values indicating more symptoms. Unit of Measure: VAS score (range: 0-10 cm)
Feasibility of Home Monitoring: Agreement Between Home-Based and Hospital-Based NT-proBNP Measurements
时间窗: From enrollment to 12 weeks
Agreement between home-based and hospital-based NT-proBNP measurements. Unit of Measure: pg/mL
次要结局
- Patient Satisfaction with Home Monitoring(12 weeks)
- Patient Usability, Feasibility and Impact of Home Monitoring(12 weeks)
- Patient Engagement with Healthcare Providers(From enrollment to the end of the study at 12 weeks)
- Impact of home monitoring on disease burden (EmPHasis-10 Score)(Baseline and 12 weeks)
- Impact of home monitoring on functional status (mMRC dyspnea scale)(Baseline and 12 weeks)
- Impact of home monitoring on symptoms (VAS symptom scales)(From enrollment to 12 weeks)
- Impact of home monitoring on systemic sclerosis disease burden (ScleroID Score)(Baseline and 12 weeks)
- Impact of Home Monitoring on Health-Related Quality of Life (EQ-5D-5L Index Score)(Baseline and 12 weeks)
- Impact of Home Monitoring on Health-Related Quality of Life (EQ VAS Score)(Baseline and 12 weeks)
- Impact of home monitoring on disability (HAQ Score)(Baseline and 12 weeks)
- Impact of home monitoring on anxiety and depression (HADS Score)(Baseline and 12 weeks)
- PAH Progression(From enrollment to the end of the study at 12 weeks)
- PAH Events(From enrollment to the end of the study at 12 weeks)
- Changes in hospital-based clinical measures: Change in WHO Functional Class (WHO-FC) from baseline to 12 weeks(Baseline and 12 weeks)
- Changes in hospital-based clinical measures: Change in 6-Minute Walk Distance (6MWD) from baseline to 12 weeks(Baseline and 12 weeks)
- Changes in hospital-based clinical measures: Change in 1-Minute Sit-to-Stand Test (1MSTS) from baseline to 12 weeks(Baseline and 12 weeks)
- Changes in hospital-based clinical measures: Change in Pulmonary Function Tests (PFTs) from baseline to 12 weeks(Baseline and 12 weeks)
- Changes in hospital-based clinical measures: Change in NT-proBNP Levels from baseline to 12 weeks(Baseline and 12 weeks)
- Changes in hospital-based clinical measures: Change in risk stratification score (ESC/ERS Four-Strata Model) from baseline to 12 weeks(Baseline and 12 weeks)
- Changes in Home-Based Clinical Measures(From enrollment to the end of the study at 12 weeks)
- Agreement Between Home-Based and Hospital-Based Risk Stratification: Determination of 1MSTS cut-offs for risk stratification based on 6MWD(From enrollment to 12 weeks)
- Agreement Between Home-Based and Hospital-Based Risk Stratification: Agreement between home-based and hospital-based ESC/ERS four-strata risk stratification(From enrollment to 12 weeks)
- Reproducibility of Home-Based Measures(From enrollment to the end of the study at 12 weeks)
- Heart Rhythm Monitoring (ECG 247 Smart Heart Sensor)(One-week monitoring during the 12-week study period)
研究者
Anna-Maria Hoffmann-Vold
Prof Dr med
Oslo University Hospital