Can Machine Learning and Patient-reported Outcomes be Used in Remote Care in People With Rheumatic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- Proportion maintaining comprehensive disease control
研究概览
简要总结
This study is a 24-months, non-inferiority randomized, controlled trial with two parallel arms to determine if a new follow-up strategy for patients with RA is non-inferior in maintaining comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up compared to the conventional follow-up regimen with regular hospital visits.
详细描述
The study will include Norwegian adult males and females with rheumatoid arthritis. Eligible patients that consent to participation will be randomized to two groups:
- Control group: conventional follow-up strategy with blood tests, patient-reported outcomes (PROs), and pre-scheduled visits at the hospital every 6th month.
- Remote monitoring: monthly remote monitoring of PROs and triage of patients using an algorithm will guide healthcare providers in scheduling patients for a video consultation or face-to-face hospital visits.
Participants will be followed for 24 months. Primary outcome is proportionn maintaining comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up1.
- Structural: Assessed with radiographs of hands and feet according to the van der Heijde modified Sharpe score (subscores for erosions (0-280) and joint space narrowing (0-168)), with a total range of 0-448. Maintenance of structural treatment target is defined as change in total score <1 unit/year (<2 units from inclusion to 2-year follow-up).
- Functional: Measured by Modified Health Assessment Questionnaire (MHAQ) measured on a scale from 0.00 to 3.00, where a change of 0.25 is considered clinical important3. Maintenance of functional treatment target is defined as a worsening <0.25 from inclusion to 2-year follow-up.
- Clinical: Measured by DAS28, categorized into remission (<2.6), low disease activity (2.6 to ≤3.2), moderate disease activity (3.2 to ≤5.1) and high disease activity (>5.1). Maintenance of clinical treatment target is defined disease activity category at 2-year follow-up ≤ baseline category.
We will use a 15% non-inferiority margin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Male or non-pregnant, non-nursing female ≥18 years of age at screening
- •Patients with a diagnosis of RA who fulfil the 2010 ACR/EULAR diagnostic criteria24 (see Appendix 5, 10.4)
- •Medical treatment with cs/ts/bDMARDs (incl. prednisolone) considered stable by the healthcare provider the last 6 months
- •Low disease activity or remission (CDAI<10 / DAS28<3.2) at inclusion
- •<2 swollen joints
- •Not deemed inappropriate for remote monitoring by the healthcare provider
- •Capable of understanding and signing an informed consent form
- •Access to a smartphone or tablet
- •Able to speak and understand Norwegian language
排除标准
- •Medical conditions:
- •Major co-morbidities, such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV), severe respiratory diseases, and/or cirrhosis.
- •Indications of active tuberculosis (TB)
- •Treated with intravenous DMARD (e.g., rituximab and infliximab)
- •Diagnostic assessments:
- •Abnormal renal function, defined as serum creatinine >142 µmol/L in female and >168 µmol/L in male, or glomerular filtration rate (GFR) <40 mL/min/1.73 m2
- •Abnormal liver function (defined as Aspartate Transaminate (AST)/Alanine Transaminase (ALT) >3 x upper normal limit), active or recent hepatitis
- •Leukopenia and/or thrombocytopenia
- •Pregnancy and/or breastfeeding (current at screening or planned within the duration of the study)
- •Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible.
- •Deemed unsuitable for remote monitoring by medical doctor
结局指标
主要结局
Proportion maintaining comprehensive disease control
时间窗: Baseline and 2 years
Comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up. * Structural: Radiographs of hands and feet according to the van der Heijde modified Sharpe score, with a total range of 0-448. Maintenance of structural treatment target is defined as change in total score \<1 unit/year (\<2 units from inclusion to 2-year follow-up). * Functional: Modified Health Assessment Questionnaire (MHAQ) measured on a scale from 0.00 to 3.00, where a change of 0.25 is considered clinical important. Maintenance of functional treatment target is defined as a worsening \<0.25 from inclusion to 2-year follow-up. * Clinical: DAS28, categorized into remission (\<2.6), low disease activity (2.6 to ≤3.2), moderate disease activity (3.2 to ≤5.1) and high disease activity (\>5.1). Maintenance of clinical treatment target is defined disease activity category at 2-year follow-up ≤ baseline category.
次要结局
- Self-reported disease activity (intervention group)(Monthly until 2 years)
- Proportion in remission/low disease activity (DAS28)(Baseline and 2 years)
- Change in joint damage progression(Baseline and 2 years)
- Disease activity in conjunction with consultation (DAS28)(Any consultation from baseline to 2 years)
- Disease activity in conjunction with consultation (CDAI)(Any consultation from baseline to 2 years)
- Patient-reported disease flares (control group)(6 months, 12 months, 18 months, 2 years)
- Number of consultations/contacts at the hospital(From baseline to 2 years)
- Activity impairment (intervention group)(Baseline and monthly until 2 years)
- Proportion in remission/low disease activity (CDAI)(Baseline and 2 years)
- Activity impairment (control group)(Baseline, 6 months, 12 months, 18 months, 2 years)
- The need to take time off for hospital visits or video consultation(Baseline)
- C-Reactive Protein (CRP) (intervention group)(Monthly until 2 years)
- Health care utilization(Baseline, 6 months, 12 months, 18 months, 2 years)
- Costs related to hospital visits(Baseline)
- Self-reported disease activity (control group)(Baseline, 6 months, 12 months, 18 months and 2 years)
- Health-related quality of life(Baseline, 6 months, 12 months, 18 months and 2 years)
- Patient-reported disease flares (intervention group)(Every month until 2 years)
- Pain (control group)(Baseline, 6 months, 12 months, 18 months, 2 years)
- Joint pain (intervention group)(Baseline and monthly until 2 years)
- Joint pain (control group)(Baseline, 6 months, 12 months, 18 months, 2 years)
- Medication use(Baseline, 6 months, 12 months, 18 months, 2 years)
- Patient acceptable symptom state(Baseline, 6 months, 12 months, 18 months, 2 years)
- Adverse events(Through study completion, maximum 2 years)
- Patient satisfaction with care(Baseline, 6 months, 12 months, 18 months, 2 year)
- PROMIS Physical function(Baseline, 6 months, 12 months, 18 months, 2 years)
- C-Reactive Protein (CRP) (control group)(Baseline, 6 months, 12 months, 18 months and 2 years)
- Modified Health Assessment Questionnaire (MHAQ)(Baseline, 6 months, 12 months, 18 months, 2 years)
- Sleep impairment(Baseline, 6 months, 12 months, 18 months, 2 years)
- Withdrawals/early discontinuation(Through study completion, maximum 2 years)
- Patient satisfaction with remote monitoring(2 years)
- Pain (intervention group)(Baseline and monthly until 2 years)
- Swollen joint count(Baseline, any hospital visits, 2 years)
- Tender joint count(Baseline, any hospital visits, 2 years)
- Extra visits, telephone and video consultations(Through study completion, maximum 2 years)
- Physical activity(Baseline, 6 months, 12 months, 18 months, 2 years)
- Fatigue(Baseline, 6 months, 12 months, 18 months, 2 years)
- eHealth literacy(Baseline)
- Patient-reported self-efficacy for using different digital devices, secure login and digital health services(Baseline)
研究者
Anne Therese Tveter
Principal Investigator, Senior researcher/Assosiate Professor
Diakonhjemmet Hospital