Clinical trial NCT04368299: Telemedicine for Follow-up of Systemic Lupus Erythematosus
Official title: Use of Telemedicine for Follow-up of Systemic Lupus Erythematosus ("TeleSLE") in the COVID-19 Outbreak: a Pragmatic Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SLE
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background Patients with systemic lupus erythematosus (SLE) might be more susceptible to Covid-19 due to the underlying disease, co-morbidities and the use of immunosuppressive drugs. The investigators hypothesize that telemedicine (TM) can be an effective mode of health-care delivery minimizing the risk of SARS-CoV-2 exposure, while maintaining disease control in these patients.

Objectives The primary aim of this study is to evaluate the effectiveness to achieve remission or lupus low disease activity state (LLDAS) using TM delivered care compared to conventional in-person outpatient follow-up in SLE. The secondary objectives are to compare the patient reported outcomes and cost between the two modes of health care delivery.

Study design This is a 12-months single centered pragmatic randomized controlled study. A total of 150 enrolled patients with SLE being followed at the Prince of Wales Hospital rheumatology clinics will be randomized to either TM (TM group) or standard care (SC group) in a 1:1 ratio. Patients in the TM group will receive scheduled follow-ups via videoconferencing using a custom-made mobile app. SC group patients will continue conventional standard in-person outpatient care. The disease and patient reported outcomes as well as the health care related costs will be compared.

Expected outcomes Data from this study will support the notion that TM based care is as effective as conventional in-person care in achieving disease remission or LLDAS, as well as addressing psychosocial implications to ensure the best possible care for our patients in a cost-effective manner during this pandemic.

Detailed description: There is a single-center pragmatic randomized controlled trial over a 12-month period. The study will be performed at the Rheumatology clinics at the Prince of Wales Hospital, which is a regional hospital in Hong Kong.

From May to October 2020, all consecutive patients with a diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology classification criteria will be invited to participate in the study if they are aged \>18 years, able to speak or understand Chinese and are willing to come back for routine blood and urine tests \[18\]. Patients (or carers) need to possess the technology needed to conduct a TM visit - a smartphone, tablet, or computer. Patients will be excluded if they are pregnant or incapable of answering a questionnaire. Patients will be randomization to either TM (TM group) or standard follow-ups (SF group 1). Patients who refused to be randomized will be offered standard in-person outpatient follow-up (SF group 2). All patients who fulfill the inclusion criteria and have given written informed consent will be asked to complete the Systemic Lupus Activity Questionnaire (SLAQ), LupusPRO, Health Assessment Questionnaire Disability Index (HAQ-DI), Medical Outcomes Survey Short Form (SF-36), Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (version 4) and Hospital Anxiety and Depression Scale (HADS). They will also be asked to rate the confidence to the mode of care on a 10-point Likert scale (0 = not at all confident to 10 = very much confident). Their demographic, socio-economic and clinical data will be collected. Patient will be randomized in a ratio of 1:1 to either TM group or SF group 1 using a computer-generated random number sequence.

Eligibility criteria: Inclusion Criteria:

1. Fulfilling the 2019 European League Against Rheumatism/American College of Rheumatology classification criteria
2. Over 18 years of age
3. able to speak or understand Chinese
4. willing to come back for routine blood and urine tests
5. possess the technology needed to conduct a TM visit

Exclusion Criteria:

1. pregnant
2. incapable of answering a questionnaire

Primary outcomes:
measure: The percentage of patients in remission or LLDAS at one year.
timeFrame: 1 year
Secondary outcomes:
measure: Direct and indirect costs after one year.
timeFrame: 1 year
measure: The change of Lupus Quality of Life (LupusQoL) at one year.
timeFrame: 1 year
measure: Patient confidence and satisfaction score at one year.
timeFrame: 1 year
measure: Rates of adverse reaction and severe adverse reaction, including contracting COVID-19 infection, after one year.
timeFrame: 1 year
measure: Numbers of clinic visits, hospitalization, overall in-person hospital visits in one year.
timeFrame: 1 year
measure: The change of (Health Assessment Questionnaire Disability Index HAQ-DI) at one year.
timeFrame: 1 year
measure: The change of (Hospital Anxiety and Depression Scale) HADS at one year.
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: