Telemedicine for Follow-up of Systemic Lupus Erythematosus

NCT ID: NCT04368299

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2022-01-31

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.

Conditions

SLE

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Telemedicine

Telemedicine group will receive scheduled follow-ups via videoconferencing.

Group Type: EXPERIMENTAL

Telemedicine

Intervention Type: OTHER

Videoconferencing for follow-up

Standard care

Standard care group patients will continue conventional standard in-person outpatient care.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Standard in-person outpatient follow-up

Interventions

Telemedicine

Videoconferencing for follow-up

Intervention Type: OTHER

Standard care

Standard in-person outpatient follow-up

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Ho SO

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

TeleSLE

Identifier Type: -

Identifier Source: org_study_id