Telemedicine for Follow-up of Systemic Lupus Erythematosus

NCT04368299 | Completed

• 1 other identifier: TeleSLE
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

SLE

Outcome Measures

Primary Outcomes (1)

• The percentage of patients in remission or LLDAS at one year.

  1 year

Secondary Outcomes (7)

• Direct and indirect costs after one year.

  1 year

• The change of Lupus Quality of Life (LupusQoL) at one year.

  1 year

• Patient confidence and satisfaction score at one year.

  1 year

• Rates of adverse reaction and severe adverse reaction, including contracting COVID-19 infection, after one year.

  1 year

• Numbers of clinic visits, hospitalization, overall in-person hospital visits in one year.

  1 year

Study Arms (2)

Telemedicine

EXPERIMENTAL

Telemedicine group will receive scheduled follow-ups via videoconferencing.

Other: Telemedicine

Standard care

ACTIVE COMPARATOR

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

Other: Standard care

Interventions

Telemedicine OTHER

Videoconferencing for follow-up

Telemedicine

Standard care OTHER

Standard in-person outpatient follow-up

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnant
• incapable of answering a questionnaire

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Telemedicine; Standard of Care

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Quality Indicators, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: April 29, 2020
• Study Start: May 1, 2020
• Primary Completion: January 17, 2022
• Study Completion: January 31, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

HK (1)