SLENCT04368299
Telemedicine for Follow-up of Systemic Lupus Erythematosus
A study testing Telemedicine in people with SLE, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SLE
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2020to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant
- incapable of answering a questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Telemedicine for Follow-up of Systemic Lupus Erythematosus ("TeleSLE") in the COVID-19 Outbreak: a Pragmatic Randomised Controlled Trial
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.
Read more
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.
Read the 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
- Being tested
- Telemedicine, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Videoconferencing for follow-up
Standard careOther
Standard in-person outpatient follow-up
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | Telemedicine group will receive scheduled follow-ups via videoconferencing. Receives: Other: Telemedicine |
| Standard care | Active comparator | Standard care group patients will continue conventional standard in-person outpatient care. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients in remission or LLDAS at one year.
Measured: 1 year
Secondary outcomes (7)
Direct and indirect costs after one year.
Measured: 1 year
The change of Lupus Quality of Life (LupusQoL) at one year.
LupusQoL evaluates 8 domains including physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Questionnaire has a 5-point Likert response format (0=all the time, 1=most of the time, 2=a good bit of the time, 3=occasionally, and 4=never). Higher score means better quality of life.
Measured: 1 year
Patient confidence and satisfaction score at one year.
They are in a 5-point Likert response format (0=strongly disagree, 1=disagree, 2=neutral, 3=agree, and 4=strongly agree). Higher score means more confident and satisfied.
Measured: 1 year
Rates of adverse reaction and severe adverse reaction, including contracting COVID-19 infection, after one year.
Measured: 1 year
Numbers of clinic visits, hospitalization, overall in-person hospital visits in one year.
Measured: 1 year
The change of (Health Assessment Questionnaire Disability Index HAQ-DI) at one year.
HAQ-DI covers various common daily activities to assess disability.It consists of 8 questions. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3). Higher score means higher disability.
Measured: 1 year
The change of (Hospital Anxiety and Depression Scale) HADS at one year.
HADS was developed to assess anxiety and depression in medical patients. Each domain has 7 items. Each item are answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. Higher score means more likely the patient has anxiety or depression.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 May 2020
- Primary completion17 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLEStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho SO, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368299
- Sponsor's protocol ID
- TeleSLE
- Status last verified
- Mar 2022
- First submitted
- 25 Apr 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Telemedicine for Follow-up of Systemic Lupus Erythematosus ("TeleSLE") in the COVID-19 Outbreak: a Pragmatic Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04368299
- Acronym / sponsor ID
- TeleSLE
- Conditions
- SLE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Other: TelemedicineTelemedicine group will receive scheduled follow-ups via videoconferencing. |
| Standard care | Active comparator | Other: Standard careStandard care group patients will continue conventional standard in-person outpatient care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- pregnant
- incapable of answering a questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineVideoconferencing for follow-up | Other | Telemedicine |
| Standard careStandard in-person outpatient follow-up | Other | Standard care |
Primary outcome
The percentage of patients in remission or LLDAS at one year.
Time frame: 1 year
7 secondary outcomes
Direct and indirect costs after one year.
Time frame: 1 year
The change of Lupus Quality of Life (LupusQoL) at one year.
Time frame: 1 year
Patient confidence and satisfaction score at one year.
Time frame: 1 year
Rates of adverse reaction and severe adverse reaction, including contracting COVID-19 infection, after one year.
Time frame: 1 year
Numbers of clinic visits, hospitalization, overall in-person hospital visits in one year.
Time frame: 1 year
The change of (Health Assessment Questionnaire Disability Index HAQ-DI) at one year.
Time frame: 1 year
The change of (Hospital Anxiety and Depression Scale) HADS at one year.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with SLE, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients in remission or LLDAS at one year. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.