Rheumatic DiseasesNCT04704544
Effectiveness of Tele-rheumatology for Delivering High Quality Rheumatology Care During the COVID-19 Crisis (EVOLVE)
A study testing Tele-rheumatology in people with Rheumatic Diseases, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
While tele-rheumatology (TR) visits are a COVID-19 related necessity, there is a lack of rigorous data on the comparative effectiveness of TR versus (vs) in-person usual care (UC) especially in medically at-risk populations such as people with rheumatic and musculoskeletal disease (RMD) using immunosuppressive drugs… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Tele-rheumatology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 652 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 18 Feb 2026
- 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
- Diagnosis of rheumatic disease (e.g. rheumatoid arthritis, SLE)
Who cannot join
- unstable rheumatic disease that needs in-person visits (e.g. recent diagnosis of severe lupus nephritis)
- expected in-office procedures (e.g., joint injection)
- lack of access to phone
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Effectiveness of Tele-rheumatology for Delivering High Quality Rheumatology Care During the COVID-19 Crisis
While tele-rheumatology (TR) visits are a COVID-19 related necessity, there is a lack of rigorous data on the comparative effectiveness of TR versus (vs) in-person usual care (UC) especially in medically at-risk populations such as people with rheumatic and musculoskeletal disease (RMD) using immunosuppressive drugs (IS). This clear research gap was highlighted by the American College of Rheumatology in its recent Task Force Report on Telehealth in the COVID era. In this study, the investigators will rigorously evaluate the comparative effectiveness of TR visits for high risk people living with RMD and among those from socially vulnerable populations, in the COVID-19 era. This study is of key public health importance and relevance to rheumatology since it addresses the urgent clinical and policy needs to provide safe, efficacious, and equitable care to diverse patients with RMD during and beyond the COVID-19 crisis. Our proposal is very responsive to the RRF's Notice of Special interest on COVID-19 in improving the care of people with RMD during the COVID-19 pandemic. The investigators will perform the first randomized experiment of tele-rheumatology, generating high quality evidence to guide the use of this technology across diverse populations of people with RMDs. Beyond the high public health impact of this study for people with RMDs, the investigators expect that our findings will have high generalizability to other at-risk patient populations with multimorbidity and inform rheumatology practice into the foreseeable future.
Read the detailed description
People with RMDs, especially those with multi-comorbidities and on IS are among the most at-risk for COVID-19-related fragmented care and poor outcomes. RMD burden is high in terms of disability-adjusted-life years (DALYs) and has been escalating. Beyond the prevailing challenges to in-person visits such as scheduling conflicts, transportation, or disability, the COVID-19 pandemic has further exacerbated RMD patient burden through disruptions in healthcare delivery (e.g. limited availability of in-person visits). Thus, high quality adaptations of healthcare services for people living with RMD including through TR in the context of the COVID-19 crisis are badly needed. The investigators found from a recent survey of 24,500 people living with RMD that 60% of respondents avoided in-person clinic visits. However, with the increasing availability of technology (90% Americans have internet access, 81% are online daily most patients and clinicians can engage in some form of TR. Due to widespread social distancing and major health policy changes necessitated by COVID-19, TR has been swiftly adopted (but minimally tested) as a means to deliver ongoing care for people with RMD. Because patients can be evaluated in their own homes, thus avoiding travel that increases COVID-19 risk, this approach provides means of healthcare for socially and medically vulnerable groups, such as those residing in rural areas and those with comorbidities, a group particularly at high risk of COVID-19 complications.
- Conditions
- Rheumatic Diseases
- Being tested
- Tele-rheumatology
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-rheumatologyOther
Participants will receive virtual visits via video conferencing and/or phone.
| Study group | Role | What they receive |
|---|---|---|
| Tele-rheumatology first visit and Usual Care second visit | Experimental | Participants randomized to this visit will receive a tele-rheumatology visit first. Receives: Other: Tele-rheumatology |
| Usual Care first visit and Tele-rheumatology second visit | Experimental | Participants randomized to this visit will receive a usual care visit first. Receives: Other: Tele-rheumatology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction with type visit. Assessed with AHRQ's Consumer Assessment of Healthcare Providers and Systems (CAHPS)® survey
Measured: 36-72 hours post visit after the first visit
Secondary outcomes (1)
Patient preference
Patient preference with type visit. Assessed using "If you had a choice, what type of visit would you prefer?" with options a. telemedicine, b. in-office
Measured: 36-72 hours post visit, after the second visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start15 Sep 2021
- Primary completion30 Nov 2023
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will conduct an open label, two-period, multi-center, non-inferiority, patient-level randomized controlled trial comparing tele-rheumatology (audio +/- video) with usual care (in-person) visits. Patients will be randomized to the sequence of care for their next two visits (V1 and V2): i) tele-rheumatology (V1) + usual care (V2), OR ii) usual care (V1) + tele-rheumatology (V2). Primary outcome will be ascertained after the first visit (V1).
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Tulane University, Rheumatology Research Foundation
- Responsible party
- Principal investigator, Maria Danila, MD, MSc, MSPH, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704544
- Sponsor's protocol ID
- IRB-300006553
- Other IDs
- 0000000
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2021
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feldman CH, Ramsey-Goldman R. Widening Disparities Among Patients With Rheumatic Diseases in the COVID-19 Era: An Urgent Call to Action. Arthritis Rheumatol. 2020 Sep;72(9):1409-1411. doi: 10.1002/art.41306. Epub 2020 Aug 9. No abstract available.
PubMed 32379381Brooks PM. The burden of musculoskeletal disease--a global perspective. Clin Rheumatol. 2006 Nov;25(6):778-81. doi: 10.1007/s10067-006-0240-3. Epub 2006 Apr 12.
PubMed 16609823Donelan K, Barreto EA, Sossong S, Michael C, Estrada JJ, Cohen AB, Wozniak J, Schwamm LH. Patient and clinician experiences with telehealth for patient follow-up care. Am J Manag Care. 2019 Jan;25(1):40-44.
PubMed 30667610Michaud K, Wipfler K, Shaw Y, Simon TA, Cornish A, England BR, Ogdie A, Katz P. Experiences of Patients With Rheumatic Diseases in the United States During Early Days of the COVID-19 Pandemic. ACR Open Rheumatol. 2020 Jun;2(6):335-343. doi: 10.1002/acr2.11148. Epub 2020 May 9.
PubMed 32311836Webster P. Virtual health care in the era of COVID-19. Lancet. 2020 Apr 11;395(10231):1180-1181. doi: 10.1016/S0140-6736(20)30818-7. No abstract available.
PubMed 32278374Bachireddy C, Chen C, Dar M. Securing the Safety Net and Protecting Public Health During a Pandemic: Medicaid's Response to COVID-19. JAMA. 2020 May 26;323(20):2009-2010. doi: 10.1001/jama.2020.4272. No abstract available.
PubMed 32191260Uscher-Pines L, Fischer S, Tong I, Mehrotra A, Malsberger R, Ray K. Virtual First Responders: the Role of Direct-to-Consumer Telemedicine in Caring for People Impacted by Natural Disasters. J Gen Intern Med. 2018 Aug;33(8):1242-1244. doi: 10.1007/s11606-018-4440-8. No abstract available.
PubMed 29691713Hayes BL, Curtis JR, Laster A, Saag K, Tanner SB, Liu C, Womack C, Johnson KC, Khaliq F, Carbone LD. Osteoporosis care in the United States after declines in reimbursements for DXA. J Clin Densitom. 2010 Oct-Dec;13(4):352-60. doi: 10.1016/j.jocd.2010.08.001.
PubMed 21029972Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
PubMed 32320003Nesbitt TS, Marcin JP, Daschbach MM, Cole SL. Perceptions of local health care quality in 7 rural communities with telemedicine. J Rural Health. 2005 Winter;21(1):79-85. doi: 10.1111/j.1748-0361.2005.tb00066.x.
PubMed 15667014Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.
PubMed 32173574Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tele-rheumatology for Delivering High Quality Rheumatology Care During the COVID-19 Crisis
- ClinicalTrials.gov ID
- NCT04704544
- Acronym / sponsor ID
- IRB-300006553
- Conditions
- Rheumatic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Tulane University, Rheumatology Research Foundation
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 11 Jan 2021 (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.
While tele-rheumatology (TR) visits are a COVID-19 related necessity, there is a lack of rigorous data on the comparative effectiveness of TR versus (vs) in-person usual care (UC) especially in medically at-risk populations such as people with rheumatic and musculoskeletal disease (RMD) using immunosuppressive drugs (IS). This clear research gap was highlighted by the American College of Rheumatology in its recent Task Force Report on Telehealth in the COVID era. In this study, the investigators will rigorously evaluate the comparative effectiveness of TR visits for high risk people living with RMD and among those from socially vulnerable populations, in the COVID-19 era. This study is of key public health importance and relevance to rheumatology since it addresses the urgent clinical and policy needs to provide safe, efficacious, and equitable care to diverse patients with RMD during and beyond the COVID-19 crisis. Our proposal is very responsive to the RRF's Notice of Special interest on COVID-19 in improving the care of people with RMD during the COVID-19 pandemic. The investigators will perform the first randomized experiment of tele-rheumatology, generating high quality evidence to guide the use of this technology across diverse populations of people with RMDs. Beyond the high public health impact of this study for people with RMDs, the investigators expect that our findings will have high generalizability to other at-risk patient populations with multimorbidity and inform rheumatology practice into the foreseeable future.
Detailed description
People with RMDs, especially those with multi-comorbidities and on IS are among the most at-risk for COVID-19-related fragmented care and poor outcomes. RMD burden is high in terms of disability-adjusted-life years (DALYs) and has been escalating. Beyond the prevailing challenges to in-person visits such as scheduling conflicts, transportation, or disability, the COVID-19 pandemic has further exacerbated RMD patient burden through disruptions in healthcare delivery (e.g. limited availability of in-person visits). Thus, high quality adaptations of healthcare services for people living with RMD including through TR in the context of the COVID-19 crisis are badly needed. The investigators found from a recent survey of 24,500 people living with RMD that 60% of respondents avoided in-person clinic visits. However, with the increasing availability of technology (90% Americans have internet access, 81% are online daily most patients and clinicians can engage in some form of TR. Due to widespread social distancing and major health policy changes necessitated by COVID-19, TR has been swiftly adopted (but minimally tested) as a means to deliver ongoing care for people with RMD. Because patients can be evaluated in their own homes, thus avoiding travel that increases COVID-19 risk, this approach provides means of healthcare for socially and medically vulnerable groups, such as those residing in rural areas and those with comorbidities, a group particularly at high risk of COVID-19 complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- We will conduct an open label, two-period, multi-center, non-inferiority, patient-level randomized controlled trial comparing tele-rheumatology (audio +/- video) with usual care (in-person) visits. Patients will be randomized to the sequence of care for their next two visits (V1 and V2): i) tele-rheumatology (V1) + usual care (V2), OR ii) usual care (V1) + tele-rheumatology (V2). Primary outcome will be ascertained after the first visit (V1).
| Arm | Type | Receives |
|---|---|---|
| Tele-rheumatology first visit and Usual Care second visit | Experimental | Other: Tele-rheumatologyParticipants randomized to this visit will receive a tele-rheumatology visit first. |
| Usual Care first visit and Tele-rheumatology second visit | Experimental | Other: Tele-rheumatologyParticipants randomized to this visit will receive a usual care visit first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of rheumatic disease (e.g. rheumatoid arthritis, SLE)
Key exclusion criteria (3 listed)
- unstable rheumatic disease that needs in-person visits (e.g. recent diagnosis of severe lupus nephritis)
- expected in-office procedures (e.g., joint injection)
- lack of access to phone
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 |
|---|---|---|
| Tele-rheumatologyParticipants will receive virtual visits via video conferencing and/or phone. | Other | Tele-rheumatology first visit and Usual Care second visit, Usual Care first visit and Tele-rheumatology second visit |
Primary outcome
Patient satisfaction
Time frame: 36-72 hours post visit after the first visit
Patient satisfaction with type visit. Assessed with AHRQ's Consumer Assessment of Healthcare Providers and Systems (CAHPS)® survey
1 secondary outcome
Patient preference
Time frame: 36-72 hours post visit, after the second visit
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 20 Feb 2026.
- Background: PubMed 32379381Feldman CH, Ramsey-Goldman R. Widening Disparities Among Patients With Rheumatic Diseases in the COVID-19 Era: An Urgent Call to Action. Arthritis Rheumatol. 2020 Sep;72(9):1409-1411. doi: 10.1002/art.41306. Epub 2020 Aug 9. No abstract available.
- Background: PubMed 16609823Brooks PM. The burden of musculoskeletal disease--a global perspective. Clin Rheumatol. 2006 Nov;25(6):778-81. doi: 10.1007/s10067-006-0240-3. Epub 2006 Apr 12.
- Background: PubMed 30667610Donelan K, Barreto EA, Sossong S, Michael C, Estrada JJ, Cohen AB, Wozniak J, Schwamm LH. Patient and clinician experiences with telehealth for patient follow-up care. Am J Manag Care. 2019 Jan;25(1):40-44.
- Background: PubMed 32311836Michaud K, Wipfler K, Shaw Y, Simon TA, Cornish A, England BR, Ogdie A, Katz P. Experiences of Patients With Rheumatic Diseases in the United States During Early Days of the COVID-19 Pandemic. ACR Open Rheumatol. 2020 Jun;2(6):335-343. doi: 10.1002/acr2.11148. Epub 2020 May 9.
- Background: PubMed 32278374Webster P. Virtual health care in the era of COVID-19. Lancet. 2020 Apr 11;395(10231):1180-1181. doi: 10.1016/S0140-6736(20)30818-7. No abstract available.
- Background: PubMed 32191260Bachireddy C, Chen C, Dar M. Securing the Safety Net and Protecting Public Health During a Pandemic: Medicaid's Response to COVID-19. JAMA. 2020 May 26;323(20):2009-2010. doi: 10.1001/jama.2020.4272. No abstract available.
- Background: PubMed 29691713Uscher-Pines L, Fischer S, Tong I, Mehrotra A, Malsberger R, Ray K. Virtual First Responders: the Role of Direct-to-Consumer Telemedicine in Caring for People Impacted by Natural Disasters. J Gen Intern Med. 2018 Aug;33(8):1242-1244. doi: 10.1007/s11606-018-4440-8. No abstract available.
- Background: PubMed 21029972Hayes BL, Curtis JR, Laster A, Saag K, Tanner SB, Liu C, Womack C, Johnson KC, Khaliq F, Carbone LD. Osteoporosis care in the United States after declines in reimbursements for DXA. J Clin Densitom. 2010 Oct-Dec;13(4):352-60. doi: 10.1016/j.jocd.2010.08.001.
- Background: PubMed 32320003Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
- Background: PubMed 15667014Nesbitt TS, Marcin JP, Daschbach MM, Cole SL. Perceptions of local health care quality in 7 rural communities with telemedicine. J Rural Health. 2005 Winter;21(1):79-85. doi: 10.1111/j.1748-0361.2005.tb00066.x.
- Background: PubMed 32173574Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.
- Background: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
- Individual participant dataSharing planned: No
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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 Tele-rheumatology in people with Rheumatic Diseases, run by University of Alabama at Birmingham at 1 site in United States.
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 1 inclusion and 3 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 20 Feb 2026. 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 United States. 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?
Patient satisfaction (time frame: 36-72 hours post visit after the first visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04704544, which also lists 12 linked publications.
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 20 Feb 2026.