Rheumatoid ArthritisNCT04558905
Impact of a Hybrid Medical Care Model in the Rheumatoid Arthritis Patient-reported-outcomes Measures
A study testing Face-to-face medical visits and Alternating face-to-face medical visits and video medical consultations in people with Rheumatoid Arthritis and Telehealth, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
Trial summary
The COVID-19 outbreak has affected health care of patients with rheumatic diseases; telemedicine might help to assist patients. The primary objective is to determine if a hybrid medical care model, which consists of alternating face-to-face medical visits and video medical consultations, is not inferior, in terms of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Telehealth
- What is being tested?
- Face-to-face medical visits and Alternating face-to-face medical visits and video medical consultations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteMexico
- Study dates
- 1 Oct 2020to 31 May 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
- Patients with RA diagnosis according to their primary rheumatologist
- With at least six months of follow-up (up to March 2020) at the outpatient clinic
- Who agree to participate
Who cannot join
- Patients lost to follow-up from the outpatient clinic before March 2020
- Patients with no access to a mobile device during their study participation
- Patients with severe cognitive, visual and hearing impairment
- Patients on palliative care because of comorbid condition
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Tlalpan, 14080
About this study
Official title: Impact of a Hybrid Medical Care Model (Face-to-face Medical Visits Alternating With Video Medical Consultations) in the Rheumatoid Arthritis Patient-reported-outcomes Measures: A Non-inferiority Study
The COVID-19 outbreak has affected health care of patients with rheumatic diseases; telemedicine might help to assist patients.
The primary objective is to determine if a hybrid medical care model, which consists of alternating face-to-face medical visits and video medical consultations, is not inferior, in terms of the Patient Reported Outcomes measures (PROMs), to the face-to-face medical care model, among rheumatoid arthritis (RA) outpatients. We also aim to investigate if adherence to RA-related treatment (considered a surrogate of patient´s education) might be improved when patients are re-integrated to the health care system, irrespective of the health care model.
Read more
In Mexico, COVID-19 pandemic still uncontrolled. Our Institution provides health care to 1500 RA patients/year and up to August 2020, it is estimated that 500 RA patients might be affected, which is our target audience. Reinstalling institutional health care provision is challenging.
This a non-inferiority, cross-over study, with 2 intervention arms. Patients will be randomized to 1. Six months of usual medical care model, followed by 4 months of a control period, and 6 months of hybrid medical care model, or 2. Six months of hybrid medical care model, followed by 4 months of a control period, and 6 months of usual medical care model.
The following PROMs will be assessed at specific time points: disease activity/disease severity (RAPID-3), disability (HAQ-DI), quality of life (WHOQOL-BREF), patient satisfaction with the medical care model (questionnaire locally developed), patient´s adherence to medical care (missed scheduled visits) and patient´s adherence to RA-related treatment (the Compliance-Questionnaire).
Read the detailed description
This a non-inferiority and cross-over study, with a planned follow-up of 16 months, with 2 intervention arms:
Intervention 1: Patients assigned to 6 months of usual medical care model, followed by 4 months control period, and finally 6 months of hybrid medical care model.
Intervention 2: Patients assigned to 6 months of hybrid medical care model, followed by 4 months control period and finally 6 months of usual medical care model.
Specific objectives are as follows:
Primary objectives
- To compare the mean disease activity of RA patients (as measured per RAPID-3), after 6 months since study entry, between patients assigned to intervention 1 and patients assigned to intervention 2.
- To compare the RA patient´s quality of life (as measured per WHOQOL-BREF) and RA patient's disability (as measured per HAQ-DI) after 6 months since study entry, between patients assigned to intervention 1 and patients assigned to intervention 2.
Secondary objectives:
- At the end of the complete follow-up period, for each patient, to compare the cumulative RA disease activity during the 6 months period where patients received usual medical care model, with the cumulative disease activity during the 6 months period where patients received hybrid medical care model.
- At the end of the complete follow-up period, for each patient, to compare patient´s satisfaction with usual medical care model and patient´s satisfaction to hybrid medical care model.
- At the end of the complete follow-up period, for each patient, to compare patient´s adherence to the usual medical care model with patient´s adherence to hybrid medical care model.
- Conditions
- Rheumatoid Arthritis, Telehealth
- Being tested
- Face-to-face medical visits, Alternating face-to-face medical visits and video medical consultations
- Keywords
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face medical visitsOther
Face-to-face medical visits
Alternating face-to-face medical visits and video medical consultationsOther
Alternating face-to-face medical visits and video medical consultations
| Study group | Role | What they receive |
|---|---|---|
| Usual Medical Care Model | Active comparator | All the patients will receive face-to-face medical visits Receives: Other: Face-to-face medical visits |
| Hybrid Medical Care Model | Experimental | The patients will receive alternating face-to-face medical visits and video medical consultations Receives: Other: Alternating face-to-face medical visits and video medical consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rheumatoid arthritis patient´s disease activity
The disease activity measured by a RAPID-3 instrument
Measured: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Rheumatoid arthritis patient´s quality of life
Quality of life measured by a WHOQOL-BREF instrument
Measured: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Rheumatoid arthritis patient's disability
Disability measured by a HAQ-DI instrument
Measured: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Secondary outcomes (2)
Satisfaction with medical care
Questionnaire locally developed
Measured: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Patient´s adherence to medical care
Number of missed scheduled visits
Measured: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- This a non-inferiority and cross-over study, with a planned follow-up of 16 months, with 2 intervention arms: Intervention 1: Patients assigned to 6 months of usual medical care model, followed by 4 months of a control period, and finally 6 months of hybrid medical care model. Intervention 2: Patients assigned to 6 months of hybrid medical care model, followed by 4 months of a control period, and finally 6 months of usual medical care model.
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Pascual Ramos, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Investigators
- Virginia Pascual-Ramos, Dr., Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558905
- Sponsor's protocol ID
- IRE-3438 20221
- Status last verified
- Sep 2022
- First submitted
- 10 Sep 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Hybrid Medical Care Model (Face-to-face Medical Visits Alternating With Video Medical Consultations) in the Rheumatoid Arthritis Patient-reported-outcomes Measures: A Non-inferiority Study
- ClinicalTrials.gov ID
- NCT04558905
- Acronym / sponsor ID
- IRE-3438 20221
- Conditions
- Rheumatoid Arthritis, Telehealth
- Keywords
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador ZubiranUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 22 Sep 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.
The COVID-19 outbreak has affected health care of patients with rheumatic diseases; telemedicine might help to assist patients.
The primary objective is to determine if a hybrid medical care model, which consists of alternating face-to-face medical visits and video medical consultations, is not inferior, in terms of the Patient Reported Outcomes measures (PROMs), to the face-to-face medical care model, among rheumatoid arthritis (RA) outpatients. We also aim to investigate if adherence to RA-related treatment (considered a surrogate of patient´s education) might be improved when patients are re-integrated to the health care system, irrespective of the health care model.
In Mexico, COVID-19 pandemic still uncontrolled. Our Institution provides health care to 1500 RA patients/year and up to August 2020, it is estimated that 500 RA patients might be affected, which is our target audience. Reinstalling institutional health care provision is challenging.
This a non-inferiority, cross-over study, with 2 intervention arms. Patients will be randomized to 1. Six months of usual medical care model, followed by 4 months of a control period, and 6 months of hybrid medical care model, or 2. Six months of hybrid medical care model, followed by 4 months of a control period, and 6 months of usual medical care model.
The following PROMs will be assessed at specific time points: disease activity/disease severity (RAPID-3), disability (HAQ-DI), quality of life (WHOQOL-BREF), patient satisfaction with the medical care model (questionnaire locally developed), patient´s adherence to medical care (missed scheduled visits) and patient´s adherence to RA-related treatment (the Compliance-Questionnaire).
Detailed description
This a non-inferiority and cross-over study, with a planned follow-up of 16 months, with 2 intervention arms:
Intervention 1: Patients assigned to 6 months of usual medical care model, followed by 4 months control period, and finally 6 months of hybrid medical care model.
Intervention 2: Patients assigned to 6 months of hybrid medical care model, followed by 4 months control period and finally 6 months of usual medical care model.
Specific objectives are as follows:
Primary objectives
- To compare the mean disease activity of RA patients (as measured per RAPID-3), after 6 months since study entry, between patients assigned to intervention 1 and patients assigned to intervention 2.
- To compare the RA patient´s quality of life (as measured per WHOQOL-BREF) and RA patient's disability (as measured per HAQ-DI) after 6 months since study entry, between patients assigned to intervention 1 and patients assigned to intervention 2.
Secondary objectives:
- At the end of the complete follow-up period, for each patient, to compare the cumulative RA disease activity during the 6 months period where patients received usual medical care model, with the cumulative disease activity during the 6 months period where patients received hybrid medical care model.
- At the end of the complete follow-up period, for each patient, to compare patient´s satisfaction with usual medical care model and patient´s satisfaction to hybrid medical care model.
- At the end of the complete follow-up period, for each patient, to compare patient´s adherence to the usual medical care model with patient´s adherence to hybrid medical care model.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This a non-inferiority and cross-over study, with a planned follow-up of 16 months, with 2 intervention arms: Intervention 1: Patients assigned to 6 months of usual medical care model, followed by 4 months of a control period, and finally 6 months of hybrid medical care model. Intervention 2: Patients assigned to 6 months of hybrid medical care model, followed by 4 months of a control period, and finally 6 months of usual medical care model.
| Arm | Type | Receives |
|---|---|---|
| Usual Medical Care Model | Active comparator | Other: Face-to-face medical visitsAll the patients will receive face-to-face medical visits |
| Hybrid Medical Care Model | Experimental | Other: Alternating face-to-face medical visits and video medical consultationsThe patients will receive alternating face-to-face medical visits and video medical consultations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with RA diagnosis according to their primary rheumatologist
- With at least six months of follow-up (up to March 2020) at the outpatient clinic
- Who agree to participate
Key exclusion criteria (4 listed)
- Patients lost to follow-up from the outpatient clinic before March 2020
- Patients with no access to a mobile device during their study participation
- Patients with severe cognitive, visual and hearing impairment
- Patients on palliative care because of comorbid condition
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 |
|---|---|---|
| Face-to-face medical visitsFace-to-face medical visits | Other | Usual Medical Care Model |
| Alternating face-to-face medical visits and video medical consultationsAlternating face-to-face medical visits and video medical consultations | Other | Hybrid Medical Care Model |
Primary outcome
Rheumatoid arthritis patient´s disease activity
Time frame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
The disease activity measured by a RAPID-3 instrument
Rheumatoid arthritis patient´s quality of life
Time frame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Quality of life measured by a WHOQOL-BREF instrument
Rheumatoid arthritis patient's disability
Time frame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Disability measured by a HAQ-DI instrument
2 secondary outcomes
Satisfaction with medical care
Time frame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Patient´s adherence to medical care
Time frame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
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 28 Sep 2022.
- 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.
Virginia Pascual-Ramos, Dr. principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face medical visits and Alternating face-to-face medical visits and video medical consultations in people with Rheumatoid Arthritis and Telehealth, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
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 3 inclusion and 4 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 28 Sep 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 Mexico. 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?
Rheumatoid arthritis patient´s disease activity (time frame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)). The study lists 3 primary outcomes in all. 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 28 Sep 2022.