Impact of a Hybrid Medical Care Model in the Rheumatoid Arthritis Patient-reported-outcomes Measures: A Non-inferiority Study
Study Details
Study Description
Brief 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 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).
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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
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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.
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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:
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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.
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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.
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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
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Usual Medical Care Model All the patients will receive face-to-face medical visits |
Other: Face-to-face medical visits
Face-to-face medical visits
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Experimental: Hybrid Medical Care Model The patients will receive alternating face-to-face medical visits and video medical consultations |
Other: Alternating face-to-face medical visits and video medical consultations
Alternating face-to-face medical visits and video medical consultations
|
Outcome Measures
Primary Outcome Measures
- Rheumatoid arthritis patient´s disease activity [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 [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 [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
Secondary Outcome Measures
- Satisfaction with medical care [During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)]
Questionnaire locally developed
- Patient´s adherence to medical care [During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)]
Number of missed scheduled visits
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with RA diagnosis according to their primary rheumatologist
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With at least six months of follow-up (up to March 2020) at the outpatient clinic
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Who agree to participate
Exclusion Criteria:
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Patients lost to follow-up from the outpatient clinic before March 2020
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Patients with no access to a mobile device during their study participation
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Patients with severe cognitive, visual and hearing impairment
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Patients on palliative care because of comorbid condition
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | Mexico City | Tlalpan | Mexico | 14080 |
Sponsors and Collaborators
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRE-3438 20221