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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).
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
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Medical Care Model | Active Comparator | All the patients will receive face-to-face medical visits |
|
| Hybrid Medical Care Model | Experimental | The patients will receive alternating face-to-face medical visits and video medical consultations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Face-to-face medical visits | Other | Face-to-face medical visits |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rheumatoid arthritis patient´s disease activity | The disease activity measured by a RAPID-3 instrument | 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 | 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 | During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models) |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with medical care | Questionnaire locally developed | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Pascual-Ramos, Dr. | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | Mexico City | Tlalpan | 14080 | Mexico |
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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.
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| Alternating face-to-face medical visits and video medical consultations |
| Other |
Alternating face-to-face medical visits and video medical consultations |
|
Number of missed scheduled visits
| During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models) |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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