Impact of a Hybrid Medical Care Model in the Rheumatoid Arthritis Patient-reported-outcomes Measures

Study Overview
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Brief Summary
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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).

Detailed Description
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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 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.

Official Title
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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

Conditions
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Rheumatoid Arthritis, Telehealth

Intervention / Treatment
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* Other: Face-to-face medical visits
* Other: Alternating face-to-face medical visits and video medical consultations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Medical Care Model<br>All the patients will receive face-to-face medical visits | Other: Face-to-face medical visits<br>* Face-to-face medical visits<br>|
| Experimental: Hybrid Medical Care Model<br>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<br>* Alternating face-to-face medical visits and video medical consultations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis