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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Rheumatoid arthritis patient´s disease activity
Overview
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).
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Satisfaction with medical care(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(During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models))
Investigators
Virginia Pascual Ramos
Rheumatologist
National Institute of Medical Sciences and Nutrition, Salvador Zubiran