An interventional study of Face-to-face medical visits and Alternating face-to-face medical visits and video medical consultations in Rheumatoid Arthritis and Telehealth, sponsored by National Institute of Medical Sciences and Nutrition, Salvador Zubiran. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by National Institute of Medical Sciences and Nutrition, Salvador Zubiran · Not applicable, Interventional, and Health services research
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:
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 156 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →National Institute of Medical Sciences and Nutrition, Salvador Zubiran is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
All the patients will receive face-to-face medical visits
Other: Face-to-face medical visits
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
Face-to-face medical visits
Alternating face-to-face medical visits and video medical consultations
Rheumatoid arthritis patient´s disease activity
The disease activity measured by a RAPID-3 instrument
Time frame: 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
Time frame: 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
Time frame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Satisfaction with medical care
Questionnaire locally developed
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
Number of missed scheduled visits
Time frame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2020 to primary completion in Apr 2022, 18 months.
Of 292 non-industry interventional studies with no phase under Arthritis, Rheumatoid, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's 18 months is below that.
Counting every sponsor, half of 348 studies reached it within 27 months; a quarter within 13 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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National Institute of Medical Sciences and Nutrition, Salvador Zubiran