NCT04558905

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

Completed NA Last updated 28 September 2022

What this trial tests

NA trial testing Face-to-face medical visits in Rheumatoid Arthritis in 156 participants. Completed in 31 May 2022.

Timeline

1 October 2020

Primary endpoint
1 April 2022

31 May 2022

Quick facts

Lead sponsor	National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	health services research
Enrollment	156
Start date	1 October 2020
Primary completion	1 April 2022
Estimated completion	31 May 2022
Sites	1 location across Mexico

Drugs / interventions tested

• Face-to-face medical visits
• Alternating face-to-face medical visits and video medical consultations

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
• Telehealth — all drugs for Telehealth →

Sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Who can join

18 and older, any sex, with Rheumatoid Arthritis or Telehealth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. [Telemedical care and IT-based systems in rheumatology].
   McCutchan R, Bosch P. · · 2021 · PMID 34618209 · DOI 10.1007/s00393-021-01098-w