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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558905
• Other study ID #: IRE-3438 20221
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: September 2022
• Source: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

1. 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.

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:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: May 31, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Telehealth

Intervention

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

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)