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

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

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).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Telehealth
• Intervention / Treatment: Other: Face-to-face medical visits; Other: Alternating face-to-face medical visits and video medical consultations

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

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Tlalpan
    • Mexico City, Tlalpan, Mexico, 14080
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: IRE-3438 20221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No