Impact of a Hybrid Medical Care Model in the Rheumatoid Arthritis Patient-reported-outcomes Measures: A Non-inferiority Study

Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran (Other)
Overall Status
Recruiting
CT.gov ID
NCT04558905
Collaborator
(none)
156
1
2
19.9
7.8

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Face-to-face medical visits
  • Other: Alternating face-to-face medical visits and video medical consultations
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
156 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model 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 of a 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 of a control period, and finally 6 months of usual medical care model.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 of a 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 of a control period, and finally 6 months of usual medical care model.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Rheumatoid arthritis patient´s disease activity [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

  2. Rheumatoid arthritis patient´s quality of life [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

  3. Rheumatoid arthritis patient's disability [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 Outcome Measures

  1. Satisfaction with medical care [During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)]

    Questionnaire locally developed

  2. 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)]

    Number of missed scheduled visits

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico City Tlalpan Mexico 14080

Sponsors and Collaborators

  • National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Pascual Ramos, Rheumatologist, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT04558905
Other Study ID Numbers:
  • IRE-3438 20221
First Posted:
Sep 22, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Virginia Pascual Ramos, Rheumatologist, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022