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

September 26, 2022 updated by: Virginia Pascual Ramos, National Institute of Medical Sciences and Nutrition, Salvador Zubiran

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rheumatoid arthritis patient´s disease activity
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfaction with medical care
Time Frame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
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
Time Frame: 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
During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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