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NCT Number: NCT04558905

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

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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Telehealth

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Tlalpan, 14080, Mexico

About this study

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

  • 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.
  • 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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Face-to-face medical visits

Other

Face-to-face medical visits

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

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2020
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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