Clinical trial NCT04558905: Impact of a Hybrid Medical Care Model in the Rheumatoid Arthritis Patient-reported-outcomes Measures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Telehealth
Keywords: Rheumatoid Arthritis
Lead sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rheumatoid arthritis patient´s disease activity
timeFrame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
measure: Rheumatoid arthritis patient´s quality of life
timeFrame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
measure: Rheumatoid arthritis patient's disability
timeFrame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Secondary outcomes:
measure: Satisfaction with medical care
timeFrame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
measure: Patient´s adherence to medical care
timeFrame: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
state: Tlalpan
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Virginia Pascual-Ramos, Dr.
role: PRINCIPAL_INVESTIGATOR
References: