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

NCT04558905 | Completed

• 1 other identifier: IRE-3438 20221
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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).

Conditions

Rheumatoid Arthritis; Telehealth

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Satisfaction with medical care

  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

  During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)

Study Arms (2)

Usual Medical Care Model

ACTIVE COMPARATOR

All the patients will receive face-to-face medical visits

Other: Face-to-face medical visits

Hybrid Medical Care Model

EXPERIMENTAL

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

Interventions

Face-to-face medical visits OTHER

Face-to-face medical visits

Usual Medical Care Model

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

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

Hybrid Medical Care Model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Tlalpan, 14080, Mexico

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Virginia Pascual-Ramos, Dr.

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rheumatologist

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 22, 2020
• Study Start: October 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: May 31, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)