Clinical trial NCT04768413: Evaluation of a Non-face to Face Multidisciplinary Health Care Model in a Population With Rheumatoid Arthritis
Official title: Evaluation of a Non-face to Face Multidisciplinary Health Care Model in a Population With Rheumatoid Arthritis Highly Vulnerable to the 2019 Novel Coronavirus Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Telemedicine
Telehealth
COVID-19
Disease Activity
Outcomes research
Lead sponsor: Fundación Universitaria de Ciencias de la Salud
Sponsor class: OTHER
Collaborators: name: Biomab I.P.S. Centro de Atencion Integral en Artritis Reumatoide
First posted: 2021-02-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatoid Arthritis patients regularly followed in a in a specialized rheumatology center in Bogota, Colombia

Brief summary: This research work proposes the evaluation of the implementation of a tele-orientation program and tele-consultation to the adult population with RA attended at a specialized rheumatology center in Bogota, Colombia, over a period of three months, by means of a observational, analytical, cohort, prospective study that will include mixed methods for collecting information (quantitative and qualitative)

Detailed description: The evaluation of the priority implementation of a non-face-to-face multidisciplinary health care model is justified in a population highly vulnerable to COVID 19, with Rheumatoid arthritis (RA) in a health emergency situation and in turn seeking to promote its well-being, taking into account the importance of interdisciplinary follow-up to strengthen self-care, avoid deterioration, hospital admissions and improve therapeutic adherence. This research work proposes the evaluation of the implementation of a tele-orientation program and tele-consultation to the adult population with RA attended at a specialized rheumatology center in Bogota, Colombia, over a period of three months, by means of a observational, analytical, cohort, prospective study that will include mixed methods for collecting information (quantitative and qualitative). The qualitative methods will include interviews with a subgroup of patients attending by the two models and with the professionals who care for them, with the aim of knowing the experiences and perceptions of both the patients and the professionals.

The impact that the project seeks is focused on evaluating the program's contribution to the control of RA symptoms and inflammation, avoiding progressive structural damage.

On the other hand, elements will be provided to advance towards telehealth educational interventions and their effect in improving the therapeutic adherence of patients with RA, as well as avoiding their displacement, maintaining quarantine measures and stimulating necessary self-care measures in search of mitigate the COVID-19 pandemic and counteract the spread of the severe acute respiratory syndrome coronavirus 2, particularly in this susceptible risk group.

Finally, this study will provide information on the characteristics of RA patients who choose telemedicine compared to face-to-face care when both are offered as usual care options during an unprecedented situation such as the COVID-19 pandemic. For this reason, the possibility of replication at the national level from the planning of telemedicine programs in rheumatology will be essential for contributing to the reduction of epidemiological indicators against contagion by coronavirus and the use of hospital service

Eligibility criteria: Inclusion Criteria:

* Quantitative and qualitative approach. Patients over 18 years of age with confirmed diagnosis of rheumatoid arthritis International Classification of Diseases: M069, M059, M060, treated at a reference center for these pathologies in the city of Bogotá.
* Quantitative approach Patients with access to information and communication technologies
* Qualitative approach: Patients seen in the teleconsultation modality on at least two occasions.
* Qualitative approach: Patients attended in the face-to-face consultation modality on at least two occasions.
* Qualitative approach: Health professionals who have carried out at least 25 teleconsultations directed at patients with rheumatoid arthritis in a reference center for these pathologies in the city of Bogotá.

Exclusion Criteria:

* Patients who due to their cognitive conditions do not have the ability to provide reliable information necessary for the development of the study.

Primary outcomes:
measure: Evaluation of the implementation of a non-face-to-face multidisciplinary consultation model in a population of rheumatoid arthritis
timeFrame: up to Week 12
Secondary outcomes:
measure: Epidemiological characterization
timeFrame: up to Week 12
measure: Proportion of individuals infected
timeFrame: up to Week 12
measure: Risk factors for infection
timeFrame: up to Week 12
measure: Risk factors for hospitalization
timeFrame: up to Week 12
measure: Risk factors for mortality
timeFrame: up to Week 12
measure: Average change from baseline in Disease Activity Score with 28-joint counts [DAS28] in face-to-face consultation group
timeFrame: up to Week 12
measure: Average change from baseline in Patient Activity Scale scores in both groups tele-assisted consultation and face-to-face consultation
timeFrame: up to Week 12
measure: Evaluation of participant's pain using visual analogue scale [VAS] in both groups tele-assisted consultation and face-to-face consultation
timeFrame: Baseline, Week 6 and 12
measure: Evaluation of the disease activity by Doctor using visual analogue scale [VAS] in both groups tele-assisted consultation and face-to-face consultation
timeFrame: Baseline, Week 6 and 12
measure: Absolute and percent change in the Health Assessment Questionnaire (HAQ) in both groups tele-assisted consultation and face-to-face consultation
timeFrame: Baseline, Week 6 and 12
measure: Average change from baseline in European Quality of Life 5 Dimensions (EQ-5D) questionnaire in both groups tele-assisted consultation and face-to-face consultation
timeFrame: up to Week 12
measure: Evaluation of the level of therapeutic adherence using a specific Scale in both groups tele-assisted consultation and face-to-face consultation
timeFrame: Baseline and week 12.
measure: Evaluation of the self-care capacity using the Appraisal of Self-care Agency Scale -Revised (ASA-R) in both groups tele-assisted consultation and face-to-face consultation
timeFrame: Baseline and week 12.
Other outcomes:
measure: Description of individual experiences of patients: Qualitative data analysis
timeFrame: The moment of the interview (week 12)
measure: Description of individual experiences of health care professionals: Qualitative data analysis
timeFrame: The moment of the interview (week 12)
Locations:
city: Bogota
country: Colombia
facility: BIOMAP IPS Centro de Atención Integral en Artritis Reumatoide
state: Cundinamarca
city: Bogota
country: Colombia
facility: Colombia Fundación Universitaria de Ciencias de la Salud-FUCS
state: Cundinamarca
Study officials:
affiliation: FUNDACION UNIVERSITARIA DE CIENCIAS DE LA SALUD
name: Adriana Rojas-Villarraga, MD;Rhe
role: PRINCIPAL_INVESTIGATOR
References: