NCT04768413

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

November 27, 2020

Last Update Submit

February 22, 2021

Conditions

Keywords

Rheumatoid ArthritisTelemedicineTelehealthCOVID-19Disease ActivityOutcomes research

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the implementation of a non-face-to-face multidisciplinary consultation model in a population of rheumatoid arthritis

    Evaluate the implementation of a non-face-to-face multidisciplinary consultation model in a population with rheumatoid arthritis, highly vulnerable to severe acute respiratory syndrome coronavirus 2 \[coronavirus disease (COVID-19)\] during a health emergency situation and evaluation of the effectiveness of their results.

    up to Week 12

Secondary Outcomes (13)

  • Epidemiological characterization

    up to Week 12

  • Proportion of individuals infected

    up to Week 12

  • Risk factors for infection

    up to Week 12

  • Risk factors for hospitalization

    up to Week 12

  • Risk factors for mortality

    up to Week 12

  • +8 more secondary outcomes

Other Outcomes (2)

  • Description of individual experiences of patients: Qualitative data analysis

    The moment of the interview (week 12)

  • Description of individual experiences of health care professionals: Qualitative data analysis

    The moment of the interview (week 12)

Study Arms (2)

Group A

A group of patients who have voluntarily adhered to the clinic's tele-assisted consultation and who receive remote, multidisciplinary team care without requiring physical displacement.

Other: Teleconsultation either by phone or by computer consultation. Quantitative and qualitative approaches to analysis

Group B

Group of patients who wish to continue with the usual face-to-face consultation, since for these patient's isolation measures allow trips to the care centers and who receive care from a multidisciplinary team on a regular basis.

Other: Care modalities. Quantitative and qualitative approaches to analysis

Interventions

A group of patients who have voluntarily adhered to the clinic's tele-assisted consultation and who receive remote, multidisciplinary team care without requiring physical displacement.

Group A

Group of patients who wish to continue with the usual face-to-face consultation, since for these patient's isolation measures allow trips to the care centers and who receive care from a multidisciplinary team on a regular basis.

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Rheumatoid Arthritis patients regularly followed in a in a specialized rheumatology center in Bogota, Colombia

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BIOMAP IPS Centro de Atención Integral en Artritis Reumatoide

Bogota, Cundinamarca, 250017, Colombia

RECRUITING

Colombia Fundación Universitaria de Ciencias de la Salud-FUCS

Bogota, Cundinamarca, 250017, Colombia

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidCOVID-19

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Adriana Rojas-Villarraga, MD;Rhe

    FUNDACION UNIVERSITARIA DE CIENCIAS DE LA SALUD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Santos Moreno, MD: Rhe

CONTACT

Adriana Rojas -Villarraga, MD; Rhe

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2020

First Posted

February 24, 2021

Study Start

June 1, 2020

Primary Completion

April 30, 2021

Study Completion

June 30, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations