Rheumatoid ArthritisNCT04768413
Evaluation of a Non-face to Face Multidisciplinary Health Care Model in a Population With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Fundación Universitaria de Ciencias de la Salud at 2 sites in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Teleconsultation either by phone or by computer consultation. Quantitative and qualitative approaches to analysis and Care modalities. Quantitative and qualitative approaches to analysis
- How many people
- 200 participants
- Where
- 2 sitesColombia
- Study dates
- 1 Jun 2020to 30 Jun 2021
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatoid Arthritis patients regularly followed in a in a specialized rheumatology center in Bogota, Colombia
Who may be able to join
- 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.
Who cannot join
- Patients who due to their cognitive conditions do not have the ability to provide reliable information necessary for the development of the study.
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites, 2 recruiting
- Recruiting
BIOMAP IPS Centro de Atención Integral en Artritis Reumatoide
Bogota, Cundinamarca, 250017
PEDRO SANTOS - MORENO, MD;Rhe, +573208094232, pedrivansamo@hotmail.com
ADRIANA ROJAS-VILLARRAGA, MD;Rhe, +573187117073, sarojas@fucsalud.edu.co
- Recruiting
Colombia Fundación Universitaria de Ciencias de la Salud-FUCS
Bogota, Cundinamarca, 250017
ADRIANA ROJAS-VILLARRAGA, MD;Rhe, +573187117073, sarojas@fucsalud.edu.co
About this study
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
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)
Read the 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
- Conditions
- Rheumatoid Arthritis
- Being tested
- Teleconsultation either by phone or by computer consultation. Quantitative and qualitative approaches to analysis, Care modalities. Quantitative and qualitative approaches to analysis
- Keywords
- Rheumatoid Arthritis, Telemedicine, Telehealth, COVID-19, Disease Activity, Outcomes research
- Medical subject headings
- Arthritis, Rheumatoid, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teleconsultation either by phone or by computer consultation. Quantitative and qualitative approaches to analysisOther
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.
Care modalities. Quantitative and qualitative approaches to analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Care modalities. Quantitative and qualitative approaches to analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to Week 12
Secondary outcomes (13)
Epidemiological characterization
Epidemiological characterization of the population evaluated under the multidisciplinary health care model, both in teleconsultation and face-to-face consultation.
Measured: up to Week 12
Proportion of individuals infected
To determine the proportion of individuals infected with severe acute respiratory syndrome coronavirus 2 [coronavirus disease (COVID-19)] in those patients who regularly receive different immunosuppressive medications under the two care models (teleconsultation and face-to-face).
Measured: up to Week 12
Risk factors for infection
Describe the risk factors for severe acute respiratory syndrome coronavirus 2 [coronavirus disease (COVID-19)] infection in the group of patients linked to the teleconsultation model and in those with regular face-to-face care.
Measured: up to Week 12
Risk factors for hospitalization
Describe the risk factors for hospitalization associated with severe acute respiratory syndrome coronavirus 2 [coronavirus disease (COVID-19)] in the group of patients linked to the teleconsultation model and in those with regular face-to-face care.
Measured: up to Week 12
Risk factors for mortality
Describe the risk factors for mortality associated with severe acute respiratory syndrome coronavirus 2 [coronavirus disease (COVID-19)] in the group of patients linked to the teleconsultation model and in those with regular face-to-face care.
Measured: up to Week 12
Average change from baseline in Disease Activity Score with 28-joint counts [DAS28] in face-to-face consultation group
A single score on a continuous scale (0-9.4). The level of disease activity will be interpreted as remission (DAS28 <2.6), low (2.6 ≤ DAS28 < 3.2), moderate (3.2 ≤DAS28≤ 5.1), or high (DAS28 >5.1).
Measured: up to Week 12
Average change from baseline in Patient Activity Scale scores in both groups tele-assisted consultation and face-to-face consultation
The Patient Activity Scale is calculated by multiplying the Health Assessment Questionnaire (HAQ) by 3.33 and then dividing the sum of the visual analogue scale (VAS) pain, Patient global assessment (PtGA), and Health Assessment Questionnaire (HAQ) by 3. Activity will be interpreted as these categories of disease activity: remission ≤0.25, low ≤3.7, moderate <8.0, and high ≥8.0.
Measured: up to Week 12
Evaluation of participant's pain using visual analogue scale [VAS] in both groups tele-assisted consultation and face-to-face consultation
Paint measurement for any disease state 0-10 centimeters VAS by the patient
Measured: Baseline, Week 6 and 12
Evaluation of the disease activity by Doctor using visual analogue scale [VAS] in both groups tele-assisted consultation and face-to-face consultation
Activity measurement for any disease state 0-10 centimeters VAS by the Doctor
Measured: Baseline, Week 6 and 12
Absolute and percent change in the Health Assessment Questionnaire (HAQ) in both groups tele-assisted consultation and face-to-face consultation
The questionary includes 20 daily life questions, grouped in 8 areas, each one containing two or three questions related to daily life activities. Each question is scored from 0-3. 0 means no disability, 3 score means completely disabled. The average of all responses is done. Average scores from 0-1 represent "mild to moderate difficulty", 1-2 means "moderate to severe disability", 3-2 indicates "severe to very severe disability".
Measured: Baseline, Week 6 and 12
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
European Quality of Life 5 Dimensions (EQ-5D) questionnaire is a self-reported health outcome which measures Quality of life (QoL) in five dimensions. An overall score is derived that measures from the least (worst) to the highest score (best). In addition, health state is measured on the vertical Visual Analogue scale (score 0 to 100) with higher scores (better health status).
Measured: up to Week 12
Evaluation of the level of therapeutic adherence using a specific Scale in both groups tele-assisted consultation and face-to-face consultation
The four item MORISKY-GREEN-LEVINE Medication Adherence Scale (MGLS) results in a score ranging from 0 to 4. There are three levels of medication adherence based on this score: high, medium and low adherence with 0, 1-2, and 3-4 points, respectively. A dichotomous definition of adherence based on MGLS will be used with 0 points indicating perfect adherence and 1+ points indicating some level of non-adherence.
Measured: Baseline and week 12.
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
The Appraisal of Self-care Agency Scale -Revised (ASA-R; Sousa et al.) is one of the main instruments to assess self-care capacity. It consists of a total of 15 questions in 3 areas, of which the area lacking self-care agency is reversely coded. Based on a 5-point Likert scale, a higher total score signified a higher level of self-care agency.
Measured: Baseline and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Jun 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria de Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Biomab I.P.S. Centro de Atencion Integral en Artritis Reumatoide
- Responsible party
- Sponsor
- Investigators
- Adriana Rojas-Villarraga, MD;Rhe, Principal investigator, FUNDACION UNIVERSITARIA DE CIENCIAS DE LA SALUD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768413
- Sponsor's protocol ID
- 5171
- Status last verified
- Feb 2021
- First submitted
- 27 Nov 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04768413
- Acronym / sponsor ID
- 5171
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Telemedicine, Telehealth, COVID-19, Disease Activity, Outcomes research
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundación Universitaria de Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Biomab I.P.S. Centro de Atencion Integral en Artritis Reumatoide
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Teleconsultation either by phone or by computer consultation. Quantitative and qualitative approaches to analysisA 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 B | – | Other: Care modalities. Quantitative and qualitative approaches to analysisGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid Arthritis patients regularly followed in a in a specialized rheumatology center in Bogota, Colombia
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who due to their cognitive conditions do not have the ability to provide reliable information necessary for the development of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teleconsultation either by phone or by computer consultation. Quantitative and qualitative approaches to analysisA 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 | Group A |
| Care modalities. Quantitative and qualitative approaches to analysisGroup 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 | Group B |
Primary outcome
Evaluation of the implementation of a non-face-to-face multidisciplinary consultation model in a population of rheumatoid arthritis
Time frame: up to Week 12
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.
13 secondary outcomes
Epidemiological characterization
Time frame: up to Week 12
Proportion of individuals infected
Time frame: up to Week 12
Risk factors for infection
Time frame: up to Week 12
Risk factors for hospitalization
Time frame: up to Week 12
Risk factors for mortality
Time frame: up to Week 12
Average change from baseline in Disease Activity Score with 28-joint counts [DAS28] in face-to-face consultation group
Time frame: up to Week 12
Average change from baseline in Patient Activity Scale scores in both groups tele-assisted consultation and face-to-face consultation
Time frame: up to Week 12
Evaluation of participant's pain using visual analogue scale [VAS] in both groups tele-assisted consultation and face-to-face consultation
Time frame: Baseline, Week 6 and 12
Evaluation of the disease activity by Doctor using visual analogue scale [VAS] in both groups tele-assisted consultation and face-to-face consultation
Time frame: Baseline, Week 6 and 12
Absolute and percent change in the Health Assessment Questionnaire (HAQ) in both groups tele-assisted consultation and face-to-face consultation
Time frame: Baseline, Week 6 and 12
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
Time frame: up to Week 12
Evaluation of the level of therapeutic adherence using a specific Scale in both groups tele-assisted consultation and face-to-face consultation
Time frame: Baseline and week 12.
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
Time frame: Baseline and week 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Rojas-Villarraga, MD;Rhe principal investigator
FUNDACION UNIVERSITARIA DE CIENCIAS DE LA SALUD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Fundación Universitaria de Ciencias de la Salud at 2 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Santos Moreno, MD: Rhe (+573208094232, pedrivansamo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the implementation of a non-face-to-face multidisciplinary consultation model in a population of rheumatoid arthritis (time frame: up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.