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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Evaluation of the implementation of a non-face-to-face multidisciplinary consultation model in a population of rheumatoid arthritis
研究概览
简要总结
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)
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who due to their cognitive conditions do not have the ability to provide reliable information necessary for the development of the study.
结局指标
主要结局
Evaluation of the implementation of a non-face-to-face multidisciplinary consultation model in a population of rheumatoid arthritis
时间窗: 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.
次要结局
- 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)
- Average change from baseline in Disease Activity Score with 28-joint counts [DAS28] in face-to-face consultation group(up to Week 12)
- Average change from baseline in Patient Activity Scale scores in both groups tele-assisted consultation and face-to-face consultation(up to Week 12)
- Absolute and percent change in the Health Assessment Questionnaire (HAQ) in both groups tele-assisted consultation and face-to-face consultation(Baseline, Week 6 and 12)
- Evaluation of the level of therapeutic adherence using a specific Scale in both groups tele-assisted consultation and face-to-face consultation(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(Baseline and week 12.)
- Evaluation of participant's pain using visual analogue scale [VAS] in both groups tele-assisted consultation and face-to-face consultation(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(up to Week 12)
- Evaluation of the disease activity by Doctor using visual analogue scale [VAS] in both groups tele-assisted consultation and face-to-face consultation(Baseline, Week 6 and 12)