NCT05248412 The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of People With Non-communicable Diseases
| NCT ID | NCT05248412 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 250,000 participants |
| Start Date | 2021-06-21 |
| Primary Completion | 2022-06-30 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
Objectives and aim: To evaluate the long-term spill-over (indirect) effect of Coronavirus disease (COVID-19) on health outcomes and healthcare utilization among people with non-communicable diseases and without COVID-19. Design: A population-based cohort study using electronic health records of the Hospital Authority (HA) clinical management system, economic modeling, and serial cross-sectional surveys on healthcare service utilization. Setting: HA public hospitals and outpatient clinics in Hong Kong Participants: People aged ≥ 18 years with a documented diagnosis of diabetes mellitus, hypertension, cardiovascular disease, cancer, chronic respiratory disease, and chronic kidney disease; without COVID-19; attending HA services between 2010 and 2024. Main outcome measures: All-cause mortality, disease-specific outcomes, healthcare service utilization, and costs. Methods: The annual incidence of each outcome in each year between 2010 and 2024 will be calculated. An interrupted time-series analysis to assess the changes in outcomes between pre-and-post-COVID-19 outbreak periods. Long term health economic impact of healthcare disruptions during the COVID-19 outbreak will be modeled using microsimulation. Multivariable Cox proportional hazards regression and Poisson/negative binomial regression to evaluate the effect of different modes of care on the risk of the outcomes. Implications: Findings will inform policies and practices on contingency care plans to avoid excessive morbidity and mortality and to assure the quality of care for patients with NCD as part of the territorial response to the health crisis.
Eligibility Criteria
(For cohort study) Inclusion Criteria: * People aged 18 years or above with a documented doctor-diagnosed NCDs (diabetes mellitus, hypertension, cardiovascular disease, cancer, chronic kidney disease, or chronic respiratory disease ) * People who attended at least once HA hospitals, general or specialist out-patients clinics between 1 January 2010 and 31 December 2024 Exclusion Criteria: \- People with a documented doctor-diagnosed COVID-19 (For cross-sectional study) Inclusion Criteria: * People aged 18 years or above with a documented doctor-diagnosed NCDs (diabetes mellitus, hypertension, cardiovascular disease, cancer, chronic kidney disease, or chronic respiratory disease ) * All participants are able to communicate in either Chinese or English and provide informed consent. Exclusion Criteria: * People with a documented diagnosis of COVID-19 during the study period.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.