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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250,000 participants in total. It began in 2021-06-21 with a primary completion date of 2022-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Cindy L.K. Lam, MD
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT05248412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05248412 currently recruiting?
Yes, NCT05248412 is actively recruiting participants. Contact the research team at clklam@hku.hk for enrollment information.
Where is the NCT05248412 trial being conducted?
This trial is being conducted at Hong Kong, China.
Who is sponsoring the NCT05248412 clinical trial?
NCT05248412 is sponsored by The University of Hong Kong. The principal investigator is Cindy L.K. Lam, MD at The University of Hong Kong. The trial plans to enroll 250,000 participants.
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