Diabetes MellitusNCT05248412
The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of People With Non-communicable Diseases
An observational study of Diabetes Mellitus and Hypertension, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Hypertension, Cancer
- What is being tested?
- COVID-19 outbreaks
- How many people
- 250,000 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2021to 30 Jun 2026
- 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: * People aged 18 years or above with 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 during the study period.
Who may be able to join
- 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
- 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.
Who cannot join
- People with a documented doctor-diagnosed COVID-19
- (For cross-sectional study)
- People with a documented diagnosis of COVID-19 during the study period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Family Medicine & Primary Care, LKS Faculty of Medicine, University of Hong Kong
Hong Kong, Hong Kong
Cindy L.K. Lam, MD, +852-25185653, clklam@hku.hk
Cindy L.K. Lam, MD
About this study
Official title: The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of Patients With Non-communicable Diseases (and Without COVID-19) : an In-depth Outcome and Health Economic Evaluation
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.
Read more
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.
Read the detailed description
This study aims to evaluate the spill-over impact of the COVID-19 outbreak on health outcomes, healthcare utilization, and costs in patients with major non-communicable diseases (NCDs). The study will include six leading NCDs (diabetes mellitus, hypertension, cardiovascular diseases (CVD), cancer, chronic kidney diseases (CKD), chronic respiratory diseases) representing the most prevalent conditions and the major causes of deaths in Hong Kong. The objectives of the study are the following:
- To determine changes in all-cause mortality, disease-specific outcomes, and healthcare utilization rates and costs among major NCD patients during the pre-and post- COVID-19 outbreak.
- To assess the long-term health economic impact of COVID-19 on health outcomes and healthcare utilization rates and costs among major NCD patients by conducting an in-depth economic evaluation
- To explore the impact of different modes of care on all-cause mortality, disease-specific outcomes, and healthcare utilization rates and costs among major NCD patients during the post-COVID-19 period.
This study consists of two study designs.
- It is a retrospective cohort study using data extracted from the electronic medical records of the Hong Kong Hospital Authority (HA) Clinical Management System (CMS) from 1 January 2010 to 31 December 2024.
- Anonymous data including socio-demographics, disease-specific parameters identified by International Classification of Primary Care, 2nd edition (ICPC-2) and the International Classification of Diseases, 9th revision, Clinical Modification (ICD-9-CM) will be extracted by the Hospital Authority statistics. There will be two phases of data extraction for the data collected in the periods 2010-2021 and 2022-2024.
- The investigators will carry out two serial cross-sectional surveys on self-reported healthcare service utilization in the second and fourth years after the COVID-19 outbreak.
- Two surveys will be conducted for patients with the major NCD recruited from outpatient clinics to collect data on healthcare service utilization patterns and rates in the years of 2020 and 2022 using a structured questionnaire.
- Conditions
- Diabetes Mellitus, Hypertension, Cancer, Cardiovascular Diseases, Chronic Respiratory Disease, Kidney Disease, Chronic
- Being tested
- COVID-19 outbreaks
- Keywords
- COVID-19 Pandemic, Morality, Complication, Utilization, Health Care, Noncommunicable Diseases
- Medical subject headings
- Diabetes Mellitus, Hypertension, Neoplasms, Cardiovascular Diseases, Renal Insufficiency, Chronic, Noncommunicable Diseases, COVID-19, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 outbreaksOther
The intervention of the study is the COVID-19 outbreaks in Hong Kong. The pre-and post-COVID-19 outbreak periods will be defined as 1 January 2010 - 31 December 2019 and 1 January 2020 - 31 December 2024, respectively.
What is being measured
The primary outcome is the main question the study is designed to answer.
Health outcomes
Incidence of all-cause mortality, and disease-specific complications (cardiovascular disease, end-stage renal disease, retinopathy, neuropathy and all-cause mortality) The disease are defined by the diagnosis codes International Classification of Primary Care, Second edition or International Classification of Diseases,Ninth Revision, Clinical Modification.
Measured: 5 years
Secondary outcomes (1)
Healthcare service utilization
Utilization rates and costs for public and private healthcare services including hospitalization (episodes, modes of admission and length of stay), specialist and general outpatient consultations (number of visits, modes of consultations, western/Chinese medicine), and Accident \& Emergency Department (AED) attendances (triage urgency level for AED attendances at public hospital).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start21 Jun 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 250,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Cindy L.K. Lam, The University of Hong Kong
- Investigators
- Cindy L.K. Lam, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248412
- Sponsor's protocol ID
- UW21-297
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of Patients With Non-communicable Diseases (and Without COVID-19) : an In-depth Outcome and Health Economic Evaluation
- ClinicalTrials.gov ID
- NCT05248412
- Acronym / sponsor ID
- UW21-297
- Conditions
- Diabetes Mellitus, Hypertension, Cancer, Cardiovascular Diseases, Chronic Respiratory Disease, Kidney Disease, Chronic
- Keywords
- COVID-19 Pandemic, Morality, Complication, Utilization, Health Care, Noncommunicable Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250,000 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 Feb 2022 (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.
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.
Detailed description
This study aims to evaluate the spill-over impact of the COVID-19 outbreak on health outcomes, healthcare utilization, and costs in patients with major non-communicable diseases (NCDs). The study will include six leading NCDs (diabetes mellitus, hypertension, cardiovascular diseases (CVD), cancer, chronic kidney diseases (CKD), chronic respiratory diseases) representing the most prevalent conditions and the major causes of deaths in Hong Kong. The objectives of the study are the following:
- To determine changes in all-cause mortality, disease-specific outcomes, and healthcare utilization rates and costs among major NCD patients during the pre-and post- COVID-19 outbreak.
- To assess the long-term health economic impact of COVID-19 on health outcomes and healthcare utilization rates and costs among major NCD patients by conducting an in-depth economic evaluation
- To explore the impact of different modes of care on all-cause mortality, disease-specific outcomes, and healthcare utilization rates and costs among major NCD patients during the post-COVID-19 period.
This study consists of two study designs.
- It is a retrospective cohort study using data extracted from the electronic medical records of the Hong Kong Hospital Authority (HA) Clinical Management System (CMS) from 1 January 2010 to 31 December 2024.
- Anonymous data including socio-demographics, disease-specific parameters identified by International Classification of Primary Care, 2nd edition (ICPC-2) and the International Classification of Diseases, 9th revision, Clinical Modification (ICD-9-CM) will be extracted by the Hospital Authority statistics. There will be two phases of data extraction for the data collected in the periods 2010-2021 and 2022-2024.
- The investigators will carry out two serial cross-sectional surveys on self-reported healthcare service utilization in the second and fourth years after the COVID-19 outbreak.
- Two surveys will be conducted for patients with the major NCD recruited from outpatient clinics to collect data on healthcare service utilization patterns and rates in the years of 2020 and 2022 using a structured questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * People aged 18 years or above with 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 during the study period.
Key inclusion criteria (4 listed)
- 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
- 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.
Key exclusion criteria (3 listed)
- People with a documented doctor-diagnosed COVID-19
- (For cross-sectional study)
- People with a documented diagnosis of COVID-19 during the study period.
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 |
|---|---|---|
| COVID-19 outbreaksThe intervention of the study is the COVID-19 outbreaks in Hong Kong. The pre-and post-COVID-19 outbreak periods will be defined as 1 January 2010 - 31 December 2019 and 1 January 2020 - 31 December 2024, respectively. | Other | – |
Primary outcome
Health outcomes
Time frame: 5 years
Incidence of all-cause mortality, and disease-specific complications (cardiovascular disease, end-stage renal disease, retinopathy, neuropathy and all-cause mortality) The disease are defined by the diagnosis codes International Classification of Primary Care, Second edition or International Classification of Diseases,Ninth Revision, Clinical Modification.
1 secondary outcome
Healthcare service utilization
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Cindy L.K. Lam, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Hypertension, run by The University of Hong Kong at 1 site in China.
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 4 inclusion and 3 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 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Cindy L.K. Lam, MD (+852-25185653, clklam@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health outcomes (time frame: 5 years). 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 8 Mar 2022.