NCT05248412

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250,000

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jun 2021Jun 2026

Study Start

First participant enrolled

June 21, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

February 17, 2022

Last Update Submit

February 20, 2022

Conditions

Keywords

COVID-19 PandemicMoralityComplicationUtilization, Health CareNoncommunicable Diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years

Secondary Outcomes (1)

  • Healthcare service utilization

    5 years

Other Outcomes (1)

  • Burden of diseases due to indirect effect of COVID-19

    5 years

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • \- People with a documented doctor-diagnosed COVID-19
  • (For cross-sectional study)
  • 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.
  • People with a documented diagnosis of COVID-19 during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Family Medicine & Primary Care, LKS Faculty of Medicine, University of Hong Kong

Hong Kong, Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusHypertensionNeoplasmsCardiovascular DiseasesRenal Insufficiency, ChronicNoncommunicable DiseasesCOVID-19Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Cindy L.K. Lam, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cindy L.K. Lam, MD

CONTACT

Eric Y.F Wan, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Chairperson of Department of Family Medicine & Primary Care

Study Record Dates

First Submitted

February 17, 2022

First Posted

February 21, 2022

Study Start

June 21, 2021

Primary Completion

June 30, 2022

Study Completion (Estimated)

June 30, 2026

Last Updated

March 8, 2022

Record last verified: 2022-02

Locations