10-year Risk Prediction Models of Complications and Mortality of DM in Hong Kong
NCT ID: NCT03299010
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
141516 participants
OBSERVATIONAL
2017-07-01
2019-12-31
Brief Summary
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Objectives:
To develop 10-year risk prediction models for CVD, end stage renal disease (ESRD) and all-cause mortality among Chinese patients with DM in primary care.
Hypotheses:
1. Patient socio-demographic, clinical parameters, disease characteristics and treatment modalities are predictive of 10-year risk of CVD, ESRD and all-cause mortality.
2. Risk prediction models developed from this study should have over 70% of discriminating power.
Design and Subjects:
10-year retrospective cohort study. All Chinese patients who were clinically diagnosed to have DM and were receiving care in the public (Hospital Authority) primary care clinics on or before 1 July 2006 will be followed up until 31 December 2016.
Main outcomes measures:
For total CVD, CHD, stroke, heart failure, ESRD, all-cause mortality
1. 10-year incidence;
2. Predictive factors
Data analysis:
Two thirds of subjects will be randomly selected as the training sample for model development. Cox regressions will be used to develop sex-specific 10-year risk prediction models for each outcome. The validity of models will be tested on the remaining one third of subjects by Harrell C statistics and ROC
Expected results:
Risk prediction models will enable accurate risk stratification and cost-effective interventions for Chinese DM patients in primary care.
Detailed Description
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The objectives are to:
1. Calculate the 10 years incidence of total CVD, all-cause mortality and each major DM complication in Chinese DM patients in primary care.
2. Determine the risk factors that significantly predict total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.
3. Develop and validate risk prediction models for total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.
4. Develop a risk prediction nomogram and chart for the risk of total CVD, all-cause mortality for Chinese DM patients in primary care
Hypotheses:
1. Patient socio-demographic, clinical parameters, disease characteristics, and treatment modalities are predictive of 10-year risk of total CVD, all-cause mortality and individual DM complication as a dependent variable.
2. The risk prediction models for total CVD, all-cause mortality and individual DM complication developed in this study can have over 70% of discriminating power.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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DM patient
Patients with a documented clinical diagnosis of DM and were receiving care in the Hospital Authority (HA) primary care General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) on or before 1 July 2006 identified from the HA clinical management system (CMS) database.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Had a CMS (Clinical Management System) record in the Hospital Authority (HA) of the coding of ICPC-2 of T89 (Diabetes insulin dependent) or T90 (Diabetes non-insulin dependent) on or before 1 July 2006
Exclusion Criteria
2. Patients exclusively managed by Specialist Out-Patient Clinic (SOPC) on or before 1 July 2006.
18 Years
ALL
Yes
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Professor Cindy L.K. Lam
Head of Department
Principal Investigators
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Cindy L.K. Lam
Role: PRINCIPAL_INVESTIGATOR
Department of Family Medicine and Primary Care, University of Hong Kong
Locations
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Department of Family Medicine & Primary Care, University of Hong Kong
Hong Kong, Hong Kong, China
The University of Hong Kong
Hong Kong, , Hong Kong
Countries
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References
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Dong W, Fong DYT, Yoon JS, Wan EYF, Bedford LE, Tang EHM, Lam CLK. Generative adversarial networks for imputing missing data for big data clinical research. BMC Med Res Methodol. 2021 Apr 20;21(1):78. doi: 10.1186/s12874-021-01272-3.
Wan EYF, Yu EYT, Chin WY, Fung CSC, Kwok RLP, Chao DVK, Chan KH, Hui EM, Tsui WWS, Tan KCB, Fong DYT, Lam CLK. Ten-year risk prediction models of complications and mortality of Chinese patients with diabetes mellitus in primary care in Hong Kong: a study protocol. BMJ Open. 2018 Oct 15;8(10):e023070. doi: 10.1136/bmjopen-2018-023070.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Review on continuity of care on health outcomes in patients with DM/HT
Continuity of care and complications in patients with HT
Other Identifiers
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HKUCTR-2232
Identifier Type: -
Identifier Source: org_study_id