Completed

NCT Number: NCT03299010

10-year Risk Prediction Models of Complications and Mortality of DM in Hong Kong

Diabetes Mellitus (DM) is a well-recognized public health issue worldwide. DM can lead to many complications resulting in morbidity and mortality, approximately 70% of DM related deaths were attributed to cardiovascular diseases (CVD).

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.

Completed

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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mortality Nutritional and Metabolic Diseases Primary Health Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Family Medicine & Primary Care, University of Hong Kong, Hong Kong, China

About this study

This study aims to develop 10-year risk prediction models for total CVD and all-cause mortality among Chinese diabetic patients in primary care. Risk prediction models for individual DM complications including CHD, heart failure, stroke and ESRD will also be developed.

The objectives are to:

Calculate the 10 years incidence of total CVD, all-cause mortality and each major DM complication in Chinese DM patients in primary care.
Determine the risk factors that significantly predict total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.
Develop and validate risk prediction models for total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.
Develop a risk prediction nomogram and chart for the risk of total CVD, all-cause mortality for Chinese DM patients in primary care

Hypotheses:

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.
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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

At least 1 GOPC/FMC attendance on or within 1 year before 1 July 2006
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

Patients who had a diagnosis of any DM complications defined by the relevant ICPC-2 or ICD-9-CM on or before 1 July 2006
Patients exclusively managed by Specialist Out-Patient Clinic (SOPC) on or before 1 July 2006.

Treatment and study plan

Primary outcomes

The incidence of total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD) over 10 years

Time frame: 10 years

Calculate the 10 years incidence of total CVD, all-cause mortality and each major DM complication in Chinese DM patients in primary care.

CVD is defined as the presence of any of CHD, heart failure and stroke. CHD includes all ischaemic heart disease, myocardial infarction, coronary death or sudden death as indicated by the ICPC-2 K74 to K76 or ICD-9-CM 410.x, 411.x to 414.x, 798.x codes. Heart failure is defined by the ICPC-2 K77 or ICD-9-CM 428.x. Stoke (fatal and non-fatal stroke) is defined by the ICPC-2 K89 to K91 or ICD-9-CM 430.x to 438.x codes.
Factors predictive of total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD) over 10 years

Time frame: 10 years

Determine the risk factors that significantly predict total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.
10-year risk prediction models for total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD)

Time frame: 10 years

Develop and validate risk prediction models for total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.
Factors that have sufficient power to classify Chinese DM patients in primary care into risk group in terms of total CVD and all-cause mortality

Time frame: 10 years

Develop a risk prediction nomogram and chart for the risk of total CVD, all-cause mortality for Chinese DM patients in primary care

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

10-year Risk Prediction Models of Complications and Mortality of Diabetes Mellitus in Chinese Patients in Primary Care in Hong Kong

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Oct 2, 2017
Registry last updated: Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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