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

NCT03299010 | Completed

• 1 other identifier: HKUCTR-2232
• Study Type: observational
• Target: 141,516
• Locations: 2 countries
• Sites: 2

Brief Summary

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. 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. 2.Risk prediction models developed from this study should have over 70% of discriminating power.
3. 3.10-year incidence;
4. 4.Predictive factors

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Mortality; Primary Health Care

Keywords

Diabetes Mellitus; Risk; Complications; Mortality; Cardiovascular Diseases; Chinese; Prediction

Outcome Measures

Primary Outcomes (4)

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

  10 years

• Factors predictive of total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD) over 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 years

• 10-year risk prediction models for total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD)

  Develop and validate risk prediction models for total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.

  10 years

• 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

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

  10 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The cohort will include all 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

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

Hong Kong, Hong Kong, China

Location

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (2)

• 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.

  PMID: 33879090 DERIVED

• 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.

  PMID: 30327405 DERIVED

Related Links

• Review on continuity of care on health outcomes in patients with DM/HT
• Continuity of care and complications in patients with HT

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Cindy L.K. Lam

  Department of Family Medicine and Primary Care, University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 2, 2017
• Study Start: July 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1); HK (1)