NCT07050407

Brief Summary

This is a prospective cohort study examining the effects of prolonged clinic visit on patient's cardiovascular (CV) risk factors control and whether it will increase the risk of adverse clinical events. This study leveraged the clinic visit deferment arrangement implemented during the COVID-19 pandemic to examine the difference in CV risk factors between patients who deferred and a control group who attended their clinic visit as scheduled.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
458

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

June 5, 2025

Last Update Submit

June 25, 2025

Conditions

Keywords

medical out-patient visitCOVID-19 outbreakCV risk factors control

Outcome Measures

Primary Outcomes (1)

  • uncontrolled CVRF

    uncontrolled CVRF, defined as the presence of any of the following: uncontrolled DM with HbA1c \>7%, uncontrolled hypertension with office systolic blood pressure (SBP)\>130mmHg and/or diastolic blood pressure (DBP) \>80mmHg, or uncontrolled dyslipidaemia defined as low-density-lipoprotein (LDL) \>1.8mmol/L.

    through study completion, an average of 1 year

Secondary Outcomes (7)

  • unscheduled emergency service visit or hospitalization

    through study completion, an average 2 years

  • major adverse cardiovascular events (MACE)

    through study completion, an average 2 years

  • all-cause death

    through study completion, an average 2 years

  • HbA1c

    through study completion, an average 2 years

  • blood pressure

    through study completion, an average 2 years

  • +2 more secondary outcomes

Study Arms (2)

Deferred

Patients who deferred their appointment

Control

patients who attended their appointment as scheduled

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study participants will be recruited primarily form Medical Specialist Outpatient Clinics of the Prince of Wales Hospital, a tertiary regional teaching hospital in Hong Kong.

You may qualify if:

  • Patients who attend outpatient clinics at the Prince of Wales Hospital
  • Patients who are followed up at the clinics for at least 1 CV risk factors, namely diabetes, hypertension, dyslipidaemia, or history of vascular events including cerebrovascular accidence, ischemic heart disease or peripheral vascular disease.

You may not qualify if:

  • New referrals to the outpatient clinics
  • Unstable patients such as patients with recent hospitalization within 3 months to the interviewing date
  • Patients with complex medical problems indicated by Charlson Comorbidity Index of equal or more than 5
  • Patients whose active medical problems are not cardiovascular related
  • Patient who are taking vitamin K antagonist
  • Patients who defaulted their follow-up appointment with no new appointment on record.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Shatin, 0000, Hong Kong

Location

Related Publications (7)

  • Singh GM, Danaei G, Farzadfar F, Stevens GA, Woodward M, Wormser D, Kaptoge S, Whitlock G, Qiao Q, Lewington S, Di Angelantonio E, Vander Hoorn S, Lawes CM, Ali MK, Mozaffarian D, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group; Asia-Pacific Cohort Studies Collaboration (APCSC); Diabetes Epidemiology: Collaborative analysis of Diagnostic criteria in Europe (DECODE); Emerging Risk Factor Collaboration (ERFC); Prospective Studies Collaboration (PSC). The age-specific quantitative effects of metabolic risk factors on cardiovascular diseases and diabetes: a pooled analysis. PLoS One. 2013 Jul 30;8(7):e65174. doi: 10.1371/journal.pone.0065174. Print 2013.

    PMID: 23935815BACKGROUND
  • Global Burden of Metabolic Risk Factors for Chronic Diseases Collaboration. Cardiovascular disease, chronic kidney disease, and diabetes mortality burden of cardiometabolic risk factors from 1980 to 2010: a comparative risk assessment. Lancet Diabetes Endocrinol. 2014 Aug;2(8):634-47. doi: 10.1016/S2213-8587(14)70102-0. Epub 2014 May 16.

    PMID: 24842598BACKGROUND
  • Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.

    PMID: 30586774BACKGROUND
  • Davies MJ, D'Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018 Dec;41(12):2669-2701. doi: 10.2337/dci18-0033. Epub 2018 Oct 4.

    PMID: 30291106BACKGROUND
  • Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018 May 15;71(19):e127-e248. doi: 10.1016/j.jacc.2017.11.006. Epub 2017 Nov 13. No abstract available.

    PMID: 29146535BACKGROUND
  • Sherman L, Pelter MA, Deamer RL, Duan L, Batech M. Association between encounter frequency and time to blood pressure control among patients with newly diagnosed hypertension: a retrospective cohort study. J Clin Hypertens (Greenwich). 2018 Mar;20(3):429-437. doi: 10.1111/jch.13223. Epub 2018 Feb 16.

    PMID: 29450983BACKGROUND
  • Morrison F, Shubina M, Turchin A. Encounter frequency and serum glucose level, blood pressure, and cholesterol level control in patients with diabetes mellitus. Arch Intern Med. 2011 Sep 26;171(17):1542-50. doi: 10.1001/archinternmed.2011.400.

    PMID: 21949161BACKGROUND

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 5, 2025

First Posted

July 3, 2025

Study Start

April 1, 2020

Primary Completion

January 31, 2022

Study Completion

June 30, 2024

Last Updated

July 3, 2025

Record last verified: 2025-06

Locations