NCT02219958

Brief Summary

Hypertension (HT) is one of the major cause of morbidity and among the top 10 causes of deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has initiated service improvement through introducing the risk assessment and management programme (RAMP) to improve the quality of care (QOC) for HT patients in general outpatient clinics (GOPC). The evaluation on the QOC is an essential part of the programme in order to inform future policy. The Department of Family Medicine and Primary Care (FMPC) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the QOC of the programme. The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the RAMP programme is achieved. Each RAMP participating clinic and hospital will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the RAMP for more than one year will be included in the evaluation on the process and outcomes of care. One thousand two hundred and forty-eight age and disease matched control patients who have not been enrolled into the RAMP programme will be selected for the comparison in the outcomes of care. A hundred and thirty participants will be followed up by telephone to evaluate the effect of the programme in quality of life (QOL), patient enablement, and global rating of change in health condition at baseline and 6 months after enrolment. Data on the process of care will be retrieved from the HA medical records. Main Outcome Measures: The primary outcomes are the proportion of participants who have received the criterion process of care, and achieved the target blood pressure levels. Data Analysis: Descriptive statistics on proportions of centers or subjects meeting the QOC criteria will be calculated. The changes in the clinical and patient reported outcomes of RAMP subjects will be compared at 12, 24, 36 and 48 months will be compared by paired sample t-test. The clinical outcomes between RAMP subjects and control group will be compared by independent sample t-test or Chi-square test. Results: The QOC of the RAMP programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified. Conclusion: The results of this study will provide empirical evidence on whether the HA's RAMP programme can achieve improvement in QOC for HT patients. The information will be used to guide service planning and policy decision making.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,496

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

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

September 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

4 years

First QC Date

August 14, 2014

Last Update Submit

September 5, 2017

Conditions

Keywords

Hypertension

Outcome Measures

Primary Outcomes (3)

  • The proportion of clinics that have satisfied each of the structure criteria

    Final analysis will evaluate the period from August, 2012 to December, 2014.

    Three years

  • The proportion of patients who have complied with the criterion process of care.

    Final analysis will evaluate the period from August, 2012 to December, 2014.

    Three years

  • The proportion of patients who have achieved a BP level <140/90mmHg.

    Final analysis will evaluate the period from August, 2012 to December, 2014.

    Three years

Secondary Outcomes (6)

  • LDL

    Three years

  • BMI (Body Mass Index)

    Three years

  • Occurrence of First Cardiovascular Complication

    Three years

  • The change in SF-12v2 scores

    Three years

  • PEI (Patient Enablement Index)

    Three years

  • +1 more secondary outcomes

Study Arms (1)

RAMP-HT and Non-RAMP-HT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All HT patients aged \<80, without prior history of diabetes and existing cardiovascular diseases, with suboptimal BP control (average systolic blood pressure (SBP) ≥ 140mmHg or average diastolic blood pressure (DBP) ≥ 90mmHg) who were enrolled into RAMP-HT.

You may qualify if:

  • aged \<80
  • Suboptimal BP control (average systolic blood pressure (SBP) ≥ 140mmHg or average diastolic blood pressure (DBP) ≥ 90mmHg)

You may not qualify if:

  • Patients will be excluded if they are unable to understand or communicate in Chinese language, or refuse to give consent.
  • Patients will be excluded if they had prior history of diabetes and existing cardiovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong Island, Hong Kong

Location

Related Publications (2)

  • Yu EY, Wan EY, Chan KH, Wong CK, Kwok RL, Fong DY, Lam CL. Evaluation of the quality of care of a multi-disciplinary Risk Factor Assessment and Management Programme for Hypertension (RAMP-HT). BMC Fam Pract. 2015 Jun 19;16:71. doi: 10.1186/s12875-015-0291-0.

  • Yu EYT, Wan EYF, Mak IL, Chao DVK, Ko WWK, Leung M, Li YC, Liang J, Luk W, Wong MMY, Ha TKH, Chan AKC, Fong DYT, Lam CLK. Assessment of Hypertension Complications and Health Service Use 5 Years After Implementation of a Multicomponent Intervention. JAMA Netw Open. 2023 May 1;6(5):e2315064. doi: 10.1001/jamanetworkopen.2023.15064.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Cindy L.K. Lam, MD

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

    STUDY CHAIR
  • Esther Y.T. Yu, MBBS

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 19, 2014

Study Start

September 1, 2012

Primary Completion

September 1, 2016

Study Completion

April 1, 2017

Last Updated

September 6, 2017

Record last verified: 2017-09

Locations