NCT00887133

Brief Summary

Background: Primary care plays an important role in health care delivery, but there is little research on its effectiveness. Western medicine is the most widely used and Traditional Chinese medicine (TCM) is gaining popularity. The investigators recent study showed that TCM consultations at the TWH were effective in improving the quality of life of patients in primary care. The aim of the present study is to evaluate the effectiveness of Western Medicine (WM) in primary care for comparison with the effectiveness of TCM consultations, so that policy makers and the public can be better informed. Objectives: To evaluate whether WM consultation can significantly improve the quality of life of patients in primary care and to find out whether there is any difference in the effectiveness of WM and TCM, overall and for different health problems. Design, Setting \& Subjects: A prospective study on 700 patients recruited from the TWH and the Ap Lei Chau primary care outpatient clinics (OPC) in Hong Kong. Methods: All patients consulting for a new episode of illness at the study OPC will be recruited if they meet the selection criteria and consent to participate. Each patient will be asked to complete a structured questionnaire on socio-demography, morbidity and service utilization, the Hong Kong version of the Chinese Quality of Life instrument (ChQOL-HK), the Chinese (Hong Kong) SF-36 (SF-36-HK) and the PEI-2 before the consultation. Each subject will be followed up two weeks later either at the clinic or by telephone to complete the ChQOL-HK and the SF-36-HK again together with the Patient Enablement Instrument (PEI), the Global Rating Scale (GRS) on change of the condition, and a questionnaire on service utilization Outcome Measures and Data Analysis: The primary outcome measures are the changes in ChQOL-HK and SF-36-HK scores after the consultation. The GRS and PEI scores will be secondary outcomes. The ChQOL -HK and SF-36-HK scores will be correlated with the the GRS and PEI. Multivariate regressions will be carried out to identify factors that are associated with effectiveness. The outcomes will be compared with those obtained from the previous study on the TCM primary care clinics. Results: This is the first study in Hong Kong to evaluate the effectiveness of WM in primary care with a validated generic outcome measure, HRQOL. It will provide information on the benefit and limitations of WM, and allow a direct comparison between WM and TCM.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,469

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2005

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
Last Updated

April 23, 2009

Status Verified

April 1, 2009

Enrollment Period

2.1 years

First QC Date

April 6, 2009

Last Update Submit

April 22, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • The change in ChQOL-HK and SF-36-HK Scores, from baseline to 2 weeks The Chinese Quality of Life Questionnaire (ChQOL) The Hong Kong version of the Chinese Quality of Life Questionnaire (ChQOL - HK) was adapte

    day 0 and day 14

Secondary Outcomes (1)

  • The Patient enablement instrument score and the Global rating of change score

    day 0 and day 14

Study Arms (1)

1

Patients consulting Western Medicine outpatient clinics for a new episode of illness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample

You may qualify if:

  • Age ≥ 18 years old
  • Patient consulted the primary care clinic for the first time or a new episode of illness
  • Gave consent to take part in the study

You may not qualify if:

  • The visit to the primary care clinic was a follow up consultation
  • Unable to communicate in Cantonese or Chinese
  • Too ill to complete an interview
  • Refused to take part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Two General Outpatient Clinics

Hong Kong, Hong Kong, China

Location

Study Officials

  • Cindy L K Lam, MD

    Family Medicine Unit, Faculty of Medicine, HKU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 23, 2009

Study Start

November 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 23, 2009

Record last verified: 2009-04

Locations