Musculoskeletal ProblemNCT00887133
Effectiveness of Western Medicine Outpatient Consultations in Primary Care
An observational study of Musculoskeletal Problem and Respiratory Problem, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Problem, Respiratory Problem, Gastrointestinal Problem
- How many people
- 1,469 participants
- Where
- 1 siteChina
- Study dates
- Nov 2005to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Western Medicine Outpatient Consultations in Primary Care - A Comparison With Chinese Medicine Consultations
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.
Read more
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.
Read the detailed description
Primary health care serves every person and manages over 90% of the illnesses. The Hospital Authority public general and family medicine outpatient clinics provide about 11 million attendances each year, which is the major source of health care for the elderly and low-income population. The effectiveness of primary care has profound impact on the health of the population as well as the demand on expensive secondary care. Western medicine (WM) is the most commonly used type of primary care but 50 to 60% of people also consult Traditional Chinese medicine (TCM) in Hong Kong. The two types of medicine are often used sequentially or concurrently. There is a constant debate on whether WM or TCM is more effective, but few if any, comparative data are available. Few studies have investigated patient satisfaction with the public primary care clinics but none has investigated the effectiveness of care. A proper evaluation with a valid outcome measure will help to inform the public and policy makers on the benefit and limitations of the different primary care.
The evaluation of the effectiveness of a health service needs to use appropriate outcome measures. Health-related quality of life (HRQOL) with an emphasis on subjective perception of well-being and function is probably the most suitable outcome measure in primary care because most of the health problems are functional rather than pathological. The other advantage of HRQOL is that it is generic in that the same standard measure can be applied to different types of patients, illnesses and medical services.
Our previous study showed that all patients had significant improvements in their HRQOL after TCM consultations at the different (internal medicine, bone-setting and acupuncture) primary care outpatient clinics in Tung Wah Hospital. We would like to carry out a study to evaluate the effectiveness of WM in improving the HRQOL of patients attending the WM general outpatient clinic of the TWH and another public primary care clinic. To the best of our knowledge, this is the first study to evaluate the effectiveness of care of the public primary care service. The results will allow a direct comparison between WM and TCM, overall and for different illnesses, which can help to determine their respective roles in primary care.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients consulting Western Medicine outpatient clinics for a new episode of illness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 0 and day 14
Secondary outcomes (1)
The Patient enablement instrument score and the Global rating of change score
Measured: day 0 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startNov 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal ProblemStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,469 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Tung Wah Group of Hospitals
- Investigators
- Cindy L K Lam, MD, Principal investigator, Family Medicine Unit, Faculty of Medicine, HKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887133
- Sponsor's protocol ID
- HKCTR-477
- Status last verified
- Apr 2009
- First submitted
- 6 Apr 2009
- Last updated
- 23 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Western Medicine Outpatient Consultations in Primary Care - A Comparison With Chinese Medicine Consultations
- ClinicalTrials.gov ID
- NCT00887133
- Acronym / sponsor ID
- HKCTR-477
- Conditions
- Musculoskeletal Problem, Respiratory Problem, Gastrointestinal Problem, All Primary Care Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,469 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Tung Wah Group of Hospitals
- Study start
- Nov 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary health care serves every person and manages over 90% of the illnesses. The Hospital Authority public general and family medicine outpatient clinics provide about 11 million attendances each year, which is the major source of health care for the elderly and low-income population. The effectiveness of primary care has profound impact on the health of the population as well as the demand on expensive secondary care. Western medicine (WM) is the most commonly used type of primary care but 50 to 60% of people also consult Traditional Chinese medicine (TCM) in Hong Kong. The two types of medicine are often used sequentially or concurrently. There is a constant debate on whether WM or TCM is more effective, but few if any, comparative data are available. Few studies have investigated patient satisfaction with the public primary care clinics but none has investigated the effectiveness of care. A proper evaluation with a valid outcome measure will help to inform the public and policy makers on the benefit and limitations of the different primary care.
The evaluation of the effectiveness of a health service needs to use appropriate outcome measures. Health-related quality of life (HRQOL) with an emphasis on subjective perception of well-being and function is probably the most suitable outcome measure in primary care because most of the health problems are functional rather than pathological. The other advantage of HRQOL is that it is generic in that the same standard measure can be applied to different types of patients, illnesses and medical services.
Our previous study showed that all patients had significant improvements in their HRQOL after TCM consultations at the different (internal medicine, bone-setting and acupuncture) primary care outpatient clinics in Tung Wah Hospital. We would like to carry out a study to evaluate the effectiveness of WM in improving the HRQOL of patients attending the WM general outpatient clinic of the TWH and another public primary care clinic. To the best of our knowledge, this is the first study to evaluate the effectiveness of care of the public primary care service. The results will allow a direct comparison between WM and TCM, overall and for different illnesses, which can help to determine their respective roles in primary care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients consulting Western Medicine outpatient clinics for a new episode of illness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: day 0 and day 14
1 secondary outcome
The Patient enablement instrument score and the Global rating of change score
Time frame: day 0 and day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy L K Lam, MD principal investigator
Family Medicine Unit, Faculty of Medicine, HKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Problem and Respiratory Problem, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: day 0 and day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2009.