Primary Health CareNCT04736992
HKCFP-HKU Primary Care Morbidity Survey in Hong Kong
An observational study of Primary Health Care, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: Information about the health problems of patients presenting in primary care is crucial to understanding the health of the general community for the planning and allocation of health care resources. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Primary Health Care
- How many people
- 49 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Mar 2021to 31 Aug 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Primary care doctors in Hong Kong who are working in the public sector (GOPC), Department of Health Clinic, private solo practices, university health services, non-profit organizations and private hospital family medicine clinics
Who may be able to join
- Consented primary care doctors in Hong Kong who are working in:
- the public sector (GOPC), or
- Department of Health Clinic, or
- private solo or group practices, or
- university health services, or
- non-profit organizations, or
- private hospital family medicine clinics
Who cannot join
- Doctors who do not consent
- Doctors who are not working as primary care doctors
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Family Medicine and Primary Care, University of Hong Kong
Hong Kong
About this study
Background:
Information about the health problems of patients presenting in primary care is crucial to understanding the health of the general community for the planning and allocation of health care resources. Practice-based morbidity studies conducted in primary care settings have proven to be helpful in documentation of disease prevalence and for service planning. With the change in morbidity pattern and the aging population, our study will help to inform primary health care policy and guide work force and service planning.
Read more
Method:
This is a prospective practice-based study of health problems presenting in primary care. Doctors who agree to participate in the study will record the health problem and type of management performed in consecutive patient encounters for one of the designated weeks during each season over the course of one year.
Analysis:
Data collected will be analysed by descriptive statistics, comparison with data from previous morbidity study, and by non-linear mixed effects for factors associated with morbidity and management patterns in primary care.
Results:
Findings will will 1) provide evidence to support the allocation of resources to continue and to expand primary care initiatives that support the provision of quality chronic disease care in private sector, 2) enable continued surveillance of the morbidity trends in Hong Kong by providing data for comparison with past and future studies, and 3) inform the content of educational curricula for medical and health care students and practitioners to prepare them to better meet the needs of the community.
- Conditions
- Primary Health Care
- Being tested
- No intervention involved
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention involvedOther
No intervention involved
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of health problems and diseases presenting in primary care
Measured: immediately after completion of data collection, up to 6 months
Rates of management activities including referral, investigation, prescription and preventive care intervention by primary care doctors
Measured: immediately after completion of data collection, up to 6 months
Distribution of health problems and diseases presenting in the public compared with the private primary care setting
Measured: immediately after completion of data collection, up to 6 months
Factors which affect the proportion and distribution of health problems in the public sector compared with the private sector
Measured: immediately after completion of data collection, up to 6 months
Secondary outcomes (3)
Prescription rates of specific classes of drugs including benzodiazepines, antidepressants, NSAIDs, and antibiotics
Measured: immediately after completion of data collection, up to 6 months
Seasonal variation in primary care morbidity pattern
Measured: immediately after completion of data collection, up to 6 months
Relationship between patient's presenting problem and doctor's diagnosis
Measured: immediately after completion of data collection, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start7 Mar 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Health CareStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Julie Yun Chen, The University of Hong Kong
- Investigators
- Julie Y Chen, MD, Principal investigator, Department of Family Medicine and Primary Care, University of Hong KongCindy LK Lam, MD, Principal investigator, Department of Family Medicine and Primary Care, University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736992
- Sponsor's protocol ID
- HKUCTR-2916
- Status last verified
- Oct 2022
- First submitted
- 26 Jan 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Chen JY, Chao D, Wong SY, Tse TYE, Wan EYF, Tsang JPY, Leung MKW, Ko W, Li YC, Chen C, Luk W, Dao MC, Wong M, Leung WM, Lam CLK. Morbidity Patterns in Primary Care in Hong Kong: Protocol for a Practice-Based Morbidity Survey. JMIR Res Protoc. 2022 Jun 22;11(6):e37334. doi: 10.2196/37334.
PubMed 35731566
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HKCFP-HKU Primary Care Morbidity Survey in Hong Kong
- ClinicalTrials.gov ID
- NCT04736992
- Acronym / sponsor ID
- HKUCTR-2916
- Conditions
- Primary Health Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 3 Feb 2021 (actual)
- 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:
Information about the health problems of patients presenting in primary care is crucial to understanding the health of the general community for the planning and allocation of health care resources. Practice-based morbidity studies conducted in primary care settings have proven to be helpful in documentation of disease prevalence and for service planning. With the change in morbidity pattern and the aging population, our study will help to inform primary health care policy and guide work force and service planning.
Method:
This is a prospective practice-based study of health problems presenting in primary care. Doctors who agree to participate in the study will record the health problem and type of management performed in consecutive patient encounters for one of the designated weeks during each season over the course of one year.
Analysis:
Data collected will be analysed by descriptive statistics, comparison with data from previous morbidity study, and by non-linear mixed effects for factors associated with morbidity and management patterns in primary care.
Results:
Findings will will 1) provide evidence to support the allocation of resources to continue and to expand primary care initiatives that support the provision of quality chronic disease care in private sector, 2) enable continued surveillance of the morbidity trends in Hong Kong by providing data for comparison with past and future studies, and 3) inform the content of educational curricula for medical and health care students and practitioners to prepare them to better meet the needs of the community.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care doctors in Hong Kong who are working in the public sector (GOPC), Department of Health Clinic, private solo practices, university health services, non-profit organizations and private hospital family medicine clinics
Key inclusion criteria (7 listed)
- Consented primary care doctors in Hong Kong who are working in:
- the public sector (GOPC), or
- Department of Health Clinic, or
- private solo or group practices, or
- university health services, or
Key exclusion criteria (2 listed)
- Doctors who do not consent
- Doctors who are not working as primary care doctors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention involvedNo intervention involved | Other | – |
Primary outcome
Prevalence of health problems and diseases presenting in primary care
Time frame: immediately after completion of data collection, up to 6 months
Rates of management activities including referral, investigation, prescription and preventive care intervention by primary care doctors
Time frame: immediately after completion of data collection, up to 6 months
Distribution of health problems and diseases presenting in the public compared with the private primary care setting
Time frame: immediately after completion of data collection, up to 6 months
Factors which affect the proportion and distribution of health problems in the public sector compared with the private sector
Time frame: immediately after completion of data collection, up to 6 months
3 secondary outcomes
Prescription rates of specific classes of drugs including benzodiazepines, antidepressants, NSAIDs, and antibiotics
Time frame: immediately after completion of data collection, up to 6 months
Seasonal variation in primary care morbidity pattern
Time frame: immediately after completion of data collection, up to 6 months
Relationship between patient's presenting problem and doctor's diagnosis
Time frame: immediately after completion of data collection, up to 6 months
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 2 Nov 2022.
- Derived from this study: PubMed 35731566Chen JY, Chao D, Wong SY, Tse TYE, Wan EYF, Tsang JPY, Leung MKW, Ko W, Li YC, Chen C, Luk W, Dao MC, Wong M, Leung WM, Lam CLK. Morbidity Patterns in Primary Care in Hong Kong: Protocol for a Practice-Based Morbidity Survey. JMIR Res Protoc. 2022 Jun 22;11(6):e37334. doi: 10.2196/37334.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Julie Y Chen, MD principal investigator
Department of Family Medicine and Primary Care, University of Hong Kong
Cindy LK Lam, MD principal investigator
Department of Family Medicine and Primary Care, University of Hong Kong
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 Primary Health Care, run by The University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 2 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 2 Nov 2022. 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 Hong Kong. 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?
Prevalence of health problems and diseases presenting in primary care (time frame: immediately after completion of data collection, up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04736992, which also lists 1 linked publication.
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 2 Nov 2022.