Cross-cultural Adaptation, Evaluation and Validation Study of Wang Qi's Constitution in TCM Questionnaire (For Old Person)NCT04491890
Cross-cultural Adaptation, Evaluation and Validation of Wang Qi's Constitution of TCM Questionnaire (For Old Person)
An observational study of Cross-cultural Adaptation, Evaluation and Validation Study of Wang Qi's Constitution in TCM Questionnaire (For Old Person), run by Hong Kong Baptist University at 1 site in China.
Trial summary
This is a cross-cultural adaptation, evaluation and validation study of Wang Qi's Constitution in TCM questionnaire (For Old Person) in Hong Kong to investigate the content validity, construct validity and reliability of the CTCMQ-C in Cantonese speaking Hong Kong Chinese elderly population. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cross-cultural Adaptation, Evaluation and Validation Study of Wang Qi's Constitution in TCM Questionnaire (For Old Person)
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2019to 8 Feb 2020
- 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 65 years and older
- All sexes
- Older adult
Study population: For the evaluation study of the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C), 10 Chinese Medicine Practitioners (CMPs) will be recruited from the outpatient clinics of Hong Kong Baptist University (HKBU) and 30 participants will be recruited from the community and the outpatient clinics of Hong Kong Baptist University (HKBU). For the validation study of the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) (final version), 264 participants will be recruited from the community and the outpatient clinics of Hong Kong Baptist University (HKBU).
Who may be able to join
- aged 65 and above;
- Hong Kong residents;
- capable of consenting and have agreed to participate.
Who cannot join
- not fulfill the above inclusion criteria;
- having serious diseases with undesirable conditions that unable to complete the survey;
- having serious mental and behavioral disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Chinese Medicine, Hong Kong Baptist University
Hong Kong, Hong Kong
About this study
This is a cross-cultural adaptation, evaluation and validation study of Wang Qi's Constitution in TCM questionnaire (For Old Person) in Hong Kong to investigate the content validity, construct validity and reliability of the CTCMQ-C in Cantonese speaking Hong Kong Chinese elderly population.
Read the detailed description
The study includes two steps. Firstly, translation of the questionnaire into Cantonese, followed by cross-cultural adaptation. Ten Chinese Medicine Practitioners (CMPs) and 30 patients will be recruited from the community and the outpatient clinics of Hong Kong Baptist University (HKBU) to evaluate the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) for content validity by the cognitive debriefing interviews. The content validity indices (CVI) of clarity, relevance and appropriateness of each item of the questionnaire rated by CMPs and patients will be quantified. The interpretations of items and suggestions of rewording by the patients and CMPs will be analyzed qualitatively to identify any item of the questionnaire that is not valid for the Chinese population in Hong Kong. Secondly following the validation study, 264 patients will be recruited. A validated CTCMQ-C will then be generated and will be endorsed by expert panel to use in the subsequent cross-sectional and cohort studies to evaluate the preventive effect with Chinese Medicine approaches. The psychometric properties including construct validity by scaling assumptions, confirmatory factor analysis (CFA) and reliability of the CTMCQ-C will also be tested.
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the psychometric properties including construct validity by scaling assumptions, confirmatory factor analysis (CFA) and reliability of the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) (final version).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start31 Jul 2019
- Primary completion8 Feb 2020
- Study completion8 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cross-cultural Adaptation, Evaluation and Validation Study of Wang Qi's Constitution in TCM Questionnaire (For Old Person)Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust
- Responsible party
- Principal investigator, ZhaoXiang Bian, Hong Kong Baptist University
- Investigators
- Zhao-xiang Bian, PhD, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491890
- Sponsor's protocol ID
- HKBU JC 001
- Status last verified
- Jul 2020
- First submitted
- 26 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation, Evaluation and Validation of Wang Qi's Constitution of TCM Questionnaire (For Old Person)
- ClinicalTrials.gov ID
- NCT04491890
- Acronym / sponsor ID
- HKBU JC 001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 8 Feb 2020 (actual)
- Study completion
- 8 Feb 2020 (actual)
- First posted
- 30 Jul 2020 (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.
This is a cross-cultural adaptation, evaluation and validation study of Wang Qi's Constitution in TCM questionnaire (For Old Person) in Hong Kong to investigate the content validity, construct validity and reliability of the CTCMQ-C in Cantonese speaking Hong Kong Chinese elderly population.
Detailed description
The study includes two steps. Firstly, translation of the questionnaire into Cantonese, followed by cross-cultural adaptation. Ten Chinese Medicine Practitioners (CMPs) and 30 patients will be recruited from the community and the outpatient clinics of Hong Kong Baptist University (HKBU) to evaluate the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) for content validity by the cognitive debriefing interviews. The content validity indices (CVI) of clarity, relevance and appropriateness of each item of the questionnaire rated by CMPs and patients will be quantified. The interpretations of items and suggestions of rewording by the patients and CMPs will be analyzed qualitatively to identify any item of the questionnaire that is not valid for the Chinese population in Hong Kong. Secondly following the validation study, 264 patients will be recruited. A validated CTCMQ-C will then be generated and will be endorsed by expert panel to use in the subsequent cross-sectional and cohort studies to evaluate the preventive effect with Chinese Medicine approaches. The psychometric properties including construct validity by scaling assumptions, confirmatory factor analysis (CFA) and reliability of the CTMCQ-C will also be tested.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- For the evaluation study of the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C), 10 Chinese Medicine Practitioners (CMPs) will be recruited from the outpatient clinics of Hong Kong Baptist University (HKBU) and 30 participants will be recruited from the community and the outpatient clinics of Hong Kong Baptist University (HKBU). For the validation study of the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) (final version), 264 participants will be recruited from the community and the outpatient clinics of Hong Kong Baptist University (HKBU).
Key inclusion criteria (3 listed)
- aged 65 and above;
- Hong Kong residents;
- capable of consenting and have agreed to participate.
Key exclusion criteria (3 listed)
- not fulfill the above inclusion criteria;
- having serious diseases with undesirable conditions that unable to complete the survey;
- having serious mental and behavioral disorders.
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
To test the psychometric properties including construct validity by scaling assumptions, confirmatory factor analysis (CFA) and reliability of the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) (final version).
Time frame: 30 minutes
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 30 Jul 2020.
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.
Zhao-xiang Bian, PhD principal investigator
Hong Kong Baptist University
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 Cross-cultural Adaptation, Evaluation and Validation Study of Wang Qi's Constitution in TCM Questionnaire (For Old Person), run by Hong Kong Baptist University 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 3 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 30 Jul 2020. 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?
To test the psychometric properties including construct validity by scaling assumptions, confirmatory factor analysis (CFA) and reliability of the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) (final version). (time frame: 30 minutes). 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 30 Jul 2020.