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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04491890
Other study ID # HKBU JC 001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 31, 2019
Est. completion date February 8, 2020

Study information

Verified date July 2020
Source Hong Kong Baptist University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 304
Est. completion date February 8, 2020
Est. primary completion date February 8, 2020
Accepts healthy volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- aged 65 and above;

- Hong Kong residents;

- capable of consenting and have agreed to participate.

Exclusion Criteria:

- not fulfill the above inclusion criteria;

- having serious diseases with undesirable conditions that unable to complete the survey;

- having serious mental and behavioral disorders.

Study Design


Related Conditions & MeSH terms

  • Cross-cultural Adaptation, Evaluation and Validation Study of Wang Qi's Constitution in TCM Questionnaire (For Old Person)

Locations

Country Name City State
China School of Chinese Medicine, Hong Kong Baptist University Hong Kong Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
Hong Kong Baptist University The Hong Kong Jockey Club Charities Trust

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other To evaluate the content validity of the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) in a Cantonese speaking Chinese elderly population in Hong Kong. 60 minutes
Primary 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). 30 minutes