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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04166123
Other study ID # 201901045RINA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 24, 2019
Est. completion date March 2021

Study information

Verified date January 2021
Source National Taiwan University Hospital
Contact Hui-Fen Mao, MS
Phone +886 2 33668178
Email huifen02@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aims of this study are to validate the reliability and validity of Elderly Health Questionnaire in assessing frailty risk of community-dwelling older adults.


Description:

The aims of this study are to validate the test-retest reliability, internal consistency, criterion-related validity, predictive validity and construct validity of Elderly Health Questionnaire in assessing frailty risk of community-dwelling older adults. The investigators conduct a prospective study to require data of health states, function, lifestyle and quality of life in community-dwelling older adults ,and will recruit about 150 subjects in NTUH and communities in Taipei City. The investigators analyze the (change) scores of Elderly Health Questionnaire to test the internal consistency and test-retest reliability. Also, the investigators test the correlation between the scores of Elderly Health Questionnaire and the scores of the other measurements (i.e., HELP-T, WHOQOL-BREF, MoCA, SPPB, UPSA-B) to validate the concurrent validity, and the correlation between the scores of Elderly Health Questionnaire and the scores of CFS to validate predictive validity. The construct validity is validated by exploratory factor analysis.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date March 2021
Est. primary completion date March 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - aged > 65 years old - able to read - Clinical frailty scale ? 6 Exclusion Criteria: - diagnosed as dementia or schizophrenia - active cancer receiving treatment - terminal cancer patient - hospitalization in 1 month - with implantable device - couldn't follow the instructions - wheelchair bound

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Elderly Health Questionnaire It is a self-report questionnaire about frailty and health conditions. Each item is scored 0 or 1, yielding a total of 0-70. The scores range from 0 (best performance) to 70 (worst performance). an average of 2-4 weeks between pretest and posttest (baseline, week 2-4)
Secondary Taiwanese version of the Health Enhancement Lifestyle Profile (HELP-T) HELP-T is a 59-item self-report questionnaire measuring various aspects of health-related lifestyles in older adults. The scores range from 0 (worst performance) to 118 (best performance). pretest (baseline)
Secondary WHOQOL-BREF Taiwan version It is a cultural-specific self-report questionnaire measuring health-related quality of life in Taiwan. The scores range from 0 (worst QoL) to 100 (best QoL). pretest (baseline)
Secondary Short physical performance battery (SPPB) SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 4 (best performance). pretest (baseline)
Secondary Montreal Cognitive Assessment (MoCA) The MoCA is a cognitive screening test designed to assist health professionals in the detection of mild cognitive impairment and Alzheimer's disease. The MoCA Test was validated in the setting of mild cognitive impairment (MCI), and has been subsequently adopted in numerous clinical settings. The sensivity of the MoCA for detecting MCI is 90%, compared to 18% for other leading cognitive screening tools such as the MMSE. The scores range from 0 (worst performance) to 30 (best performance). pretest (baseline)
Secondary Brief University of California at San Diego Performance-Based Skills Assessment (UPSA-B) UPSA-B is a shorter version of the UPSA-2 that uses only the financial skills and communication skills subscales (i.e. counting change, telephone calls, and paying bills). This version of the UPSA takes approximately 15 minutes to complete and has been shown to be an accurate predictor of patient ability to live independently, as compared to the full version of the UPSA. The scores range from 0 (worst performance) to 20 (best performance). pretest (baseline)
Secondary Canadian Study of Health and Aging Clinical Frailty Scale (CFS) CFS is a frailty tool derived using data from the Canadian Study of Health and Aging, a national 5-year prospective cohort study. The CFS is a judgment-based scale that considers clinical data on a patient's cognition, mobility, function, and comorbidities. The scores range from 1 (very fit) to 9 (terminally ill). pretest (baseline)
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