FrailtyNCT04166123
Psychometric Properties of the Elderly Health Questionnaire Among Community-dwelling Older People
An observational study of Frailty, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Apr 2019to Mar 2021
- 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
- Healthy volunteers accepted
- Older adult
Study population: over 65 years old community-dwelling elderly
Who may be able to join
- aged > 65 years old
- able to read
- Clinical frailty scale ≦ 6
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Hui-Fen Mao, MS, +886 2 33668178, huifen02@gmail.com
About this study
Official title: Psychometric Properties of the Elderly Health Questionnaire in Frailty Risk Assessment Among Community-dwelling Older People
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.
Read the detailed 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.
- Conditions
- Frailty
- Keywords
- frailty, older adults, instrument, community
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: an average of 2-4 weeks between pretest and posttest (baseline, week 2-4)
Secondary outcomes (6)
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).
Measured: pretest (baseline)
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).
Measured: pretest (baseline)
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).
Measured: pretest (baseline)
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).
Measured: pretest (baseline)
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).
Measured: pretest (baseline)
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).
Measured: pretest (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start24 Apr 2019
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Fen Mao, MS, Principal investigator, School of Occupational Therapy, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166123
- Sponsor's protocol ID
- 201901045RINA
- Status last verified
- Jan 2021
- First submitted
- 14 Nov 2019
- Last updated
- 20 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of the Elderly Health Questionnaire in Frailty Risk Assessment Among Community-dwelling Older People
- ClinicalTrials.gov ID
- NCT04166123
- Acronym / sponsor ID
- 201901045RINA
- Conditions
- Frailty
- Keywords
- frailty, older adults, instrument, community
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 18 Nov 2019 (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.
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.
Detailed 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- over 65 years old community-dwelling elderly
Key inclusion criteria (3 listed)
- aged > 65 years old
- able to read
- Clinical frailty scale ≦ 6
Key exclusion criteria (7 listed)
- diagnosed as dementia or schizophrenia
- active cancer receiving treatment
- terminal cancer patient
- hospitalization in 1 month
- with implantable device
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
Elderly Health Questionnaire
Time frame: an average of 2-4 weeks between pretest and posttest (baseline, week 2-4)
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).
6 secondary outcomes
Taiwanese version of the Health Enhancement Lifestyle Profile (HELP-T)
Time frame: pretest (baseline)
WHOQOL-BREF Taiwan version
Time frame: pretest (baseline)
Short physical performance battery (SPPB)
Time frame: pretest (baseline)
Montreal Cognitive Assessment (MoCA)
Time frame: pretest (baseline)
Brief University of California at San Diego Performance-Based Skills Assessment (UPSA-B)
Time frame: pretest (baseline)
Canadian Study of Health and Aging Clinical Frailty Scale (CFS)
Time frame: pretest (baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
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.
Hui-Fen Mao, MS principal investigator
School of Occupational Therapy, College of Medicine, National Taiwan 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 Frailty, run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 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: status not confirmed, as of the sponsor's last update on 20 Jan 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Fen Mao, MS (+886 2 33668178, huifen02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elderly Health Questionnaire (time frame: an average of 2-4 weeks between pretest and posttest (baseline, week 2-4)). 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 20 Jan 2021.