FrailtyNCT04139837
Frailty in Daily Practice: Screening, Consultation and Education Activities
An observational study of Frailty, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The present study is designed to to estimate the prevalence of frailty and pre-frailty and their associated factors in community-dwelling populations aged 50 years and above in Hong Kong, and to explore the views of participants taking part in a community health talks or activities on frailty about what the… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- Health screening, community health talks or activities on frailty
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,951 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2020to 25 May 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People aged 50 years or older will be identified in community facilities (e.g., neighbourhood elderly centre, social centre for the elderly).
Who may be able to join
- People aged 50 years or older
- Chinese origin
- Normally reside in Hong Kong
- Could speak and understand Chinese
- Willing to follow the study procedures
Who cannot join
- -Live in a residential aged care facility
Trial locations and contacts
1 site in 1 country.
About this study
The present study is designed to to estimate the prevalence of frailty and pre-frailty and their associated factors in community-dwelling populations aged 50 years and above in Hong Kong, and to explore the views of participants taking part in a community health talks or activities on frailty about what the participants felt or had gained from participating, concerns, and suggestions for change or improvement.
A survey of 15000 people aged 50 years or older identified in community facilities will be conducted. The participants will be invited to their affiliated centres for a brief screening using the FRAIL scale and assessment. A series of community health talks or activities on frailty will be offered to the participants based on the frailty status.Questionnaire and screening tools will be administered by trained researchers.
Read the detailed description
A 30-month community survey will be conducted, and the survey will be divided into three phases, namely study preparation and subject recruitment (6 months), data collection (18 months), and data entry and analysis (6 months).
A survey of 15000 people aged 50 years or older identified in community facilities (e.g., neighbourhood elderly centre, social centre for the elderly) will be conducted. The participants will be invited to their affiliated centres for a brief screening using the FRAIL scale and assessment. A series of community health talks or activities on frailty will be offered to the participants based on the frailty status. Questionnaire and screening tools will be administered by trained researchers.
The primary outcome will be the prevalence of frailty and pre-frailty. Secondary outcomes will cover physical performance measures including hand-grip strength and 5-chair stand test. Anthropometric and demographic data will also be collected using standardized methods and questionnaires respectively.
Views of participants taking part in a community health talks or activities on frailty about what the participants felt or had gained from participating, concerns, and suggestions for change or improvement will be explored by client satisfaction questionnaires.
- Conditions
- Frailty
- Being tested
- Health screening, community health talks or activities on frailty
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health screening, community health talks or activities on frailtyBehavioural
Screening for frailty using the FRAIL scale to categorize participant's status as robust, prefrail and frail. A series of community health talks or activities on frailty will be provided to each category of participants for the prevention or management of frailty.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty status
Frailty status (i.e. robust, prefrail or frail) measured using the frailty scale (FRAIL) in which unabbreviated scale name is unavailable for this scale. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) and represent robust (0), pre-frail (1-2), and frail (3-5) health status.
Measured: 1 day (Once only at screening)
Secondary outcomes (2)
Handgrip strength
Handgrip strength measured using a dynamometer
Measured: 1 day (Once only at screening)
5 chair stands
Muscle endurance in the lower extremities - Participant will be required to rise from a chair a total of 5 times, as quickly as they could, with arms across their chest. The amount of time required to complete all 5 repetitions will be recorded.
Measured: 1 day (Once only at screening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start3 Jan 2020
- Primary completion30 Apr 2022
- Study completion25 May 2022
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 Chinese 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 5,951 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Woo, Chinese University of Hong Kong
- Investigators
- Jean Woo, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139837
- Sponsor's protocol ID
- 2019.475
- Status last verified
- May 2022
- First submitted
- 23 Oct 2019
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty in Daily Practice: Screening, Consultation and Education Activities
- ClinicalTrials.gov ID
- NCT04139837
- Acronym / sponsor ID
- 2019.475
- Conditions
- Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,951 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 25 Oct 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 present study is designed to to estimate the prevalence of frailty and pre-frailty and their associated factors in community-dwelling populations aged 50 years and above in Hong Kong, and to explore the views of participants taking part in a community health talks or activities on frailty about what the participants felt or had gained from participating, concerns, and suggestions for change or improvement.
A survey of 15000 people aged 50 years or older identified in community facilities will be conducted. The participants will be invited to their affiliated centres for a brief screening using the FRAIL scale and assessment. A series of community health talks or activities on frailty will be offered to the participants based on the frailty status.Questionnaire and screening tools will be administered by trained researchers.
Detailed description
A 30-month community survey will be conducted, and the survey will be divided into three phases, namely study preparation and subject recruitment (6 months), data collection (18 months), and data entry and analysis (6 months).
A survey of 15000 people aged 50 years or older identified in community facilities (e.g., neighbourhood elderly centre, social centre for the elderly) will be conducted. The participants will be invited to their affiliated centres for a brief screening using the FRAIL scale and assessment. A series of community health talks or activities on frailty will be offered to the participants based on the frailty status. Questionnaire and screening tools will be administered by trained researchers.
The primary outcome will be the prevalence of frailty and pre-frailty. Secondary outcomes will cover physical performance measures including hand-grip strength and 5-chair stand test. Anthropometric and demographic data will also be collected using standardized methods and questionnaires respectively.
Views of participants taking part in a community health talks or activities on frailty about what the participants felt or had gained from participating, concerns, and suggestions for change or improvement will be explored by client satisfaction questionnaires.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People aged 50 years or older will be identified in community facilities (e.g., neighbourhood elderly centre, social centre for the elderly).
Key inclusion criteria (5 listed)
- People aged 50 years or older
- Chinese origin
- Normally reside in Hong Kong
- Could speak and understand Chinese
- Willing to follow the study procedures
Key exclusion criteria (1 listed)
- -Live in a residential aged care facility
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 |
|---|---|---|
| Health screening, community health talks or activities on frailtyScreening for frailty using the FRAIL scale to categorize participant's status as robust, prefrail and frail. A series of community health talks or activities on frailty will be provided to each category of participants for the prevention or management of frailty. | Behavioural | – |
Primary outcome
Frailty status
Time frame: 1 day (Once only at screening)
Frailty status (i.e. robust, prefrail or frail) measured using the frailty scale (FRAIL) in which unabbreviated scale name is unavailable for this scale. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) and represent robust (0), pre-frail (1-2), and frail (3-5) health status.
2 secondary outcomes
Handgrip strength
Time frame: 1 day (Once only at screening)
5 chair stands
Time frame: 1 day (Once only at screening)
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 26 May 2022.
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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.
Jean Woo, MD principal investigator
Chinese 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 Frailty, run by Chinese University of Hong Kong 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 5 inclusion and 1 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 26 May 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 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?
Frailty status (time frame: 1 day (Once only at screening)). 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 26 May 2022.