Ambulatory Geriatric Outpatients at High Risk of FrailtyNCT02160093
Impact of Chronic Disease Control and Aging Psychology on Outcomes of Frailty-Sarcopenia Syndrome in Ambulatory Geriatric Patients
An observational study of Ambulatory Geriatric Outpatients at High Risk of Frailty, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Pursuant to our previous longitudinal study (ClinicalTrials.gov ID: NCT02073370) in geriatric outpatients cooperated with the Department of Family Medicine, Department of Geriatrics and Gerontology, National Taiwan University Hospital, this study will be conducted to examine the impacts of the specific co-morbidities… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ambulatory Geriatric Outpatients at High Risk of Frailty
- How many people
- 151 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2014to Aug 2016
- 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: Ambulatory geriatric outpatients aged 65 and over from NTUH
Who may be able to join
- functional decline in recent one year
- cognitive function decline
- depressive symptom
- mobility impairment
- fall in recent one year
- eating or feeding problems/weight loss
Show all 12Show fewer
- co-morbid conditions≧5
- tracking by different physician ≧3 in recent half year
- polypharmacy≧8 in recent 3 months
- hospitalization ≧1 in recent one year
- emergency visits≧2 in recent one year
- aged ≧ 80
Who cannot join
- non-ambulatory (bed-ridden) patients
- long-term residents at nursing homes
- patients with a life expectancy shorter than six months
- impairment in vision, hearing, or communicative ability
- making convenience of clinical evaluation during the study period impossible.
Trial locations and contacts
1 site in 1 country.
About this study
Pursuant to our previous longitudinal study (ClinicalTrials.gov ID: NCT02073370) in geriatric outpatients cooperated with the Department of Family Medicine, Department of Geriatrics and Gerontology, National Taiwan University Hospital, this study will be conducted to examine the impacts of the specific co-morbidities and ageing psychology on the outcomes of frailty/sarcopenia syndrome. The thresholds of specific chronic disease will be reviewed after frailty being considered in the elderly with co-morbidity condition. In addition, the conceptual framework and corresponding measuring instrument of "mental frailty" will be expected developed.
- Keywords
- sarcopenia, frailty, chronic disease control, aging psychology
- Medical subject headings
- Sarcopenia, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation instrument of mental frailty for older adults
The psychological adaptation to aging is a dynamic process. The dynamic process and the Selection-Optimization-Compensation process will have their effect on the actual coping actions in everyday life. The instruments will be set up to evaluate the aging psychology process
Measured: Up to 2 years
Secondary outcomes (1)
Compare the well chronic disease control and inappropriate condition on the dynamic frail transitions in ambulatory geriatric outpatients
The records of chronic disease control status of the same ambulatory geriatric outpatients from previous study, "Clinical evaluation, biomarkers and metabolomics of sarcopenia in frail older adults at ambulatory clinics", will be linked to this study.
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ambulatory Geriatric Outpatients at High Risk of 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Yu Chen, MD, Principal investigator, National Taiwan University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160093
- Sponsor's protocol ID
- 201404030RIND
- Status last verified
- Nov 2016
- First submitted
- 3 Jun 2014
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Disease Control and Aging Psychology on Outcomes of Frailty-Sarcopenia Syndrome in Ambulatory Geriatric Patients
- ClinicalTrials.gov ID
- NCT02160093
- Acronym / sponsor ID
- 201404030RIND
- Keywords
- sarcopenia, frailty, chronic disease control, aging psychology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Jun 2014 (estimated)
- 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.
Pursuant to our previous longitudinal study (ClinicalTrials.gov ID: NCT02073370) in geriatric outpatients cooperated with the Department of Family Medicine, Department of Geriatrics and Gerontology, National Taiwan University Hospital, this study will be conducted to examine the impacts of the specific co-morbidities and ageing psychology on the outcomes of frailty/sarcopenia syndrome. The thresholds of specific chronic disease will be reviewed after frailty being considered in the elderly with co-morbidity condition. In addition, the conceptual framework and corresponding measuring instrument of "mental frailty" will be expected developed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Ambulatory geriatric outpatients aged 65 and over from NTUH
Key inclusion criteria (12 listed)
- functional decline in recent one year
- cognitive function decline
- depressive symptom
- mobility impairment
- fall in recent one year
Key exclusion criteria (5 listed)
- non-ambulatory (bed-ridden) patients
- long-term residents at nursing homes
- patients with a life expectancy shorter than six months
- impairment in vision, hearing, or communicative ability
- making convenience of clinical evaluation during the study period impossible.
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
Operation instrument of mental frailty for older adults
Time frame: Up to 2 years
The psychological adaptation to aging is a dynamic process. The dynamic process and the Selection-Optimization-Compensation process will have their effect on the actual coping actions in everyday life. The instruments will be set up to evaluate the aging psychology process
1 secondary outcome
Compare the well chronic disease control and inappropriate condition on the dynamic frail transitions in ambulatory geriatric outpatients
Time frame: up to 4 years
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 10 Nov 2016.
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.
Ching-Yu Chen, MD principal investigator
National Taiwan University, College of Medicine
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 Ambulatory Geriatric Outpatients at High Risk 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 12 inclusion and 5 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 10 Nov 2016. 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?
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?
Operation instrument of mental frailty for older adults (time frame: Up to 2 years). 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 10 Nov 2016.