FrailtyNCT05452395
Post-acute Care for Patients With Frailty
A study testing Post-acute care in people with Frailty and Retrospective Study, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
Acute illness could be enormous stress for frail people. Combining comprehensive geriatric assessment and multifactorial intervention has positive effects on frail community older adults. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frailty, Retrospective Study
- What is being tested?
- Post-acute care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Jun 2020to 31 Dec 2020
- Phase
- Interventional
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Mild to severe frailty identified by the Clinical Frailty Scale
- Age ≥ 75 years
- Diagnosis with Parkinson's disease, dementia, chronic obstructive pulmonary disease, or chronic kidney disease stage three or worse
- Acute hospital stays between 3 to 30 days with deconditioning
- Stable medical condition with no need of intensive care, laboratory examination, or oxygen dependence
Who cannot join
- Refused to participate in the program
- Candidate for other post-acute care programs (i.e. stroke, traumatic neurological injury, or fracture)
- Unable to cooperate with the program due to mental or cognitive impairment
- Long-term ventilator-dependence
- Long-term bed-ridden status (> 6 months)
- Diagnosed as end of life and in need of palliative care
Show all 9Show fewer
- Diagnosed as major illness (i.e. end-stage renal disease) and in need of frequent inpatient treatment ( > 3 times over recent 6 months)
- Institutional residents
- Home medical care participants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Post-Acute Care Program for Frail Elderly
Acute illness could be enormous stress for frail people. Combining comprehensive geriatric assessment and multifactorial intervention has positive effects on frail community older adults. However, few studies investigated the effects of post-acute care (PAC) in frail older patients who just recovered from acute hospitalization. This study aimed to evaluate the effects of PAC on frail older adults in Taiwan.
Read the detailed description
Frail patients aged >= 75 were recruited and divided into PAC or control groups. The PAC group received comprehensive geriatric assessment (CGA) and multifactorial intervention for two to four weeks. The control group received CGA only. The primary outcomes were 90-day emergency room visits, readmissions, and mortality after PAC.
- Conditions
- Frailty, Retrospective Study
- Being tested
- Post-acute care
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-acute careOther
A personalized care program, focusing on managing geriatric syndromes and improving functional performances.
Strength training, activities of daily living (ADL) and instrumental activities of daily living (IADL) practice, basic mobility training, reconditioning exercise, and home environment assessment and modification.
| Study group | Role | What they receive |
|---|---|---|
| Post-acute care | Experimental | comprehensive geriatric assessment, and either home-based or hospital-based post-acute care Receives: Other: Post-acute care |
| control group | No intervention | comprehensive geriatric assessment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day emergency room visits
Emergency room visits after post-acute care
Measured: 90 days after post-acute care
90-day readmissions
Readmissions visits after post-acute care
Measured: 90 days after post-acute care
90-day mortality
Mortality after post-acute care
Measured: 90 days after post-acute care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start19 Jun 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tai-Yin Wu, Taipei City Hospital
- Investigators
- Tai-Yin Wu, PhD, Principal investigator, Department of Family Medicine, Taipei City Hospital, Zhongxing Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452395
- Sponsor's protocol ID
- TPECH-frailty
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee MC, Wu TY, Huang SJ, Chen YM, Hsiao SH, Tsai CY. Post-acute care for frail older people decreases 90-day emergency room visits, readmissions and mortality: An interventional study. PLoS One. 2023 Jan 6;18(1):e0279654. doi: 10.1371/journal.pone.0279654. eCollection 2023.
PubMed 36607971
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Post-Acute Care Program for Frail Elderly
- ClinicalTrials.gov ID
- NCT05452395
- Acronym / sponsor ID
- TPECH-frailty
- Conditions
- Frailty, Retrospective Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 11 Jul 2022 (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.
Acute illness could be enormous stress for frail people. Combining comprehensive geriatric assessment and multifactorial intervention has positive effects on frail community older adults. However, few studies investigated the effects of post-acute care (PAC) in frail older patients who just recovered from acute hospitalization. This study aimed to evaluate the effects of PAC on frail older adults in Taiwan.
Detailed description
Frail patients aged >= 75 were recruited and divided into PAC or control groups. The PAC group received comprehensive geriatric assessment (CGA) and multifactorial intervention for two to four weeks. The control group received CGA only. The primary outcomes were 90-day emergency room visits, readmissions, and mortality after PAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-acute care | Experimental | Other: Post-acute carecomprehensive geriatric assessment, and either home-based or hospital-based post-acute care |
| control group | No intervention | –comprehensive geriatric assessment only |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Mild to severe frailty identified by the Clinical Frailty Scale
- Age ≥ 75 years
- Diagnosis with Parkinson's disease, dementia, chronic obstructive pulmonary disease, or chronic kidney disease stage three or worse
- Acute hospital stays between 3 to 30 days with deconditioning
- Stable medical condition with no need of intensive care, laboratory examination, or oxygen dependence
Key exclusion criteria (9 listed)
- Refused to participate in the program
- Candidate for other post-acute care programs (i.e. stroke, traumatic neurological injury, or fracture)
- Unable to cooperate with the program due to mental or cognitive impairment
- Long-term ventilator-dependence
- Long-term bed-ridden status (> 6 months)
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 |
|---|---|---|
| Post-acute careA personalized care program, focusing on managing geriatric syndromes and improving functional performances. Strength training, activities of daily living (ADL) and instrumental activities of daily living (IADL) practice, basic mobility training, reconditioning exercise, and home environment assessment and modification. | Other | Post-acute care |
Primary outcome
90-day emergency room visits
Time frame: 90 days after post-acute care
Emergency room visits after post-acute care
90-day readmissions
Time frame: 90 days after post-acute care
Readmissions visits after post-acute care
90-day mortality
Time frame: 90 days after post-acute care
Mortality after post-acute care
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 11 Jul 2022.
- Derived from this study: PubMed 36607971Lee MC, Wu TY, Huang SJ, Chen YM, Hsiao SH, Tsai CY. Post-acute care for frail older people decreases 90-day emergency room visits, readmissions and mortality: An interventional study. PLoS One. 2023 Jan 6;18(1):e0279654. doi: 10.1371/journal.pone.0279654. eCollection 2023.
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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.
Tai-Yin Wu, PhD principal investigator
Department of Family Medicine, Taipei City Hospital, Zhongxing Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-acute care in people with Frailty and Retrospective Study, run by Taipei City 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 5 inclusion and 9 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 11 Jul 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 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?
90-day emergency room visits (time frame: 90 days after post-acute care). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05452395, which also lists 1 linked publication.
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 11 Jul 2022.