- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05452395
Post-acute Care for Patients With Frailty
July 6, 2022 updated by: Tai-Yin Wu, Taipei City Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
254
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei City, Taiwan
- Taipei City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Post-acute care
comprehensive geriatric assessment, and either home-based or hospital-based post-acute care
|
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. |
|
No Intervention: control group
comprehensive geriatric assessment only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
90-day emergency room visits
Time Frame: 90 days after post-acute care
|
Emergency room visits after post-acute care
|
90 days after post-acute care
|
|
90-day readmissions
Time Frame: 90 days after post-acute care
|
Readmissions visits after post-acute care
|
90 days after post-acute care
|
|
90-day mortality
Time Frame: 90 days after post-acute care
|
Mortality after post-acute care
|
90 days after post-acute care
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tai-Yin Wu, PhD, Department of Family Medicine, Taipei City Hospital, Zhongxing Branch
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 19, 2020
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
July 6, 2022
First Submitted That Met QC Criteria
July 6, 2022
First Posted (Actual)
July 11, 2022
Study Record Updates
Last Update Posted (Actual)
July 11, 2022
Last Update Submitted That Met QC Criteria
July 6, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TPECH-frailty
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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