Back to resultsPost-acute Care for Patients With Frailty
Primary Purpose
Frailty, Retrospective Study
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Post-acute care
Sponsored by
About this trial
This is an interventional treatment trial for Frailty
Eligibility Criteria
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
Sites / Locations
- Taipei City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Post-acute care
control group
Arm Description
comprehensive geriatric assessment, and either home-based or hospital-based post-acute care
comprehensive geriatric assessment only
Outcomes
Primary Outcome Measures
90-day emergency room visits
Emergency room visits after post-acute care
90-day readmissions
Readmissions visits after post-acute care
90-day mortality
Mortality after post-acute care
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05452395
Brief Title
Post-acute Care for Patients With Frailty
Official Title
Integrated Post-Acute Care Program for Frail Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 19, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei City Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Retrospective Study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Post-acute care
Arm Type
Experimental
Arm Description
comprehensive geriatric assessment, and either home-based or hospital-based post-acute care
Arm Title
control group
Arm Type
No Intervention
Arm Description
comprehensive geriatric assessment only
Intervention Type
Other
Intervention Name(s)
Post-acute care
Intervention Description
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.
Primary Outcome Measure Information:
Title
90-day emergency room visits
Description
Emergency room visits after post-acute care
Time Frame
90 days after post-acute care
Title
90-day readmissions
Description
Readmissions visits after post-acute care
Time Frame
90 days after post-acute care
Title
90-day mortality
Description
Mortality after post-acute care
Time Frame
90 days after post-acute care
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tai-Yin Wu, PhD
Organizational Affiliation
Department of Family Medicine, Taipei City Hospital, Zhongxing Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei City Hospital
City
Taipei City
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Post-acute Care for Patients With Frailty
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