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Post-acute Care for Patients With Hip Fracture

Primary Purpose

Hip Fractures, Activities of Daily Living

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Post-operative PT and OT
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Hip fractures, Post-acute care, Home-based care, Hospital-based care, Activities of daily living, Cost effectiveness analysis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged ≥ 50
  2. First hip fracture
  3. Stable medical condition

Exclusion Criteria:

  1. Hip fracture caused by major trauma or pathological condition
  2. Multiple fractures
  3. Severe physical disability before the hip fracture
  4. Unable to cooperate with treatment
  5. Further inpatient treatment

Sites / Locations

  • Taipei City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

home PAC

hospital PAC

conventional care group

Arm Description

A home PAC team will care for patients in his/her home within 3 weeks after acute hospitalization. The patient will get a physical therapy (PT) or occupational therapy (OT) 1 to 6 session(s) per week.

A rehabilitation PAC team will care for patients in the hospital within 3 weeks after acute hospitalization. The patient will have 1 to 2 session(s) of PT or OT on weekdays, and a daily physician visit and nurse care.

usual care

Outcomes

Primary Outcome Measures

30-second sit to stand
Ask participants to cross their arms at the chest, and to perform sit to stand as more as possible within 30 seconds. Measure the repetitions the participants do. Higher repetition indicates more strength of lower extremities.
Activities of daily living Using the Barthel Index (BI)
Using the Barthel Index (BI) to measure participants' activities of daily living. The self-care domain is self-report by the patient or their families. The mobility domain is observed by the assessor. The greater score indicates more independence.
Functional performance of hip Using the Harris hip score (HHS)
Using the Harris hip score (HHS) to measure participants' functional performance of hip. The pain domain is self-report by the patient. The function, deformity, and range of motion domain are observed by the assessor. The greater score indicates the better functional performance of hip.
Pain intensity Using the numerical pain rating scale (NPRS)
Using the numerical pain rating scale (NPRS) to measure participants' pain intensity. Ask participants to report their pain intensity with the 11-point scale (from 0 no pain to 10 worst possible pain).
Quality of lives Using the EuroQol instrument (EQ-5D)
Part 1: Ask participants to measure their mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with the 3-point scale. The greater score indicates poor quality of life.
Quality of lives Using the EuroQol instrument (EQ-5D)
Part 2: Ask participants to measure their quality of life with a 20-cm visual analog scale. The greater score indicates a better quality of life.
Caregiver strain Using the caregiver strain index (CSI)
Using the caregiver strain index (CSI) to measure the strain of caregiver. Ask them to fill a 13-item questionnaire. Greater value indicates a higher strain.
Medical Costs
Ask participants to record their direct medical cost and indirect medical cost within one year after hip fracture.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2020
Last Updated
June 30, 2022
Sponsor
Taipei City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04287101
Brief Title
Post-acute Care for Patients With Hip Fracture
Official Title
Home-Based Integrated Post-Acute Care Program for Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2021 (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
Background and purpose: Hip fracture, a common injury occurred in people aged over 50, may result in disability, poor quality of life, and higher care stress for their families. Aging population and growing number of hip fractures have increased medical expenses, so developed countries implemented post-acute care (PAC) to reduce acute hospitalization, and to improve the quality of care. PAC services can be delivered by hospital/facility-based and home-based services. Previous studies showed that both services could significantly improve patients' activities of daily living and quality of life, and reduce readmissions, long-term care and costs. Taiwan has implemented PAC plan for hip fractures since 2017, but relevant evidences are limited. Therefore, the purpose of this study is to analyze the efficacy and cost-effectiveness of PAC for patients with hip fractures.
Detailed Description
Methods: This is a prospective cohort study which will recruit patients aged over 50 with hip fractures receiving surgical treatment in the Taipei City Hospital. They will be provided home-based PAC, hospital-based PAC, or no formal PAC based on the medical judgment and patients/families' willingness. The period of PAC will be two to three weeks after the acute hospitalization. Assessments include physical function (30 seconds sit to stand, Barthel index, and Harris Hip Score), numerical pain rating scale, EuroQol instrument (EQ-5D), Caregiver Strain Index, and using of medical resources. The assessments will be on the day before discharge from acute hospitalization, and on the discharge day from post-acute care. The follow-up assessment will be at 1, 3, 6, and 12 months after operation. The cost-effectiveness ratio will be defined as the New Taiwan dollars paid for 1-unit improvement of functional performance and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Activities of Daily Living
Keywords
Hip fractures, Post-acute care, Home-based care, Hospital-based care, Activities of daily living, Cost effectiveness analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
home PAC
Arm Type
Experimental
Arm Description
A home PAC team will care for patients in his/her home within 3 weeks after acute hospitalization. The patient will get a physical therapy (PT) or occupational therapy (OT) 1 to 6 session(s) per week.
Arm Title
hospital PAC
Arm Type
Active Comparator
Arm Description
A rehabilitation PAC team will care for patients in the hospital within 3 weeks after acute hospitalization. The patient will have 1 to 2 session(s) of PT or OT on weekdays, and a daily physician visit and nurse care.
Arm Title
conventional care group
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Other
Intervention Name(s)
Post-operative PT and OT
Intervention Description
Strengthening exercise, range-of-motion exercise, functional training, balance training, adjustment for assistive devices, adaptation and modification of the home environment, and patient/caregiver education
Primary Outcome Measure Information:
Title
30-second sit to stand
Description
Ask participants to cross their arms at the chest, and to perform sit to stand as more as possible within 30 seconds. Measure the repetitions the participants do. Higher repetition indicates more strength of lower extremities.
Time Frame
within 1 year
Title
Activities of daily living Using the Barthel Index (BI)
Description
Using the Barthel Index (BI) to measure participants' activities of daily living. The self-care domain is self-report by the patient or their families. The mobility domain is observed by the assessor. The greater score indicates more independence.
Time Frame
within 1 year
Title
Functional performance of hip Using the Harris hip score (HHS)
Description
Using the Harris hip score (HHS) to measure participants' functional performance of hip. The pain domain is self-report by the patient. The function, deformity, and range of motion domain are observed by the assessor. The greater score indicates the better functional performance of hip.
Time Frame
within 1 year
Title
Pain intensity Using the numerical pain rating scale (NPRS)
Description
Using the numerical pain rating scale (NPRS) to measure participants' pain intensity. Ask participants to report their pain intensity with the 11-point scale (from 0 no pain to 10 worst possible pain).
Time Frame
within 1 year
Title
Quality of lives Using the EuroQol instrument (EQ-5D)
Description
Part 1: Ask participants to measure their mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with the 3-point scale. The greater score indicates poor quality of life.
Time Frame
within 1 year
Title
Quality of lives Using the EuroQol instrument (EQ-5D)
Description
Part 2: Ask participants to measure their quality of life with a 20-cm visual analog scale. The greater score indicates a better quality of life.
Time Frame
within 1 year
Title
Caregiver strain Using the caregiver strain index (CSI)
Description
Using the caregiver strain index (CSI) to measure the strain of caregiver. Ask them to fill a 13-item questionnaire. Greater value indicates a higher strain.
Time Frame
within 1 year
Title
Medical Costs
Description
Ask participants to record their direct medical cost and indirect medical cost within one year after hip fracture.
Time Frame
within 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥ 50 First hip fracture Stable medical condition Exclusion Criteria: Hip fracture caused by major trauma or pathological condition Multiple fractures Severe physical disability before the hip fracture Unable to cooperate with treatment Further inpatient treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih-Liang Shih, PhD.
Organizational Affiliation
Department of Orthopaedic, Taipei City Hospital, Zhongxing Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei City Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Post-acute Care for Patients With Hip Fracture

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