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Clinical Trials/NCT04287101
NCT04287101CompletedNot Applicable

Home-Based Integrated Post-Acute Care Program for Hip Fracture

Taipei City Hospital1 site in 1 country41 target enrollmentStarted: March 2, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
41
Locations
1
Primary Endpoint
Quality of lives Using the EuroQol instrument (EQ-5D)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Arms & Interventions

home PAC

Experimental

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.

Intervention: Post-operative PT and OT (Other)

hospital PAC

Active Comparator

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.

Intervention: Post-operative PT and OT (Other)

conventional care group

No Intervention

usual care

Outcomes

Primary Outcomes

Quality of lives Using the EuroQol instrument (EQ-5D)

Time Frame: within 1 year

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.

Activities of daily living Using the Barthel Index (BI)

Time Frame: within 1 year

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.

Pain intensity Using the numerical pain rating scale (NPRS)

Time Frame: within 1 year

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).

Functional performance of hip Using the Harris hip score (HHS)

Time Frame: within 1 year

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.

Caregiver strain Using the caregiver strain index (CSI)

Time Frame: within 1 year

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.

30-second sit to stand

Time Frame: within 1 year

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.

Medical Costs

Time Frame: within 1 year

Ask participants to record their direct medical cost and indirect medical cost within one year after hip fracture.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Shih-Liang Shih

Director of Orthopedics

Taipei City Hospital

Study Sites (1)

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