Hip FracturesNCT04287101
Post-acute Care for Patients With Hip Fracture
A study testing Post-operative PT and OT in people with Hip Fractures and Activities of Daily Living, run by Taipei City Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fractures, Activities of Daily Living
- What is being tested?
- Post-operative PT and OT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Mar 2020to 31 Dec 2021
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 50
- First hip fracture
- Stable medical condition
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-Based Integrated Post-Acute Care Program for Hip Fracture
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.
Read the 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.
- Conditions
- Hip Fractures, Activities of Daily Living
- Being tested
- Post-operative PT and OT
- Keywords
- Hip fractures, Post-acute care, Home-based care, Hospital-based care, Activities of daily living, Cost effectiveness analysis
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-operative PT and OTOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Post-operative PT and OT |
| 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. Receives: Other: Post-operative PT and OT |
| conventional care group | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 1 year
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.
Measured: within 1 year
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.
Measured: within 1 year
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).
Measured: within 1 year
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.
Measured: within 1 year
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.
Measured: within 1 year
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.
Measured: within 1 year
Medical Costs
Ask participants to record their direct medical cost and indirect medical cost within one year after hip fracture.
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start2 Mar 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shih-Liang Shih, Taipei City Hospital
- Investigators
- Shih-Liang Shih, PhD., Principal investigator, Department of Orthopaedic, Taipei City Hospital, Zhongxing Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287101
- Sponsor's protocol ID
- PAC for hip fracture
- Status last verified
- Jun 2022
- First submitted
- 25 Feb 2020
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Integrated Post-Acute Care Program for Hip Fracture
- ClinicalTrials.gov ID
- NCT04287101
- Acronym / sponsor ID
- PAC for hip fracture
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Feb 2020 (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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| home PAC | Experimental | Other: Post-operative PT and OTA 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. |
| hospital PAC | Active comparator | Other: Post-operative PT and OTA 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. |
| conventional care group | No intervention | –usual care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥ 50
- First hip fracture
- Stable medical condition
Key exclusion criteria (5 listed)
- 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
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-operative PT and OTStrengthening exercise, range-of-motion exercise, functional training, balance training, adjustment for assistive devices, adaptation and modification of the home environment, and patient/caregiver education | Other | home PAC, hospital PAC |
Primary outcome
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.
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.
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.
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).
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.
Quality of lives Using the EuroQol instrument (EQ-5D)
Time frame: within 1 year
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)
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.
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.
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 5 Jul 2022.
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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.
Shih-Liang Shih, PhD. principal investigator
Department of Orthopaedic, 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-operative PT and OT in people with Hip Fractures and Activities of Daily Living, 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 3 inclusion and 5 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 5 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?
30-second sit to stand (time frame: within 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2022.