Geriatric Hip Fractures Caregiver Programme
Primary Purpose
Geriatric Hip Fracture
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fractures
Sponsored by
About this trial
This is an interventional treatment trial for Geriatric Hip Fracture focused on measuring Empowerment, Caregiver, Geriatric Hip Fractures, Functional outcomes
Eligibility Criteria
Inclusion Criteria:
- Age ≥65
- Acute intracapsular or extracapsular proximal femur fracture
- Surgical treatment: Hemiarthroplasty or reduction-internal fixation
- Availability of caregiver
Exclusion Criteria:
- No caregiver support
- Non-operative treatment
- Pathological fracture
- Multiple fractures
- Patient discharged directly from the acute hospital without convalescence 6. Premorbid bedbound/chairbound status
Sites / Locations
- Queen Mary Hospital, The University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Standard Group
Arm Description
Outcomes
Primary Outcome Measures
Functional scores
Modified Barthel Index
Functional scores
EQ-5D-5L
Walking function
Timed-up-and-go test
Walking function
Timed-up-and-go test
Secondary Outcome Measures
Cumulative readmission rates
Cumulative readmission rates
Cumulative readmission rates
The length of stay in convalescent hospital
Number of subsequent injury with fractures
Full Information
NCT ID
NCT05393349
First Posted
April 26, 2022
Last Updated
May 23, 2022
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05393349
Brief Title
Geriatric Hip Fractures Caregiver Programme
Official Title
'Home Sweet Home' Programme: Empowering the Patient and Caregiver for Early and Safe Discharge of Patients With Geriatric Hip Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objective:
To study whether fracture hip patients can be benefited from the empowerment program
Hypothesis to be tested Primary hypothesis: empowerment program can improve the patient's functional recovery.
Secondary hypothesis: the program can improve readmission rate, length of stay, and secondary fracture.
Design and subjects This is a prospective randomised controlled trial and subjects are fracture hip patients
Instruments Ipads are needed to show the videos of the rehabilitation program
Interventions
The empowerment program consists of three main areas which directly correspond to the contents that the patients and caregivers expressed as most needed in interviews conducted by the investigators during hip fracture patients' follow up:
Knowledge of the disease
Confidence and skills in self-care management
Support in the post-discharge period
Main outcome measures
Primary outcomes:
Functional scores (Modified Barthel Index and EQ-5D-5L) at the first follow-up visit (3 months postop).
Timed-up-and-go test at follow-up at 6 months and 1 year.
Secondary outcome:
Cumulative readmission rates at 1 month, 6 months, and 1 year The length of stay in the convalescent hospital Subsequent injury with fractures within 1 year
Data analysis Chi-square test is used for categorical variables. For continuous variables, the normal distribution is determined by the Kolmogorov-Smirnov test. Independent t-test is used for comparing average values of normally distributed continuous variables, while the Wilcoxon rank sum test is used for comparing median values of abnormally distributed variables.
Binary logistic regression is used to determine predictive factors for outcomes. Multivariate analysis is performed to verify independent predictive factors for outcomes.
Expected results Fracture hip patients can be benefited from the empowerment program.
Detailed Description
Introduction:
Health care consequences of hip fracture The global incidence of geriatric hip fractures is projected to increase by more than 250% in the next twenty-five years. Local data showed that there was a steady increase from 3500 to more than 4500 hip fractures per year from 2000 to 2011. Nevertheless, the consequence of hip fractures is serious and costly. Ten percent of patients have a contralateral hip fracture, 30% of the patients are readmitted for other acute reasons, 25% need long-term care, 10-25% die within 1 year and almost 50% have residual functional disabilities.
Geriatric hip fracture clinical pathway decreased preoperative length of stay Since 2006, the geriatric hip fracture clinical pathway (GFH) has been implemented in the Hong Kong West Cluster. The implementation of GFH resulted in a decreased preoperative length of stay, decreased surgical site infection, decreased pressure sore, and decreased 30-day and 12-month mortality rate.
High dependency of patients upon discharge:
However, according to our data, a significant number of patients still required an extended length of stay, which is defined as more than 28 days in a rehabilitation hospital. More than 60% of the patients were discharged home, however, 39% and 51% of the patients had severe and moderate dependency respectively upon discharge from the rehabilitation hospital (Modified Barthel Index 0-60 and 61-90 respectively). Current training provided to those patients and their caregivers was brief and inadequate. The lack of a trained caregiver affects the decision to return home and patients may need settlement in nursing homes. Moreover, 12% had readmission within 28 days of discharge, with repeated falls accounting for the majority.
The patients were referred to a geriatric day hospital after discharge from the convalescent hospital. However, the waiting time for geriatric day hospital was 2 months. During this interval, the patients were discharged home and taken care of by the caregivers. The caregivers were unsupported and inadequately trained for the job.
Patient and caregiver empowerment for hip fracture patients in Hong Kong:
Patient empowerment has been used in patients with stroke and other geriatric conditions. There are only scarce studies focussing on geriatric hip fractures which required special care in terms of ambulation, transfers, and activities of daily living training. So far prospective randomized studies are lacking. A previous study showed patient empowerment resulted in a shortened length of stay and earlier return to previous living by comparing two hospitals.
In Hong Kong, the elderly hip fracture patients returning home are often taken care of by domestic helpers or family members. Caring for older patients after hospital discharge is challenging and many of their caregivers lack the confidence to do so. Hence, we opine that caregivers need special attention as well. Another study also studied the caregivers' burden of hip fracture patients in Taiwan. The caregivers experienced moderate burdens. Caregivers who could not access other resources for help experienced a higher burden.
There has been an increasing trend for patient and caregiver empowerment programs. A study done by Hendrix (2013) investigated the effects of an individualized caregiver training program on self-efficacy in-home care and symptom management. Results revealed a significant increase in self-efficacy after the training in the treatment group, however, their study focused on cancer patients only. Another study done by Coleman in the year 2004 tested whether an intervention designed to encourage older patients and their caregivers to assert a more active role during discharge could result in decreased rehospitalization rates. He showed the adjusted odds ratio comparing rehospitalization of intervention subjects with that of controls was 0.52 at 30 days, 0.43 at 90 days, and 0.57 at 180 days. Intervention patients reported high levels of confidence in obtaining essential information for managing their condition, communicating with members of the healthcare team, and understanding their medication regimen. Their patient population is heterogeneous and includes various medical and orthopaedic patients.
Most studies on patient and caregiver empowerment had shown positive results. The proposed study focuses on empowering hip fracture patients and their caregivers in all aspects in terms of ambulation, transfers, and activities of daily living training. The impact of empowerment on hip fracture patients and their caregivers has not been studied in Hong Kong and the aim of the project is to investigate if those fracture hip patients can be benefited from the empowerment program in terms of functional outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geriatric Hip Fracture
Keywords
Empowerment, Caregiver, Geriatric Hip Fractures, Functional outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Standard Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fractures
Intervention Description
Orthopaedic surgeon, geriatrician, physiotherapists, occupational therapists, and nurses will make videos (each 3-5 minutes long) which are available to the patients and caregivers during both the hospitalization period and after discharge. They will complement the therapists' training sessions and allow revision of the contents by the patients and caregivers anytime. The patients and caregivers will be asked to complete an assessment after they view the videos to reinforce the knowledge they learn in the videos. Caregivers can be patient's relatives, friends or domestic helper who can commit to visiting the patient at least two days per week during the early discharge period.
Primary Outcome Measure Information:
Title
Functional scores
Description
Modified Barthel Index
Time Frame
First follow up visit (3 months postop)
Title
Functional scores
Description
EQ-5D-5L
Time Frame
First follow up visit (3 months postop)
Title
Walking function
Description
Timed-up-and-go test
Time Frame
6 months
Title
Walking function
Description
Timed-up-and-go test
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cumulative readmission rates
Time Frame
1 month after hip surgery
Title
Cumulative readmission rates
Time Frame
6 months after hip surgery
Title
Cumulative readmission rates
Time Frame
2 years after hip surgery
Title
The length of stay in convalescent hospital
Time Frame
Up to discharge back to home
Title
Number of subsequent injury with fractures
Time Frame
within 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥65
Acute intracapsular or extracapsular proximal femur fracture
Surgical treatment: Hemiarthroplasty or reduction-internal fixation
Availability of caregiver
Exclusion Criteria:
No caregiver support
Non-operative treatment
Pathological fracture
Multiple fractures
Patient discharged directly from the acute hospital without convalescence 6. Premorbid bedbound/chairbound status
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathine Ching
Phone
22554466
Email
kathine@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tak Man Wong
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathine Ching
Phone
22554466
Email
kathine@hku.hk
First Name & Middle Initial & Last Name & Degree
Tak Man Wong
First Name & Middle Initial & Last Name & Degree
Frankie Ka Li Leung
First Name & Middle Initial & Last Name & Degree
Christian Xinshuo Fang
First Name & Middle Initial & Last Name & Degree
Dennis King Hang Yee
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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