Geriatric Hip Fractures Caregiver Programme

NCT ID: NCT05393349

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-05
• Study Completion Date: 2023-08-31

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.

Conditions

Geriatric Hip Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

Group Type: EXPERIMENTAL

Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fractures

Intervention Type: BEHAVIORAL

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.

Standard Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fractures

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age ≥65

2. Acute intracapsular or extracapsular proximal femur fracture

3. Surgical treatment: Hemiarthroplasty or reduction-internal fixation

4. Availability of caregiver

Exclusion Criteria

1. No caregiver support

2. Non-operative treatment

3. Pathological fracture

4. Multiple fractures

5. Patient discharged directly from the acute hospital without convalescence 6. Premorbid bedbound/chairbound status

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Wong Tak-Man

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tak Man Wong

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Queen Mary Hospital, The University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Kathine Ching

Role: CONTACT

kathine@hku.hk

22554466

Facility Contacts

Kathine Ching

Role: primary

kathine@hku.hk

22554466

Other Identifiers

UW 19-574

Identifier Type: -

Identifier Source: org_study_id