Geriatric Hip FractureNCT05823129
'Home Sweet Home' Programme-2
A study testing Tele-rehabilitation caregiver empowerment enhanced post- discharge rehabilitation directive in people with Geriatric Hip Fracture, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Objectives: To determine the effectiveness of telerehabilitation on the quality of life and mobility of early post-discharge in hip fracture patients, and to investigate whether telerehabilitation in the form of daily TUG tests recorded digitally will improve recovery outcomes for post-surgery hip fracture patients. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Hip Fracture
- What is being tested?
- Tele-rehabilitation caregiver empowerment enhanced post- discharge rehabilitation directive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jul 2022to 20 Jan 2025
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Have provided informed consent to be included in the study
- Geriatrics ≥ 65 years of age
- Suffered hip fracture accompanied by successful surgery
- Less than 2 weeks following patient discharge from rehabilitation
- Less than four months post-operation
- Patients capable of walking on fracture without endangering their fracture fixation,
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- Patients have been taught how to walk in the rehabilitation centre
- Caretaker/family has the ability to conduct the TUG test
- patient's residence is spacious enough to safely perform TUG test
- Video calling showing the performance of the TUG test should be supported
- Caretaker should have basic technological competency
- Caretaker should have sufficient cognitive ability to understand the TUG test
- Caretaker should have the ability to supervise patient during the TUG test
- Patients should have similar post-surgery recovery progress
- Record at the start if each patient requires assistance - with or without aid, e.g. walking frame etc
- Should at least have the potential to walk
Who cannot join
- Patients with multiple fractures affecting mobility
- chair-bound or bed-bound
- Patients with severe cognitive impairment
- Assessed based on:
- unable to follow command to walk
- unable to identify time, person and space
Show all 10Show fewer
- Presence of terminal illnesses/diseases
- Presence of multiple medical illnesses
- Determined by the Charleson comorbidity score
- Patients excluded if the score is larger or equal to 6
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Christian Xinshuo Fang, 22554581, cfang@hku.hk
Christian Xinshuo Fang
About this study
Official title: Effectiveness of Telerehabilitation on Quality of Life and Mobility of Early Post-discharge Hip Fracture Patients
Objectives:
To determine the effectiveness of telerehabilitation on the quality of life and mobility of early post-discharge in hip fracture patients, and to investigate whether telerehabilitation in the form of daily TUG tests recorded digitally will improve recovery outcomes for post-surgery hip fracture patients.
Read more
Hypothesis to be tested:
Main hypothesis: Caregiver empowerment can improve functional walking and quality of life at 1 month after discharge Secondary hypothesis: Hospital readmission and mortality rate can be reduced.
Design and subjects:
This is a prospective randomised controlled trial and subjects are fracture hip patients
Instruments:
Timed-Up-and-Go (TUG) test, EuroQol EQ5D-5L, Parker Mobility score
Interventions:
A videoconference scheduled at the 1st post-discharge week provides clear instructions and directions on how to perform daily exercise prescriptions based on the TUG test. Video instructions and multimedia for review will be provided. Interim videoconference will be conducted again after week 2 to ascertain adherence.
Main outcome measures:
Primary outcomes:
Timed-Up-and-Go (TUG) test taken at day 0 and 28
Secondary outcome:
EQ5D-3L and Parker Mobility Score taken on day 0 and 28
Other covariates Patient baseline demographics Classification of hip fractures Type of surgical intervention Comorbidities
Any adverse events occurring:
- Severe adverse events including: unplanned hospital readmissions, fall injury causing fractures, failure of internal fixation, death
- Other adverse events including: unplanned clinic visits, complications requiring change in rehabilitation plan or additional medical/ surgical intervention, complications requiring closer observation
Data analysis:
Shapiro-Wilk test and independent sample t-test is performed for variables to ascertain normal distribution and compared for main outcomes. Binary variables and categorical variables with Chi-squared tests. Time-based outcomes are compared using Kaplan-Meier time to event analysis and log-rank test. A type 1 error rate / p value of 0.05 is used for statistical significance.
Expected results:
Fracture hip patients can be benefited from the empowerment program
Read the detailed description
Rehabilitation after hip fracture surgery is crucial in the recovery process for hip fracture patients. Although huge emphasis has been placed on the importance of undertaking post-surgery daily exercise routines to patients, some patients still neglect these exercise routines due to various reasons, leading to insufficient recovery.
The Geriatric Hip Fracture Clinical Pathway (GHFCP) is first designed and implemented in the Hong Kong West Cluster. The implementation of the GHFCP resulted in a decreased preoperative and total length of stay, decreased surgical site infection, decreased pressure sore, decreased 30-days and 12-months mortality rate.
GHFCP specifically streamline acute and rehabilitation in-patient healthcare delivery and ends after the patient is discharged.
Through many studies, telerehabilitation has proven to promote recovery in post-surgery patients, especially those that had undergone orthopaedic surgery. Present evidence indicates a strong positive effect for patients undergoing telerehabilitation post-orthoepaedic surgery, with a systematic review and meta-analysis suggesting that "increased intensity provided by telerehabilitation is a promising option to be offered to patients."
At the same time, the Timed-up-and-Go (TUG) test has proven to be an accurate and objective assessment of the physical mobility of geriatric individuals. It is quick and easy to perform without the requirement for special equipment or training. When utilized as a descriptive tool, Timed-up-and-Go test data can detail a patient's balance, gait speed, and functional ability. As such, it is a suitable test to be utilized for telerehabilitation due to its easy operation and ability to communicate sufficient patient data, all of which can be done in a patient's own home and sent electronically through the internet to healthcare professionals. TUG when performs daily may incent by patients' adherence to rehabilitation in form of a biofeedback loop.
With evidence displaying the effectiveness of the TUG test and telerehabilitation in their respective fields, this research aims to combine the two and provide telerehabilitation in the format of regular TUG tests in conjunction with an e-response system, encouraging patients to perform the exercise appropriately, thus improving their post-surgical outcomes.
- Conditions
- Geriatric Hip Fracture
- Being tested
- Tele-rehabilitation caregiver empowerment enhanced post- discharge rehabilitation directive
- Keywords
- Empowerment, Telerehabilitation, Geriatric Hip Fractures, Functional outcomes
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-rehabilitation caregiver empowerment enhanced post- discharge rehabilitation directiveBehavioural
The intervention group will receive an implemented TUG test-based telerehabilitation program. The TUG test-based telerehabilitation involves patients routinely doing two TUG tests by themselves twice daily. Each patient will be provided with a unique link to the TUGstopwatch, a prerecorded video outlining instructions on how to properly conduct a TUG test, and support and guidance for patients and caregivers throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Standard Group | No intervention | Usual clinical protocol is followed, the caregiver is given verbal training and assistive instructions by therapists and clinicians before patient discharge. Brief pamphlets are provided on post-operative care of patients. Patients are encouraged to perform rehabilitative exercises according to "what they have learned" during the in-patient stay. "Remote-TUG" app is only used in the first and final assessment at day 30. |
| Intervention Group | Experimental | A recruitment assessment videoconference is scheduled at the 1st post-discharge week providing clear instructions on how to perform daily TUG test. The TUG test is to be performed at least twice in the morning and twice afternoon and complimented by other specific training exercises as specified in HSH1. Training instructions and assessment is performed by videoconference to ascertain that both the patient and the caregiver can follow instructions in using the "remote-TUG" smartphone app and safety measures are understood and applied when assisting the patients in exercises. Clear video instructions and multimedia for review will be provided. Interim videoconference will be conducted again after week 2 to ascertain adherence. Non-adherence can be immediately detected by remote data collection from the "remote-TUG" server interface. Non-adherence will trigger phone calls and videoconferences serving as reminders and performing troubleshooting. Receives: Behavioral: Tele-rehabilitation caregiver empowerment enhanced post- discharge rehabilitation directive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking function between Day 0 and Day 28
Timed-Up-and-Go (TUG) test
Measured: Change in TUG test between Day 0 and Day 28
Secondary outcomes (3)
Change in Health-related quality of life between Day 0 and Day 28
The EQ5D-5L is a patient-reported outcome measure of health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each level is rated on scale that describes the degree of problems in that area. This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.
Measured: Change in quality of life between Day 0 and Day 28
Change in Patient's mobility measured by Parker Mobility Score between Day 0 and Day 28
The Parker Mobility Score is a composite measurement of the patient's mobility indoors, outdoors, and during shopping. It is a 3-item patient-reported measure, each item valued 0-3 points, the total score ranges from 0 (worst possible mobility) to 9 (best possible mobility)
Measured: Change in mobility score between Day 0 and Day 28
Incidence of severe adverse events
Incidence of unplanned hospital readmissions, fall injury causing fractures, failure of internal fixation, death will be recorded
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start15 Jul 2022
- Primary completion16 Jul 2024 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric Hip FractureStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823129
- Sponsor's protocol ID
- UW 22-095
- Status last verified
- Apr 2023
- First submitted
- 27 Oct 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Telerehabilitation on Quality of Life and Mobility of Early Post-discharge Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT05823129
- Acronym / sponsor ID
- UW 22-095
- Conditions
- Geriatric Hip Fracture
- Keywords
- Empowerment, Telerehabilitation, Geriatric Hip Fractures, Functional outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 16 Jul 2024 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 21 Apr 2023 (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.
Objectives:
To determine the effectiveness of telerehabilitation on the quality of life and mobility of early post-discharge in hip fracture patients, and to investigate whether telerehabilitation in the form of daily TUG tests recorded digitally will improve recovery outcomes for post-surgery hip fracture patients.
Hypothesis to be tested:
Main hypothesis: Caregiver empowerment can improve functional walking and quality of life at 1 month after discharge Secondary hypothesis: Hospital readmission and mortality rate can be reduced.
Design and subjects:
This is a prospective randomised controlled trial and subjects are fracture hip patients
Instruments:
Timed-Up-and-Go (TUG) test, EuroQol EQ5D-5L, Parker Mobility score
Interventions:
A videoconference scheduled at the 1st post-discharge week provides clear instructions and directions on how to perform daily exercise prescriptions based on the TUG test. Video instructions and multimedia for review will be provided. Interim videoconference will be conducted again after week 2 to ascertain adherence.
Main outcome measures:
Primary outcomes:
Timed-Up-and-Go (TUG) test taken at day 0 and 28
Secondary outcome:
EQ5D-3L and Parker Mobility Score taken on day 0 and 28
Other covariates Patient baseline demographics Classification of hip fractures Type of surgical intervention Comorbidities
Any adverse events occurring:
- Severe adverse events including: unplanned hospital readmissions, fall injury causing fractures, failure of internal fixation, death
- Other adverse events including: unplanned clinic visits, complications requiring change in rehabilitation plan or additional medical/ surgical intervention, complications requiring closer observation
Data analysis:
Shapiro-Wilk test and independent sample t-test is performed for variables to ascertain normal distribution and compared for main outcomes. Binary variables and categorical variables with Chi-squared tests. Time-based outcomes are compared using Kaplan-Meier time to event analysis and log-rank test. A type 1 error rate / p value of 0.05 is used for statistical significance.
Expected results:
Fracture hip patients can be benefited from the empowerment program
Detailed description
Rehabilitation after hip fracture surgery is crucial in the recovery process for hip fracture patients. Although huge emphasis has been placed on the importance of undertaking post-surgery daily exercise routines to patients, some patients still neglect these exercise routines due to various reasons, leading to insufficient recovery.
The Geriatric Hip Fracture Clinical Pathway (GHFCP) is first designed and implemented in the Hong Kong West Cluster. The implementation of the GHFCP resulted in a decreased preoperative and total length of stay, decreased surgical site infection, decreased pressure sore, decreased 30-days and 12-months mortality rate.
GHFCP specifically streamline acute and rehabilitation in-patient healthcare delivery and ends after the patient is discharged.
Through many studies, telerehabilitation has proven to promote recovery in post-surgery patients, especially those that had undergone orthopaedic surgery. Present evidence indicates a strong positive effect for patients undergoing telerehabilitation post-orthoepaedic surgery, with a systematic review and meta-analysis suggesting that "increased intensity provided by telerehabilitation is a promising option to be offered to patients."
At the same time, the Timed-up-and-Go (TUG) test has proven to be an accurate and objective assessment of the physical mobility of geriatric individuals. It is quick and easy to perform without the requirement for special equipment or training. When utilized as a descriptive tool, Timed-up-and-Go test data can detail a patient's balance, gait speed, and functional ability. As such, it is a suitable test to be utilized for telerehabilitation due to its easy operation and ability to communicate sufficient patient data, all of which can be done in a patient's own home and sent electronically through the internet to healthcare professionals. TUG when performs daily may incent by patients' adherence to rehabilitation in form of a biofeedback loop.
With evidence displaying the effectiveness of the TUG test and telerehabilitation in their respective fields, this research aims to combine the two and provide telerehabilitation in the format of regular TUG tests in conjunction with an e-response system, encouraging patients to perform the exercise appropriately, thus improving their post-surgical outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Group | No intervention | –Usual clinical protocol is followed, the caregiver is given verbal training and assistive instructions by therapists and clinicians before patient discharge. Brief pamphlets are provided on post-operative care of patients. Patients are encouraged to perform rehabilitative exercises according to "what they have learned" during the in-patient stay. "Remote-TUG" app is only used in the first and final assessment at day 30. |
| Intervention Group | Experimental | Behavioral: Tele-rehabilitation caregiver empowerment enhanced post- discharge rehabilitation directiveA recruitment assessment videoconference is scheduled at the 1st post-discharge week providing clear instructions on how to perform daily TUG test. The TUG test is to be performed at least twice in the morning and twice afternoon and complimented by other specific training exercises as specified in HSH1. Training instructions and assessment is performed by videoconference to ascertain that both the patient and the caregiver can follow instructions in using the "remote-TUG" smartphone app and safety measures are understood and applied when assisting the patients in exercises. Clear video instructions and multimedia for review will be provided. Interim videoconference will be conducted again after week 2 to ascertain adherence. Non-adherence can be immediately detected by remote data collection from the "remote-TUG" server interface. Non-adherence will trigger phone calls and videoconferences serving as reminders and performing troubleshooting. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- Have provided informed consent to be included in the study
- Geriatrics ≥ 65 years of age
- Suffered hip fracture accompanied by successful surgery
- Patients capable of walking on fracture without endangering their fracture fixation,
- Patients have been taught how to walk in the rehabilitation centre
Key exclusion criteria (10 listed)
- Patients with multiple fractures affecting mobility
- chair-bound or bed-bound
- Patients with severe cognitive impairment
- Presence of terminal illnesses/diseases
- Presence of multiple medical illnesses
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 |
|---|---|---|
| Tele-rehabilitation caregiver empowerment enhanced post- discharge rehabilitation directiveThe intervention group will receive an implemented TUG test-based telerehabilitation program. The TUG test-based telerehabilitation involves patients routinely doing two TUG tests by themselves twice daily. Each patient will be provided with a unique link to the TUGstopwatch, a prerecorded video outlining instructions on how to properly conduct a TUG test, and support and guidance for patients and caregivers throughout the study period. | Behavioural | Intervention Group |
Primary outcome
Change in Walking function between Day 0 and Day 28
Time frame: Change in TUG test between Day 0 and Day 28
Timed-Up-and-Go (TUG) test
3 secondary outcomes
Change in Health-related quality of life between Day 0 and Day 28
Time frame: Change in quality of life between Day 0 and Day 28
Change in Patient's mobility measured by Parker Mobility Score between Day 0 and Day 28
Time frame: Change in mobility score between Day 0 and Day 28
Incidence of severe adverse events
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-rehabilitation caregiver empowerment enhanced post- discharge rehabilitation directive in people with Geriatric Hip Fracture, run by The University of Hong Kong at 1 site in Hong Kong.
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 16 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Walking function between Day 0 and Day 28 (time frame: Change in TUG test between Day 0 and Day 28). 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 6 May 2023.