Clinical trial NCT05823129: 'Home Sweet Home' Programme-2
Official title: Effectiveness of Telerehabilitation on Quality of Life and Mobility of Early Post-discharge Hip Fracture Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Geriatric Hip Fracture
Keywords: Empowerment
Telerehabilitation
Geriatric Hip Fractures
Functional outcomes
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 138
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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,
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in Walking function between Day 0 and Day 28
timeFrame: Change in TUG test between Day 0 and Day 28
Secondary outcomes:
measure: Change in Health-related quality of life between Day 0 and Day 28
timeFrame: Change in quality of life between Day 0 and Day 28
measure: Change in Patient's mobility measured by Parker Mobility Score between Day 0 and Day 28
timeFrame: Change in mobility score between Day 0 and Day 28
measure: Incidence of severe adverse events
timeFrame: Day 28
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
Study officials:
References: