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'Home Sweet Home' Programme-2

NCT05823129 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2023-05-06

No results posted yet for this study

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

Conditions

  • Geriatric Hip Fracture

Interventions

BEHAVIORAL

Tele-rehabilitation caregiver empowerment enhanced post- discharge rehabilitation directive

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.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2024-07-16
Completion
2025-01-20

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05823129 on ClinicalTrials.gov