NCT04053348

Brief Summary

The steady increase in the incidence of geriatric hip fracture places an increasing burden on health care service in Hong Kong. Post fracture limitations are prominent and restrain many of the elderly from returning to community, rehabilitation is therefore important for reducing their long-term disability. By integrating the results from pilot application of video guided training and tele-physiotherapy program in different phases of rehabilitation, a Mobile Application (app) is developed aiming to improve hip fracture patients' and their carers' experience throughout the healthcare journey and empower them to manage their own health. A steering group comprised of physiotherapists, informatics and university research expert is formed to co-design the app, compose education content and formulate the promulgation and evaluation strategies. Meetings are also held with all involved clinicians to refine the app before implementation. This app provides features for hip fracture rehabilitation including "Understanding Hip Fracture", "Hip Fracture Care", "Training" and "Companion". Patients and their carers can obtain hip fracture care related information through the app anywhere, anytime, instead of coming to the clinics in person or reading the information on pamphlets. Physiotherapists can use the app to set training program for discharged patients with "Push Reminder" function and training record can be saved in "Progress Summary", which facilitates them and carers to get a grip on the patients' rehabilitation progress. Clinical study is therefore planned to be conducted to evaluate the effectiveness of the app from different perspectives, including the users' acceptance and satisfaction, patients' program compliance and functional recovery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

August 8, 2019

Last Update Submit

February 9, 2021

Conditions

Keywords

Mobile AppTelerehabilitationPhysiotherapyHip Fractures

Outcome Measures

Primary Outcomes (4)

  • Lower extremity functional scale

    LEFS is a 20-item questionnaire intended to measure patients' functions with a wide range of lower extremity conditions. Each item is rated on a five-point scale (0 - extreme difficulty or unable to perform activity, 4 - no difficulty); total scores range from 0 to 80, and lower scores represent greater difficulty. It has been shown to be highly reliable, correlates with other constructs, and is an independent predictor of patient and physician assessment of change in patients. The minimal clinically important difference (MCID) for the LEFS is 9 points.

    2 months

  • Elderly Mobility Scale

    The Elderly Mobility scale (EMS) is used to assess an individual's mobility problems through seven functional activities including lying, siting, standing and walking. The possible total score is 20. Patients that get a score under 10 indicate they are dependent in mobility. They require other people to assist their basic activities of daily living (ADL). Patients that get a score between 10 and 13 indicate they are marginal in terms of safe mobility however independent in ADL to a certain extent. Patients that get a score over 14 indicate they are able to perform mobility independently and safely. They are independent in basic ADL. EMS has been demonstrated a good inter-rater reliability and concurrent validity.

    2 months

  • Modified Functional Ambulatory Category

    The MFAC is a 7-point Likert Scale (1 -7) that is used to classify a patient's walking capacity. Gait is divided into seven categories, ranging from no ability to walk and requires manual assistance to sit or is unable to sit for 1 minute without back or hand support (MFAC 1) to the ability to walk independently on level and non-level surfaces, stairs, and inclines (MFAC 7). The inter-rater reliability of the MFAC (intraclass coefficient \[ICC\]) was 0.982 (0.971-0.989), with a kappa coefficient of 0.923 and a consistency ratio of 94% for stroke patient and the ICC of the MFAC in patients with hip fractures is 0.96, with a construct validity of r=0.81 on the Elderly Mobility Scale (EMS).

    2 months

  • Time Up and Go Test

    A test that assesses mobility, balance, walking ability, and fall risk in older adults

    2 months

Secondary Outcomes (4)

  • Self-reported exercise adherence

    2 months

  • Exercise logs

    2 months

  • Modified Caregiver Strain Index

    2 months

  • System Usability Scale

    2 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants allocated to the intervention group will receive their home-based rehabilitation program using mobile app installed in the mobile device.

Procedure: Home-based rehabilitation program using mobile app

Control

ACTIVE COMPARATOR

Those assigned to the control group will receive the same home-based rehabilitation program but with information and instructions delivered through the use of paper-based handouts.

Procedure: Home-based rehabilitation program using mobile app

Interventions

Home-based rehabilitation program

Also known as: Home-based rehabilitation program using paper-based handouts
ControlIntervention

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants who completed the inpatient Geriatric Hip Fracture Rehabilitation Program in the Department of Orthopedic Rehabilitation (DOR) of TPH will be recruited by convenience sampling before discharge. To be eligible for enrolment, participants should:
  • have a primary diagnosis of hip fracture,
  • be 60 to 90 years old,
  • be literate enough to read and understand simple questions in Chinese,
  • be discharged home and taken care by caregiver,
  • have at least level III measured by Modified Functional Ambulatory Category (MFAC) upon discharge,
  • have access to a smart phone or tablets (iOS or Android platform)
  • have signed the written informed consent.

You may not qualify if:

  • Participants will be excluded from the study if they:
  • have a bilateral hip fracture or hip fracture is the result of a malignancy,
  • have significant cognitive deficits,
  • have significant cardiopulmonary contraindications or preexisting conditions that precluded participation in an exercise program,
  • have a terminal illness (survival expected to be \<1 year),
  • have severe visual deficits or legally blind,
  • have request that their participation be terminated. All eligible participants will be given a detailed explanation and ethics approval will be obtained from the Joint CUHK-NTEC CREC prior to commencing the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tai Po Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • Cheng KC, Lau KMK, Cheng ASK, Lau TSK, Lau FOT, Lau MCH, Law SW. Use of mobile app to enhance functional outcomes and adherence of home-based rehabilitation program for elderly with hip fracture: A randomized controlled trial. Hong Kong Physiother J. 2022 Dec;42(2):99-110. doi: 10.1142/S101370252250010X. Epub 2022 Jun 15.

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Central Study Contacts

Kin Ming Ken Lau, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist I

Study Record Dates

First Submitted

August 8, 2019

First Posted

August 12, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2022

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations