AzTrials
AzTrials

Hip FracturesNCT04053348

Use of Mobile App to Enhance Geriatric Hip Fracture Rehabilitation

A study testing Home-based rehabilitation program using mobile app in people with Hip Fractures and Rehabilitation, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 to 90 years
Conditions the study is for
Hip Fractures, Rehabilitation
What is being tested?
Home-based rehabilitation program using mobile app
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteHong Kong
Study dates
1 Oct 2019to 1 Oct 2022
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 60 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Kin Ming Ken Lau, MSc contact

852 2607 6523

lkm824@ha.org.hk

Hong Kong1 site, 1 recruiting

  • Tai Po Hospital

    Hong Kong

    Kin Ming Lau, MSc, 26076523, lkm824@ha.org.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Use of Mobile App to Enhance Functional Outcomes and Adherence of Home-based Rehabilitation Program for Elderly With Hip Fracture: A Randomized Controlled Trial

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.

Read more

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.

Being tested
Home-based rehabilitation program using mobile app
Keywords
Mobile App, Telerehabilitation, Physiotherapy, Hip Fractures
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based rehabilitation program using mobile appProcedure or surgery

    Also called Home-based rehabilitation program using paper-based handouts

    Home-based rehabilitation program

Study groups in NCT04053348
Study groupRoleWhat they receive
InterventionExperimentalParticipants allocated to the intervention group will receive their home-based rehabilitation program using mobile app installed in the mobile device.
Receives: Procedure: Home-based rehabilitation program using mobile app
ControlActive comparatorThose 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.
Receives: Procedure: Home-based rehabilitation program using mobile app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 months

  2. 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.

    Measured: 2 months

  3. 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).

    Measured: 2 months

  4. Time Up and Go Test

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

    Measured: 2 months

Secondary outcomes (4)

  1. Self-reported exercise adherence

    Participants will be asked to rate their adherence to their home program using 11-point numerical rating scale (0='never performed my exercises' to 10 = 'always performed my exercises'. This method of capturing adherence is selected because there are few alternative ways of determining adherence that does not involve full-time surveillance.

    Measured: 2 months

  2. Exercise logs

    Participants will be asked to report their exercise log either by the use of Progress summary function of the app in experimental group or by exercise diaries set out in calendar format prepared in the exercise pamphlet in control group

    Measured: 2 months

  3. Modified Caregiver Strain Index

    It was designed to detect the physical, psychological, social and financial strain of the informal caregiver. It consisted of 13-items. There were only 3 options (score 2 if the respondent choose "yes", 1 if the respondent choose "yes, sometimes", otherwise score 0 if the respondent choose "no") for the respondent to choose. The CSI score ranged from 0 to 26. Caregivers face a high level of strain if they score high. The modified version of CSI (M-CSI) achieved a high internal reliabilty (α=.90).

    Measured: 2 months

  4. System Usability Scale

    It is a quick survey to assess the usability of a given product or service. The survey consist ten questions with five possible answers ranging from 'strongly agree' to 'strongly disagree'.

    Scoring SUS

    • For each of the odd numbered questions, subtract 1 from the score.
    • For each of the even numbered questions, subtract their value from 5.
    • Take these new values which you have found, and add up the total score. Then multiply this by 2.5.

    Interpreting Scores The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.

    Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves "normalizing" the scores to produce a percentile ranking.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2019
  2. Study start1 Oct 2019
  3. Primary completion1 Oct 2021 (estimated)
  4. Study completion1 Oct 2022 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04053348
Sponsor's protocol ID
2019.231
Status last verified
Feb 2021
First submitted
8 Aug 2019
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37560168

Questions about this trial

What is this clinical trial studying?

A study testing Home-based rehabilitation program using mobile app in people with Hip Fractures and Rehabilitation, run by Hospital Authority, 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 8 inclusion and 7 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 10 Feb 2021. 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?

Contact Kin Ming Ken Lau, MSc (852 2607 6523, lkm824@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lower extremity functional scale (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04053348, which also lists 1 linked publication.

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 10 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in