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Use of Mobile App to Enhance Geriatric Hip Fracture Rehabilitation

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ClinicalTrials.gov Identifier: NCT04053348
Recruitment Status : Not yet recruiting
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
The Hong Kong Polytechnic University
Information provided by (Responsible Party):
Ken Lau Kin Ming, Hospital Authority, Hong Kong

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.


Condition or disease Intervention/treatment Phase
Hip Fractures Rehabilitation Procedure: Home-based rehabilitation program using mobile app Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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
Home-based rehabilitation program
Other Name: Home-based rehabilitation program using paper-based handouts

Active Comparator: Control
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
Home-based rehabilitation program
Other Name: Home-based rehabilitation program using paper-based handouts




Primary Outcome Measures :
  1. Lower extremity functional scale [ Time Frame: 2 months ]
    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. Elderly Mobility Scale [ Time Frame: 2 months ]
    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.

  3. Modified Functional Ambulatory Category [ Time Frame: 2 months ]
    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).

  4. Time Up and Go Test [ Time Frame: 2 months ]
    A test that assesses mobility, balance, walking ability, and fall risk in older adults


Secondary Outcome Measures :
  1. Self-reported exercise adherence [ Time Frame: 2 months ]
    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.

  2. Exercise logs [ Time Frame: 2 months ]
    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

  3. Modified Caregiver Strain Index [ Time Frame: 2 months ]
    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).

  4. System Usability Scale [ Time Frame: 2 months ]

    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.




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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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:

  1. have a primary diagnosis of hip fracture,
  2. be 60 to 90 years old,
  3. be literate enough to read and understand simple questions in Chinese,
  4. be discharged home and taken care by caregiver,
  5. have at least level III measured by Modified Functional Ambulatory Category (MFAC) upon discharge,
  6. have access to a smart phone or tablets (iOS or Android platform)
  7. have signed the written informed consent.

Exclusion Criteria:

Participants will be excluded from the study if they:

  1. have a bilateral hip fracture or hip fracture is the result of a malignancy,
  2. have significant cognitive deficits,
  3. have significant cardiopulmonary contraindications or preexisting conditions that precluded participation in an exercise program,
  4. have a terminal illness (survival expected to be <1 year),
  5. have severe visual deficits or legally blind,
  6. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053348


Contacts
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Contact: Kin Ming Ken Lau, MSc 852 2607 6523 lkm824@ha.org.hk

Sponsors and Collaborators
Hospital Authority, Hong Kong
The Hong Kong Polytechnic University

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Responsible Party: Ken Lau Kin Ming, Physiotherapist I, Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier: NCT04053348     History of Changes
Other Study ID Numbers: 2019.231
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ken Lau Kin Ming, Hospital Authority, Hong Kong:
Mobile App
Telerehabilitation
Physiotherapy
Hip Fractures
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries