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临床试验/NCT04053348
NCT04053348Unknown不适用

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

Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
144
试验地点
1
主要终点
Time Up and Go Test

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Time Up and Go Test

时间窗: 2 months

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

Lower extremity functional scale

时间窗: 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.

Modified Functional Ambulatory Category

时间窗: 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).

Elderly Mobility Scale

时间窗: 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.

次要结局

  • Self-reported exercise adherence(2 months)
  • Exercise logs(2 months)
  • Modified Caregiver Strain Index(2 months)
  • System Usability Scale(2 months)

研究者

发起方
Hospital Authority, Hong Kong
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ken Lau Kin Ming

Physiotherapist I

Hospital Authority, Hong Kong

研究点 (1)

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