Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001630101
Ethics application status
Approved
Date submitted
20/09/2019
Date registered
25/11/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a goal-setting coaching intervention using accelerometer guided objective real-time feedback on sedentary behaviour and physical activity in older hip fracture patients: The HIP-MOVE Study
Scientific title
A pre-post feasibility and acceptability study investigating the effects of a goal-setting coaching intervention using accelerometer guided objective real-time feedback on sedentary behaviour and physical activity in hip fracture patients: The HIP-MOVE Study.
Secondary ID [1] 299219 0
Nil known
Universal Trial Number (UTN)
U1111-1239-8907
Trial acronym
The HIP-MOVE Study
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Hip Fracture 314522 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312868 312868 0 0
Physiotherapy
Musculoskeletal 312869 312869 0 0
Other muscular and skeletal disorders
Public Health 312870 312870 0 0
Health promotion/education
Injuries and Accidents 313330 313330 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Objective real-time feedback with ActiGraph
All participants will wear an ActiGraph GT9X (ActiGraph LLC, Pensacola, FL, USA) on their non-dominant wrist from day 3 post-operatively, even though research has shown that wearing it on the wrist and ankle has lower validity than wearing it on the waist. However, participants may not feel comfortable wearing it on the waist immediately after surgery. In addition, we chose the wrist because participants, clinical staff and carers will be required to read off real-time feedback on activity level. For this study, the GT9X device will be programmed to record accelerations in 1-sec (sec) epochs with low-frequency extension in order to increase its sensitivity to capture low-intensity movements. The ActiGraph GT9X was chosen for its ability to provide real-time activity feedback on the number of steps a participant has taken over a given period as well as energy expenditure. Participants will be asked to wear the device for 24 hours for 10 days or before discharge, whichever comes first. Adherence to the trial will be measured by wear adherence (explored using GT9X analytics), missing data and participation in activities prescribed by the physiotherapists (physiotherapists will record exercise administered, intensity and duration on an excel sheet)
SMART Goal setting
Physiotherapists will guide participants to set daily SMART goals on improving step counts, increase the number of sedentary breaks and increase the time spent standing or stepping. SMART goals involve participants setting activity goals (e.g. number of steps, number of transitions, reps of weight-bearing exercises) with the physiotherapist daily or twice daily and working to achieve these goals with the physiotherapist, personally and other members of the health team. Goals are set during one-on-one sessions with the physiotherapist in the hospital. The goals, as well as the frequency and duration of each session, will depend on the participant’s ability and physiotherapist’s assessment. On weekdays, if a participant meets goals in the morning, the goals will be reviewed during the afternoon physiotherapy session. The physiotherapist will set weekend goals for the participants on Friday and it is to be noted that on weekends, physiotherapy input is limited to once daily visits. It should also be noted that there will no goal-setting over the weekend and there will be no coaching given the weekend rostering arrangements. Adherence will be measured by participation in activities prescribed by the physiotherapists (physiotherapists will record exercise administered, intensity and duration on an excel sheet)
Coaching
The participants will be coached one-on-one by the physiotherapist in hospital on weekdays about the deleterious effects of sedentary behaviour (SB) on outcomes for older adults following hip fracture surgery in the hospital and afterwards. Coaching sessions are expected to last for less than 10 minutes. The advantages of breaking sedentary time incrementally will be taught verbally and barriers to doing this will also be discussed. Based on their responses, the perceived barriers to achieving their objective will be discussed and addressed. Participants will also be offered the opportunity to view their X-rays by the Physiotherapist as a way of allaying their fear of re-fracture. Coaching sessions will last for 10 minutes twice daily for the duration of patient stay in hospital
Intervention is expected to last for 6 months. Participants in the intervention group will receive usual care in addition to intervention
Intervention code [1] 315630 0
Treatment: Other
Intervention code [2] 315631 0
Rehabilitation
Intervention code [3] 315632 0
Behaviour
Comparator / control treatment
Usual Care
Usual care consists of the treatment received from the multi-disciplinary orthopaedics service for all hip fractures. A geriatrics registrar reviews participants six days per week and is supported by a geriatrician who rounds 2 to 3 times per week. There is a weekly multi-disciplinary team meeting.
The physiotherapist provides patients with a flyer that details the types of exercises they are supposed to carry out with the physiotherapist and on their own. The type of exercises depends on their level of recovery (early bed exercises, general bed exercises, chair exercises and standing exercises). On average, hip fracture participants currently receive the following physiotherapy treatment:
• mobilisation within 24-48 hours depending on participants’ level of function (if participant cannot mobilise independently, they are mobilised with a standing machine)
• bed, chair and standing exercises
• gait re-education with a walking frame
The amount of time participants stand each day with the physiotherapy team is usually not recorded but participants are encouraged to progress the next day. Walking distance during gait re-education estimated (either in number of steps or metres) and efforts are made to increase the distance from the previous session using the physiotherapists’ discretion. The exercises administered are usually recorded, and participants are encouraged to improve in the next session. Participants are advised of the need to carry out ward exercises as well as its benefit to their regaining strength on the affected limb. In addition, they are encouraged to sit out of bed more rather than lying down all day. The physiotherapist assistant or physiotherapist sees participants twice each day, in the morning by the physiotherapist and in the afternoon by either of them. However, the physiotherapist visits the participant first to assess and establish treatment goals before the physiotherapist assistant administers the exercise/walking goals. Treatment goals vary according to each participant, depending on participant’s pain level, level of function, exercise tolerance and advice from the surgeon/physician.
The physiotherapists guide nurses with regard to participant’s level of mobility, weight status, and distance participant can walk. The nursing team provide participants with a flyer that advises the participant that the physiotherapists and nurses will help get them back on their feet starting from the first day after their operation. The flyer also advises of the importance of the orthogeriatric medical team in managing their co-morbidities as well as details of complications, discharge plan and discharge advice (pain medication, wound closure and need to continue and slowly increase exercises taught by the physiotherapist). The physiotherapists instruct nurses on the level of weight-bearing the participant needs as well as the level of assistance with functional activities required by the participant. However, the nurses do not receive any guidance from the physiotherapist or medical team on the level of activity a participant needs to engage in while on admission.
There is also a weekly multi-disciplinary discharge-planning meeting. The flyers for this study is designed specifically for this intervention
Control group
Active

Outcomes
Primary outcome [1] 321480 0
Sedentary Behaviour (number of sedentary breaks) measured with ActivPAL
Timepoint [1] 321480 0
At 10 days post-admission or discharge, whichever comes first and 12-weeks post admission
Primary outcome [2] 321481 0
Feasibility of the intervention measured by recruitment, acceptability, completion, safety, and adherence, which all will be recorded. The number of potential participants who refused to participate in the intervention will be used to assess recruitment. Adherence to the trial will be measured by wear adherence, missing data and participation in activities prescribed by the physiotherapists aimed at meeting goals obtained from ActiGraph feedback. Safety will be evaluated by collecting and comparing the number of adverse events and falls during the intervention to data before the intervention started.
Timepoint [2] 321481 0
10 days post-admission and 12 weeks post-discharge
Primary outcome [3] 321808 0
Physical Activity (time spent standing/stepping) measured with ActivPAL
Timepoint [3] 321808 0
10 days post-admission, 3 weeks, 6weeks and 12 weeks post-discharge
Secondary outcome [1] 375078 0
Mobility measured by De Morton Mobility Index (DEMMI) at 12 weeks post-admission
Timepoint [1] 375078 0
12 weeks post-discharge
Secondary outcome [2] 376257 0
total sedentary time and bouts measured with ActivPAL
Timepoint [2] 376257 0
10 days and 12 weeks post admission
Secondary outcome [3] 376258 0
sit to stand transitions measured with ActivPAL
Timepoint [3] 376258 0
10 days and 12 weeks post-admission
Secondary outcome [4] 376259 0
Functional recovery measured with Hip Fracture Functional Recovery Scale (Zuckerman et al. 2000)
Timepoint [4] 376259 0
measured at admission and 3/6 weeks post admission
Secondary outcome [5] 376260 0
Quality of life measured with the EQ5D
Timepoint [5] 376260 0
12 weeks post admission
Secondary outcome [6] 376261 0
Falls measured with the Falls Efficacy Scale
Timepoint [6] 376261 0
12 weeks post admission
Secondary outcome [7] 376262 0
Frailty with Clinical Frailty Scale
Timepoint [7] 376262 0
10 days post-admission and 3, 6 and 12 weeks post-admission
Secondary outcome [8] 376263 0
Domain or activity-specific sedentary time with MOST questionnaire
Timepoint [8] 376263 0
10 days post-admission and 3, 6 and 12 weeks post-admission
Secondary outcome [9] 376264 0
Self-reported physical activity with IPAQ-elderly
Timepoint [9] 376264 0
10 days post-admission and 3, 6 and 12 weeks post-admission

Eligibility
Key inclusion criteria
i. aged 65 years and above;
ii. admitted to the orthopaedic ward;
iii. able to converse in English;
iv. mobilising independently (with or without a walking aid) prior to admission;
v. living at home or independent living unit prior to hospitalisation;
vi. able to commence the study within 72 hours of admission.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. they are admitted from a nursing home, skilled nursing facility (e.g. Sutherland Court) or hospital;
ii. deemed too unwell to participate by the orthogeriatrician (or registrar);
iii. deemed to require palliation by the orthogeriatrician (or registrar);
iv. deemed unable to provide informed consent by the orthogeriatrician (or registrar).
v. they have footdrop following surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study design is pre-post. Standard care will be administered for 6 months (pre) and this will be followed by the 6-month intervention phase (post) with a one-month break in-between
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary outcomes will be analysed using an intention-to-treat approach utilising data from all participants. A multilevel repeated measures analysis will be used to test for differences between groups and change over time. In addition, each group analysis will also be reported for the primary outcomes. Baseline data will be examined to ensure that the intervention and control groups are compared using descriptive statistics with 95% confidence intervals. Differences in primary and secondary outcomes between the two groups will be explored independently at the 0.05 level of significance.
Descriptive statistics of mean (standard deviation), percentages and frequency will be used to describe baseline characteristics such as age, gender, ethnicity, self-reported SB, self-reported PA, physical function, health status, level of cognition, frailty, pre-hip fracture status, nutritional status, co-morbidities and quality of life.
Chi-square test will be used to explore differences in frequency of variables. Mean group differences will be examined using independent samples t-test for normally distributed variables and Kruskal-Wallis/Mann-Whitney U) for non-normally distributed variables. Analysis of variance (ANOVA) will be used to explore differences post-intervention at 3, 6 and 12 weeks between the two groups. Relevant measures at baseline will be used as covariates in the analysis. Changes in self-reported SB will be tested with the Wilcoxon Signed Rank Test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2019
Actual
Date of last participant enrolment
Anticipated
29/01/2021
Actual
Date of last data collection
Anticipated
31/01/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 14847 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 28100 0
5011 - Woodville
Recruitment postcode(s) [2] 28101 0
5011 - Woodville South

Funding & Sponsors
Funding source category [1] 303760 0
Hospital
Name [1] 303760 0
The Queen Elizabeth Hospital
Country [1] 303760 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Address: GPO Box 498
ADELAIDE SA 5001
Country
Australia
Secondary sponsor category [1] 304500 0
None
Name [1] 304500 0
Address [1] 304500 0
Country [1] 304500 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304283 0
Central Adelaide Health Network HREC
Ethics committee address [1] 304283 0
Ethics committee country [1] 304283 0
Australia
Date submitted for ethics approval [1] 304283 0
05/03/2019
Approval date [1] 304283 0
12/06/2019
Ethics approval number [1] 304283 0
HREC/19/CALHN/149

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96386 0
Prof Renuka Visvanathan
Address 96386 0
Aged & Extended Care Services, The Queen Elizabeth Hospital, and
Adelaide Geriatrics Training and Research with Aged Care (GTRAC) Centre
Adelaide Medical School
Faculty of Health and Medical Sciences
University of Adelaide
28 Woodville Road
Woodville South, SA 5011
Australia
Country 96386 0
Australia
Phone 96386 0
+61 8 82226000
Fax 96386 0
Email 96386 0
[email protected]
Contact person for public queries
Name 96387 0
Unyime Jasper
Address 96387 0
Centre for Research Excellence; Frailty and Healthy Ageing, University of Adelaide, South Australia,
The Basil Hetzel Institute,
37 Woodville Road,
Woodville
5011 South Australia
Country 96387 0
Australia
Phone 96387 0
+61 882227676
Fax 96387 0
Email 96387 0
[email protected]
Contact person for scientific queries
Name 96388 0
Unyime Jasper
Address 96388 0
Centre for Research Excellence; Frailty and Healthy Ageing, University of Adelaide, South Australia,
The Basil Hetzel Institute,
37 Woodville Road,
Woodville
5011 South Australia
Country 96388 0
Australia
Phone 96388 0
+61 882227676
Fax 96388 0
Email 96388 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All
When will data be available (start and end dates)?
Immediately after publication for up to 5 years
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
any purpose
How or where can data be obtained?
By emailing the principal investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5006Informed consent form    378332-(Uploaded-28-10-2019-13-38-01)-Study-related document.docx
5007Ethical approval    378332-(Uploaded-20-09-2019-21-19-14)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.