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Trial registered on ANZCTR


Registration number
ACTRN12619000936123
Ethics application status
Approved
Date submitted
24/06/2019
Date registered
5/07/2019
Date last updated
5/07/2019
Date data sharing statement initially provided
5/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Motivational interviewing to increase walking in community-dwelling older adults after hip fracture
Scientific title
Motivational interviewing to increase walking in community-dwelling older adults after hip fracture
Secondary ID [1] 298568 0
None
Universal Trial Number (UTN)
U1111-1235-8189
Trial acronym
MIHip
Linked study record
Not linked

Health condition
Health condition(s) or problem(s) studied:
hip fracture 313406 0
Condition category
Condition code
Injuries and Accidents 311840 311840 0 0
Fractures
Physical Medicine / Rehabilitation 311841 311841 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name of intervention: Motivational interviewing
Who will deliver the intervention and what is their training: The intervention will be delivered by an allied health professional who has received training in motivational interviewing, through workshop attendance, on-line training, and one-on-one coaching from an expert motivational interviewing practitioner.
Mode of delivery: Telephone
Dose: There will be one session weekly for the first 8 weeks followed by two booster sessions, one at week-12 and one at week-16. The duration of each session will be 30 minutes.
Location/Timing: The intervention will be delivered when participants have been discharged home from hospital to enable the motivational interviewing discussions to be contextualised to daily life.
Procedures and Personalisation: The content of each session with each individual will follow the recommended process of Engagement, Focusing, Evoking and Planning. Sessions 1-2 will focus on introduction and participant engagement while sessions 3-8 will focus on increasing confidence about walking. As a means of sustaining outcomes participants will also receive 2 booster sessions focusing on maintenance of confidence in walking behaviour in weeks 12 and 16.
Fidelity: The allied health professional’s proficiency and fidelity in using motivational interviewing (intervention fidelity) will be confirmed through audio-recording of a small number of motivational interviewing sessions by an independent accredited assessor using the validated Motivational Interviewing Integrity scale.
Intervention code [1] 314825 0
Treatment: Other
Intervention code [2] 314826 0
Rehabilitation
Comparator / control treatment
Name of comparator treatment: Nutritional education
Who will deliver the intervention and what is their training: an accredited practising dietitian
Mode of delivery: Telephone
Dose: There will be one session weekly for the first 8 weeks followed by two booster sessions, one at week-12 and one at week-16. The duration of each session will be 30 minutes.
Location/Timing: The intervention will be delivered when participants have been discharged home from hospital.
Procedures and Personalisation: Health education will focus on nutritional education (dietary assessment and intervention) as nutrition is an issue for all older people after hip fracture. A nutritional education intervention has been demonstrated to be feasible after hip fracture and credible as it has been successfully applied as a placebo attention control in a hip fracture trial. The content of the telephone calls will be benign, that is not expected to have any effect on walking confidence or physical activity.
Fidelity: The dietitian’s proficiency and fidelity in providing nutritional education will be confirmed through audio-recording a small number of sessions under the supervision of a senior dietitian clinician researcher.
Control group
Active

Outcomes
Primary outcome [1] 320514 0
Daily time spent walking as assessed by accelerometer-based activity monitor (activPAL)
Timepoint [1] 320514 0
Baseline, 9 weeks, 26 weeks and 52 weeks (primary endpoint) after randomisation
Secondary outcome [1] 371864 0
Daily steps as assessed by an accelerometer-based activity monitor (activPAL)
Timepoint [1] 371864 0
Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation
Secondary outcome [2] 371865 0
Daily time spent in moderate to vigorous activity as assessed by an accelerometer-based activity monitor (activPAL) using a threshold of 60 steps/minute
Timepoint [2] 371865 0
Baseline, 9 weeks, 26 weeks, and 52 weeks after randomisation
Secondary outcome [3] 371866 0
Daily time sitting or lying as assessed by an accelerometer-based activity monitor (activPAL)
Timepoint [3] 371866 0
Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation
Secondary outcome [4] 371867 0
Self-efficacy associated with walking and falls will be assessed with the 14-item Modified Falls Efficacy Scale
Timepoint [4] 371867 0
Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation
Secondary outcome [5] 371868 0
Confidence related to walking in different situations as assessed by the 22-item Ambulatory Self-Confidence Questionnaire
Timepoint [5] 371868 0
Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation
Secondary outcome [6] 371869 0
Depression, anxiety, and stress as assessed by the 21-item Depression Anxiety and Stress Scale
Timepoint [6] 371869 0
Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation
Secondary outcome [7] 371870 0
Mobility-related function as assessed by the de Morton Mobility Index (DEMMI), a 15-item unidimensional measure of mobility based on clinician observation
Timepoint [7] 371870 0
Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation
Secondary outcome [8] 371871 0
The frequency of domestic, outdoor, and leisure/work activities as assessed by the 15-item Frenchay Activities Index
Timepoint [8] 371871 0
Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation
Secondary outcome [9] 371872 0
Participant-report of whether they walk outdoors alone or with company, and to report the frequency of outdoor walks as assessed by a participation questionnaire reported by Ziden et al
Timepoint [9] 371872 0
Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation
Secondary outcome [10] 371873 0
Health-related quality of life as assessed by the 35-item Assessment of Quality of Life Instrument (AQoL) 8-D
Timepoint [10] 371873 0
Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation
Secondary outcome [11] 371874 0
Well being and capability as assessed by the 5-item ICECAP-O
Timepoint [11] 371874 0
Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation
Secondary outcome [12] 371875 0
Falls, as assessed by participants maintaining a falls calendar (participants will receive a monthly phone call reminder to return their falls calendar)
Timepoint [12] 371875 0
Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation
Secondary outcome [13] 371876 0
Hospital readmissions as assessed through participating health service databases.
Timepoint [13] 371876 0
9 weeks, 26 weeks and 52 weeks after randomisation
Secondary outcome [14] 371877 0
Healthcare utilisation and cost data will be collected via a patient health service utilisation questionnaire developed for the trial and will include questions on hospital admissions and community allied health visits not related to falls.
Timepoint [14] 371877 0
Baseline, 26 weeks and 52 weeks after randomisation
Secondary outcome [15] 371878 0
Medical services and pharmaceutical use as assessed by Medicare Australia records
Timepoint [15] 371878 0
52 weeks after randomisation
Secondary outcome [16] 371879 0
Exploration of perceptions about receiving the motivational interviewing intervention with participants in the motivational interviewing group as assessed by inductive thematic analysis of in-depth semi-structured interviews
Timepoint [16] 371879 0
26 weeks after randomisation
Secondary outcome [17] 371880 0
Exploration of experiences of rehabilitation after hip fracture, and recovery of mobility for a purposive sample of participants in both groups as assessed by inductive thematic analysis of in-depth semi-structured interviews
Timepoint [17] 371880 0
52 weeks after randomisation
Secondary outcome [18] 371881 0
Experiences of the allied health professionals who delivered the motivational interviewing intervention on the feasibility, advantages and disadvantages of the intervention as assessed by inductive thematic analysis of in-depth semi-structured interviews
Timepoint [18] 371881 0
26 weeks after randomisation
Secondary outcome [19] 371882 0
Nutritional status as assessed by the Malnutrition Screening Tool, and body weight as assessed by digital scales
Timepoint [19] 371882 0
Baseline, 26 weeks and 52 weeks after randomisation
Secondary outcome [20] 371883 0
Cost effectiveness from a health care system perspective, with outcomes based on the primary intermediate clinical outcome (daily time spent walking) and the secondary outcome of health-related quality of life (AQoL-8D) as assessed by incremental cost effectiveness ratios (ICER)
Timepoint [20] 371883 0
52 weeks after randomisation
Secondary outcome [21] 372254 0
Any injuries as a result of a fall as assessed by a brief survey of any participant reporting a fall in their falls calendar (see secondary outcome above)
Timepoint [21] 372254 0
Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation

Eligibility
Key inclusion criteria
Participants will be included if they:
• had a hip fracture (S72.0–S72.2 according to the International Classification of Diseases 10th revision (ICD-10)),
• live at home independently,
• are aged 65 years or older,
• have been discharged from hospital within the last 6 months,
• are able to walk independently with or without an assistive device
• can communicate with conversational English,
• and are insufficiently active (defined as obtaining less than 150 minutes of moderate intensity activity per week). The level of baseline physical activity will be screened using an accelerometer-based activity monitor over 7 days
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
• score in the severe range of depression or anxiety as measured by the Depression Anxiety and Stress Scale (DASS), because they would require high level psychological support,
• score more than two errors on the 10-item Short Portable Mental Status Questionnaire indicative of impaired intellectual functioning,
• are medically unstable to walk. Clinicians making the initial approach to potential participants will be informed of this eligibility criterion. On initial screen a member of the research team will ask: ‘Do you have any medical condition that would stop you from walking?’; ‘Do you ever have unexplained pains in your chest at rest or during walking?’; ‘Do you consistently feel faint or suffer from dizzy spells?’ (https://www.physicalactivityaustralia.org.au/wp-content/uploads/2016/09/Pre-Exercise-Screening-Form.pdf). If the participant answers yes to any of these questions the local doctor will be consulted before enrolment in the project.
• are unable to converse over the telephone (for example, due to hearing loss)
• live in residential care

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be determined by email contact with an independent researcher using a centralised web-based randomisation system after the member of the research team has determined eligibility for the study, participants have consented to take part, and baseline assessment has been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to the experimental group receiving motivational interviewing or the attention placebo control group receiving health education about nutrition using permuted blocks stratified for site (health service) and sex. Participants will be randomly assigned remotely using a permuted block design with a computer random number generator prepared by a researcher independent of the research team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size estimation: To detect a clinically relevant difference in the primary outcome (daily time spent walking) of 15 minutes, n=230 participants will be required, assuming a conservative standard deviation of 40.4 mins/day at power of 80% and 2-tailed alpha level of 5%. Assuming attrition of approximately 15% a sample of n=270 will be recruited. The sample size of n=270, will have greater than 90% power to detect a clinically relevant difference in the number of daily steps taken, estimated to be d=0.5 in our pilot. The trial will be sufficiently powered (power >90%) to detect clinically relevant changes (standardised mean difference> 0.5) in secondary outcomes of psychological-related function, mobility-related function, and quality of life. Assuming a rate of 1 fall per year in the control group and a 30% reduction in falls in the treatment group (IRR = 0.7), this sample size is powered at approximately 77% to detect a significant difference at the 5% level using negative binomial regression to account for multiple falls and over-dispersion.
Analysis: The primary outcome (daily time spent walking at 12 months) will be analysed using linear mixed effects models. Modelling will account for variation in baseline values and participant sex. If more than 5% of data are missing, a multiple imputation process will be used, providing the assumption data are missing at random is met. A similar approach will be used for analysis of secondary outcomes collected longitudinally. The proportion of participants meeting physical activity guidelines for older people will be reported as risk ratios. The number of falls and hospital admissions will be reported as an incidence rate ratio using a negative binomial regression model. Risk ratios will be calculated to compare the proportion of participants meeting targets in the participation questionnaire. To avoid bias and to maximize the randomisation process, all available data will be analysed according to allocation (intention to treat analysis), regardless of compliance. Process evaluation will assess intervention fidelity, explore casual mechanisms and identify factors associated with variation in outcomes. Mediation analysis will explore whether increased walking is mediated through the effect of motivational interviewing on psychological factors such as confidence. Instrumental variable regression will be used to estimate the complier average causal effect on the primary outcome, with participants considered to have adhered if they completed at least 8 motivational interviewing sessions.

Qualitative data will be analysed using an inductive thematic approach. Using qualitative software to help manage data, codes will be assigned to text independently by two assessors. Codes will be organised into categories and emergent themes. Methods to enhance rigour and trustworthiness of the qualitative analysis will include member checking and the use of verbatim quotations.

The health economic analysis is a cost effectiveness analysis from a health care system perspective, with outcomes based on the primary intermediate clinical outcome (daily time spent walking) and the secondary outcome of health-related quality of life (AQoL-8D). Total costs for each participant will be determined from the intervention costs and cost of health services utilised over 12 months for experimental group participants; and the cost of health services utilised over 12 months for control group participants. The incremental cost effectiveness ratio (ICER) around the primary outcome will be calculated as the difference in total program and health service costs per mean difference in time spent walking/day between the control and experimental groups over 12 months. A cost utility ratio will be calculated based on the secondary outcome measure (AQoL-8D) as the change in total program and health service cost per change in quality adjusted life year saved in the experimental and control groups over 12 months. One-way sensitivity analyses will investigate the robustness of the cost effectiveness ratio to a range of cost and effect estimates. On the cost side, this may include alternative delivery arrangements, including scaling up the intervention, wage rates and program length; on the effect side health-related quality of life and daily time spent walking.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14061 0
Peter James Centre - Forest Hill
Recruitment hospital [2] 14062 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [3] 14063 0
Yarra Ranges Health - Lilydale
Recruitment hospital [4] 14064 0
Wantirna Health - Wantirna
Recruitment hospital [5] 14065 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 14066 0
Maroondah Hospital - Ringwood East
Recruitment hospital [7] 14067 0
Frankston Hospital - Frankston
Recruitment hospital [8] 14068 0
Rosebud Hospital - Rosebud
Recruitment hospital [9] 14069 0
Golf Links Road Rehabilitation Centre - Frankston
Recruitment hospital [10] 14070 0
The Mornington Centre - Mornington
Recruitment hospital [11] 14071 0
Healesville & District Hospital - Healesville
Recruitment postcode(s) [1] 26852 0
3131 - Forest Hill
Recruitment postcode(s) [2] 26853 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [3] 26854 0
3140 - Lilydale
Recruitment postcode(s) [4] 26855 0
3152 - Wantirna
Recruitment postcode(s) [5] 26856 0
3128 - Box Hill
Recruitment postcode(s) [6] 26857 0
3135 - Ringwood East
Recruitment postcode(s) [7] 26858 0
3199 - Frankston
Recruitment postcode(s) [8] 26859 0
3939 - Rosebud
Recruitment postcode(s) [9] 26860 0
3931 - Mornington
Recruitment postcode(s) [10] 26861 0
3777 - Healesville

Funding & Sponsors
Funding source category [1] 303107 0
Government body
Name [1] 303107 0
National Health and Medical Research Council
Address [1] 303107 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 303107 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Plenty Road, Bundoora,
Melbourne VIC 3086
Country
Australia
Secondary sponsor category [1] 303100 0
None
Name [1] 303100 0
Address [1] 303100 0
Country [1] 303100 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303652 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 303652 0
Office for Research and Ethics
Eastern Health
Box Hill Hospital
Level 2, 5 Arnold Street
Box Hill VIC 3128
Ethics committee country [1] 303652 0
Australia
Date submitted for ethics approval [1] 303652 0
31/01/2019
Approval date [1] 303652 0
02/04/2019
Ethics approval number [1] 303652 0
E19/002/50261
Ethics committee name [2] 303660 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [2] 303660 0
Office for Research
Frankston Hospital
2 Hastings Road
PO Box 52
Frankston VIC 3199
Ethics committee country [2] 303660 0
Australia
Date submitted for ethics approval [2] 303660 0
09/04/2019
Approval date [2] 303660 0
08/05/2019
Ethics approval number [2] 303660 0
SSA/50261/PH-2019
Ethics committee name [3] 303661 0
La Trobe University Human Research Ethics Committee
Ethics committee address [3] 303661 0
Research Office
La Trobe University
Plenty Road, Bundoora, Melbourne VIC 3086
Ethics committee country [3] 303661 0
Australia
Date submitted for ethics approval [3] 303661 0
01/04/2019
Approval date [3] 303661 0
11/04/2019
Ethics approval number [3] 303661 0
E19/002/50261

Summary
Brief summary
Hip fractures result in poor outcomes for older adults. Rehabilitation emphasises physical capacity and does not address lack of confidence. Motivational interviewing has a specific focus on increasing confidence for behaviour change. The primary aim is to determine if motivational interviewing increases walking at 12 months in community-dwelling people after hip fracture compared with an attention placebo control group. The secondary aims are to determine if motivational interviewing is a cost effective intervention that improves mobility-related function, physical activity, participation, and psychological outcomes, and reduces falls and hospital readmissions. In addition to receiving usual care, 270 people aged at least 65 years who have returned home after hip fracture will be randomly allocated to receive 10 telephone-based sessions of motivational interviewing to encourage walking or a control group receiving 10 telephone-based sessions of nutritional advice. Outcomes will be measured at 0, 9, 26, and 52 weeks. It is hypothesised that the motivational interviewing will be a cost effective intervention to help people return to living in the community after hip fracture.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94406 0
Prof Nicholas Taylor
Address 94406 0
Allied Health Clinical Research Office (Eastern Health / La Trobe University)
level 2/5 Arnold Street
Box Hill VIC 3128
Country 94406 0
Australia
Phone 94406 0
+61 3 90918874
Fax 94406 0
Email 94406 0
n.taylor@latrobe.edu.au
Contact person for public queries
Name 94407 0
Prof Nicholas Taylor
Address 94407 0
Allied Health Clinical Research Office (Eastern Health / La Trobe University)
level 2/5 Arnold Street
Box Hill VIC 3128
Country 94407 0
Australia
Phone 94407 0
+61 3 90918874
Fax 94407 0
Email 94407 0
n.taylor@latrobe.edu.au
Contact person for scientific queries
Name 94408 0
Prof Nicholas Taylor
Address 94408 0
Allied Health Clinical Research Office (Eastern Health / La Trobe University)
level 2/5 Arnold Street
Box Hill VIC 3128
Country 94408 0
Australia
Phone 94408 0
+61 3 90918874
Fax 94408 0
Email 94408 0
n.taylor@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Unrestricted access via website of journal publication linking to supplementary file containing individual participant data.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2424 0
Study protocol
Citation [1] 2424 0
Link [1] 2424 0
Email [1] 2424 0
Other [1] 2424 0
Study protocol including statistical analysis plan and details of ethical approval will be available through publication of protocol and/or deposit in institutional repository at La Trobe University
Attachment [1] 2424 0
Summary results
No Results