Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000680763
Ethics application status
Not yet submitted
Date submitted
16/06/2013
Date registered
20/06/2013
Date last updated
20/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating the use of Motivational Interviewing compared to usual care to increase physical activity in people living in the community after a hip fracture
Scientific title
A randomised controlled trial evaluating the use of Motivational Interviewing compared to usual care to increase physical activity in people living in the community after a hip fracture
Secondary ID [1] 282717 0
nil
Universal Trial Number (UTN)
U1111-1144-5538
Trial acronym
MIPAHIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip fracture rehabilitation - increasing activity 289390 0
hip fracture rehabilitation - quality of life 289391 0
hip fracture rehabilitation - mental health 289392 0
Condition category
Condition code
Musculoskeletal 289720 289720 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants who are randomly allocated to receive the Motivational Interviewing intervention will receive usual care they would receive in the community plus the 8 weekly 30-minute sessions of motivational interviewing (Miller & Rollnick, 2002, 2013) over the telephone for 8 weeks. This intervention is a directive style of communication in which the person delivering the intervention works collaboratively with the client to assist the client to increase his/her motivation to change their behaviour (in this case physical activity). This is done through a process of clients forming their own arguments for change which builds the clients importance and confidence of change (Miller & Rollnick, 2002, 2013). Motivational Interviewing has been demonstrated to lead to health behaviour change, in non-hip fracture populations, in several large meta-analytic studies (Hettema et al., 2005; Rubak et al., 2005; Lundahl et al., 2010).
Intervention code [1] 287343 0
Rehabilitation
Intervention code [2] 287344 0
Behaviour
Comparator / control treatment
standard care in the community, which may involve people seeing their GP or physiotherapist when required
Control group
Active

Outcomes
Primary outcome [1] 289812 0
Physical activity – 1-week assessments at baseline and 8 weeks as measured by ActivPal accelerometer and log diary (type of activity, whether inside or outside activity, when monitor was removed)
Timepoint [1] 289812 0
7-day assessments at baseline and then 8 weeks - immediately after the intervention
Secondary outcome [1] 303286 0
Quality of life: as measured by the Assessment of Quality of Life Instrument(AQoL) 8-D (35 items, measures Independent Living, Happiness, Mental Health, Coping, Relationships, Self Worth, Pain, Senses)
Timepoint [1] 303286 0
assessed at baseline and then at 8 weeks - immediately after the intervention
Secondary outcome [2] 303287 0
Depression and Anxiety: as measured by the Depression Anxiety and Stress Scale (DASS) 21 (21 items – normed for older people)
Timepoint [2] 303287 0
assessed at baseline and then at 8 weeks - immediately after the intervention
Secondary outcome [3] 303288 0
Self-efficacy (associated with activity and falls – e.g. Modified falls efficacy scale – 14 questions, Ambulatory Self-Confidence Questionnaire – 22 items)
Timepoint [3] 303288 0
assessed at baseline and then at 8 weeks - immediately after the intervention
Secondary outcome [4] 303289 0
Physical activity stages of change (simple single-item measure tick one box)
Timepoint [4] 303289 0
assessed at baseline and then at 8 weeks - immediately after the intervention
Secondary outcome [5] 303290 0
Mobility: de Morton mobility index (DEMMI – 15 items)
Timepoint [5] 303290 0
assessed at baseline and then at 8 weeks - immediately after the intervention

Eligibility
Key inclusion criteria
1. They have had a hip fracture and are now living at home independently within 6 months of discharge
2. They are aged over 65 years
3. They speak conversational English
4. They are currently insufficiently active – as defined by obtaining less than 30 minutes of activity most days of the week
Minimum age
65 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. They have a cognitive impairment of any kind – this is because the Motivational Interviewing intervention is a talking intervention that requires people to be able to think clearly and generate their own ideas of how they can change their behaviour
2. They score in the severe range of depression or anxiety as measured by the Depression Anxiety and Stress Scale (DASS: Lovibond & Lovibond, 1995)
3. They do not speak conversational English - this is because the Motivational Interviewing intervention is a talking intervention and the person delivering the intervention only speaks English and there are not sufficient funds to employ another person who is able to speak in other languages
4. They are less than 65 years of age – this is because the population of interest for the current study is people 65+, because this is the group who is most likely to experience problems with reduced mobility following a hip fracture
5. They are highly dependent on medical care, in either high level or low level care – this is because the population of interest is people living independently in the community who are capable of becoming more active
6. They are already sufficiently active, as defined as obtaining at least 30 minutes of activity most days of the week

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)
Method of randomisation - Participants will be allocated to the intervention or usual care group based on a random number sequence produced by a random number generator produced by MS excel. Specific details about group allocation for each participant will be sealed in sequentially numbered opaque envelopes prepared by an independent researcher.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
the use of a random number generator produced by MS excel
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
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data on outcome measures will be analysed on an intention-to-treat basis. Groups will be compared on primary and secondary outcomes using Analysis of Covariance (ANCOVA) which will compare the group means at week 8 using baseline scores as covariates. Effect sizes will be calculated, by calculating Hedges g, in order to be able to obtain a measure of the magnitude of the impact of the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/07/2013
Actual
Date of last participant enrolment
Anticipated
1/03/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287456 0
University
Name [1] 287456 0
La Trobe University
Faculty of Health Sciences
Physical Activity and Rehabilitation group
Country [1] 287456 0
Australia
Primary sponsor type
Individual
Name
Dr Paul O'Halloran from La Trobe University
Address
Faculty of Health Sciences
plenty road
Bundoora
Victoria 3086
Country
Australia
Secondary sponsor category [1] 286200 0
Hospital
Name [1] 286200 0
Eastern Health
Address [1] 286200 0
Eastern Health, Level 4, 5 Arnold St, Box Hill,
Victoria 3128 Australia
Country [1] 286200 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289431 0
Eastern Health
Ethics committee address [1] 289431 0
Eastern Health, Level 4, 5 Arnold St, Box Hill,
Victoria 3128 Australia
Ethics committee country [1] 289431 0
Australia
Date submitted for ethics approval [1] 289431 0
26/06/2013
Approval date [1] 289431 0
Ethics approval number [1] 289431 0

Summary
Brief summary
The primary aim of the study is to examine if a telephone based intervention designed to increase confidence and motivation (i.e. Motivational Interviewing) increases physical activity in people living in the community following a hip fracture. Secondary aims relate to the effect of this intervention on confidence, quality of life, mental health and mobility.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40674 0
Dr Paul OHalloran
Address 40674 0
Faculty of Health Sciences
La Trobe University
Bundoora
Victoria
3086
Country 40674 0
Australia
Phone 40674 0
+61 03 9479 5607
Fax 40674 0
Email 40674 0
p.ohalloran@latrobe.edu.au
Contact person for public queries
Name 40675 0
Dr Paul OHalloran
Address 40675 0
Faculty of Health Sciences
La Trobe University
Bundoora
Victoria
3086
Country 40675 0
Australia
Phone 40675 0
+61 (03) 9479 5607
Fax 40675 0
Email 40675 0
p.ohalloran@latrobe.edu.au
Contact person for scientific queries
Name 40676 0
Dr Paul OHalloran
Address 40676 0
Faculty of Health Sciences
La Trobe University
Bundoora
Victoria
3086
Country 40676 0
Australia
Phone 40676 0
+61 (03) 9479 5607
Fax 40676 0
Email 40676 0
p.ohalloran@latrobe.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
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Documents added automatically
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