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Trial registered on ANZCTR


Registration number
ACTRN12614000592640
Ethics application status
Approved
Date submitted
8/05/2014
Date registered
4/06/2014
Date last updated
29/06/2021
Date data sharing statement initially provided
25/02/2019
Date results information initially provided
4/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a brief behavioural counselling intervention on physical activity behaviour in people with peripheral artery disease.
Scientific title
Effect of a brief behavioural counselling intervention on physical activity behaviour in people with peripheral artery disease.
Secondary ID [1] 284564 0
Nil
Universal Trial Number (UTN)
U1111-1156-5669
Trial acronym
BIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease 291869 0
Condition category
Condition code
Cardiovascular 292200 292200 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomized to the intervention group will receive a brief behaviour counselling intervention based on the 5A's framework (assess, advise, agree, assist, arrange). The intervention will provide peripheral arterial disease (PAD) patients with brief physical activity advice and counselling over either two individual face to face sessions and or either two to four telephone calls. This will be based on the patients availability to attend the face to face sessions. The initial phone call/face to face sessions will occur at Week 1 will last for 15 minutes-60 minutes. The second phone call/face to face session will occur at Week 2 and last for 10-60 minutes. At Week 6 and Week 12 another phone call will take place and will last for 10-15 minutes. The phone calls/face to face sessions will also be used to ensure patients are adhereing to the intervention. All assessments will be repeated at 4, 12 and 24 months.
Intervention code [1] 289336 0
Behaviour
Comparator / control treatment
Participants randomised to the control group will receive a similar number and timing of face to face and telephone sessions as the intervention group, however these sessions will consist of non-physical activity related conversation about general health and PAD. Participants will be blinded to the investigator's hypotheses.
Control group
Placebo

Outcomes
Primary outcome [1] 292070 0
Physical activity behaviour measured by an accelerometer
Timepoint [1] 292070 0
4, 12, 24 months
Secondary outcome [1] 308137 0
Patient physical activity recall and sitting time evaluated with the Walking Impairment Questionnaire, International Physical Activity Questionnaire (IPAQ), Paffenberger Physical Activity Questionnaire and the Sit-Q-7d Questionnaire.
Timepoint [1] 308137 0
4, 12, 24 months
Secondary outcome [2] 308138 0
Ambulatory ability and cardiovascular fitness using the six minute walk test and the short physical performance battery (SPPB).
Timepoint [2] 308138 0
4, 12, 24 months
Secondary outcome [3] 308139 0
Event-based claudication index (EBCI)
Timepoint [3] 308139 0
4, 12, 24 months
Secondary outcome [4] 308140 0
Peripheral vascular interventions including endovascular and surgical lower limb revascularisations and amputations.
Timepoint [4] 308140 0
4, 12, 24 months
Secondary outcome [5] 308141 0
Health-related quality of life assessed by the intermittent claudication questionnaire (ICQ), the PADQOL, the Short Form-36 (SF-36), the EQ-5D-5L Questionnaire and the WHO Health and Performance Questionnaire.
Timepoint [5] 308141 0
4, 12, 24 months
Secondary outcome [6] 308143 0
Circulating markers of atherosclerosis (SST tubes x 2, EDTA tubes x 2, citrate tube x 1, paxgene tube x 1).
Timepoint [6] 308143 0
4, 12, 24 months
Secondary outcome [7] 308146 0
Cost-effectiveness of the behaviour intervention compared to usual care, assessed by cost-utility analysis
Timepoint [7] 308146 0
4, 12, 24 months
Secondary outcome [8] 308147 0
Physiological measures including cardiovascular function (heart rate and blood pressure) and body composition (waist circumference and body mass index)
Timepoint [8] 308147 0
4, 12, 24 months
Secondary outcome [9] 320717 0
Advanced glycation end products (AGEs) will be measured by skin autofluoresence
Timepoint [9] 320717 0
4, 12, 24 months (all measurements at Townsville-site only)
Secondary outcome [10] 320718 0
Endothelial function will be measured by peripheral arterial tone (EndoPAT)
Timepoint [10] 320718 0
4, 12, 24 months (all measurements at Townsville-site only)
Secondary outcome [11] 320719 0
Arterial stiffness will be measured by applanation tonometry (SphygmoCor)
Timepoint [11] 320719 0
4, 12, 24 months (all measurements at Townsville- and Sydney-sites only)
Secondary outcome [12] 320720 0
Dietary intake will be assessed via interview with a nutritionist
Timepoint [12] 320720 0
4, 12, 24 months (all measurements at Townsville-site only)
Secondary outcome [13] 320721 0
Maximal muscle strength will be measured by 1 Repetition Maximum of major muscle groups
Timepoint [13] 320721 0
4, 12, 24 months (all measurements at Sydney-site only)
Secondary outcome [14] 320722 0
Peak aerobic capacity and claudication distances will be measured via testing on a treadmill
Timepoint [14] 320722 0
4, 12, 24 months (all measurements at Sydney-site only)
Secondary outcome [15] 320723 0
Whole body and regional fat, fat free mass, skeletal muscle mass and bone mineral density will be measured by Dual-energy X-ray absorptiometry (DEXA)
Timepoint [15] 320723 0
12, 24 months (all measurements at Sydney-site only)
Secondary outcome [16] 320724 0
Heart rate variability will be measured by time and frequency domain analyses
Timepoint [16] 320724 0
4, 12, 24 months (all measurements at Sydney-site only)
Secondary outcome [17] 320725 0
Framingham risk score will be calculated
Timepoint [17] 320725 0
4, 12, 24 months (all measurements at Sydney-site only)

Eligibility
Key inclusion criteria
1. PAD diagnosed by vascular specialist
2. Ambulatory males and females
3. No current or planned involvement in an organised exercise program
4. Physician assessed ability to participate in the intervention
5. Ability to comprehend the behaviour intervention according to the treating physician
Minimum age
40 Years
Maximum age
110 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with severe PAD, such as rest pain, arterial ulceration or gangrene requring urgent vascular intervention

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants who meet the inclusion/exclusion criteria and provide Informed Consent. Randomisation will be effected by the research assistant entering complete baseline data into the secure trial website which will generate allocation of patient to intervention or usual care control group. Hence allocation of intervention will occur by the trial website which will generate an email to the appropriate researcher who will administer the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be computer generated using a random number sequence and will be stratified by ABPI, gender and centre.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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

Recruitment
Recruitment status
Active, not 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)
NSW,QLD,WA
Recruitment hospital [1] 2433 0
The Townsville Hospital - Douglas
Recruitment hospital [2] 2434 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [3] 2435 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 2438 0
Mater Hospital Pimlico - Pimlico
Recruitment hospital [5] 5261 0
Fiona Stanley Hospital - Murdoch

Funding & Sponsors
Funding source category [1] 289192 0
Government body
Name [1] 289192 0
NHMRC
Address [1] 289192 0
Level 1
16 Marcus Clarke Street
Canberra
ACT 2601
Country [1] 289192 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
1 James Cook Drive
Townsville QLD 4811
Country
Australia
Secondary sponsor category [1] 287862 0
None
Name [1] 287862 0
None
Address [1] 287862 0
None
Country [1] 287862 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290968 0
Metro North - Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 290968 0
Royal Brisbane and Women's Hospital
Level 7, Block 7, Butterfield Street
Herston QLD 4029
Ethics committee country [1] 290968 0
Australia
Date submitted for ethics approval [1] 290968 0
19/02/2014
Approval date [1] 290968 0
16/05/2014
Ethics approval number [1] 290968 0
HREC/14/QRBW/60
Ethics committee name [2] 291073 0
South Metropolitan Health Service
Ethics committee address [2] 291073 0
Fremantle Hospital
Demountable 3, G Block
Fremantle WA 6959
Ethics committee country [2] 291073 0
Australia
Date submitted for ethics approval [2] 291073 0
06/05/2014
Approval date [2] 291073 0
Ethics approval number [2] 291073 0
14/26
Ethics committee name [3] 291096 0
The University of Queensland
Ethics committee address [3] 291096 0
UQ Research and Innovation
Cumbrae-Stewart Building
Brisbane QLD 4072
Ethics committee country [3] 291096 0
Australia
Date submitted for ethics approval [3] 291096 0
16/05/2014
Approval date [3] 291096 0
29/05/2014
Ethics approval number [3] 291096 0
2014000707
Ethics committee name [4] 294371 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [4] 294371 0
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006
Ethics committee country [4] 294371 0
Australia
Date submitted for ethics approval [4] 294371 0
Approval date [4] 294371 0
30/06/2015
Ethics approval number [4] 294371 0
2015/341

Summary
Brief summary
Occlusion of the lower limb arteries due to atherosclerosis (peripheral artery disease; PAD) affects
~10% of older adults and is associated with impaired quality of life, disability and a high mortality rate. Low physical activity levels are associated with PAD and predict worse outcomes. Exercise programs improve outcomes for PAD patients but on leaving such programs patients return to previous low activity levels. Previous research has identified that the major impediments to physical activity behaviour change in PAD patients are dysfunctional illness beliefs and low perceived efficacy of physical activity to improve PAD related outcomes. Previous research has also shown that brief behavioural counselling by a psychologist in patients' homes to redress these activity barriers can improve physical activity and other PAD outcomes for up to two years. More work is needed to evaluate behavioural counselling delivered by other health professionals and in other settings.

The primary aim of the current study is to assess the efficacy of a brief behaviour counselling intervention delivered by allied health workers in health facilities to improve physical activity in patients with PAD over 4 months and then maintain this improvement at 12 and 24 months.
We hypothesize that among patients with PAD, a brief behaviour counselling intervention will increase physical activity by ~50% compared to patients undertaking standard medical care (controls) evidenced by mean daily step counts of 5000+/-3400 for those patients receiving the intervention compared to 3300+/-2200 for those randomised to the control group at 4 months follow-up. We also hypothesise this improvement will be maintained at 12 and 24 months.

Secondary aims of this study include examining the effect of the brief behaviour counselling intervention on participants’ functional capacity, psychological profile, revascularisation rate, resource use; and to perform an economic evaluation of the brief behaviour counselling intervention compared to usual care.
Trial website
http://ncre-pad.registry.org.au/clinical-studies
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 48194 0
Prof Jonathan Golledge
Address 48194 0
Vascular Biology Unit
James Cook University
James Cook Drive
Townsville, Queensland 4810
Country 48194 0
Australia
Phone 48194 0
+61 7 4433 1417
Fax 48194 0
+61 7 4433 1401
Email 48194 0
jonathan.golledge@jcu.edu.au
Contact person for public queries
Name 48195 0
Mrs Alkira Deren
Address 48195 0
Queensland Research Centre for Peripheral Vascular Disease
JCU Clinical School
The Townsville Hospital
IMB 52
PO Box 670
Townsville
QLD 4810
Country 48195 0
Australia
Phone 48195 0
+61 744331749
Fax 48195 0
+61 7 4781 3652
Email 48195 0
QRCPVD@jcu.edu.au
Contact person for scientific queries
Name 48196 0
Prof Jonathan Golledge
Address 48196 0
Vascular Biology Unit
James Cook University
James Cook Drive
Townsville, Queensland 4810
Country 48196 0
Australia
Phone 48196 0
+61 7 4433 1417
Fax 48196 0
+61 7 4781 3179
Email 48196 0
jonathan.golledge@jcu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not planned at this stage as stipulated in our ethics applications and protocols.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary