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Efficacy of brief behavioral counselling by allied health professionals to promote physical activity in people with peripheral arterial disease (BIPP): study protocol for a multi-center randomized controlled trial.

BMC public health
January 1, 1970
Nicola W Burton et al. (17 authors)
Journal ArticleMulticenter StudyRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the efficacy and cost-effectiveness of a brief behavioral counselling intervention to improve physical activity (specifically interval walking) in people with peripheral arterial disease (PAD).

Results Summary

The study will assess whether behavioral counselling promotes interval walking (3 × 40 min/week) and improves outcomes such as physical activity, walking capacity, and quality of life, with evaluations at baseline, 4, 12, and 24 months.

Population

Adults with peripheral arterial disease (PAD) recruited from vascular clinics, general practitioners, and research databases in Australia.

Effective Dosage

Interval walking for 3 × 40 min/week.

Duration

3 months (with follow-ups up to 24 months).

Interactions

None mentioned.

Extracted Claims (7)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Physical activity
increase
walking capacity
people with peripheral arterial disease (PAD)
-
can improve
#1
Physical activity
increase
quality of life
people with peripheral arterial disease (PAD)
-
can improve
#2
Physical activity
decrease
pain
people with peripheral arterial disease (PAD)
-
can reduce
#3
Physical activity
decrease
requirement for surgery
people with peripheral arterial disease (PAD)
-
can reduce
#4
Physical activity
decrease
cardiovascular events
people with peripheral arterial disease (PAD)
-
can reduce
#5
brief behavioral counselling intervention delivered by allied health professionals
increase
physical activity
people with PAD
-
will assess the efficacy
#6
interval walking
increase
interval walking for 3 × 40 min/week
intervention group
3 × 40 min/week
will promote
#7
Abstract

BACKGROUND: Physical activity is recommended for people with peripheral arterial disease (PAD), and can improve walking capacity and quality of life; and reduce pain, requirement for surgery and cardiovascular events. This trial will assess the efficacy of a brief behavioral counselling intervention delivered by allied health professionals to improve physical activity in people with PAD. METHODS: This is a multi-center randomised controlled trial in four cities across Australia. Participants (N = 200) will be recruited from specialist vascular clinics, general practitioners and research databases and randomised to either the control or intervention group. Both groups will receive usual medical care, a written PAD management information sheet including advice to walk, and four individualised contacts from a protocol-trained allied health professional over 3 months (weeks 1, 2, 6, 12). The control group will receive four 15-min telephone calls with general discussion about PAD symptoms and health and wellbeing. The intervention group will receive behavioral counselling via two 1-h face-to-face sessions and two 15-min telephone calls. The counselling is based on the 5A framework and will promote interval walking for 3 × 40 min/week. Assessments will be conducted at baseline, and 4, 12 and 24 months by staff blinded to participant allocation. Objectively assessed outcomes include physical activity (primary), sedentary behavior, lower limb body function, walking capacity, cardiorespiratory fitness, event-based claudication index, vascular interventions, clinical events, cardiovascular function, circulating markers, and anthropometric measures. Self-reported outcomes include physical activity and sedentary behavior, walking ability, pain severity, and health-related quality of life. Data will be analysed using an intention-to-treat approach. An economic evaluation will assess whether embedding the intervention into routine care would likely be value for money. A cost-effectiveness analysis will estimate change in cost per change in activity indicators due to the intervention, and a cost-utility analysis will assess change in cost per quality-adjusted life year. A full uncertainty analysis will be undertaken, including a value of information analysis, to evaluate the economic case for further research. DISCUSSION: This trial will evaluate the efficacy and cost-effectiveness of a brief behavioral counselling intervention for a common cardiovascular disease with significant burden. TRIAL REGISTRATION: ACTRN 12614000592640 Australian New Zealand Clinical Trials Registry. Registration Date 4 June 2014.

Medical Subject Headings (MeSH)
AdultAllied Health PersonnelAustraliaBehavior TherapyClinical ProtocolsCost-Benefit AnalysisCounselingExerciseFemaleHumansMaleNew ZealandPeripheral Arterial DiseaseQuality of LifeQuality-Adjusted Life YearsTreatment OutcomeWalking
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations9
Citations/Year1.0
Relative Citation Ratio0.46
NIH Percentile24.7%
Research Impact Scores
APT Score0.50
Weight Score1.71
Normalized Score0.67
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