None listed
Conditions
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.
Interventions
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
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.
Sponsors
James Cook University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 110 Years
Healthy volunteers
No
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
Exclusion criteria
1. Patients with severe PAD, such as rest pain, arterial ulceration or gangrene requring urgent vascular intervention
Outcome results
None listed