Aortic & peripheral vascular disease

Effect of Brief Counseling by Allied Health Professionals on Step Count of People With Peripheral Artery Disease: A Randomized Clinical Trial

JAMA CardiolPublished Randomised controlled trial

Errata to this article were published (JAMA Cardiol, 1 Dec 2023 ↗ · 1 Dec 2023 ↗)

Authors' conclusion

This randomized clinical trial found no significant effect of brief counseling on step count in people with PAD.

Study context

Population
Patients with symptomatic PAD, Australia175 (87.5%) step count at 4 months
Participants
200 patients
Comparison
Brief counseling by allied health professionals vs attention control
  • Counselingn = 102
  • Attention controln = 98reference
Primary endpoint
Between-group difference in change in daily step count (7-day accelerometer recordings), imputation for missing values
Follow-up
4 months
Methodological detailsattention-controlled, multicentre (Australia)
  • Attention-controlled
  • Multicentre (Australia)

Primary result

As reported in the abstract

Change in daily step count (between-group difference)

No significant between-group difference in change in daily step count, mean steps

415

95% CI −62 to 893P = .07

Secondary outcomes

OutcomeDifference (points) (95% CI)P value
Intermittent Claudication Questionnaire score · 4, 12 and 24 monthsCounselingvs Attention control4 months3.2 (0.1–6.4)P = 0.04
Intermittent Claudication Questionnaire score · 4, 12 and 24 monthsCounselingvs Attention control12 months4.3 (0.5–8.1)P = 0.03
Intermittent Claudication Questionnaire score · 4, 12 and 24 monthsCounselingvs Attention control24 months1.2 (−3.1 to 5.6)P = 0.57

PAD Quality of Life Questionnaire, symptoms and limitations in physical functioning (between-group difference) · 4, 12 and 24 months

4 months, points
1.5 (95% CI, 0.3-2.8; P = .02)
12 months, points
1.8 (95% CI, 0.3-3.3; P = .02)
24 months, points
1.3 (95% CI −0.5 to 3.1; P = .16)

Change in mean 6-minute walking distance (between-group difference) · 4, 12 and 24 months

No significant effect; 4 months, m
9.3 (95% CI, −3.7 to 22.3; P = .16)
12 months, m
13.8 (95% CI, −4.2 to 31.7; P = .13)
24 months, m
1.2 (95% CI, −20.0 to 22.5; P = .91)

Safety

Major adverse limb events · 24 months

P > 0.99

Original publication

Effect of Brief Counseling by Allied Health Professionals on Step Count of People With Peripheral Artery Disease: A Randomized Clinical Trial. JAMA Cardiol. Published 1 April 2023. doi:10.1001/jamacardio.2022.5437

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