Randomised controlled trial
Effect of Brief Counseling by Allied Health Professionals on Step Count of People With Peripheral Artery Disease
- Randomised controlled trial
- attention-controlled
- multicentre (Australia)
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
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 893; P = .07)
Secondary outcomes
| Outcome | difference (points) (95% CI) | P value | |
|---|---|---|---|
| Intermittent Claudication Questionnaire score · 4, 12 and 24 months — Counseling vs Attention control · 4 months | 3.2 (0.1–6.4) | P = 0.04 | |
| Intermittent Claudication Questionnaire score · 4, 12 and 24 months — Counseling vs Attention control · 12 months | 4.3 (0.5–8.1) | P = 0.03 | |
| Intermittent Claudication Questionnaire score · 4, 12 and 24 months — Counseling vs Attention control · 24 months | 1.2 (−3.1 to 5.6) | P = 0.57 | |
| −50510Difference, points (linear scale) |
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. JAMA Cardiol. Published 1 April 2023. doi:10.1001/jamacardio.2022.5437
Summarised from the published abstract; every number is checked against it