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

Abstract

Importance: It is unclear how to effectively promote walking in people with peripheral artery disease (PAD).

Objective: To test whether brief counseling delivered by allied health professionals increases step count in participants with PAD.

Design, setting, and participants: In this randomized clinical trial, participants with symptomatic PAD were recruited from sites in Australia and randomly allocated 1:1 to the counseling intervention or an attention control. Data were collected from January 2015 to July 2021, and data were analyzed from March to November 2022.

Interventions: Two 1-hour face-to-face and two 15-minute telephone counseling sessions designed to increase walking.

Main outcomes and measures: The primary outcome was the between-group difference in change in daily step count estimated by accelerometer recordings over 7 days at baseline and 4 months, using imputation for missing values. Other outcomes at 4, 12, and 24 months included step count, 6-minute walk distance, and disease-specific and generic measures of health-related quality of life. Risk of major adverse limb events was assessed over 24 months.

Results: Of 200 included participants, 144 (72.0%) were male, and the mean (SD) age was 69.2 (9.3) years. The planned sample of 200 participants was allocated to the counseling intervention group (n = 102) or attention control group (n = 98). Overall, 198 (99.0%), 175 (87.5%), 160 (80.0%) and 143 (71.5%) had step count assessed at entry and 4, 12, and 24 months, respectively. There was no significant between-group difference in the primary outcome of change in daily step count over 4 months (mean steps, 415; 95% CI, -62 to 893; P = .07). Participants in the counseling group had significantly greater improvement in the secondary outcome of disease-specific Intermittent Claudication Questionnaire score at 4 months (3.2 points; 95% CI, 0.1-6.4; P = .04) and 12 months (4.3 points; 95% CI, 0.5-8.1; P = .03) but not at 24 months (1.2 points; 95% CI, -3.1 to 5.6; P = .57). Findings were similar for mean PAD Quality of Life Questionnaire component assessing symptoms and limitations in physical functioning (4 months: 1.5 points; 95% CI, 0.3-2.8; P = .02; 12 months: 1.8 points; 95% CI, 0.3-3.3; P = .02; 24 months: 1.3 points; 95% CI. -0.5 to 3.1; P = .16). There was no significant effect of the intervention on change in mean 6-minute walking distance (4 months: 9.3 m; 95% CI, -3.7 to 22.3; P = .16; 12 months: 13.8 m; 95% CI, -4.2 to 31.7; P = .13; 24 months: 1.2 m; 95% CI, -20.0 to 22.5; P = .91). The counseling intervention did not affect the rate of major adverse limb events over 24 months (12 [6.0%] in the intervention group vs 11 [5.5%] in the control group; P > .99).

Conclusions and relevance: This randomized clinical trial found no significant effect of brief counseling on step count in people with PAD. Alternate interventions are needed to enable walking.

Trial registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614000592640.

Figure.. Flow of Included Participants

Some participants completed some but not all outcome assessments when assessed at 4, 12, and 24 months as they declined or were unable to do some of the outcome tests due to illness, adverse events, or personal reasons. See eTable 1 in Supplement 1 for a detailed list of number of participants that completed each assessment. ^aFour completed some but not all outcome assessments. ^bThree completed some but not all outcome assessments. ^cSeven completed some but not all outcome assessments. ^dTwo completed some but not all outcome assessments. ^eFive completed some but not all outcome assessments.