A randomized controlled feasibility trial of a home-based walking behavior-change intervention for people with intermittent claudication.
Study Goal
The researchers aimed to evaluate the feasibility and acceptability of a home-delivered behavior-change intervention (MOSAIC) to increase walking in people with intermittent claudication (IC).
Results Summary
The MOSAIC trial was feasible to conduct, with high participant retention (92%) and adherence (71%), though missing pedometer data was a limitation. The intervention was acceptable to participants and clinicians, suggesting potential for facilitating walking in IC patients.
Population
Adults aged ≥18 years diagnosed with intermittent claudication (IC) identified from vascular outpatient clinics (mean age: 66.8 ± 9.4 years, 79% male).
Effective Dosage
Two 60-minute home-based sessions and two 20-minute booster telephone calls incorporating behavior-change techniques.
Duration
16 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Walking treatment | increase | intermittent claudication | people with IC | - | recommended for improving | #1 |
center-based exercise programs | decrease | implementation and adherence | people with IC | - | often not implemented or adhered to | #2 |
MOtivating Structured walking Activity in Intermittent Claudication (MOSAIC) | increase | walking | people with IC | - | developed to increase | #3 |
MOSAIC treatment | no change | recruitment rate | adults aged ≥18 years diagnosed with IC identified from vascular outpatient clinics | 25% | feasibility criteria achieved for recruitment rate | #4 |
MOSAIC treatment | no change | participant retention | adults aged ≥18 years diagnosed with IC identified from vascular outpatient clinics | 92% | feasibility criteria achieved for participant retention | #5 |
MOSAIC treatment | no change | adherence to assigned treatment or attention-control sessions | adults aged ≥18 years diagnosed with IC identified from vascular outpatient clinics | 71% | feasibility criteria achieved for adherence to assigned treatment or attention-control sessions | #6 |
MOSAIC treatment | decrease | missing data rates | adults aged ≥18 years diagnosed with IC identified from vascular outpatient clinics | <10% | missing data rates were | #7 |
MOSAIC treatment | increase | baseline daily walking activity | adults aged ≥18 years diagnosed with IC identified from vascular outpatient clinics | 36% | missing data rates were high for | #8 |
MOSAIC trial | no change | feasibility | adults aged ≥18 years diagnosed with IC identified from vascular outpatient clinics | - | was feasible to conduct | #9 |
MOSAIC intervention | increase | walking | people with IC | - | is an acceptable approach to facilitate | #10 |
Walking treatment is recommended for improving intermittent claudication (IC), a debilitating symptom of leg pain caused by peripheral arterial disease. However, center-based exercise programs offered in a community or hospital setting are often not implemented or adhered to. We developed a home-delivered behavior-change intervention, MOtivating Structured walking Activity in Intermittent Claudication (MOSAIC), to increase walking in people with IC. A feasibility randomized controlled trial with nested qualitative interviews involving a subsample of trial participants was conducted. Feasibility criteria evaluated participant recruitment and retention; suitability of proposed outcome measures; and acceptability and adherence to the intervention and trial. Participants (adults aged ≥18 years diagnosed with IC identified from vascular outpatient clinics) were randomized 1:1 to receive MOSAIC treatment (two 60-minute home-based sessions and two 20-minute booster telephone calls incorporating behavior-change techniques) or an attention-control comparison. Outcomes (baseline and 16-week follow-up) included the 6-minute walking distance (meters), pedometer-assessed daily walking activity (steps/d), health-related quality of life, physical functioning, and beliefs about walking treatment, peripheral arterial disease, and self-regulatory processes. Twenty-four participants (mean age: 66.8 ± 9.4 years, 79% male) were included. Feasibility criteria achieved were recruitment rate (25%), participant retention (92%), and adherence to assigned treatment or attention-control sessions (71%). Missing data rates were <10% for all outcomes except for baseline daily walking activity (36%). The trial protocol and interventions were acceptable to participants and the clinician. In conclusion, the MOSAIC trial was feasible to conduct, with the exception of high missing pedometer data. The intervention is an acceptable approach to facilitate walking among people with IC.