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A randomized controlled feasibility trial of a home-based walking behavior-change intervention for people with intermittent claudication.

Journal of vascular nursing : official publication of the Society for Peripheral Vascular Nursing
June 1, 2019
Melissa N Galea Holmes et al. (3 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

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

Extracted Claims (10)
InterventionDirectionEndpointPopulationDosageImpactClaim #
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
Abstract

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.

Medical Subject Headings (MeSH)
AgedExercise TherapyFeasibility StudiesFemaleHome Care ServicesHumansIntermittent ClaudicationMalePeripheral Arterial DiseaseQuality of LifeWalking
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality80/10
Citation Metrics
Total Citations16
Citations/Year2.7
Relative Citation Ratio1.43
NIH Percentile63.4%
Research Impact Scores
APT Score0.75
Weight Score2.24
Normalized Score0.66
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