Bearne L1, Galea Holmes M1, Weinman J2
1King's College London, Department of Population Health Sciences, London, United Kingdom, 2King's College London, Institute of Pharmaceutical Science, London, United Kingdom
Background: Intermittent claudication (IC) is a symptom of peripheral arterial disease which affects an individual's physical function, mental health and quality of life. Management guidelines recommend 30-60 minutes walking exercise, 3 times/week for 3 months but adherence to walking tends to be poor. The MOtivating Structured walking Activity for Intermittent Claudication (MOSAIC) intervention is a systematically developed, physiotherapist-led, behaviour-change intervention which aims to increase walking in people with IC.
Purpose: This feasibility study evaluated the suitability of outcomes (e.g. candidate primary measures: 6-Minute Walk Distance (6MWD), pedometer-assessed walking), rates of participant recruitment, retention and adherence to and acceptability of MOSAIC to inform the development of a randomised controlled trial.
Methods: This two-arm, randomised, controlled feasibility study recruited participants aged ≥18 years diagnosed with peripheral arterial disease and IC from two public hospitals.
Interventions: MOSAIC included 2x60-minute individual face-to-face sessions and 2x20-minute telephone calls comprising behaviour-change techniques (e.g. motivational interviewing) targeting walking and delivered by a trained physiotherapist over 12 weeks. A matched attention-control comparison intervention followed the same structure and format as MOSAIC but focused on dietary behaviour.
Measures: Sociodemographic and clinical descriptive data were collected by self-report at baseline. 6MWD (metres), pedometer-assessed 6-day walking activity (mean steps/day), health-related quality of life (MOS Short Form-12v2), and beliefs about walking treatment, illness cognitions and self-regulation were assessed at baseline and 16 weeks by a blinded researcher.
Analysis: The proportion of participants with incomplete data at each assessment for each measure was calculated (% missing data). Within-group change from baseline (mean difference (standard deviation)) and standardised response mean (SEM) was calculated for walking outcomes. Participant recruitment, and rates of retention and adherence to the intervention were assessed at 16 weeks (%).
The acceptability of MOSAIC and trial procedures were explored with a sub-sample of participants and the physiotherapist using semi-structured interviews. Qualitative data was transcribed verbatim, anonymised and analysed thematically.
Results: 24 participants (mean age±standard deviation: 66.8±9.4 years, 79% male) were enrolled. Participant recruitment, retention and adherence to intervention rates were 25%, 92% and 71% respectively. 6MWD (MOSAIC:-8.2(42.3)metres;SEM:-0.20, Comparison:9.9(42.1)metres) had no missing data whereas there was up to 36% missing data for daily walking activity (MOSAIC:836.9(625.8)steps;SEM:1.4, Comparison:-29.5(1471.4)steps).
Four themes were generated from interviews with 12 participants and the physiotherapist:
1) Acceptability of the research process and protocol;
2) Acceptability of the treatment and attention-control interventions;
3) Perceived expectations and outcomes of the treatment and attention-control interventions;
4) Physiotherapist role as a person and professional.
Conclusion(s): Overall, rates of participant recruitment, retention and intervention adherence were high, and the intervention and trial processes were acceptable. The 6MWD was the superior outcome. Informed by this successful feasibility study, a multi-centre, 2-arm, superiority trial (primary outcome: 6MWD at 3 months) with a nested qualitative study and process evaluation was developed to investigate the efficacy of MOSAIC compared to usual care in older people with IC.
Implications: If efficacious, MOSAIC will enable people with IC to improve their symptoms and mobility by increasing knowledge and self-management skills. It will provide physiotherapists with additional skills and treatments to help support patients with IC.
Keywords: Intermittent Claudication, Walking, Behaviour change
Funding acknowledgements: This work was supported by The Dunhill Medical Trust [grant number: RTF09/0110]
Purpose: This feasibility study evaluated the suitability of outcomes (e.g. candidate primary measures: 6-Minute Walk Distance (6MWD), pedometer-assessed walking), rates of participant recruitment, retention and adherence to and acceptability of MOSAIC to inform the development of a randomised controlled trial.
Methods: This two-arm, randomised, controlled feasibility study recruited participants aged ≥18 years diagnosed with peripheral arterial disease and IC from two public hospitals.
Interventions: MOSAIC included 2x60-minute individual face-to-face sessions and 2x20-minute telephone calls comprising behaviour-change techniques (e.g. motivational interviewing) targeting walking and delivered by a trained physiotherapist over 12 weeks. A matched attention-control comparison intervention followed the same structure and format as MOSAIC but focused on dietary behaviour.
Measures: Sociodemographic and clinical descriptive data were collected by self-report at baseline. 6MWD (metres), pedometer-assessed 6-day walking activity (mean steps/day), health-related quality of life (MOS Short Form-12v2), and beliefs about walking treatment, illness cognitions and self-regulation were assessed at baseline and 16 weeks by a blinded researcher.
Analysis: The proportion of participants with incomplete data at each assessment for each measure was calculated (% missing data). Within-group change from baseline (mean difference (standard deviation)) and standardised response mean (SEM) was calculated for walking outcomes. Participant recruitment, and rates of retention and adherence to the intervention were assessed at 16 weeks (%).
The acceptability of MOSAIC and trial procedures were explored with a sub-sample of participants and the physiotherapist using semi-structured interviews. Qualitative data was transcribed verbatim, anonymised and analysed thematically.
Results: 24 participants (mean age±standard deviation: 66.8±9.4 years, 79% male) were enrolled. Participant recruitment, retention and adherence to intervention rates were 25%, 92% and 71% respectively. 6MWD (MOSAIC:-8.2(42.3)metres;SEM:-0.20, Comparison:9.9(42.1)metres) had no missing data whereas there was up to 36% missing data for daily walking activity (MOSAIC:836.9(625.8)steps;SEM:1.4, Comparison:-29.5(1471.4)steps).
Four themes were generated from interviews with 12 participants and the physiotherapist:
1) Acceptability of the research process and protocol;
2) Acceptability of the treatment and attention-control interventions;
3) Perceived expectations and outcomes of the treatment and attention-control interventions;
4) Physiotherapist role as a person and professional.
Conclusion(s): Overall, rates of participant recruitment, retention and intervention adherence were high, and the intervention and trial processes were acceptable. The 6MWD was the superior outcome. Informed by this successful feasibility study, a multi-centre, 2-arm, superiority trial (primary outcome: 6MWD at 3 months) with a nested qualitative study and process evaluation was developed to investigate the efficacy of MOSAIC compared to usual care in older people with IC.
Implications: If efficacious, MOSAIC will enable people with IC to improve their symptoms and mobility by increasing knowledge and self-management skills. It will provide physiotherapists with additional skills and treatments to help support patients with IC.
Keywords: Intermittent Claudication, Walking, Behaviour change
Funding acknowledgements: This work was supported by The Dunhill Medical Trust [grant number: RTF09/0110]
Topic: Professional practice: other; Older people
Ethics approval required: Yes
Institution: King''s College London
Ethics committee: North West – Greater Manchester West Ethics Committee
Ethics number: 14/NW/0089
All authors, affiliations and abstracts have been published as submitted.
