Follow-up after surgical treatment for intermittent claudication (FASTIC): a study protocol for a multicentre randomised controlled clinical trial
Open Access
- 4 June 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in BMC Nursing
- Vol. 19 (1), 1-12
- https://doi.org/10.1186/s12912-020-00437-7
Abstract
Intermittent claudication (IC) is a classic symptom of peripheral arterial disease, and strongly associated with coronary heart disease and cerebrovascular disease. Treatment of IC and secondary prevention of vascular events include best medical treatment (BMT), changes in lifestyle, most importantly smoking cessation and increased physical exercise, and in appropriate cases surgery. A person-centred and health promotion approach might facilitate breaking barriers to lifestyle changes and increasing adherence to secondary prevention therapy. The FASTIC study aims to evaluate a nurse-led, person-centred, health-promoting follow-up programme compared with standard follow-up by a vascular surgeon after surgical treatment for IC. The FASTIC-study is a multicentre randomised controlled clinical trial. Patients will be recruited from two hospitals in Stockholm, Sweden after surgical treatment of IC through open and/or endovascular revascularisation and will be randomly assigned into two groups. The intervention group is offered a nurse-led, person-centred, health-promoting programme, which includes two telephone calls and three visits to a vascular nurse the first year after surgical treatment. The control group is offered standard care, which consists of a visit to a vascular surgeon 4–8 weeks after surgery and a visit to the outpatient clinic 1 year after surgical treatment. The primary outcome is adherence to BMT 1 year after surgical treatment and will be measured using The Swedish Prescribed Drug Registry. Clinical assessments, biomarkers, and questionnaires will be used to evaluate several secondary outcomes, such as predicted 10-year risk of cardiovascular and cerebrovascular events, health-related quality of life, and patients’ perceptions of care quality. The FASTIC study will provide important information about interventions aimed at improving adherence to medication, which is an unexplored field among patients with IC. The study will also contribute to knowledge on how to implement person-centred care in a clinical context. ClinicalTrials.gov NCT03283358, registration date 06/13/2016.Keywords
Funding Information
- Karolinska Institutet, Department of Clinical Science and Education Södersjukhuset
- Department of Surgery, Södersjukhuset
- Vascular Research Group
- Sophiahemmet Foundation
- The Swedish Society of Nursing
This publication has 49 references indexed in Scilit:
- Developing and evaluating complex interventions: Reflections on the 2008 MRC guidanceInternational Journal of Nursing Studies, 2013
- Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country studyQuality of Life Research, 2012
- Experiences of living with intermittent claudicationJournal of Vascular Nursing, 2012
- Response Burden and Questionnaire Length: Is Shorter Better? A Review and Meta-analysisValue in Health, 2011
- Effects of person-centred care in patients with chronic heart failure: the PCC-HF studyEuropean Heart Journal, 2011
- Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)Quality of Life Research, 2011
- Ankle Brachial Index Combined With Framingham Risk Score to Predict Cardiovascular Events and MortalityJAMA, 2008
- The new Swedish Prescribed Drug Register—Opportunities for pharmacoepidemiological research and experience from the first six monthsPharmacoepidemiology and Drug Safety, 2006
- Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patientsBMJ, 2002
- The beliefs about medicines questionnaire: The development and evaluation of a new method for assessing the cognitive representation of medicationPsychology & Health, 1999