Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication
FASTIC
1 other identifier
interventional
213
1 country
2
Brief Summary
The overall aim of the study is to evaluate a nurse-led intervention (person-centered follow up and health promotion) program in comparison to standard follow up for patients treated with surgical or endovascular revascularization of Intermittent Claudication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2016
CompletedStudy Start
First participant enrolled
June 13, 2016
CompletedFirst Posted
Study publicly available on registry
September 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedOctober 28, 2020
October 1, 2020
3.5 years
June 13, 2016
October 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to medication
Adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents) according to the Swedish Prescribed Drug Registry (PDR). dispensed anticoagulant agents, antiplatelet agents (ATC-register B01A) and lipid-lowering agents (ATC-register C10). Those participants who have fetched both medications for the second refill after treatment will be considered adherent.
One year after surgical or endovascular treatment for Intermittent Claudication
Secondary Outcomes (1)
Risk for 10-year predicted coronary heart disease (CHD)
One year after surgical or endovascular treatment for Intermittent Claudication
Other Outcomes (9)
Patient reported adherence to medication
One year after surgical or endovascular treatment for Intermittent Claudication
Generic Health-related Quality of Life (HRQOL)
One year after surgical or endovascular treatment for Intermittent Claudication
Condition specific Health-related Quality of Life (HRQOL)
One year after surgical or endovascular treatment for Intermittent Claudication
- +6 more other outcomes
Study Arms (2)
Person-centered follow up
EXPERIMENTALThe intervention program is a person-centered health promotion program led by a nurse and consists of two telephone calls (15 minutes each) at two weeks and nine months after surgical treatment for Intermittent Claudication and three visits (45 - 60 min) at six weeks, six months and one year after treatment. The program includes a baseline assessment, an individual plan for self-care and educational information about Intermittent Claudication, received treatment and secondary prevention (medication and modifiable risk factors). The purpose is to enhance self-care in terms of adherence to medication and to recommended changes of lifestyle.
Standard follow up
NO INTERVENTIONStandard follow-up consist of two follow up appointments á 20 minutes at four-six weeks and one year after surgical treatment of Intermittent Claudication. The patients meet a vascular surgeon at the first follow up and a vascular nurse or a surgeon at the second follow up visit.
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients who is scheduled for revascularization, through open and/or endovascular surgery for IC diagnosed according to Diagnosis Related Group (DRG) with I70.2 or I739B
You may not qualify if:
- Patients not treated through surgery or revascularization
- Patients diagnosed with dementia
- Patients discharge to a nursery home,
- Patients not accountable for administrating their own medications
- Patients with a survival expectancy less than one year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Surgery, Unit of Vascular Surgery, Södersjukhuset
Stockholm, SE-11883, Sweden
Karolinska University Hospital, Dept of Vascular Surgery
Stockholm, Sweden
Related Publications (2)
Haile ST, Olsson M, Lindstrand R, Loof H, Linne A, Johansson UB, Joelsson-Alm E. Patient Reported Experiences of Receiving Person-Centred, Nurse-Led Follow-Up After Revascularisation for Intermittent Claudication: Secondary Analysis of a Randomised Controlled Trial. J Clin Nurs. 2025 Jul;34(7):3003-3016. doi: 10.1111/jocn.17762. Epub 2025 May 20.
PMID: 40390575DERIVEDHaile S, Linne A, Johansson UB, Joelsson-Alm E. Follow-up after surgical treatment for intermittent claudication (FASTIC): a study protocol for a multicentre randomised controlled clinical trial. BMC Nurs. 2020 Jun 4;19:45. doi: 10.1186/s12912-020-00437-7. eCollection 2020.
PMID: 32518518DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anneli Linné, MD, PhD
Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 13, 2016
First Posted
September 14, 2017
Study Start
June 13, 2016
Primary Completion
November 30, 2019
Study Completion
May 31, 2020
Last Updated
October 28, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share