Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication
NCT ID: NCT03283358
Last Updated: 2020-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
213 participants
INTERVENTIONAL
2016-06-13
2020-05-31
Brief Summary
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Detailed Description
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1. To evaluate the effect of the intervention program on patient's adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents), risk modification and surgical treatment outcomes
2. To investigate the effect of the intervention program on patient reported outcomes
3. To investigate the effect of the intervention program on patient reported experiences
4. To investigate the long-term effect of the intervention program on mortality, cause of death, occurrence/recurrence of cardiovascular disease up to 10 years after the surgical/endovascular treatment
5. To compare patient-reported adherence to medication and patient data registry adherence to medication
Hypothesis: Participants in the Intervention Group have better adherence to prescribed medication and a reduced risk for 10-year predicted coronary heart disease (CHD) compared to participants in the Control Group.
Study population:
Patients with Intermittent Claudication scheduled for revascularization, through open surgery or endovascular method, in Stockholm will be screened for inclusion. After informed consent, the participants will be randomized to either Intervention Group or Control Group. Those participants who couldn't receive revascularization after giving consent will be withdrawn from the study and counted as drop outs. Power analysis has showed a required sample size of 186 participants to detect a statistically significant increase in adherence to medication from 50% to 70% (power 0.80, significance value 0.05, two-sided). Expecting 10% drop-out we plan to recruit 210 participants.
Data collection:
Data on primary and secondary outcomes, serum cholesterol, smoking status, serum carbon monoxide, Hba1c, BMI, waist circumference, physical exercise, diet, alcohol consumption, graft patency, re-intervention, hospitalization during the study year, mortality and patient characteristics/demographics will be collected at baseline and one year after treatment. All data will be registered at a local research data base at Karolinska Institutet. All patient-reported outcomes will be collected using web-based questionnaires linked to the data base.
Data analysis:
Comparisons between the Intervention Group and the Control Group will be made using t-test and ANOVA for repeated-measures or Wilcoxon rank-signed test and Kruskall-Wallis according to the underlying distribution for continuous data, and Fischers Exact test for categorical data. Logistic regression analysis will also be performed to adjust for confounding factors. All analyses will be performed according to the Intention-to-treat principle.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Person-centered follow up
The 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.
Person-centered follow up
Standard follow up
Standard 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.
No interventions assigned to this group
Interventions
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Person-centered follow up
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Anneli Linné
MD, PhD
Principal Investigators
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Anneli Linné, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset
Locations
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Department of Surgery, Unit of Vascular Surgery, Södersjukhuset
Stockholm, , Sweden
Karolinska University Hospital, Dept of Vascular Surgery
Stockholm, , Sweden
Countries
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References
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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.
Haile 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.
Other Identifiers
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FASTIC-1
Identifier Type: -
Identifier Source: org_study_id