An interventional study of Person-centered follow up in Intermittent Claudication, sponsored by Karolinska Institutet. Completed at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-28.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention
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.
Specific Aims:
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 Those participants who couldn't receive revascularization after giving consent will be withdrawn from the study and counted as drop outs.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.
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's enrollment of 213 is above the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Person-centered 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.
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.
Time frame: One year after surgical or endovascular treatment for Intermittent Claudication
Risk for 10-year predicted coronary heart disease (CHD)
Changes in risk for CHD within 10-years measured by Framingham Risk Score (FRHS).
Time frame: One year after surgical or endovascular treatment for Intermittent Claudication
Patient reported adherence to medication
Patient-reported adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents).
Time frame: One year after surgical or endovascular treatment for Intermittent Claudication
Generic Health-related Quality of Life (HRQOL)
Patient-reported generic HrQoL measured by EQ-5D
Time frame: One year after surgical or endovascular treatment for Intermittent Claudication
Condition specific Health-related Quality of Life (HRQOL)
Patient-reported specific HrQoL measured by VascQol-6
Time frame: One year after surgical or endovascular treatment for Intermittent Claudication
Beliefs on medication
Patient-reported beliefs on medication measured by Beliefs about Meicines Questionnaire (BMQ)
Time frame: One year after surgical or endovascular treatment for Intermittent Claudication
Self-efficacy
Patient-reported Self-efficacy measured by Swedish Version of the General Self-Efficacy Scale
Time frame: One year after surgical or endovascular treatment for Intermittent Claudication
Health literacy
Patient-reported health literacy measured by HLS-EU-Q16 SE
Time frame: One year after surgical or endovascular treatment for Intermittent Claudication
Patient-experienced quality of care
Patient-experienced quality of care measured by Quality of Care from Patient's Perspective (Swedish version of QPP)
Time frame: One year after surgical or endovascular treatment for Intermittent Claudication
Mortality
Data on mortality will be extracted from the National Patient Registry and Stockholm County Council's administrative data (VårdanalysdataLager - VAL).
Time frame: Ten years after surgical or endovascular treatment for Intermittent Claudication
Cardiovascular disease
Data on occurrence/reoccurrence of cardiovascular disease with hospitalization will be extracted from the National Patient Registry and Stockholm County Council's administrative data (VårdanalysdataLager - VAL).
Time frame: Ten years after surgical or endovascular treatment for Intermittent Claudication
Plan to share: No
Ran from Jun 2016 to primary completion in Nov 2019, 41 months.
Of 73 non-industry interventional studies with no phase under Intermittent Claudication, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 77. This study's 41 months is below that.
Counting every sponsor, half of 84 studies reached it within 41 months; a quarter within 17 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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