Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication

Not Applicable

Completed

• Conditions: Intermittent Claudication
• Interventions: Behavioral: Person-centered follow up

• Registration Number: NCT03283358
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Specific Aims:

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 Those participants who couldn't receive revascularization after giving consent will be withdrawn from the study and counted as drop outs.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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06-13
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-14
• Primary Completion: 2019-11-30
• Study Completion: 2020-05-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Person-centered follow up	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.

Primary Outcome Measures

Name	Time	Method
Adherence to medication	One year after surgical or endovascular treatment for Intermittent Claudication	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.

Secondary Outcome Measures

Name	Time	Method
Risk for 10-year predicted coronary heart disease (CHD)	One year after surgical or endovascular treatment for Intermittent Claudication	Changes in risk for CHD within 10-years measured by Framingham Risk Score (FRHS).

Trial Locations

Locations (2)

Department of Surgery, Unit of Vascular Surgery, Södersjukhuset; 🇸🇪 Stockholm, Sweden

Karolinska University Hospital, Dept of Vascular Surgery; 🇸🇪 Stockholm, Sweden