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

October 27, 2020 updated by: Anneli Linné, Karolinska Institutet
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Those participants who couldn't receive revascularization after giving consent will be withdrawn from the study and counted as drop outs.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

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, SE-11883
        • Department of Surgery, Unit of Vascular Surgery, Södersjukhuset
      • Stockholm, Sweden
        • Karolinska University Hospital, Dept of Vascular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Person-centered follow up
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to medication
Time Frame: 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.
One year after surgical or endovascular treatment for Intermittent Claudication

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported adherence to medication
Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication
Patient-reported adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents).
One year after surgical or endovascular treatment for Intermittent Claudication
Generic Health-related Quality of Life (HRQOL)
Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication
Patient-reported generic HrQoL measured by EQ-5D
One year after surgical or endovascular treatment for Intermittent Claudication
Condition specific Health-related Quality of Life (HRQOL)
Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication
Patient-reported specific HrQoL measured by VascQol-6
One year after surgical or endovascular treatment for Intermittent Claudication
Beliefs on medication
Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication
Patient-reported beliefs on medication measured by Beliefs about Meicines Questionnaire (BMQ)
One year after surgical or endovascular treatment for Intermittent Claudication
Self-efficacy
Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication
Patient-reported Self-efficacy measured by Swedish Version of the General Self-Efficacy Scale
One year after surgical or endovascular treatment for Intermittent Claudication
Health literacy
Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication
Patient-reported health literacy measured by HLS-EU-Q16 SE
One year after surgical or endovascular treatment for Intermittent Claudication
Patient-experienced quality of care
Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication
Patient-experienced quality of care measured by Quality of Care from Patient's Perspective (Swedish version of QPP)
One year after surgical or endovascular treatment for Intermittent Claudication
Mortality
Time Frame: Ten years after surgical or endovascular treatment for Intermittent Claudication
Data on mortality will be extracted from the National Patient Registry and Stockholm County Council's administrative data (VårdanalysdataLager - VAL).
Ten years after surgical or endovascular treatment for Intermittent Claudication
Cardiovascular disease
Time Frame: Ten years after surgical or endovascular treatment for Intermittent Claudication
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).
Ten years after surgical or endovascular treatment for Intermittent Claudication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Anneli Linné, MD, PhD, Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2016

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 14, 2017

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FASTIC-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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