<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03283358</url>
  </required_header>
  <id_info>
    <org_study_id>FASTIC-1</org_study_id>
    <nct_id>NCT03283358</nct_id>
  </id_info>
  <brief_title>Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication</brief_title>
  <acronym>FASTIC</acronym>
  <official_title>Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aim of the study is to evaluate a nurse-led intervention (person-centered follow&#xD;
      up and health promotion) program in comparison to standard follow up for patients treated&#xD;
      with surgical or endovascular revascularization of Intermittent Claudication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aims:&#xD;
&#xD;
        1. To evaluate the effect of the intervention program on patient's adherence to medication&#xD;
           (anticoagulant agents, antiplatelet agents and lipid-lowering agents), risk modification&#xD;
           and surgical treatment outcomes&#xD;
&#xD;
        2. To investigate the effect of the intervention program on patient reported outcomes&#xD;
&#xD;
        3. To investigate the effect of the intervention program on patient reported experiences&#xD;
&#xD;
        4. To investigate the long-term effect of the intervention program on mortality, cause of&#xD;
           death, occurrence/recurrence of cardiovascular disease up to 10 years after the&#xD;
           surgical/endovascular treatment&#xD;
&#xD;
        5. To compare patient-reported adherence to medication and patient data registry adherence&#xD;
           to medication&#xD;
&#xD;
      Hypothesis: Participants in the Intervention Group have better adherence to prescribed&#xD;
      medication and a reduced risk for 10-year predicted coronary heart disease (CHD) compared to&#xD;
      participants in the Control Group.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      Patients with Intermittent Claudication scheduled for revascularization, through open surgery&#xD;
      or endovascular method, in Stockholm will be screened for inclusion. After informed consent,&#xD;
      the participants will be randomized to either Intervention Group or Control Group. Those&#xD;
      participants who couldn't receive revascularization after giving consent will be withdrawn&#xD;
      from the study and counted as drop outs. Power analysis has showed a required sample size of&#xD;
      186 participants to detect a statistically significant increase in adherence to medication&#xD;
      from 50% to 70% (power 0.80, significance value 0.05, two-sided). Expecting 10% drop-out we&#xD;
      plan to recruit 210 participants.&#xD;
&#xD;
      Data collection:&#xD;
&#xD;
      Data on primary and secondary outcomes, serum cholesterol, smoking status, serum carbon&#xD;
      monoxide, Hba1c, BMI, waist circumference, physical exercise, diet, alcohol consumption,&#xD;
      graft patency, re-intervention, hospitalization during the study year, mortality and patient&#xD;
      characteristics/demographics will be collected at baseline and one year after treatment. All&#xD;
      data will be registered at a local research data base at Karolinska Institutet. All&#xD;
      patient-reported outcomes will be collected using web-based questionnaires linked to the data&#xD;
      base.&#xD;
&#xD;
      Data analysis:&#xD;
&#xD;
      Comparisons between the Intervention Group and the Control Group will be made using t-test&#xD;
      and ANOVA for repeated-measures or Wilcoxon rank-signed test and Kruskall-Wallis according to&#xD;
      the underlying distribution for continuous data, and Fischers Exact test for categorical&#xD;
      data. Logistic regression analysis will also be performed to adjust for confounding factors.&#xD;
      All analyses will be performed according to the Intention-to-treat principle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2016</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to medication</measure>
    <time_frame>One year after surgical or endovascular treatment for Intermittent Claudication</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk for 10-year predicted coronary heart disease (CHD)</measure>
    <time_frame>One year after surgical or endovascular treatment for Intermittent Claudication</time_frame>
    <description>Changes in risk for CHD within 10-years measured by Framingham Risk Score (FRHS).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient reported adherence to medication</measure>
    <time_frame>One year after surgical or endovascular treatment for Intermittent Claudication</time_frame>
    <description>Patient-reported adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents).</description>
  </other_outcome>
  <other_outcome>
    <measure>Generic Health-related Quality of Life (HRQOL)</measure>
    <time_frame>One year after surgical or endovascular treatment for Intermittent Claudication</time_frame>
    <description>Patient-reported generic HrQoL measured by EQ-5D</description>
  </other_outcome>
  <other_outcome>
    <measure>Condition specific Health-related Quality of Life (HRQOL)</measure>
    <time_frame>One year after surgical or endovascular treatment for Intermittent Claudication</time_frame>
    <description>Patient-reported specific HrQoL measured by VascQol-6</description>
  </other_outcome>
  <other_outcome>
    <measure>Beliefs on medication</measure>
    <time_frame>One year after surgical or endovascular treatment for Intermittent Claudication</time_frame>
    <description>Patient-reported beliefs on medication measured by Beliefs about Meicines Questionnaire (BMQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>One year after surgical or endovascular treatment for Intermittent Claudication</time_frame>
    <description>Patient-reported Self-efficacy measured by Swedish Version of the General Self-Efficacy Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Health literacy</measure>
    <time_frame>One year after surgical or endovascular treatment for Intermittent Claudication</time_frame>
    <description>Patient-reported health literacy measured by HLS-EU-Q16 SE</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient-experienced quality of care</measure>
    <time_frame>One year after surgical or endovascular treatment for Intermittent Claudication</time_frame>
    <description>Patient-experienced quality of care measured by Quality of Care from Patient's Perspective (Swedish version of QPP)</description>
  </other_outcome>
  <other_outcome>
    <measure>Mortality</measure>
    <time_frame>Ten years after surgical or endovascular treatment for Intermittent Claudication</time_frame>
    <description>Data on mortality will be extracted from the National Patient Registry and Stockholm County Council's administrative data (VårdanalysdataLager - VAL).</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiovascular disease</measure>
    <time_frame>Ten years after surgical or endovascular treatment for Intermittent Claudication</time_frame>
    <description>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).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">213</enrollment>
  <condition>Intermittent Claudication</condition>
  <arm_group>
    <arm_group_label>Person-centered follow up</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard follow up</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Person-centered follow up</intervention_name>
    <arm_group_label>Person-centered follow up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients who is scheduled for revascularization, through open and/or&#xD;
             endovascular surgery for IC diagnosed according to Diagnosis Related Group (DRG) with&#xD;
             I70.2 or I739B&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not treated through surgery or revascularization&#xD;
&#xD;
          -  Patients diagnosed with dementia&#xD;
&#xD;
          -  Patients discharge to a nursery home,&#xD;
&#xD;
          -  Patients not accountable for administrating their own medications&#xD;
&#xD;
          -  Patients with a survival expectancy less than one year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anneli Linné, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Surgery, Unit of Vascular Surgery, Södersjukhuset</name>
      <address>
        <city>Stockholm</city>
        <zip>SE-11883</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital, Dept of Vascular Surgery</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 13, 2016</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>October 27, 2020</last_update_submitted>
  <last_update_submitted_qc>October 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Anneli Linné</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Prevention and control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intermittent Claudication</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03283358
org study id: FASTIC-1
nct id: NCT03283358
lead sponsor: 
has dmc: No
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:

        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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Adherence to medication
time frame: One year after surgical or endovascular treatment for Intermittent Claudication
description: 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.
measure: Risk for 10-year predicted coronary heart disease (CHD)
time frame: One year after surgical or endovascular treatment for Intermittent Claudication
description: Changes in risk for CHD within 10-years measured by Framingham Risk Score (FRHS).
measure: Patient reported adherence to medication
time frame: One year after surgical or endovascular treatment for Intermittent Claudication
description: Patient-reported adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents).
measure: Generic Health-related Quality of Life (HRQOL)
time frame: One year after surgical or endovascular treatment for Intermittent Claudication
description: Patient-reported generic HrQoL measured by EQ-5D
measure: Condition specific Health-related Quality of Life (HRQOL)
time frame: One year after surgical or endovascular treatment for Intermittent Claudication
description: Patient-reported specific HrQoL measured by VascQol-6
measure: Beliefs on medication
time frame: One year after surgical or endovascular treatment for Intermittent Claudication
description: Patient-reported beliefs on medication measured by Beliefs about Meicines Questionnaire (BMQ)
measure: Self-efficacy
time frame: One year after surgical or endovascular treatment for Intermittent Claudication
description: Patient-reported Self-efficacy measured by Swedish Version of the General Self-Efficacy Scale
measure: Health literacy
time frame: One year after surgical or endovascular treatment for Intermittent Claudication
description: Patient-reported health literacy measured by HLS-EU-Q16 SE
measure: Patient-experienced quality of care
time frame: One year after surgical or endovascular treatment for Intermittent Claudication
description: Patient-experienced quality of care measured by Quality of Care from Patient's Perspective (Swedish version of QPP)
measure: Mortality
time frame: Ten years after surgical or endovascular treatment for Intermittent Claudication
description: Data on mortality will be extracted from the National Patient Registry and Stockholm County Council's administrative data (VårdanalysdataLager - VAL).
measure: Cardiovascular disease
time frame: Ten years after surgical or endovascular treatment for Intermittent Claudication
description: 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).
arm group label: Person-centered follow up
arm group type: Experimental
description: 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.
arm group label: Standard follow up
arm group type: No Intervention
description: 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.
intervention type: Behavioral
intervention name: Person-centered follow up
arm group label: Person-centered follow up
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anneli Linné, MD, PhD
role: Principal Investigator
affiliation: Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset
facility: 
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Anneli Linné
investigator title: MD, PhD
mesh term: Intermittent Claudication
sharing ipd: No