<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/NCT02226575</url>
  </required_header>
  <id_info>
    <org_study_id>SMAC-PAFHM11</org_study_id>
    <nct_id>NCT02226575</nct_id>
  </id_info>
  <brief_title>Management and Coaching in Atrial Fibrillation</brief_title>
  <acronym>MANCAF</acronym>
  <official_title>Study of Management and Coaching in Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helena Ekblad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>School of Health Sciences, Jönköping University, Jönköping Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Jönköping County</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of a cognitive behavior therapy distress&#xD;
      management program targeting wellbeing in patients with atrial fibrillation and their&#xD;
      relatives.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled design with pre- and 12 month posttest including persons living with&#xD;
      atrial fibrillation and their relatives.&#xD;
&#xD;
      The distress management program (cognitive behavioral therapy) delivered in groups by a&#xD;
      specialistnurse, a pedagogue and a cardiologist all trained in the distress management&#xD;
      program. The program delivered to participants into three group- sessions extensive two hours&#xD;
      each during a five weeks period 2011-2013.&#xD;
&#xD;
      Eligible participants were all consecutive identified when discharge after hospital care due&#xD;
      to atrial fibrillation. The random process were managed by an open-label computer as block -&#xD;
      randomization. Participants were enrolled and randomized during 2011-2013 into two arms;&#xD;
      either to an experiment group to the distress management program or the control group. The&#xD;
      trial, run alongside the standard care all of the participants received at a cardiology unit&#xD;
      in a county hospital. The standard care was required to following actual guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2011</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in self-rated sense of coherence (13-item); The sense of coherens scale, SOC 13-item at week 52.</measure>
    <time_frame>baseline and after 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in self-rated Health related quality of Life (36 item); The SF 36 - item short-form health status survey at week 52</measure>
    <time_frame>baseline and after 12 mounth</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52</measure>
    <time_frame>baseline and after 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in self-rated Health related quality of life (5 item); EuroQol Five Dimensions, EQ-5D at week 52</measure>
    <time_frame>baseline and after 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Distress management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The distress management program (cognitive behavioral therapy) alongside standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Controls only dilivery standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives</intervention_name>
    <description>Controls only delivery standard care. Experimental group deliver standard care plus a distress management program (cognitive behavioral therapy) performed in groups by a nurse, a pedagogue and a cardiologist (all trained in the distress management program).</description>
    <arm_group_label>Distress management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with atrial fibrillation.&#xD;
&#xD;
          -  Relative to patient with atrial fibrillation.&#xD;
&#xD;
          -  To be over 18 years old .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwillingness to participate in the study.&#xD;
&#xD;
          -  Other complicating illness'.&#xD;
&#xD;
          -  Language difficulties that prevent answering surveys.&#xD;
&#xD;
          -  Participation in another study.&#xD;
&#xD;
          -  Accommodation outside the hospital's catchment area.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bengt Fridlund, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Health Sciences, Jönköping University, Jönköping Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>County Hospital Ryhov</name>
      <address>
        <city>Jönköping</city>
        <state>Jönköping county</state>
        <zip>551 11</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Thrall G, Lip GY, Carroll D, Lane D. Depression, anxiety, and quality of life in patients with atrial fibrillation. Chest. 2007 Oct;132(4):1259-64. doi: 10.1378/chest.07-0036. Epub 2007 Jul 23.</citation>
    <PMID>17646231</PMID>
  </reference>
  <reference>
    <citation>Dalteg T, Benzein E, Sandgren A, Fridlund B, Malm D. Managing uncertainty in couples living with atrial fibrillation. J Cardiovasc Nurs. 2014 May-Jun;29(3):E1-10. doi: 10.1097/JCN.0b013e3182a180da.</citation>
    <PMID>24108265</PMID>
  </reference>
  <reference>
    <citation>Ekblad H, Ronning H, Fridlund B, Malm D. Patients' well-being: experience and actions in their preventing and handling of atrial fibrillation. Eur J Cardiovasc Nurs. 2013 Apr;12(2):132-9. doi: 10.1177/1474515112457132. Epub 2012 Aug 30.</citation>
    <PMID>22936792</PMID>
  </reference>
  <reference>
    <citation>Lane DA, Langman CM, Lip GY, Nouwen A. Illness perceptions, affective response, and health-related quality of life in patients with atrial fibrillation. J Psychosom Res. 2009 Mar;66(3):203-10. doi: 10.1016/j.jpsychores.2008.10.007.</citation>
    <PMID>19232232</PMID>
  </reference>
  <reference>
    <citation>Kupper N, van den Broek KC, Widdershoven J, Denollet J. Subjectively reported symptoms in patients with persistent atrial fibrillation and emotional distress. Front Psychol. 2013 Apr 24;4:192. doi: 10.3389/fpsyg.2013.00192. eCollection 2013.</citation>
    <PMID>23630509</PMID>
  </reference>
  <reference>
    <citation>Smith D, Lip GY, Lane DA. Impact of symptom control on health-related quality of life in atrial fibrillation patients: the psychologist's viewpoint. Europace. 2010 May;12(5):608-10. doi: 10.1093/europace/euq083. Epub 2010 Mar 30. No abstract available.</citation>
    <PMID>20353966</PMID>
  </reference>
  <reference>
    <citation>Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svardsudd K. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). Arch Intern Med. 2011 Jan 24;171(2):134-40. doi: 10.1001/archinternmed.2010.510.</citation>
    <PMID>21263103</PMID>
  </reference>
  <reference>
    <citation>Eriksson M, Lindstrom B. Antonovsky's sense of coherence scale and the relation with health: a systematic review. J Epidemiol Community Health. 2006 May;60(5):376-81. doi: 10.1136/jech.2005.041616.</citation>
    <PMID>16614325</PMID>
  </reference>
  <reference>
    <citation>McCabe PJ. Psychological distress in patients diagnosed with atrial fibrillation: the state of the science. J Cardiovasc Nurs. 2010 Jan-Feb;25(1):40-51. doi: 10.1097/JCN.0b013e3181b7be36.</citation>
    <PMID>19935428</PMID>
  </reference>
  <reference>
    <citation>Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011 Aug;124(2):102-19. doi: 10.1111/j.1600-0447.2011.01704.x. Epub 2011 Apr 28.</citation>
    <PMID>21534932</PMID>
  </reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>March 5, 2015</last_update_submitted>
  <last_update_submitted_qc>March 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Region Jönköping County</investigator_affiliation>
    <investigator_full_name>Helena Ekblad</investigator_full_name>
    <investigator_title>RN, BSC, PhD-student</investigator_title>
  </responsible_party>
  <keyword>Sense of coherence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- 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/NCT02226575
org study id: SMAC-PAFHM11
nct id: NCT02226575
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the effect of a cognitive behavior therapy distress
      management program targeting wellbeing in patients with atrial fibrillation and their
      relatives.
A randomized controlled design with pre- and 12 month posttest including persons living with
      atrial fibrillation and their relatives.

      The distress management program (cognitive behavioral therapy) delivered in groups by a
      specialistnurse, a pedagogue and a cardiologist all trained in the distress management
      program. The program delivered to participants into three group- sessions extensive two hours
      each during a five weeks period 2011-2013.

      Eligible participants were all consecutive identified when discharge after hospital care due
      to atrial fibrillation. The random process were managed by an open-label computer as block -
      randomization. Participants were enrolled and randomized during 2011-2013 into two arms;
      either to an experiment group to the distress management program or the control group. The
      trial, run alongside the standard care all of the participants received at a cardiology unit
      in a county hospital. The standard care was required to following actual guidelines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from baseline in self-rated sense of coherence (13-item); The sense of coherens scale, SOC 13-item at week 52.
time frame: baseline and after 12 months
measure: Changes from baseline in self-rated Health related quality of Life (36 item); The SF 36 - item short-form health status survey at week 52
time frame: baseline and after 12 mounth
measure: Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52
time frame: baseline and after 12 months
measure: Changes from baseline in self-rated Health related quality of life (5 item); EuroQol Five Dimensions, EQ-5D at week 52
time frame: baseline and after 12 months
arm group label: Distress management
arm group type: Experimental
description: The distress management program (cognitive behavioral therapy) alongside standard care
arm group label: Control
arm group type: No Intervention
description: Controls only dilivery standard care
intervention type: Behavioral
intervention name: A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives
description: Controls only delivery standard care. Experimental group deliver standard care plus a distress management program (cognitive behavioral therapy) performed in groups by a nurse, a pedagogue and a cardiologist (all trained in the distress management program).
arm group label: Distress management
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bengt Fridlund, Professor
role: Principal Investigator
affiliation: School of Health Sciences, Jönköping University, Jönköping Sweden
facility: 
country: Sweden
citation: Thrall G, Lip GY, Carroll D, Lane D. Depression, anxiety, and quality of life in patients with atrial fibrillation. Chest. 2007 Oct;132(4):1259-64. doi: 10.1378/chest.07-0036. Epub 2007 Jul 23.
PMID: 17646231
citation: Dalteg T, Benzein E, Sandgren A, Fridlund B, Malm D. Managing uncertainty in couples living with atrial fibrillation. J Cardiovasc Nurs. 2014 May-Jun;29(3):E1-10. doi: 10.1097/JCN.0b013e3182a180da.
PMID: 24108265
citation: Ekblad H, Ronning H, Fridlund B, Malm D. Patients' well-being: experience and actions in their preventing and handling of atrial fibrillation. Eur J Cardiovasc Nurs. 2013 Apr;12(2):132-9. doi: 10.1177/1474515112457132. Epub 2012 Aug 30.
PMID: 22936792
citation: Lane DA, Langman CM, Lip GY, Nouwen A. Illness perceptions, affective response, and health-related quality of life in patients with atrial fibrillation. J Psychosom Res. 2009 Mar;66(3):203-10. doi: 10.1016/j.jpsychores.2008.10.007.
PMID: 19232232
citation: Kupper N, van den Broek KC, Widdershoven J, Denollet J. Subjectively reported symptoms in patients with persistent atrial fibrillation and emotional distress. Front Psychol. 2013 Apr 24;4:192. doi: 10.3389/fpsyg.2013.00192. eCollection 2013.
PMID: 23630509
citation: Smith D, Lip GY, Lane DA. Impact of symptom control on health-related quality of life in atrial fibrillation patients: the psychologist's viewpoint. Europace. 2010 May;12(5):608-10. doi: 10.1093/europace/euq083. Epub 2010 Mar 30. No abstract available.
PMID: 20353966
citation: Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svardsudd K. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). Arch Intern Med. 2011 Jan 24;171(2):134-40. doi: 10.1001/archinternmed.2010.510.
PMID: 21263103
citation: Eriksson M, Lindstrom B. Antonovsky's sense of coherence scale and the relation with health: a systematic review. J Epidemiol Community Health. 2006 May;60(5):376-81. doi: 10.1136/jech.2005.041616.
PMID: 16614325
citation: McCabe PJ. Psychological distress in patients diagnosed with atrial fibrillation: the state of the science. J Cardiovasc Nurs. 2010 Jan-Feb;25(1):40-51. doi: 10.1097/JCN.0b013e3181b7be36.
PMID: 19935428
citation: Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011 Aug;124(2):102-19. doi: 10.1111/j.1600-0447.2011.01704.x. Epub 2011 Apr 28.
PMID: 21534932
responsible party type: Sponsor-Investigator
investigator affiliation: Region Jönköping County
investigator full name: Helena Ekblad
investigator title: RN, BSC, PhD-student
mesh term: Atrial Fibrillation