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Management and Coaching in Atrial Fibrillation (MANCAF)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Helena Ekblad, FUTURUM, Academy of Health and Science.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02226575
First Posted: August 27, 2014
Last Update Posted: March 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
School of Health Sciences, Jönköping University, Jönköping Sweden
Information provided by (Responsible Party):
Helena Ekblad, FUTURUM, Academy of Health and Science
  Purpose
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.

Condition Intervention
Atrial Fibrillation Behavioral: A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Study of Management and Coaching in Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Helena Ekblad, FUTURUM, Academy of Health and Science:

Primary Outcome Measures:
  • 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 ]
  • 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 ]
  • Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52 [ Time Frame: baseline and after 12 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Distress management
The distress management program (cognitive behavioral therapy) alongside standard care
Behavioral: A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives
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).
No Intervention: Control
Controls only dilivery standard care

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients diagnosed with atrial fibrillation.
  • Relative to patient with atrial fibrillation.
  • To be over 18 years old .

Exclusion Criteria:

  • Unwillingness to participate in the study.
  • Other complicating illness'.
  • Language difficulties that prevent answering surveys.
  • Participation in another study.
  • Accommodation outside the hospital's catchment area.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226575


Locations
Sweden
County Hospital Ryhov
Jönköping, Jönköping county, Sweden, 551 11
Sponsors and Collaborators
Helena Ekblad
School of Health Sciences, Jönköping University, Jönköping Sweden
Investigators
Principal Investigator: Bengt Fridlund, Professor School of Health Sciences, Jönköping University, Jönköping Sweden
  More Information

Publications:
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. Epub 2007 Jul 23.
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.
Ekblad H, Rönning 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.
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.
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.
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.
Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svärdsudd 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.
Eriksson M, Lindström 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. Review.
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. Review.
Fjorback LO, Arendt M, Ornbøl 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. Review.

Responsible Party: Helena Ekblad, RN, BSC, PhD-student, FUTURUM, Academy of Health and Science
ClinicalTrials.gov Identifier: NCT02226575     History of Changes
Other Study ID Numbers: SMAC-PAFHM11
First Submitted: August 19, 2014
First Posted: August 27, 2014
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Helena Ekblad, FUTURUM, Academy of Health and Science:
Sense of coherence

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes


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