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Management and Coaching in Atrial Fibrillation (MANCAF)

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ClinicalTrials.gov Identifier: NCT02226575
Recruitment Status : Unknown
Verified March 2015 by Helena Ekblad, FUTURUM, Academy of Health and Science.
Recruitment status was:  Active, not recruiting
First Posted : August 27, 2014
Last Update Posted : March 6, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Atrial Fibrillation Behavioral: A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Study of Management and Coaching in Atrial Fibrillation
Study Start Date : September 2011
Primary Completion Date : November 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 :
  1. 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 ]

Eligibility Criteria

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:

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 Posted: August 27, 2014    Key Record Dates
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