Management and Coaching in Atrial Fibrillation (MANCAF)
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|ClinicalTrials.gov Identifier: NCT02226575|
Recruitment Status : Unknown
Verified March 2015 by Helena Ekblad, Region Jönköping County.
Recruitment status was: Active, not recruiting
First Posted : August 27, 2014
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Behavioral: A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|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|
|Actual Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||December 2015|
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
- 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 ]
- 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 ]
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
|County Hospital Ryhov|
|Jönköping, Jönköping county, Sweden, 551 11|
|Principal Investigator:||Bengt Fridlund, Professor||School of Health Sciences, Jönköping University, Jönköping Sweden|