Management and Coaching in Atrial Fibrillation (MANCAF)
|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
|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|
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|
|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 ]
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|