Management and Coaching in Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of Management and Coaching in Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Behavioral: A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distress management<br>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<br>* 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).<br>|
| No Intervention: Control<br>Controls only dilivery standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in self-rated sense of coherence (13-item); The sense of coherens scale, SOC 13-item at week 52. |  | 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 |  | baseline and after 12 mounth | 
| Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52 |  | baseline and after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in self-rated Health related quality of life (5 item); EuroQol Five Dimensions, EQ-5D at week 52 |  | baseline and after 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sense of coherence