Atrial Fibrillation
Conditions
Keywords
Sense of coherence
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.
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.
Interventions
BEHAVIORALA 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).
Sponsors
School of Health Sciences, Jönköping University, Jönköping Sweden
Helena Ekblad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Sweden
Outcome results
None listed