Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatment a cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives
Sponsor Helena Ekblad
Collaborator School of Health Sciences, Jönköping University, Jönköping Sweden
Start date September 2011
End date November 2014
Trial size 150 participants
Trial identifier NCT02226575, SMAC-PAFHM11

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
The distress management program (cognitive behavioral therapy) alongside standard care
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)
Controls only dilivery standard care

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Male or female participants at least 18 years old.

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.

Additional Information

Official title Study of Management and Coaching in Atrial Fibrillation
Principal investigator Bengt Fridlund, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by FUTURUM, Academy of Health and Science.