Management and Coaching in Atrial Fibrillation

Helena Ekblad150 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

150

Conditions

Atrial Fibrillation

Interventions

A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relativesBEHAVIORAL

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).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

County Hospital Ryhov

Jönköping, Jönköping County, Sweden

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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