Management and Coaching in Atrial Fibrillation (MANCAF)

Helena Ekblad

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Behavioral: A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives

Study type: Interventional

Funder types: Other

Identifiers

NCT02226575

SMAC-PAFHM11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Distress management

Experimental group

Description:

The distress management program (cognitive behavioral therapy) alongside standard care

Treatment:

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

Control

No Intervention group

Description:

Controls only dilivery standard care