Management and Coaching in Atrial Fibrillation (MANCAF)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
School of Health Sciences, Jönköping University, Jönköping Sweden
Information provided by (Responsible Party):
Helena Ekblad, FUTURUM, Academy of Health and Science
ClinicalTrials.gov Identifier:
NCT02226575
First received: August 19, 2014
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Study of Management and Coaching in Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by FUTURUM, Academy of Health and Science:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52 [ Time Frame: baseline and after 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Distress management
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
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: Control
Controls only dilivery standard care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02226575

Locations
Sweden
County Hospital Ryhov
Jönköping, Jönköping county, Sweden, 551 11
Sponsors and Collaborators
Helena Ekblad
School of Health Sciences, Jönköping University, Jönköping Sweden
Investigators
Principal Investigator: Bengt Fridlund, Professor School of Health Sciences, Jönköping University, Jönköping Sweden
  More Information

Publications:

Responsible Party: Helena Ekblad, RN, BSC, PhD-student, FUTURUM, Academy of Health and Science
ClinicalTrials.gov Identifier: NCT02226575     History of Changes
Other Study ID Numbers: SMAC-PAFHM11
Study First Received: August 19, 2014
Last Updated: August 25, 2014
Health Authority: Sweden: Swedish National Council on Medical Ethics
Sweden: The National Board of Health and Welfare

Keywords provided by FUTURUM, Academy of Health and Science:
Sense of coherence

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 15, 2014