Management and Coaching in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— MANCAF  

Official title:

Study of Management and Coaching in Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02226575
• Other study ID #: SMAC-PAFHM11
• Status: Active, not recruiting
• Phase: N/A
• First received: August 19, 2014
• Last updated: March 5, 2015
• Start date: September 2011
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: FUTURUM, Academy of Health and Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical EthicsSweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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).

Locations

Country	Name	City	State
Sweden	County Hospital Ryhov	Jönköping	Jönköping county

Sponsors (2)

Lead Sponsor	Collaborator
Helena Ekblad	School of Health Sciences, Jönköping University, Jönköping Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (10)

Dalteg T, Benzein E, Sandgren A, Fridlund B, Malm D. Managing uncertainty in couples living with atrial fibrillation. J Cardiovasc Nurs. 2014 May-Jun;29(3):E1-10. doi: 10.1097/JCN.0b013e3182a180da. — View Citation

Ekblad H, Rönning H, Fridlund B, Malm D. Patients' well-being: experience and actions in their preventing and handling of atrial fibrillation. Eur J Cardiovasc Nurs. 2013 Apr;12(2):132-9. doi: 10.1177/1474515112457132. Epub 2012 Aug 30. — View Citation

Eriksson M, Lindström B. Antonovsky's sense of coherence scale and the relation with health: a systematic review. J Epidemiol Community Health. 2006 May;60(5):376-81. Review. — View Citation

Fjorback LO, Arendt M, Ornbøl E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011 Aug;124(2):102-19. doi: 10.1111/j.1600-0447.2011.01704.x. Epub 2011 Apr 28. Review. — View Citation

Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svärdsudd K. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). Arch Intern Med. 2011 Jan 24;171(2):134-40. doi: 10.1001/archinternmed.2010.510. — View Citation

Kupper N, van den Broek KC, Widdershoven J, Denollet J. Subjectively reported symptoms in patients with persistent atrial fibrillation and emotional distress. Front Psychol. 2013 Apr 24;4:192. doi: 10.3389/fpsyg.2013.00192. eCollection 2013. — View Citation

Lane DA, Langman CM, Lip GY, Nouwen A. Illness perceptions, affective response, and health-related quality of life in patients with atrial fibrillation. J Psychosom Res. 2009 Mar;66(3):203-10. doi: 10.1016/j.jpsychores.2008.10.007. — View Citation

McCabe PJ. Psychological distress in patients diagnosed with atrial fibrillation: the state of the science. J Cardiovasc Nurs. 2010 Jan-Feb;25(1):40-51. doi: 10.1097/JCN.0b013e3181b7be36. Review. — View Citation

Smith D, Lip GY, Lane DA. Impact of symptom control on health-related quality of life in atrial fibrillation patients: the psychologist's viewpoint. Europace. 2010 May;12(5):608-10. doi: 10.1093/europace/euq083. Epub 2010 Mar 30. — View Citation

Thrall G, Lip GY, Carroll D, Lane D. Depression, anxiety, and quality of life in patients with atrial fibrillation. Chest. 2007 Oct;132(4):1259-64. Epub 2007 Jul 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52		baseline and after 12 months	No
Secondary	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	No