Clinical trial NCT02226575: Management and Coaching in Atrial Fibrillation
Official title: Study of Management and Coaching in Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Sense of coherence
Lead sponsor: Region Jönköping County
Sponsor class: OTHER_GOV
Collaborators: name: School of Health Sciences, Jönköping University, Jönköping Sweden
First posted: 2014-08-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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.

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.
timeFrame: baseline and after 12 months
measure: 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
timeFrame: baseline and after 12 mounth
measure: Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52
timeFrame: 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
timeFrame: baseline and after 12 months
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: County Hospital Ryhov
state: Jönköping county
Study officials:
affiliation: School of Health Sciences, Jönköping University, Jönköping Sweden
name: Bengt Fridlund, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1378/chest.07-0036. Epub 2007 Jul 23.
citation: 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.
citation: Ekblad H, Ronning 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.
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.
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.
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. No abstract available.
citation: Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svardsudd 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.
citation: Eriksson M, Lindstrom 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. doi: 10.1136/jech.2005.041616.
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.
citation: Fjorback LO, Arendt M, Ornbol 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.
citation: Malm D, Fridlund B, Ekblad H, Karlstrom P, Hag E, Pakpour AH. Effects of brief mindfulness-based cognitive behavioural therapy on health-related quality of life and sense of coherence in atrial fibrillation patients. Eur J Cardiovasc Nurs. 2018 Oct;17(7):589-597. doi: 10.1177/1474515118762796. Epub 2018 Mar 1.