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Management and Coaching in Atrial Fibrillation (MANCAF)

Primary Purpose

Atrial Fibrillation

Status

Unknown status

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

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

About this trial

This is an interventional supportive care trial for Atrial Fibrillation focused on measuring Sense of coherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

County Hospital Ryhov

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Distress management

Control

Arm Description

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

Controls only dilivery standard care

Outcomes

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.

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

Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52

Secondary Outcome Measures

Changes from baseline in self-rated Health related quality of life (5 item); EuroQol Five Dimensions, EQ-5D at week 52

Full Information

NCT ID

NCT02226575

First Posted

August 19, 2014

Last Updated

March 5, 2015

Sponsor

Helena Ekblad

Collaborators

School of Health Sciences, Jönköping University, Jönköping Sweden

1. Study Identification

Unique Protocol Identification Number

NCT02226575

Brief Title

Management and Coaching in Atrial Fibrillation

Acronym

MANCAF

Official Title

Study of Management and Coaching in Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Helena Ekblad

Collaborators

School of Health Sciences, Jönköping University, Jönköping Sweden

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Sense of coherence

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Distress management

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

Controls only dilivery standard care

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Title

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

Title

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 Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bengt Fridlund, Professor

Organizational Affiliation

School of Health Sciences, Jönköping University, Jönköping Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

County Hospital Ryhov

City

Jönköping

State/Province

Jönköping county

ZIP/Postal Code

551 11

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

17646231

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.

Results Reference

background

PubMed Identifier

24108265

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.

Results Reference

background

PubMed Identifier

22936792

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.

Results Reference

background

PubMed Identifier

19232232

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.

Results Reference

background

PubMed Identifier

23630509

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.

Results Reference

background

PubMed Identifier

20353966

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.

Results Reference

background

PubMed Identifier

21263103

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.

Results Reference

background

PubMed Identifier

16614325

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.

Results Reference

background

PubMed Identifier

19935428

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.

Results Reference

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PubMed Identifier

21534932

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.

Results Reference

background

PubMed Identifier

29493266

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. Erratum In: Eur J Cardiovasc Nurs. 2018 Oct;17(7):668.

Results Reference

derived

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Management and Coaching in Atrial Fibrillation

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