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Atrial FibrillationMANCAFNCT02226575

Management and Coaching in Atrial Fibrillation

A study testing A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives in people with Atrial Fibrillation, run by Helena Ekblad at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation
What is being tested?
A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSweden
Study dates
Sep 2011to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with atrial fibrillation.
  • Relative to patient with atrial fibrillation.
  • To be over 18 years old .

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Sweden1 site

  • County Hospital Ryhov

    Jönköping, Jönköping County, 551 11

Other trials in Sweden

About this study

Official title: Study of Management and Coaching in Atrial Fibrillation

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.

Read the 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.

Being tested
A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives
Keywords
Sense of coherence
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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).

Study groups in NCT02226575
Study groupRoleWhat they receive
Distress managementExperimentalThe distress management program (cognitive behavioral therapy) alongside standard care
Receives: Behavioral: A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives
ControlNo interventionControls only dilivery standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in self-rated sense of coherence (13-item); The sense of coherens scale, SOC 13-item at week 52.

    Measured: baseline and after 12 months

  2. 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

    Measured: baseline and after 12 mounth

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

    Measured: baseline and after 12 months

Secondary outcomes (1)

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

    Measured: baseline and after 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2014 (estimated)
  2. Study startSep 2011
  3. Primary completionNov 2014
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02226575
Sponsor's protocol ID
SMAC-PAFHM11
Acronym
MANCAF
Status last verified
Mar 2015
First submitted
19 Aug 2014
Last updated
6 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17646231

  • 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.

    PubMed 24108265

  • 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.

    PubMed 22936792

  • 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.

    PubMed 19232232

  • 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.

    PubMed 23630509

  • 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.

    PubMed 20353966

  • 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.

    PubMed 21263103

  • 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.

    PubMed 16614325

  • 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.

    PubMed 19935428

  • 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.

    PubMed 21534932

  • 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.

    PubMed 29493266

Questions about this trial

What is this clinical trial studying?

A study testing A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives in people with Atrial Fibrillation, run by Helena Ekblad at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02226575, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.

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