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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2015 |
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Main ID: |
NCT02226575 |
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Date of registration:
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19/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Management and Coaching in Atrial Fibrillation
MANCAF |
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Scientific title:
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Study of Management and Coaching in Atrial Fibrillation |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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150 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02226575 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Bengt Fridlund, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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School of Health Sciences, Jönköping University, Jönköping Sweden |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atrial Fibrillation
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Intervention(s)
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Behavioral: A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives
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Primary Outcome(s)
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Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52
[Time Frame: baseline and after 12 months]
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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]
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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SMAC-PAFHM11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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