Main aim: Evaluating the effects of self management interventions on life style and complications in patients with Atrial Fibrillation. Inclusion criteria: All patients should be with chronic AF on the following basis: Sustained AF being treated with long-term pharmacological therapy with the intention of establishing optimal ventricular rate control and/or minimization of thrombotic risk, Recurrent paroxysmal or sustained AF being treated with pharmacological or electrical cardio-version with long-term pharmacotherapy to prevent recurrent AF and/or minimize thrombotic risk, Recurrent paroxysmal AF being treated with long term pharmacological therapy to minimize thrombotic risk; All patients should be more than 18; should not participate in any other study simultaneously; should be eager to participate in study and fill informed consent. Exclusion Criteria: Patients with C.V.A, cancer and liver failure; absence for more than two Sessions; suffering from psychological problems; not participating in study for any reason. Method: randomized controlled trial. Study population: all patients with atrial fibrillation in Fasa. Sample size:72 cases. Intervention: patients in intervention group will receive teaching in six sessions during three week period. Then we will call the patients fore three times (after the fourth, eighth, and twelfth week of intervention). Walker questionnaire and check lists will be completed for all cases in three times: before intervention, four weeks after intervention and twelve weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082023606N3
Registration date:2015-11-10, 1394/08/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-10, 1394/08/19
Registrant information
Name
Farzaneh Kazemi Ara
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4254 7375
Email address
stud2392002274@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-06-20, 1394/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of self management interventions on life style and complications in patients with Atrial Fibrillation
Public title
The effects of self management interventions on life style and complications in patients with Atrial Fibrillation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Sustained AF being treated with long-term pharmacological therapy with the intention of establishing optimal ventricular rate control and/or minimization of thrombotic risk; Recurrent paroxysmal or sustained AF being treated with pharmacological or electrical cardio-version with long-term pharmacotherapy to prevent recurrent AF and/or minimize thrombotic risk; Recurrent paroxysmal AF being treated with long term pharmacological therapy to minimize thrombotic risk; All patients should be more than 18; should not participate in any other study simultaneously; should be able to comprehend Persian and communicate; should be eager to participate in study and fill informed consent.
Exclusion Criteria: Patients with C.V.A, cancer and liver failure; absence for more than two Sessions; suffering from psychological problems; not participating in study for any reason.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
7th floor, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Postal code
1978-71345
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
ct-9377-7347
Health conditions studied
1
Description of health condition studied
Atrial Fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial Fibrillation and flutter
Primary outcomes
1
Description
Life style
Timepoint
before education, four weeks after education, at the end of twelfth week
Method of measurement
Walker Questionnaire
Secondary outcomes
1
Description
Atrial Fibrillation Complications
Timepoint
before education, four weeks and twelve weeks after education
Method of measurement
Check list
Intervention groups
1
Description
Patients in intervention group will receive education in six sessions during three weeks and telephone follows up after fourth week, eighth week and twelfth week of intervention.