Objectives: The aim of this study is to determine the effect of continuous care model on self-care behaviors in patients with heart failure in the Abbasi hospital of Miyandoab. Design: randomized, single blinded, controlled trial in which patients with heart failure will be included in the study by convenient sampling method and then assigned to the experiment and control groups using random allocation, without placebo. The study is a quasi-experimental clinical trial with pre- and post-test design. The experiment group will receive follow-up based on continuous care model during 3 months of the study period and the control group will received only routine cares. Inclusion criteria: subjects over 30 years with heart failure based on clinical symptoms; ECG and echocardiography; classification in level II and III heart failure based on category system of New York Heart Association; availability for follow up during the study, and informed consent to participate in the study. Exclusion criteria: patients with severe mental or cognitive disorders; patients with a history of working in therapeutic centers; receiving information about self-care of heart failure disease. Intervention: after completing the research forms, the experiment group will be followed-up based on self-care model for three months. Control group will receive the routine care without any education. Then the items related to self-care behaviors will be assessed in both groups by a questionnaire and compared. Main outcome variable: maintenance, management, and assuring of self-care behaviors among patients with heart failure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111930963N1
Registration date:2017-02-09, 1395/11/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-09, 1395/11/21
Registrant information
Name
Khadijeh Aghakarimi
Name of organization / entity
Urmia University of medical sciences, Urmia Faculty of Nursing
Country
Iran (Islamic Republic of)
Phone
+98 44 4522 7929
Email address
aghakarimi.khadijeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Research Deputy of Urmia University of Medical Sciences
Expected recruitment start date
2016-03-29, 1395/01/10
Expected recruitment end date
2016-06-14, 1395/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of continuous care pattern on self-care behaviors of hospitalized heart failure patients
Public title
The impact of education on self-care behaviors in patients with heart failure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: subjects over 30 years with heart failure based on clinical symptoms; ECG and echocardiography which represent ejection deficiency less than 40 percent; classification in level II and III heart failure based on categorization system of New York Heart Association; availability for follow up during the study; informed consent to participate in the study. Exclusion criteria: patients with severe mental or cognitive disorders; patients with a history of working in therapeutic centers; receiving information about self-care of heart failure disease.
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
40 red cards and 40 yellow cards will be prepared and put into a bag. Then the patients will be allocated to the intervention group or the control group according to the chosen card
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Ethics Committee of Urmia University of Medical Sciences, Resalat St., Urmia, Iran Urmia
City
Urmia
Postal code
5714783734
Approval date
2016-04-04, 1395/01/16
Ethics committee reference number
Ir.umsu.rec.1395.11
Health conditions studied
1
Description of health condition studied
heart failure
ICD-10 code
150
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Maintenance (keeping) of self-care
Timepoint
Three months
Method of measurement
Specific questionnaire of indicators self-care in patients with heart failure
2
Description
Management of self-care
Timepoint
Three months
Method of measurement
Specific questionnaire of indicators self-care in patients with heart failure
3
Description
Specific questionnaire of indicators self-care in patients with heart failure
Timepoint
Three months
Method of measurement
Specific questionnaire of indicators self-care in patients with heart failure
Secondary outcomes
1
Description
Self-care behaviors
Timepoint
Three months
Method of measurement
Chek list
Intervention groups
1
Description
Experiment group: this group will complete specific questionnaire of self-care indicators. The continuous care model consisting of 4 stages of orientation,sensitization,implementation and evaluation will be deployed. The first stage will be orientation stage and providing the background the necessary sensitivity. Sessions of 30 to 45 minutes will be attended by the patients and their families. Demographic characteristics as well as specific questionnaire of self-care indicators in patients with heart failure will be completed.
Category
Prevention
2
Description
Control group will receive routine cares without any educational program. After three months, again the items related to self-care behaviors will be assessed by the questionnaire.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Miyandoab Abbassi Hospital
Full name of responsible person
Khadijeh Aghakarimi
Street address
Abbassi hospital, Shohadayeh Garaveran street, Miyandoab, West Azarbijan province, Iran
City
Miyan doab
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Urmia University of Medical Sciences
Full name of responsible person
Rahim Baghaei
Street address
Vice chancellor for research, Urmia University of Medical Sciences, Resalat St., Urmia, Iran Urmia
City
Urmia
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Urmia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Khadijeh Aghakarimi
Position
MSc student
Other areas of specialty/work
Street address
Abbassi hospital, Shohadayeh ۀaraveran street, Miyandoab, West Azarbijan province, Iran province
City
Miyandoab
Postal code
5971757555
Phone
+98 44 4535 1800
Fax
+98 45350924
Email
aghakarimi.khadijeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery School
Full name of responsible person
Alireza Rahmani
Position
Master of Nursing
Other areas of specialty/work
Street address
Nursing & Midwifery school, Urmia University of Medical Sciences Campus, 11th Km of Sero Road, Urmia, Iran
City
Urmia
Postal code
5714783734
Phone
+98 44 3275 4918
Fax
+98 44 3275 4913
Email
alirezarahmani2003@yahoo.com
Web page address
umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Khadijeh Agakarimi
Position
MSc Student
Other areas of specialty/work
Street address
Abbassi hospital,Shohadayeh Garaveran street, Miyandoab, West Azarbijan, Iran
City
Miyandoab
Postal code
5971757555
Phone
+98 44 4522 3975
Fax
-
Email
aghakarimi.khadijeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)