The aim of this study was to determine effect of self-management program on self-efficacy, self-care behaviors and health status of elderly patients with heart failure.This clinical trial research is applied parallel that has taken place in 2015 in 22 Bahman Hospitals in Neyshabour on 90 elderly patients with heart failure.
Samples were selected from patients in the cardiology clinic and eligible for participation the study and With the appointment randomized into two groups using random blocks 1 (test) and 2 intervention (control) group. Inclusion criteria included age over 60 years, class 2 and 3 heart failure divided by the America Heart Association, not having motor disabilities and handicaps and desire to participate in the program. Data collection tools by demographic specification form, heart self-efficacy questionnaire; European questionnaires self-care behaviors in heart failure patients and health status questionnaires for patients with heart failure. The intervention included education face to face and group according to chronic disease self-management program at Stanford University for six weeks, every week was a 90 minute session. After intervention were followed by phone call and fill self-report check list in patients at home. Interventions consisted of provided the information about the diagnosis, treatment, diet, energy conservation methods and control negative emotions and relaxation and exercise. Questionnaires was completed in three stages: Before, after and two months after the intervention. Results were analyzed with statistical tests.
General information
Acronym
CDSM
IRCT registration information
IRCT registration number:IRCT2016052628089N1
Registration date:2016-09-11, 1395/06/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-11, 1395/06/21
Registrant information
Name
Tayebe Aghamohamadi
Name of organization / entity
University of Social Welfare & Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4333 6826
Email address
aghamohammadit1@nums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2015-09-06, 1394/06/15
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self management program on self efficacy, self care behaviors and health status in old patients with heart failure
Public title
The effect of self management program on self efficacy, self care behaviors and health status in old patients with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: ability to read and write; age 60 years and older; no motor disabilities and handicaps; Class 2 and 3 heart failure; no previous training in the field of self-management; passing at least six months of the disease, willingness to participate in the program.
Exclusion criteria: severity of the disease; died as a result of illness; unwillingness to continue the program
Age
From 60 years old to 92 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
In this study, was performed inclusion criteria were randomized into two groups using random blocks 1 and 2 intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of Welfare and Rehabilitation Sciences
Street address
University of Social Welfare and Rehabilitation Sciences, koodakyar Blvd, Daneshjoo Stre, Evin Ave, Tehran.
City
Tehran
Postal code
1985713834
Approval date
2015-05-22, 1394/03/01
Ethics committee reference number
IR.USWR Rec.1394.157
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
150.0
ICD-10 code description
Congestive heart failure
2
Description of health condition studied
Heart failure
ICD-10 code
150.1
ICD-10 code description
Left ventricular failure
3
Description of health condition studied
Heart failure
ICD-10 code
150.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
Self Efficacy
Timepoint
Before, after and two month after intervention
Method of measurement
heart Self-Efficacy Questionnaire, Sullivan
Secondary outcomes
1
Description
Self care behaviore
Timepoint
Before, after and two month after intervention
Method of measurement
European questionnaire self-care behaviors in heart failure
2
Description
Health status
Timepoint
Before, after and two month after intervention
Method of measurement
Health Status Questionnaire cardiomyopathy Kansas City
Intervention groups
1
Description
The intervention group 2 (control group) received only usual care. This group completed with the group1, in parallel before, after and two months after intervention self-efficacy , heart failure self-care behaviors and health status questionnaires. At the end of two months of study and after completion of the investigation, according to moral considerations in research was placed management program to provide training manual intervention group 2.
Category
Lifestyle
2
Description
Chronic disease self-management program schedule at Stanford University. In this study, were divided research unit for random assignment into using random blocks in two intervention group 1 (test group) and intervention group 2 (control group). The intervention group 1 was held for the implementation of the program into three sub groups of 15 and self-management program in six weeks and each week a meeting for 90 minutes for each subgroup separately. Education was face to face and group. The content of the program include knowledge of disease, therapies, problem-solving process, diet, exercise, stress control and relaxation. Educational content were similar for all subgroups in intervention group. The opportunity to implement self-management program at home two months were given to them And were given self-reporting checklist to them. At this time, the researcher monitored the phone calls of the implementation of the program. The control group received only usual care. At the end of control group also were given an educational booklet. questionnaires was completed at three points in time: Before, after and two months after intervention and the data analyzed.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Tayebe Aghamohamadi
Street address
22 Bahman Hospital, Emam Street, Neyshabour
City
Neyshabour
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, University of Social Welfare and Rehabilitation Sciences, Tehran
Full name of responsible person
Khankeh Hamid Reza
Street address
University of Welfare and Rehabilitation Sciences, koodakyar Blvd, Daneshjoo Stre, Evin Ave, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, University of Social Welfare and Rehabilitation Sciences, Tehran
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
University of Social Welfare and Rehabilitation Sciences