Protocol summary

Summary
The purposes of this study is to compare the effectiveness of self-management education using Integrated and Compact disc approaches on quality of life in patients with chronic heart failure. In this randomized controlled trial will conduct in 120 subjects with chronic heart failure in Shahid Rajaee hospital in Tehran, Iran that 40 of them chose to join the Integrated education (In addition to conventional methods, Teaching strategies Lecture and the use of PowerPoint, photos, video in three consecutive sessions) group, 40 of them chose to join Compact (Education through CD) disc education group and 40 of them chose to join control (usual care) group. Two questionnaires will use to collect the data, which is the demographic questionnaire, and the quality of life questionnaire (Minnesota Living with Heart Failure Questionnaire). To investigate the effectiveness of the intervention, the collected data before and after 3 months follow up will be used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015032021521N1
Registration date: 2015-05-23, 1394/03/02
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-05-23, 1394/03/02
Registrant information
Name
Alireza Abbasi Hosseinabadi
Name of organization / entity
Iran Univercity Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 4650 2367
Email address
abasi-hosseinabadi.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of self-management education using Integrated and Compact disc approaches on quality of life in patients with chronic heart failure
Public title
Effect of self-management education on quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age over 18 years; Confirmed diagnosis of heart failure by the physician (in records); Non-acute conditions (conditions for learning); The absence of sensory - conceptual problems; Ability to communicate and to read and write; The ability to use a computer by a patient or family member; Married people; Living with a family member (spouse, child) Exclusion criteria: Lack of attend one of the training sessions for the experimental groups and the lack of willingness to continue participation in the study for both groups.
Age
From 18 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
tehran
Postal code
Approval date
2015-04-11, 1394/01/22
Ethics committee reference number
107/105/د/94

Health conditions studied

1

Description of health condition studied
Chronic heart failure
ICD-10 code
I50.0
ICD-10 code description
Congestive heart failure

Primary outcomes

1

Description
Quality of Life
Timepoint
Three months after the intervention.
Method of measurement
Minnesota Living with Heart Failure Questionnaire (MLHFQ)

Secondary outcomes

empty

Intervention groups

1

Description
Self-management education through an integrated approach: The purpose of Self-management education through an integrated approach is combination of lecture, question and answer, using PowerPoint, pamphlets, photos and videos with conventional training methods (face to face training and provide an educational pamphlet discharge). The content of the training includes anatomy and physiology of the heart, the introduction of chronic heart failure, risk factors, symptoms, disease management, diagnostic approach, diet, proper exercise, drug therapy and drug reactions, control of blood pressure, body mass index calculation method that by researcher in groups up to 10 persons (with the patient and one of his companions) for 45 to 60 minutes in three consecutive sessions offered.
Category
Other

2

Description
Self-management education with CD: The CD is designed to teach self-management. The content of the CD includes anatomy and physiology of the heart, Presentation of chronic heart failure, risk factors, symptoms, disease management, diagnostic approach, diet, proper exercise, drug therapy and drug reactions, blood pressure control method, the method of calculation BMI, videos, photos and animation training in patients with chronic heart failure.Researcher in a 20-15 minute sessions for patients and their companions on the CD-ROM training and asked them and their families use it after discharge at home during the Period of three months.
Category
Other

3

Description
Control group: received conventional training
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaei Cardiovascular, Medical & Research Center
Full name of responsible person
Alireza Abbasi Hosseinabadi
Street address
Shaheed Rajaei Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
School Of Nursing of Iran Medical Center
Full name of responsible person
Professor Forough Rafii
Street address
Rashid Yasemi Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School Of Nursing of Iran Medical Center
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
Iran University of Medical Sciences
Full name of responsible person
Alireza Abbasi Hosseinabadi
Position
Master degree
Other areas of specialty/work
Street address
Sadegheyeh 2 Square -Ayatollah Kashani ST-Golh aval-Alley 16
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
Abbasi.isf@gmail.com abasi-hosseinabadi.a@tak.iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tahereh Najafi Qezeljeh
Position
Nurse Phd
Other areas of specialty/work
Street address
Rashid Yasemi St.Valiasr St.
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
taherehpaniz@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Alireza Abbasi Hosseinabadi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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