Protocol summary

Summary
Background Nowadays Chronic heart failure is a major health and social problem. Due to the chronic nature of the disease, self-care behaviors can has a major impact on managing of this chronic condition. Therefore To improve self-care behaviors and prevent potential self-care deficits, education and support can be important issues in nursing care in this population. Objectives The aim of this trial was to evaluate the effect of a supportive educational intervention on CHF self-care behaviors and readmission rates of patients referred to Shahid Madani Medical Training & Research Hospital(Tabriz, Iran, 2011) for 3 months after discharge. Methods We conducted a prospective, randomized trial of an education and support intervention on self-care behaviors and three-month readmission for patients hospitalized with Hf. A total of 80 patients were randomly assigned to either supportive educational or to usual care. Data were collected using the, SCHFI and CHFPLNI tools. The data were analyzed using SPSS- 11.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107041464N4
Registration date: 2012-06-05, 1391/03/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-06-05, 1391/03/16
Registrant information
Name
Vahid Zamanzadeh
Name of organization / entity
University of Tabriz Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
zamanzadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-07-11, 1390/04/20
Expected recruitment end date
2011-08-11, 1390/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Supportive- Educative interventions on Self-Care behaviors & readmission rates of patients with heart failure
Public title
The effect of education on Self-Care behaviors & readmission of patients with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria : 18 years or older patients who were hospitalized because of congestive heart failure; to have echocardiography form (EF lesser than 40%); talking in Turkish or Persian; consciousness at reception; accessibility after release by phone call; agreement with training at release time and self care pursuit; not to accompany at another study. Exclusion Criteria : death of patients; disagreement with continuance of pursuit; long time journey after release from hospital up to 6 months; to have acute and progressive disease other than congestive heart failure and distinguished mental disorder.
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Ethical Committee of Tabriz University of medical sciences
Street address
Emam Ave
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
9088

Health conditions studied

1

Description of health condition studied
Heart Failure
ICD-10 code
I50
ICD-10 code description
Heart Failure

Primary outcomes

1

Description
self-care behavior
Timepoint
each month until three month
Method of measurement
based on self-care behaviour index tools

2

Description
Readmission
Timepoint
Each month until three month
Method of measurement
Rate of admission to the hospital with worsen of heart failur

Secondary outcomes

1

Description
visit of physician
Timepoint
each month until three month
Method of measurement
rate of referal to the physician fore worsen of heart failur

2

Description
Costs of treatment
Timepoint
Each month until three month
Method of measurement
Rate of costs for readmissions and visit of physician

Intervention groups

1

Description
The present study was included a two-part intervention. The first part of the intervention was included patient education in the intervention group. Patients in the intervention group were educated by nurses who worked in cardiac wards. Education had been personalized for each patient. After determining the learning needs of patients about heart failure and according to the previous information, the educational level and cognitive level of patients, researcher done the training. Training performed with the goal of improving self-care behavior such as receiving proper medical regimes, fluid and sodium restriction, Improving physical activity, control symptoms and signs of worsening the heart failure to prevent worsening of the disease in the patients with heart failure. Patients and their families were educated for an hour. Training was contain information about heart failure definition, signs and symptoms of the disease, information about the diet, Information about medications, information about the activities and appropriate sports. The booklet was given to patients or their families at the time of discharge. The second part of the intervention, was include telephone follow-up of patients after discharge from the hospital. This support was to strengthen the basic education and providing strategies for improvement of patients self-care behaviors. In the first stage of the follow-up phone call was conducted after two days of hospital discharge to confirm the patient information and for establishment of the next time of phone contacts. Then, every two weeks for three months, the phone calls were conducted in order to support patients in the intervention group. At the end of each month during the period of study phone calls were conducted with patients, in both study groups, in order to obtain information about self-care behaviors, the cost of care, readmission rates and refer to physician.
Category
Rehabilitation

2

Description
Patients in the control group received All cares and treatments provided by Hospital and physician during the intervention.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Teaching Hospital
Full name of responsible person
Fatemeh Jamshidi
Street address
Golbad street , Shahid Madane Hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Tabriz University of Medical Sciences
Street address
Golbad Ave. Shahid Madani Heart Research Center
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Vahid zamanzadeh
Position
PhD /Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery Scool
City
Tabriz
Postal code
51745-347
Phone
+98 41 1381 9129
Fax
+98 41 1479 6969
Email
zamanzadeh@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Vahid zamanzadeh
Position
PhD /Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery Scool
City
Tabriz
Postal code
51745347
Phone
+98 41 1381 9129
Fax
+98 41 1479 6969
Email
zamanzadeh@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz Univercity of Medical Sciences
Full name of responsible person
Dr. Vahid Zamanzadeh
Position
PhD/Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery Scool
City
Tabriz
Postal code
51745347
Phone
Fax
+98 41 1479 6969
Email
zamanzadeh@tbzmed.ac.ir
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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