To compare the effect of continuous care and educational intervention (home visit) over a nine-month period on the rate of re-admissions, health care costs and quality of life in heart failure patients discharged from hospital
The present study aimed to compare the effect of continuous care and educational intervention (home visit) over a nine-month period on the rate of re-admissions, health care costs and quality of life in heart failure patients discharged from hospital. In this study, 110 available hospitalized patients with heart failure were selected and were simple randomly divided into two intervention and control groups. Inclusion criterion was heart failure diagnosed by a cardiologist while those with a chronic progressive disease, except heart failure, as well as those who were not trainable were excluded from the study. The intervention which was carried out by a trained nurse included training patients or their families about heart failure disease, drugs being used, self care plan, diet, signs of disease recurrence and improvement as well as changing patient’s life style according to the disease and also enabling families to take on care needs. This continuous care and educational plan was carried out in four-home visits over a nine-month period for the patients in the intervention group. Quality of life at baseline and end of study was evaluated by SF36 questionnaires . The rate and cost of hospital readmission of patients in both groups were evaluated at the end of the study by an information form.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012612279N1
Registration date:2013-09-16, 1392/06/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-16, 1392/06/25
Registrant information
Name
Hoseinali Mehralian
Name of organization / entity
Shahr -e-Kored University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 1150
Email address
mehralian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of research,Shahr-e-Kored University of Medical Sciences
Expected recruitment start date
2006-10-27, 1385/08/05
Expected recruitment end date
2007-04-09, 1386/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare the effect of continuous care and educational intervention (home visit) over a nine-month period on the rate of re-admissions, health care costs and quality of life in heart failure patients discharged from hospital
Public title
Continuous care and educational intervention and treatment costs and quality of life in heart failure patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
1- Heart failure diagnosed by cardiologist
2- Ejection fraction less than 45%
3- Literacy
4- Full consent to participate in the study
Exclusion criteria
1- Having chronic progressive disease except heart failure
2- Heart surgery
3- Lack of mental health
4- No accessibility to the patients
5- Medical staff
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
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 Shahr-e-Kored University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Ave, Shahrekord
City
Shar-e-Kored
Postal code
8815713471
Approval date
2005-07-23, 1384/05/01
Ethics committee reference number
1-5-1384
Health conditions studied
1
Description of health condition studied
Ischemic Heart Failure
ICD-10 code
I25.9
ICD-10 code description
Chronic Ischaemic heart diseases
Primary outcomes
1
Description
quality of life
Timepoint
Beginning and end of the study
Method of measurement
SF 36 questionnaire
2
Description
Hospital Readmission
Timepoint
During the study
Method of measurement
Hospital Admission Form
3
Description
health care costs
Timepoint
At the end of the study
Method of measurement
Health Care Costs Form
Secondary outcomes
empty
Intervention groups
1
Description
The intervention which was carried out by a trained nurse included training patients or their families about heart failure disease, drugs being used, self care plan, diet, signs of disease recurrence and improvement as well as changing patient’s life style according to the disease and also enabling families to take on care needs. This continuous care and educational plan was carried out in four-home visits over a nine-month period for the patients in the intervention group.
SF36 questionnaire were completed for all participants at beginning and end of study.
Category
Behavior
2
Description
In control group, there was no intervention. SF36 questionnaire were completed for all participants at beginning and end of study.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital affiliated shahr-e-kored Medical Sciences
Full name of responsible person
Hoseinali Mehralian
Street address
Hajar hospital, Parastar Ave, Shahrekord
City
Shar-e-Kored
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of research,Shahr-e-Kored University of Medical Sciences
Full name of responsible person
Hosenali Mehralian
Street address
Vice Chancellor of research,Shahr-e-Kored University of Medical Sciences,Kashani Ave, Shahrekord
City
Shar-e-Kored
Grant name
شهرکرد-خیابا کاشانی -معاونت پژوهشی دانشگاه علوم پزشکی شهرکرد
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of research,Shahr-e-Kored 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
Shahr-e-Kored University of Medical Sciences
Full name of responsible person
Hoseinali Mehralian
Position
Master of Science in nursing (academic member)
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani Ave, Shahrekord
City
Shar-e-Kored
Postal code
8815713471
Phone
+98 38 1333 1150
Fax
+98 38 1333 1150
Email
mehralian@skums.ac.ir; mehralian_2003@yahoo.com
Web page address
www.skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahr-e-Kored University of Medical Sciences
Full name of responsible person
Shahriar Salehi tali
Position
PhD student in nursing and academic member
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences,Kashani Ave.,Shahrekored
City
Shar-e-Kored
Postal code
8814834566
Phone
+98 38 1334 9321
Fax
+98 38 1334 6714
Email
sh_salehitali@yahoo.com; sh_salehi@skums.ac.ir
Web page address
www.skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahr-e-Kored University of Medical Sciences
Full name of responsible person
Shahriar Salehi Tali
Position
phD student in nursing and academic member
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani Ave, Shahrekord
City
Shar-e-Kored
Postal code
8814834566
Phone
+98 38 1334 9321
Fax
+98 38 1334 6714
Email
sh_salehitali@yahoo.com ; sh_salehi@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)