Protocol summary

Summary
The main objective of this study was to determine the impact of education and follow-up on readmission rates for the heart failure patients after discharge. Major inclusion criteria were: stabilized heart failure, literacy, tendency of the patients to participate the study, minimum age of 20, telephone access. Major exclusion criteria were: stabilized psychiatric disorders, concurrent fatal disease, and severe hearing impairment. Design and setting: randomized, single blind, single center, placebo not used, trial phase 3. Study population included 120 patients with heart failure who were divided randomly with Block Randomization Method in two control and intervention groups, immediately after discharge. Demographic data of two groups were recorded. There are two parts of intervention; the first part is educating the patient and his/her family immediately after discharge, and also educational pamphlets were given to them. The second part is follow-up using phone call once a week in first month and then every two weeks in the later two months. In every phone call, the information about main outcome measures such as frequency readmissions, frequency outpatient physician visits, drug consumption, and improvement should be asked according to the control check lists. The patients will be guided according to their needs. But patients in control group get the routine care and had been called just every two weeks to record the information about primary outcome.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051717727N1
Registration date: 2014-08-23, 1393/06/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-23, 1393/06/01
Registrant information
Name
Nastaran Laal
Name of organization / entity
Shahid Beheshti university of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9936
Email address
laalnastaran@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of education and follow-up on readmission rates for the heart failure patients after discharge
Public title
Effect of education and follow up on readmission for the heart failure patients after discharge
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria were: stabilized heart failure, literacy, tendency of the patients to participate the study, minimum age of 20, telephone access. Exclusion criteria were: stabilized psychiatric disorders, concurrent fatal disease, and severe hearing impairment.
Age
From 20 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For the purpose of blinding random allocation was done with other person. Randomization Method: Block Randomization was used to equalized the number of patients in both control and intervention groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Koodakyar Ave., Daneshju Blvd., Velenjak, Tehran
City
Tehran
Postal code
1985717443
Approval date
2014-05-25, 1393/03/04
Ethics committee reference number
400/982

Health conditions studied

1

Description of health condition studied
Related of education and follow-up on readmission rates for the Heart Failure Patients after discharge
ICD-10 code
Z74.3
ICD-10 code description
Need for continuous supervision

Primary outcomes

1

Description
Frequency of Hospital readmission in control and intervention groups
Timepoint
Every two weeks until three month after intervention
Method of measurement
Asking the patient

2

Description
Frequency of outpatient physician visits in control and intervention groups
Timepoint
Every two weeks until three month after intervention
Method of measurement
Asking the patient

3

Description
Drug consumption in control and intervention groups
Timepoint
Every two weeks until 3 month after intervention
Method of measurement
Asking the patient

4

Description
Improvement in control and intervention groups
Timepoint
Every two weeks until 3 month after intervention
Method of measurement
Asking the patient

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: there are two parts of intervention; the first part is Patients and their family education about the life style, drug consumption, and warning signs were performed in 20 till 25 minutes immediately after discharge, according to the educational package endorsed by Community Medicine Specialist and Cardiologists, then educational pamphlets were given to them. The second part is Phone call follow-up was performed once a week in first month and then every two weeks in the latter two months and the time spending on every session were 10 minutes which could be changed according to the patients’ needs. In every phone call, the information about primary outcomes were asked and recorded according to the control check lists. The patients guided according to their needs, and their questions were answered.
Category
Prevention

2

Description
Control group: Patients in control group get the routine care and had been called just every two weeks to record the information about primary data according to the control check lists and the time spending on every session was 5 minutes.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr.Afshin Mohammadalizadeh, Hospital administration
Street address
Taleghani Hospital, Velenjak St., Shahid Chamran Highway,Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti university of Medical Sciences
Full name of responsible person
Dr.Hossein Goodarzi
Street address
Shahid Beheshti University of Medical Sciences., Koodakyar Ave., Daneshju Blvd., Velenjak, Tehran, IRAN
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti university of Medical sciences
Full name of responsible person
Nastaran Laal
Position
Assistant of Community Medicine
Other areas of specialty/work
Street address
Department of Community Medicine, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Koodakyar Ave., Daneshju Blvd., Velenjak, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2243 9936
Fax
Email
laalnastaran@gmail.com; laalnastaran@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Reza Shekarriz
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Community Medicine, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Koodakyar Ave., Daneshju Blvd., Velenjak, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2243 9936
Fax
Email
R.shekarriz@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nastaran Laal
Position
Assistant of community medicine
Other areas of specialty/work
Street address
Department of Community Medicine, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Koodakyar Ave., Daneshju Blvd., Velenjak, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2243 9936
Fax
Email
laalnastaran@gmail.com; laalnastaran@sbmu.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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