Determining the effect of lifestyle modification on the readmission of patients with heart failure
Design
Clinical trial with control group, with parallel groups,Two blind, randomized, with a sample size of 174.
Settings and conduct
The lifestyle modification program in the Intervention group starts at the time of admitting the patient at Torbat Heydarieh Hospital. During the period of admission, nutrition education, medical education, education for light stomatal improvement, etc. are given. Training is provided by the nurse and with the help of a pamphlet, a drug booklet, and so on. Trainings are performed after telephone service and continue until 12 weeks after discharge.
Participants/Inclusion and exclusion criteria
"Inclusion criteria" 1- age 18 to 90 year old 2-patient access to the telephone 3-No known psychological illness 4-patient and none of his family members have medical education and related fields 5-Have full satisfaction to cooperate 6-known patients in class 2 and 3 of heart failure.
"Exclusion criteria" 1'-Unwillingness to participate in study
Intervention groups
"Intervention group" The lifestyle modification program in the Intervention group starts from the time of admission and continues until 12 weeks after discharge from the hospital. Each patient in the Intervention group will be required to undergo a visit at least two times according to the need for training. After discharge, the researcher will contact the patients in the Intervention group every two weeks for 12 weeks and will examine the patient's progress and achieve goals and adherence to the curriculum. The first telephone call is made by the researcher within the first 24 hours after discharge.
"control group" Except for the usual self-care education that all patients receive, no further action will be taken
Main outcome variables
Blood Pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180727040610N1
Registration date:2019-01-02, 1397/10/12
Registration timing:retrospective
Last update:2019-01-02, 1397/10/12
Update count:0
Registration date
2019-01-02, 1397/10/12
Registrant information
Name
Tahere Sarboozi Hosein Abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5414 3311
Email address
sarboozit1@thums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-11, 1396/08/20
Expected recruitment end date
2018-11-11, 1397/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lifestyle modification on the readmission of patients with heart failure
Public title
Lifestyle modification and readmission of patients with heart failure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 90-18 years
The patient has access to the telephone
Not known to have a known psychological illness
The patient and none of his family have medical education and related disciplines
Complete satisfaction for cooperation
Have at least reading and writing skills
Exclusion criteria:
Do not want to participate in research.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
174
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Simple randomization, using 174-bit Random Excel software with Excel, is generated sequentially with A and B bursts. The reader now has a patient range of 1 to 174, depending on whether he is in either of the A or B grades, in either of these two groups of patients.
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 Torbat Heydarieh University of Medical Sciences
Street address
THUMS Building., Razi St., Ferdawsi St.
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
95196-33787
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.THUMS.REC.1395.27
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50.2
ICD-10 code description
Systolic (congestive) heart failure
Primary outcomes
1
Description
Blood Pressure
Timepoint
Blood Pressure will be measured once before the first intervention and once after the last intervention session.
Method of measurement
Mercury pressure gauge device
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group: The lifestyle modification program in the Intervention group starts from the time of admission and continues until 12 weeks after discharge from the hospital. Each patient in the Intervention group will be required to undergo a pre-discharge test at least two times (within 24 hours) according to the need for training. After discharge, the researcher will contact the patients in the Intervention group every two weeks for 12 weeks and will examine the patient's progress and achieve goals and adherence to the curriculum. The first telephone call is made by the researcher within the first 24 hours after discharge. Each phone call will be divided into two parts: the first part will include routine recommendations regarding the care required in patients with heart failure, and the second part will be determined based on the specific needs and underlying illnesses of the patient. During the call, patients will be encouraged and supported in relation to the individual risk reduction plan, including exercise, diet, smoking cessation and adherence to drugs. The last phone call for each individual patient will be established in the 12th week after the discharge, during which, in addition to the counseling, coordination will be required for the last appointment. The patients will have a total of 3 face-to-face meetings (2 sessions at the beginning of the study and 1 The end of the study) and five sessions of telephone training will be held every two weeks with the researcher.
Category
Lifestyle
2
Description
control group: Except for the usual self-care education that all patients receive, no further action will be taken.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Nohome day Hospital, Torbat Heydarieh University of Medical Sciences
Full name of responsible person
Tahereh Sarbuzi Hossein Abadi
Street address
THUMS Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95195481$6
Phone
+98 51 5222 6014
Email
DeyHospital@thums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Dr Hasann Azhdari Zarmehri
Street address
THUMS Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95196-33787
Phone
+98 51 5222 8023
Email
azhdarizarmehri1@thums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Torbate-Heidaria University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Tahereh Sarbuzi Hossein Abadi
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
THUMS Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95196-33787
Phone
+98 51 5222 6013
Email
sarboozit1@thums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Tahere Sarboozi Hosein Abadi
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
THUMS Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95169-33787
Phone
+98 51 5222 6013
Email
sarboozit1@thums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Tahere Sarboozi Hosein Abadi
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
THUMS Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9519633787
Phone
+98 51 5222 6013
Email
sarboozit1@thums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main consequence after being unidentified will be shared.
When the data will become available and for how long
Start the access period 6 months after Publish results
To whom data/document is available
Everyone
Under which criteria data/document could be used
The results obtained in this study can be used without restriction by researchers.
From where data/document is obtainable
Referring to Torbat Heidarieh Nursing and Midwifery Faculty
What processes are involved for a request to access data/document
After sending the email to the person responsible for the response process begins.