Providing executive guidance to reduce the cost of care for heart failure patients
Design
Randomized clinical trials with parallel groups, not blind, uncontrolled, multi-centered.
Settings and conduct
The present study is a randomized clinical trial with intervention and control groups in Amiralmomenin Hospital and Amir Kabir Hospital in Arak among patients with heart failure.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the desire to participate in the study; detection of heart failure according to a cardiologist; passed at least 6 months of diagnosis of heart failure; 40 to 75 years old; having a mobile phone equipped with Telegram software; reading and writing skills; having a phone at home
Exclusion criteria: unwilling to participate in the study; hearing and speaking problems; history of mental disorders
Intervention groups
Intervention group: patients at the time of admission will receive care package includes face-to-face training for up to 30 minutes in the CCU and PCCU wards of the Amir Kabir and Amiralmomenin hospitals. The care package also includes phone follow up two weeks, one month, and two months after discharge.
Control group: control group samples do not receive any interventions, but after completion of the intervention, the training package will also be available to them.
Main outcome variables
Caring costs in patients with heart failure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180101038172N1
Registration date:2018-02-18, 1396/11/29
Registration timing:registered_while_recruiting
Last update:2018-02-18, 1396/11/29
Update count:0
Registration date
2018-02-18, 1396/11/29
Registrant information
Name
Hamid Reza Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
h.heidari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing care package on medical expenditures in heart failure patients
Public title
The effect of nursing care package on medical expenditures in heart failure patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
Detection of heart failure according to a cardiologist
Passed at least 6 months of diagnosis of heart failure
40 to 75 years old
Having a mobile phone equipped with Telegram software
Reading and writing skills
Having a phone at home
Exclusion criteria:
Unwillingness to participate in the study
Hearing and speaking problems
History of mental disorders
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
After explaining the method of work and the goals of the research and obtaining informed consent, the participants are randomly assigned to two groups of intervention and control by permuted block randomization.
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 Arak University of Medical Sciences
Street address
Alamolhoda St, Rah ahan Sq
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.ARAKMU..REC.1396.223
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
Treatment costs for patients with heart failure
Timepoint
Two weeks, one month and two months after the discharge
Method of measurement
Questionnaire made by researcher
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients in the intervention group receive a care pack at the time of admission including face-to-face training for 30 minutes. The session was taught about how the heart works, the nature of the disease, the importance of drug and nutrition, and the change in lifestyle, the continuation of home treatment, the necessary skills for self-care, stress and its control methods, and the reasons for re-admission and its control methods. Gets Then a booklet containing the need for drug compliance, diet and lifestyle modifications are given at the time of discharge.
Category
Lifestyle
2
Description
Control group: samples of the control group are patients who, according to the usual routine of the hospital, receive training on how to use drugs, diet and lifestyle modifications, and their nurse-training form is completed. It should be noted that in order to observe the ethical aspect of the study, after the end of data collection, the training book will be provided to the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-al-momenin Hospital
Full name of responsible person
Abolfazl Mohtarami
Street address
Basij Sq. Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir
2
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Alireza Kamali
Street address
Alamolhoda St. Rah ahan Sq.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 4715
Email
info@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Basij Sq. Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3638
Email
Rsearch@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hamidreza Heydari
Position
MSc Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij Sq. Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
z.zeinali@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamidreza Heydari
Position
MSc Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij Sq. Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
z.zeinali@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamidreza Heydari
Position
MSc Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij Sq. Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
z.zeinali@arakmu.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information on the main outcome and the demographic information, can be shared after unidentifiable of people.
When the data will become available and for how long
The beginning of the access period is 24 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In order to utilize scientific purposes and mention the source used.
From where data/document is obtainable
Hamidreza Heydari, MSc Student of Nursing, Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.
E-mail address: h.heidari@arakmu.ac.ir
What processes are involved for a request to access data/document
After receiving the email from the requester, the information will be sent within 5 to 10 business days.