Protocol summary

Study aim
Determining the impact of follow-up nurse plan on the quality of life of heart failure patients
Design
Clinical trial of one group on 44 patients with available sampling method
Settings and conduct
After the discharge from Allameh Bohloul Gonabadi Hospital, the patients will visit the care unit in person on the day of discharge from the hospital, their educational and care needs will be evaluated in different areas, and based on the patient's needs, necessary trainings will be given in the desired area. will be. Follow-ups and training will be by phone and continuously during the three-month period. The trainings include proper diet, how to take medicines, how to do activities, familiarizing the patient and his family with the risk symptoms of the disease, introducing the patient to home care centers contracted by the hospital and service providers if necessary, increasing self-confidence. In the patient, it is to prevent dependence and isolation, etc. Questionnaires will be completed by patients before the intervention on the day of discharge from the hospital and three months after the intervention.
Participants/Inclusion and exclusion criteria
Entry requirements:Having heart failure and confirmation by a cardiologist, Willingness and satisfaction, towards cooperation and participation in the study, Age above 18 years, Access to a landline or mobile phone Non-entry conditions: Getting nervous and mental diseases, Getting malignant diseases, Vision and hearing disorders, Occurrence of physical and mental misfortune in the last 6 months
Intervention groups
The intervention will include telephone follow-up to examine and evaluate the patient in terms of the effectiveness of the training provided during the hospitalization period and the needs after discharge in the ward, in order to achieve the maximum attainable level of health.
Main outcome variables
Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230227057546N1
Registration date: 2023-03-03, 1401/12/12
Registration timing: prospective

Last update: 2023-03-03, 1401/12/12
Update count: 0
Registration date
2023-03-03, 1401/12/12
Registrant information
Name
Reza Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3513
Email address
reza12.rahimi12345@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of follow-up nurse plan on the quality of life of heart failure patients
Public title
The effect of follow-up nurse plan on the quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having heart failure and confirmation by a cardiologist Willingness and satisfaction towards cooperation and participation in the study Age above 18 years Access to a landline or mobile phone
Exclusion criteria:
Getting nervous and mental diseases Getting malignant diseases Vision and hearing disorders Occurrence of physical and mental misfortune in the last 6 months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
On the side of Asian Road - Gonabad University of Medical Sciences campus
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2023-02-21, 1401/12/02
Ethics committee reference number
IR.GMU.REC.1401.180

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
Quality of life
Timepoint
Before the intervention, on the day of discharge from the hospital and three months after the intervention
Method of measurement
Quality of life questionnaire related to chronic heart failure (CHFQOLQ-20)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After the discharge, the patients will visit the care unit in person on the day of discharge from the hospital, their educational and care needs will be evaluated in different areas, and based on the patient's needs, necessary trainings will be given in the desired area. will be. Follow-ups and training will be by phone and continuously during the three-month period. The trainings include proper diet, how to take medicines, how to do activities, familiarizing the patient and his family with the risk symptoms of the disease, introducing the patient to home care centers contracted by the hospital and service providers if necessary, increasing self-confidence. In the patient, it is to prevent dependence and isolation, etc. Questionnaires will be completed by patients before the intervention on the day of discharge from the hospital and three months after the intervention.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Allameh Bohloul Gonabadi Hospital
Full name of responsible person
Reza Rahimi
Street address
Nurse Blvd- Allameh Bahloul Gonabadi Hospital
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5723 6843
Email
Reza12.rahimi12345@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr.Reza Ahmadi
Street address
On the side of Asian Road - Gonabad University of Medical Sciences campus
City
Gonabad
Province
Razavi Khorasan
Postal code
96917 93718
Phone
+98 51 5722 3515
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Reza Rahimi
Position
Master's student in community health nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
On the side of Asian Road - Gonabad University of Medical Sciences campus
City
Gonabad
Province
Razavi Khorasan
Postal code
9391947161
Phone
+98 51 5722 3515
Email
Reza12.rahimi12345@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Elham Saberi Noghabi
Position
Instructor of Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
On the side of Asian Road - Gonabad University of Medical Sciences campus
City
Gonabad
Province
Razavi Khorasan
Postal code
9691947161
Phone
+98 51 5722 3515
Email
saberi.e@gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Reza Rahimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Side of the Asian road-gonabad university of medical sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691947161
Phone
+98 51 5722 3513
Fax
Email
reza12.rahimi12345@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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