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Survey of the Impact of a nurse-led home- based self- care program on Quality Of Life and physiological indicators of Heart Failure patients

Protocol summary

Study aim
This study was designed with the aim of determining the effect of a self-care program at home with the guidance of a nurse on the quality of life and physiological indicators of patients with heart failure at the Heshmat educational-therapeutic center in Rasht in2023
Design
The clinical trial has a control group, with parallel groups, without blinding, randomized and will be conducted in 2 phases and on 58 patients. . The online randomization service of Sealed Envelope Ltd will be used to generate the randomization list.
Settings and conduct
The location of this project is the inpatient wards of Dr. Heshmat Rasht Hospital and the follow-up nurse's room, and it is measured through general and specific quality of life questionnaires and blood pressure and pulse oximetry devices.
Participants/Inclusion and exclusion criteria
inclusion criteria: age range of 20-70 years with a diagnosis of heart failure who is not a candidate for heart surgery and according to the ICD in the category of heart failure and based on the NYHA classification in the category II-III of heart failure and have not participated in another research project with this content, their living area is Rasht city and its suburbs, and in terms of history of suffering from the disease, they are in the weak classification of the Charleston criteria are included in this study
Intervention groups
In the intervention group, before discharge, nurse-oriented trainings are given in seven areas mentioned subjects is also given to the patients on the day of discharge, and after discharge, these trainings will be repeated for the patients over the phone in eight weeks. The control group will receive only routine interventions according to hospital guidelines.
Main outcome variables
physiological index(blood pressure, pulse rate, breathing rate, oxygen saturation level of arterial blood); General and private quality of life

General information

Reason for update
Acronym
nurse-led home- based self- care program
IRCT registration information
IRCT registration number: IRCT20101019004971N6
Registration date: 2023-05-09, 1402/02/19
Registration timing: prospective

Last update: 2023-05-09, 1402/02/19
Update count: 0
Registration date
2023-05-09, 1402/02/19
Registrant information
Name
Mohamadtaghi Moghadabnia
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 2088
Email address
moghadamnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-21, 1402/02/31
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of the Impact of a nurse-led home- based self- care program on Quality Of Life and physiological indicators of Heart Failure patients
Public title
Survey of the Impact of a nurse-led home- based self- care program on Quality Of Life and physiological indicators of Heart Failure patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be in the age range of 20-70 years. With the diagnosis of heart failure, they should not be candidates for heart surgery. According to the International Classification of Diseases (ICD), fall into the category of heart failure. According to the NYHA classification, they are classified as II-III heart failure. have not participated in another research project with this content The area of ​​their residence should be the city of Rasht and its suburbs. In terms of the history of suffering from the disease, they should be in the weak classification of the Charleston criterion. (This criterion has three classifications: weak, moderate and severe).
Exclusion criteria:
Be in the age range of under 20 years and over 70 years According to the NYHA classification, they are classified as I and IV heart failure In terms of history of suffering from the disease, they should be in the moderate and severe classification of the Charleston criteria.(This criterion has three classifications: weak, moderate and severe). The living area of ​​the patients should be outside the city of Rasht and its suburbs.
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible people will be divided equally (ratio 1:1) into two groups of self-care program at home under the guidance of a nurse and control using the block randomization method with the size of 4 and 6 blocks. Sealed Envelope Ltd online randomization service and random sequence sealed opaque envelopes (SNOSE) will be used to generate the randomization list.
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 guilan university of medical sciences
Street address
Shahid Beheshti Highway, Student Street, Shahid Beheshti College of Nursing and Midwifery
City
Rasht
Province
Guilan
Postal code
4146939814
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.GUMS.REC.1402.008

Health conditions studied

1

Description of health condition studied
Heart failure
ICD-10 code
I59
ICD-10 code description
Cardiac, heart or myocardial failure NOS

Primary outcomes

1

Description
Physiological indicators (systolic blood pressure, pulse rate, breathing rate, arterial blood oxygen saturation level)
Timepoint
The measurement of this index is done before the discharge of the patients and eight weeks after the intervention.
Method of measurement
The method of measurement is by using a mercury sphygmomanometer and a pulse oximetry device and paying attention to the up and down movements of the chest.

Secondary outcomes

1

Description
General quality of life
Timepoint
This index will be done before the discharge of the patients and eight weeks after the discharge of the patients and one month after the completion of the intervention
Method of measurement
Measuring the general quality of life will be done using a 12-question general quality of life questionnaire.

2

Description
specific quality of life
Timepoint
This index will be done before the discharge of the patients and eight weeks after the discharge of the patients and one month after the completion of the intervention.
Method of measurement
Specific quality of life measurement will be done using the Minnesota Heart Failure Questionnaire

Intervention groups

1

Description
Intervention group: self-care program at home under the guidance of a nurse. the intervention is carried out in two stages before discharge and after discharge Pre-discharge intervention in the form of nurse-centered self-care programs training in seven areas, which include 1- identifying dangerous symptoms of the disease and consulting symptoms and tests, 2- drug regimen, 3- diet, 4- activity and sports activity, 5- control stress and anxiety, 6- education about sexual issues and 7- life style modification, In the intervention group, after stabilization of the clinical condition and on day of discharge will be given. And an educational booklet focusing on the mentioned topics is also given to the patients on the day of discharge Also, post-discharge training will be repeated for this group patients through telephone calls, weekly for eight weeks and with the training of one area of ​​the mentioned training program (except for the last week).
Category
Lifestyle

2

Description
Control group: Patients with heart failure who will only receive routine interventions based on hospital guidelines.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Heshmat Rasht educational-therapeutic center
Full name of responsible person
MohammadTaghi Moghaddamnia
Street address
Shahid Beheshti Highway, Rasht, Student Street, Shahid Beheshti College of Nursing and Midwifery
City
Rasht
Province
Guilan
Postal code
4146939814
Phone
+98 13 3355 3202
Email
moghadamnia@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Atefeh Ghanbari
Street address
Shahid Beheshti Highway, Student Street, Shahid Beheshti Faculty of Nursing and Midwifery
City
Rasht
Province
Guilan
Postal code
4146939814
Phone
+98 13 3355 3202
Email
nursing@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Taghi Moghaddamnia
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Highway, Shahid Beheshti College of Nursing and Midwifery
City
Rasht
Province
Guilan
Postal code
4146939814
Phone
+98 13 3355 3202
Email
Moghadamnia@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Taghi Moghaddamnia
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Highway, Student Street, Shahid Beheshti College of Nursing and Midwifery
City
Rasht
Province
Guilan
Postal code
4146939814
Phone
+98 13 3355 3302
Email
moghadamnia@gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Taghi Moghaddamnia
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Highway, Student Street، Shahid Beheshti College of Nursing and Midwifery
City
Rasht
Province
Guilan
Postal code
4146939814
Phone
+98 13 3355 3202
Email
moghaddamnia@gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Considering that the collected data is used only for this study, its confidentiality will be maintained and will not be published.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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
Not applicable
Data Dictionary
Not applicable
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