1- Determination of caregiver burden score in family caregivers of patients with heart failure, before and one month after intervention in intervention group
2- Determination of caregiver burden score in family caregivers of patients with heart failure, before and one month after intervention in control group
3- Comparison of caregiver burden score in family caregivers of patients with heart failure, before and one month after intervention in the intervention and control groups
Design
66 patient caregivers will be enrolled admitted. At the first a list of all heart failure patients admitted to Hospital will be prepared during the last few years and then using random number table in groups of standard discharge plan and telenursing and standard discharge plan will be placed.
Settings and conduct
Pre-intervention caregiver pressure will be measured in two groups before intervention. The intervention program will be conducted in the intervention group and both groups will have regular telephone contact and counseling. In addition to standard care, the intervention group's family caregivers will load the relevant data into the data transfer software and send to cardiologist. Caregiver burden will be measured in the two groups at the end of one month of intervention.
Participants/Inclusion and exclusion criteria
Inpatient Criteria:
At least six months have passed since the diagnosis of heart failure.
The patient has a family.
The patient has a family caregiver who has the highest share of patient care.
Outpatient Criteria:
Not able to communicate with telemedicine care for 2 weeks.
Intervention groups
Both groups will be given discharged time training. Contact and telephone counseling will be conducted with both study groups. Training will be given to the intervention group on telenursing equipment and how to upload data into the data transfer software.
Main outcome variables
Caregiver Burden
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161018030366N3
Registration date:2019-12-16, 1398/09/25
Registration timing:prospective
Last update:2019-12-16, 1398/09/25
Update count:0
Registration date
2019-12-16, 1398/09/25
Registrant information
Name
Mohammad Ghaderi
Name of organization / entity
North Khorasan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7097
Email address
m.ghaderi@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family supportive program through telenursing care on caregivers burden in family with Congestive Heart failure in Bojnurd in 2019
Public title
The effect telenursing care on caregivers burden in family with Chronic Heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least six months have passed since the diagnosis of heart failure.
The patient has a family.
The patient has a family caregiver who has the highest share of patient care.
Have a caregiver over 18 years of age.
Lack of family caregivers with mental disorder and chronic diseases
Ability to read and respond to the Farsi questionnaire.
Exclusion criteria:
Not be able to provide appropriate telemedicine care after receiving trained nursing education
Not able to communicate with telemedicine for 2 weeks.
If the patient also has a private nurse and the patient's caregiver uses other educational programs.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
First, a list of all chronic heart failure patients admitted to Imam Hassan Hospital in Bojnourd during the past year will be compiled and the samples will be randomly divided into tele-nursing group and standard care group by random number table. Based on this, the researcher will go to the cardiology department and the sample will be selected based on which group the patient was previously in. To blind patients, sampling will be done at discharge so that other patients are not aware of the study method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both groups of participants will be contacted by telephone and counseled, and neither participant will be aware of the actual intervention. In this study, the researchers will try not to be aware of the intervention group.for blinding the data analyzer, the study groups would be coded and thus the analyst would not know the nature of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of North Khorasan University of Medical Sciences
Street address
Shahryar Street, School of Nursing
City
Bojnurd
Province
North Khorasan
Postal code
96786-94176
Approval date
2019-10-27, 1398/08/05
Ethics committee reference number
IR.NKUMS.REC.1398.073
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
Family Caregiver burden
Timepoint
Pre- intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention in the tele-nursing group will consist of three parts: 1- Discharge training to family caregivers at discharge 2- Manage scheduled contacts 3- Remote monitoring of vital signs and weight of the patient at home. The discharge plan will be taught by a research nurse who is not a member of the patient treatment team. Through Booklet, he will teach family caregivers training on heart failure, medication, salt avoidance, fluid monitoring, exercise training, daily weight control and foot swelling, and limb time. Discharge planning training, training on how to measure vital signs, and working with tele-nursing equipment individually and face-to-face will be given to the patient's family caregiver prior to discharge. These tutorials will include how to use tele-nuring, how to measure physiological parameters and their importance. The patient contact plan will be conducted by one patient call coach. Patients will be given a heart failure educational booklet, a 7-day, one-month checklist and informed consent form. Patients in the intervention group should have an Internet-enabled smartphone and an approved information exchange software such as Whats App, Telegram or Soroush and a blood pressure monitor to measure blood pressure. Patient caregivers will be taught how to measure blood pressure, pulse rate, respiration and weighting to measure the physiological parameters of the patient on a daily basis and to upload the software. The call coach will teach caregivers about the pathophysiology of the disease, the symptoms, the treatment regimen and the fluid restriction. The call coach will provide caregivers a weekly counseling and pharmacy program. The phone caller will record and monitor patient vital information and weight information daily and provide feedback to caregivers. Will provide a patient visit if necessary.
Category
Rehabilitation
2
Description
Control group, Standard care: Common discharge plans for the standard care group will include a heart failure training booklet for family caregivers of patients to examine symptoms and symptoms, teach health care skills, and assist in understanding illness and facilities, and if they have problems call to call coach. The call coach should contact the family caregiver of the patients, actively and weekly after discharge, to inform them of the patient's condition and to provide counseling if needed.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hassan Mojtaba Hospital
Full name of responsible person
Dr Haghighi
Street address
8 kilometer Road of Arkan
City
Bojnurd
Province
North Khorasan
Postal code
1111111111
Phone
+98 58 3151 0000
Email
Imamhasan@nkums.ac.ir
Web page address
http://imamhasan.nkums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Seyed Kaveh Hojjat
Street address
Emam Ali Blv, Shahriyar Street.
City
Bojnurd
Province
North Khorasan
Postal code
1111111111
Phone
+98 58 3229 6769
Email
research@nkums.ac.ir
Web page address
http://research.nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Mohammad Ghaderi
Position
Instructore
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahryar Street, Emam Ali Blvd, School of nursing
City
Bojnurd
Province
North Khorasan
Postal code
9678694176
Phone
+98 58 3229 7095
Email
ghaderi.mohammad1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mohammad Ghaderi
Position
Faculty of member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sharyar Ave, Emam Ali Blvd, School of nursing
City
Bojnurd
Province
North Khorasan
Postal code
9678694176
Phone
+98 58 3229 7095
Fax
+98 58 3229 7097
Email
m.ghaderi@nkums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mohammad Ghaderi
Position
Faculty of member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sharyar Ave, Emam Ali Blvd, School of nursing
City
Bojnurd
Province
North Khorasan
Postal code
9678694176
Phone
+98 58 3229 7095
Fax
+98 58 3229 7097
Email
Ghaderi.mohammad1@gmail.com
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
For greater security of participants' data
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