Determining the effect of social network-based support intervention on social isolation and loneliness of HF patients
Design
The CT with an intervention&control group will be conducted without blinding with randomization (through spss) phase 3 on 72 patients.
Settings and conduct
The research population is all HF patients in the cardiac department and CCU of Imam Reza and Qaim teaching hospitals.72 patients will be selected based on the entry criteria and available sampling method. The intervention will last 8-week, which will be in the form of communicating with each other and with relatives and friends. In this way, in the intervention group, 2 face-to-face meetings will be held at the beginning to teach how to perform the intervention and training items. Then, during 6 weeks, the groups will communicate with each other through messenger calls at least once a week.
Participants/Inclusion and exclusion criteria
Entry:consent/HF/SI/not having mental disorders &psychoactive drugs/access to smart phone&Qarar messenger/speaking Farsi/over18years old
Exclusion:instability of the patient's clinical condition/failure to participate in half of the meetings/unwillingness to continue the study/death
Intervention groups
In the intervention group, 2 face-to-face meetings in groups of 2-3 patients and caregivers will be held in the department,where the researcher will teach the intervention method to the families&patients.Then, during 6 weeks, the groups once a week with the presence of the researcher through messenger calls and with relatives&friends.In control group, only routine care and face-to-face education and pamphlet will be done.
Main outcome variables
The results of this study are the level of social isolation and loneliness of HF patients, which will be measured in two intervention and control groups using the social support questionnaire, Luben and UCLA before& after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221021056260N1
Registration date:2023-02-24, 1401/12/05
Registration timing:prospective
Last update:2023-02-24, 1401/12/05
Update count:0
Registration date
2023-02-24, 1401/12/05
Registrant information
Name
Fatemeh Tajari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
tajarif992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supportive intervention based on social network on social isolation and loneliness in patients with heart failure
Public title
the effect of social network support on on social isolation and loneliness in heart failures
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Heart failure class 2 and above at least 6 months ago
Social isolation based on Luben's social network tool (at a cut point of less than 12)
Not having a history of known mental disorders and psychoactive drugs
Access to a smart mobile phone and the ability to use the WhatsApp application (self or family caregiver).
bility to speak Persian
Age over 18 years
Exclusion criteria:
Instability of the patient's clinical condition
Failure to participate in half of the WhatsApp meetings
Unwillingness to continue studying
Death of the patient
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomly assigning people to two intervention and control groups will be by time block method. In this way, sampling in the intervention and control groups will be done on a weekly basis (even and odd weeks). The first group will be randomly selected using SPSS software. Then it will continue as even and odd weeks in two groups.
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
Faculty of Nursing and Midwifery - Mashhad University of Medical Sciences (Research Ethics Committee
Street address
ibn sina st
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2022-11-22, 1401/09/01
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.095
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
social isolation
Timepoint
The beginning of the study- The eighth week
Method of measurement
Luben Social Network Scale
2
Description
loneliness
Timepoint
The beginning of the study- The eighth week
Method of measurement
UCLA Loneliness Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, first, 2 face-to-face meetings in groups of 2-3 patients and family caregivers will be held in the department, in which training on how to perform the intervention in order to establish communication between patients and deal with loneliness and social isolation, encouraging the patient to communicate with Relatives and friends, as well as education related to heart failure will be provided by the researcher to families and patients. Then, during 6 weeks, the groups will communicate with each other through Qarar messenger calls once a week with the presence of the researcher, and they will communicate with relatives and friends once a week. The desired questionnaires (perceived social support, Luben social network scale and UCLA loneliness scale) will be completed by the researcher before the intervention (face-to-face) and after the end of the intervention via phone or messenger.
Category
Other
2
Description
Control group: In the control group, only routine care and face-to-face education and pamphlet presentation will be done. The desired questionnaires will be completed at the same time as the intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem Aj educational research and treatment hospital
Full name of responsible person
Mohsen Muhebati
Street address
Dr. Shariati Square - the beginning of Ahmad Abad St. - Ghaem Aj
City
mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Fax
+98 51 3845 3239
Email
b.ghaem@mums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Reza Educational Research and Treatment Hospital (AS)
Full name of responsible person
Behzad Alizadeh
Street address
Ibn Sina St. - Imam Reza Hospital Square - Imam Reza Educational Research and Treatment Hospital (AS)
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
b.ImamReza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hasan Qavami
Street address
University Street, Central Organization of Qurashi Building University
City
mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
zahra Dalir
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
ibn sina St
City
mshhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
zdalir@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
zahra Dalir
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
ibn sina ST
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 915 311 2764
Fax
Email
zdalir@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
zahra Dalir
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
ibn sina St
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 911 311 2764
Fax
Email
zdalir@mums.ac.ir
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