The effect of supportive intervention based on social network on psychological well-being and caregiving Appraisal in family caregivers of patients with heart failure
Determining the effect of supportive intervention based on social network on psychological well-being and caregiving Appraisal in family caregivers of patients with heart failure
Design
The clinical trial with two intervention and control groups, with parallel groups, without blinded, randomized, phase 3 on 72 caregivers. PASS 11 software is used for randomization.
Settings and conduct
The research population is all family caregivers of heart failure (main caregiver) hospitalized in the cardiac department, CCU and POST CCU of Imam Reza (AS) and Qaim (AS) teaching hospitals. The intervention will last for a period of one month. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Family caregivers of heart failure patients who are willing to participate in research and have the ability to use a smartphone; Exit criteria: Caregiver's unwillingness to continue cooperation in the study, death of the patient
Intervention groups
In the intervention group, first a face-to-face meeting of half an hour to one hour will be held in the presence of the main family caregivers of the patients in the department, in which, in addition to introducing and stating the goals, explanations will be given on how to implement the research and the messenger, and help the caregiver to install it and provide training How to communicate in online meetings is provided.Then, after the patient's discharge, in 8 sessions for one month (twice a week), the researcher will communicate with the caregivers in specific groups of 5-6 people through online messenger and voice or video calls. The control group will receive routine care only.
Main outcome variables
Psychological well-being; caregiving appraisal
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231206060282N1
Registration date:2024-01-08, 1402/10/18
Registration timing:prospective
Last update:2024-01-08, 1402/10/18
Update count:0
Registration date
2024-01-08, 1402/10/18
Registrant information
Name
Marzieh Kohantorabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3249 3656
Email address
kohantorabim4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-10, 1402/10/20
Expected recruitment end date
2024-03-10, 1402/12/20
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 psychological well-being and caregiving Appraisal in family caregivers of patients with heart failure
Public title
The effect of social network support on psychological well-being and caregiving Appraisal of family caregivers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A patient with heart failure class 2 or higher for at least 3 months ago
Hospitalization of the patient in the ward due to heart failure
Caregiver's willingness to participate in research
Caregiver age over 18 years
Being the main caregiver of the patient in family
A history of at least 3 months of caring for a heart failure patient
Caregiver access to a smart phone and the ability to use messengers
Ability to speak and understand Persian language
Ability to read and write
Not having a history of known mental disorders and psychoactive drugs
Exclusion criteria:
Caregiver's unwillingness to continue cooperation in any of the stages of the research
Non-participation of the caregiver in half of the messenger sessions
Transferring the care of the patient to someone other than the main caregiver at home
Experiencing a stressful event or severe emotional problem during the follow-up period for the caregiver
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
Random allocation will be done in such a way that people will be divided into two groups through the PASS 11 software using blocks of four. In this way, after determining the sequence, we put them in the envelopes and number them in order. Caregivers take the envelope in the order of their entry into the study and are placed in the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The content of online meetings in Messenger is held as follows: Session 1: introducing people to the group members, questions and answers about heart failure disease and the care needed for these patients and their role in care, asking the group members to be ready to present their experiences in care for the next session. Session 2: Inviting the group members to share their negative and positive experiences in providing patient care, their solutions in providing care and how to deal with the patient's condition. Session 3: emphasizing the importance of physical and mental health of caregivers, asking caregivers to express how they take care of themselves, then providing self-care strategies for caregivers by the researcher. Session 4: Expressing the impact of stress on the health of caregivers and family members, asking caregivers to express their strategies to deal with caregiving stress, then presenting strategies for managing stress, anger, and depression with deep breathing techniques, relaxation, and planning to do favorite activities by researcher. Session 5: Ways to interact and communicate with other family members and others, peers, maintaining humor in difficult situations. Session 6: Emphasis on positive thinking, skills of creating and maintaining positive thoughts in daily life events, asking caregivers to express their strategies for positive thinking in caregiving and daily life. Session 7: Questions and answers from the caregivers about their experiences of using the strategies presented in the previous sessions by the peers and the researcher. Session 8: Final summary of the intervention, if necessary, refer the caregivers to available support resources in the community, such as (psychiatrist, psychologist, social worker...)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Nursing and Midwifery Faculty - Mashhad University of Medical Sciences
Street address
Shahid Dr. Kharazmi Educational Complex, East Gate of Ferdowsi University of Mashhad, Medical Sciences Campus, Azadi Square,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Approval date
2023-11-28, 1402/09/07
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.106
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
Psychological well-being
Timepoint
The level of psychological well-being in the research units participating in the study will be measured at the beginning of the study (before the start of the intervention) and one month after the start of the intervention.
Method of measurement
In this research, the level of psychological well-being will be measured using Ryff's Psychological Well-being questionnaire.
2
Description
Caregiving appraisal
Timepoint
The level of caregiving appraisal in the research units participating in the study will be measured at the beginning of the study (before the start of the intervention) and one month after the start of the intervention.
Method of measurement
In this research, caregiving appraisal will be measured using revised caregiving appraisal scale(2000).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, First, a half-hour to one-hour face-to-face training session with the presence of the main family caregivers of the patients will be held in one of the rooms of the aforementioned departments that in this meeting, in addition to introducing and stating the goals, explanations about how to carry out the research and messenger and help the caregiver to install it and training how to communicate in online meetings will be provided. Then, after the patient's discharge, in 8 sessions for one month (2 times a week), the researcher will communicate with the caregivers in specific groups of 5-6 people through online messenger and audio or video calls whose content includes: The care needed by the patient and the caregiver's role in care, sharing their negative and positive experiences in providing patient care, the importance of the caregiver's physical and mental health and self-care strategies, stress and anger management, methods of interacting with others, maintaining a sense of humor, strategies Positive thinking in care and daily life events and if necessary referring caregivers to support resources available in society (psychiatrist, psychologist, social worker). The researcher will be present and actively cooperate in all face-to-face and non-face-to-face meetings of messaging groups and will use the advice of a psychologist.
Category
Other
2
Description
Control group: The control group will receive only usual care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Heart, CCU and post CCU departments
Full name of responsible person
Zahra Dalir
Street address
Imam Reza Teaching, Research and Treatment Hospital, Imam Reza Hospital Square, Ibn Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
b.ImamReza@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ghaem Hospital, Heart, CCU and post CCU departments
Full name of responsible person
Zahra Dalir
Street address
Ghaem Educational, Research and Treatment Center, the beginning of Ahmedabad Ave, Dr. Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Momsen Tafaghodi
Street address
Research and Technology Vice-Chancellor of Mashhad University of Medical Sciences, Second Floor, Qureshi Building, Front of 16 University Ave, University Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Azadi Square, East Gate of Ferdowsi University of Mashhad, Medical Sciences Campus, Shahid Dr. Kharazmi Educational Complex
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3884 6730
Email
DalirZ@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Kohantorabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Kharazmi Educational Complex, East Gate of Ferdowsi University of Mashhad, Medical Sciences Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3884 6730
Fax
Email
Kohantorabim4001@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Kohantorabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Kharazmi Educational Complex, East Gate of Ferdowsi University of Mashhad, Medical Sciences Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3884 6730
Fax
Email
Kohantorabim4001@mums.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All the data obtained from this research will be shared after completion.
When the data will become available and for how long
Access to the data will be possible 3 months after the results are published.
To whom data/document is available
These data will be used for researchers working in academic and scientific institutions, as well as for family caregivers of heart failure patients.
Under which criteria data/document could be used
The data obtained from this research can be used in other scientific studies.
From where data/document is obtainable
Copying (in any way) either from the full text or from the extracts is possible only with the coordination of the supervisor and the registered author and according to the instructions provided by the Central Library of Mashhad University of Medical Sciences. Details can be accessed through the relevant faculty library. The use of the thesis in articles or any scientific writing is subject to citing the source in compliance with the Mashhad University of Medical Sciences publishing regulations. Zahra Dalir: DalirZ@mums.ac.ir, Marzieh Kohantorabi: Kohantorabim4001@mums.ac.ir
What processes are involved for a request to access data/document
The applicant should send an email to the responsible author and register his request. After verifying the correctness of the information of the mentioned person, the required content will be provided to him by mentioning the source.