Protocol summary

Study aim
Determining the effect of sharing experiences in virtual support group on the compassion fatigue and resiliency of family caregivers of disabled elderly
Design
Randomized controlled clinical trial with a parallel group design; with a sample size of 50 disable elderly caregivers
Settings and conduct
In this study, elderly patients referred to the clinic and neurosurgical departments of Ghaem and Imam Reza (AS) hospitals in Mashhad that have informed consent to participate in the study, will be assessed for disabilities. The primary caregiver of the elderly with moderate or severe disability who are met inclusion criteria of the study, include to the study. There will be no blinding in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Have informed consent to participate in the study (elderly and caregiver); Over 60 years old (elderly); Moderate or severe disability according to the WHO-DAS II scale (elderly); Giving care at home (elderly). Non-inclusion criteria: have major physical problems or problems under treatment (caregiver); being a member of other related support groups(caregiver); receiving money for providing care (caregiver)
Intervention groups
Intervention group: In the first session: Introducing the research plan; the second session: finding the most basic problems of these caregivers in caring for the elderly through the brine storming; then adding them to a group on a virtual network and sharing their experiences each week on one of the issues (up to eight weeks) . Control group: Only the introduction of the research plan.
Main outcome variables
Fatigue compassion; Resilience

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200118046173N1
Registration date: 2020-06-22, 1399/04/02
Registration timing: retrospective

Last update: 2020-06-22, 1399/04/02
Update count: 0
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Fatemeh Esmaelzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
esmaeilzadehf@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-05-04, 1399/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of sharing experiences in virtual support group on compassion fatigue and resilience of family caregivers of disabled elderly
Public title
The effect of sharing experiences on compassion fatigue and resilience of family caregivers of disabled elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have informed consent to participate in the study (elderly and caregiver) Over 60 years old (elderly) Moderate or severe disability according to the WHO-DAS II scale(elderly) Giving care at home (elderly) Giving care from family members (elderly) Being a member of the family of an elderly person (caregiver) Being the primary caregiver means spending the most time with the elderly among the other caregivers (caregiver) Take care of the elderly for at least three months (caregiver) Being literate (caregiver) Being able to participate in virtual social groups or use the Internet (caregiver)
Exclusion criteria:
have major physical problems or problems under treatment (caregiver) being a member of other related support groups (caregiver) receiving money for providing care (caregiver)
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be divided into control and intervention groups using permuted block method. The permuted block method is one of the random allocation methods in which each block is selected as the number of groups studied. There are two blocks AB and BA in this study. Randomly one of the blocks will be selected. If the first block selected is AB, the first is assigned to group A and the second to group B. And this process continues until all the samples are allocated. The value of this method is that the two study groups will have equal numbers. All steps are performed using Random Allocation software.
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 Mashhad University of Medical Sciences
Street address
Nursing and midwifery school; Ebne Sina street; Doctora intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9175776965
Approval date
2019-12-31, 1398/10/10
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.088

Health conditions studied

1

Description of health condition studied
Fatigue compassion
ICD-10 code
ICD-10 code description

2

Description of health condition studied
resilience
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fatigue compassion
Timepoint
At the beginning of study and after the intervention
Method of measurement
by using of fatigue compassion questionnaire

2

Description
Resilience
Timepoint
At the beginning of the study and after intervention
Method of measurement
by using the resilience questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first session, the researcher will introduce the research for both intervention and control groups and inform them about the general principles of care for the disabled elderly as well as discuss home care problems. The second session, which is dedicated to the intervention group, will focus on finding the most basic problems for these caregivers in the care of the elderly through the brain storming. The intervention group will then join a virtual group in one of the virtual networks, sharing their experiences each week on one of the problems posed. And this process will be continued for up to eight weeks, depending on the number of problems encountered during the thought session.
Category
Lifestyle

2

Description
Control group: The control group will attend the first session at the beginning of study . If intervention will be effective, they will also be added to the virtual support group after ending the intervention and will be shared the results and summary of study discussions.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Dr Fatemeh Tara
Street address
Ahmadabad street
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Web page address
https://quaem.mums.ac.ir/chairman-and-managing-domains/about-the-head

2

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Ali Khorsand Vakilzadeh
Street address
Imam Reza hospital, Imam Reza square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
b.Imamreza@mums.ac.ir
Web page address
https://emamreza.mums.ac.ir/index.php/hoze-riasat/2014-07-06-04-24-47

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Seyed Mohammad Hosein Bahreini Toosi
Street address
In front of Daneshgah NO.18, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Phone
+98 51 3841 3007
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
Dr Fatemeh Esmaelzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery school; Ebne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
esmaeilzadehf@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Fatemeh Esmaelzadeh
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery school; EbneSina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
esmaeilzadehf@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Fatemeh Esmaelzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School; Ebne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
esmaeilzadehf@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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after making people unidentifiable
When the data will become available and for how long
after publishing of finding
To whom data/document is available
other researcher
Under which criteria data/document could be used
nothing
From where data/document is obtainable
responsible researcher
What processes are involved for a request to access data/document
Email to responsible researcher
Comments
Loading...