: Determining the effect of sharing experiences via social networks on the general health of hemodialysis patients
Design
A clinical trial with the control group, with parallel, simple randomized groups on 72 patients .randomized with the timeline in special day in week
Settings and conduct
After admitting the patient to Imam Ali (AS) and Al-Kindi hospitals in Baghdad and obtaining the patient's informed consent, they will enter the study if the inclusion criteria are met. In the first session, the researcher will introduce the plan in both intervention and control groups. The intervention group will then become a member of a virtual group on the WhatsApp social network, sharing their experiences for 4 weeks. Each week will be devoted to one of the issues raised (nutrition, medication, rest and activity, care, and hospital visits in hospitals). In this plan, the researcher will play the role of facilitator and manager of the group for validation of the shared experiences.
Participants/Inclusion and exclusion criteria
Inclusion: To be a hemodialysis patient, can read and write, have a smartphone
exclusion: death to occur, Failure to complete the intervening period
Intervention groups
Intervention: Forming a WhatsApp group for participants to share their experiences and researcher manages the group and topic
Control: The researcher does not interfere in this group, and the group remains within the usual routine care
Main outcome variables
The general health of hemodialysis patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210304050575N1
Registration date:2021-07-18, 1400/04/27
Registration timing:prospective
Last update:2021-07-18, 1400/04/27
Update count:0
Registration date
2021-07-18, 1400/04/27
Registrant information
Name
Husam Abd Al-Sadeh
Name of organization / entity
Country
Iraq
Phone
+964 1 125 4941
Email address
abdsadehh982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-28, 1400/05/06
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sharing experiences via social networks on the general health of hemodialysis patients
Public title
The effect of sharing experiences on the general health of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least two months have passed since the first hemodialysis
Willingness to participate in the study
Having patients' informed consent
Age between 18-70 years
Ability to communicate verbally
No history of diagnosed anxiety and depression problems
Having a smartphone connected to the Internet
Being literate
Exclusion criteria:
Failure to complete the intervention period for any reason
Performing a kidney transplant
Reluctance to continue participating in the study
Not participating in the post-test
Exacerbation of the disease or occurrence of an unpleasant accident for the patient
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by writing the names of the research groups on two identical sheets (of course, to prevent bias, the names of the groups will be abbreviated as A and B), then by drawing lots, it will be determined that sampling is initiated with which group. If that day is one of the even days of the week and the determined lot is the control group, sampling will be done from the control group on even days. This sequence will continue until the end of sampling (to prevent the dissemination of information) and until the sample size is completed in both 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
research ethics committee of school of nursing & midwifery - Mashhad university of medical science
Street address
Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-05-18, 1400/02/28
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.022
Health conditions studied
1
Description of health condition studied
chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
general health: Health is a state that depends not only on a person's body functions but also on many aspects of his/her mental functions. "Health is a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity
Timepoint
Pre-test: At the beginning of enrollment Post-test: After 4 weeks of enrollment
Method of measurement
Self-reporting of general health questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The starting point of the intervention phase begins with the General Health Questionnaire (GHQ28). Patients in the intervention group, after joining the WhatsApp group, share their experiences with other patients for 4 weeks. Each week will be devoted to one topic (nutrition, medication, rest and activity, care). In this design, the researcher plays the role of facilitator. Examines shared content scientifically. Corrects content as needed and manages the discussion on the topic. At the end of the intervention, after four weeks, the general health of both groups is assessed.
Category
Lifestyle
2
Description
Control group: In the control group, patients are routinely cared for in the ward and this group will have no intervention. Routine care includes face-to-face training and educational pamphlets by the ward nurse.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Husam Abd Al-sadeh
Street address
Al-Sadr City - Al-Rusafa District - Baghdad
City
Baghdad city
Postal code
10001
Phone
+964 1 415 0076
Email
abdsadehH982@mums.ac.ir
2
Recruitment center
Name of recruitment center
Al Kindi Hospital
Full name of responsible person
Husam Abd Al-sadeh
Street address
Al-Nahdha - Al-Rusafa District - Baghdad
City
Baghdad
Postal code
10001
Phone
+964 1 415 0076
Email
abdsadehH982@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Tayebe PourGhaznein
Street address
Khorasan Razavi, Mashhad, Danshgah Street
City
Mashhad city
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
PourghazneinT@mums.ac.ir
Web page address
https://www.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
Sponsor: country of origin
Country of origin
IQ
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
Husam Abd Al-sadeh
Position
Master's degree student in medical-surgery
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
Baghdad-Al-Rusafa-House No 15, Street No 40, Section No 333
City
Baghdad
Province
Baghdad city
Postal code
10001
Phone
+964 1 521 1494
Email
abdsadehH982@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Tayebe Pourghaznain
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Daneshgah St., Doktora. Intersection, Ibn Sina St., School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3859 1511
Email
PourghazneinT@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Husam Abd Al-sadeh
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
Rusafa: House No 15, Street No 40, Section No 333
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
abdsadehH982@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
After printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Permission from the person in charge
From where data/document is obtainable
cominiucate with AbdsadehH982@mums.ac.ir
What processes are involved for a request to access data/document