Determination of adherence to treatment regimen in hemodialysis patients using telenursing training in case group before, during and after intervention
Determination of adherence to treatment regimen in hemodialysis patients using telenursing training in the control group before, during and after the intervention
Comparison of adherence to treatment regimen in hemodialysis patients in two groups before and after intervention
Design
A randomized controlled trial will be conducted on 56 patients
Settings and conduct
After splitting the patients, the intervention group will receive training via mobile phone line twice a week for 3 months and each time for 20 minutes. Once again, the questionnaire of adherence to treatment is completed every month and the patient's tests and weight gain are recorded.
Participants/Inclusion and exclusion criteria
Diagnosis of ESRD by a specialist physician and recorded in the relevant file
No history of kidney transplantation in the past 6 months
Passing at least three months after the first hemodialysis
Hemodialysis twice a week or more and each session 3 to 4 hours
Age 18 to 65 years
Ability to understand questions and literacy of reading and writing
Not having mental disorders
No vision or hearing problems
Intervention groups
The method of the study is that before the intervention, the patients' compliance with the standard questionnaire of treatment adherence in hemodialysis patients will be measured and the results of laboratory tests will be recorded on the basis of the patient's records in the relevant form and the patient's weight gain will be recorded.
All research units will receive three training sessions with the same content individually and three times a week.
Main outcome variables
Score of treatment adherence questionnaire; monthly tests; weight gain between dialysis sessions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230531058349N1
Registration date:2023-06-14, 1402/03/24
Registration timing:prospective
Last update:2023-06-14, 1402/03/24
Update count:0
Registration date
2023-06-14, 1402/03/24
Registrant information
Name
Sadegh Moslehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5524 0793
Email address
moslehiali93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-07-01, 1402/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Telenursing Training on Adherence to Treatment Regimen in Hemodialysis Patients
Public title
The Effect of Telenursing Training on Adherence to Treatment Regimen in Hemodialysis Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of ESRD by a Specialist Physician and Recorded in the Relevant File
Fill out a Consent Form
At least 3 Months after the First round of Hemodialysis
Hemodialysis twice a week or more and each session 3 to 4 hours
Age 18 to 65
Ability to Understand questions and Literacy of Reading and Writing
Having a fixed line or Mobile phone and the Ability to make Phone calls
Exclusion criteria:
No History of Kidney Transplantation in the past 6 months
Lack of Experience of a Stressful event within the last 6 months (Such as the death of a Family member or relative)
No Mental disorder
No vision or Hearing problems
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by simple and purposeful method according to the inclusion and exclusion criteria. Then, they will be randomly assigned to intervention and control groups by permutation block method. Six possible cases (BABA, ABBA, BAAB, AABB ABAB, BBAA) will be listed, and by throwing dice of block numbers randomly up to the number of samples will be selected and the subjects will be divided into two groups of intervention (A) and control (B).
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants and their families are fully aware of the study and its complications and benefits and after obtaining informed consent, they are kept blind to random allocation in the experimental and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Imam Khomeini St., Ghadir Sq., Gonabad Medical Sciences Headquarters
City
Gonabad
Province
Razavi Khorasan
Postal code
9671668618
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.GMU.REC.1402.047
Health conditions studied
1
Description of health condition studied
Adherence to Treatment Regimen in Hemodialysis Patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Adherence to the treatment regimen
Timepoint
Before the start of the study, after the training, after the intervention, for four months
Method of measurement
Dietary Adherence Questionnaire (ESRD-AQ)
2
Description
Monthly Tests
Timepoint
After intervention, monthly for up to four months
Method of measurement
Tests recorded in the patient's record
3
Description
Weight gain between dialysis sessions
Timepoint
After intervention, monthly for up to four months
Method of measurement
Patient records
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this stage, training will be given to the research units via mobile phone line twice a week for 3 months and each time for 20 minutes. The content of the conversations includes self-introduction, questions about the patient's general health status, encouraging the patient to follow the recommendations and aspects of general and dedicated self-care, follow-up of educational needs that will be based on the patient's educational needs checklist, and the patient will be provided with the necessary training and recommendations and answers to patients' questions.Phone calls and their content for each participant are recorded in certain sheets and at the end of the phone call with the patient's agreement the time of the next call is determined. The recorded file of the call will be sent to the patient by iGap or Soroush. Also, a text containing educational outline will be sent to the patient once a week.
Category
Rehabilitation
2
Description
Control group: Lack of follow-up and telephone training
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashmar Shahid Modares Hospital
Full name of responsible person
Mohammad Hashemi
Street address
Second Razi St., Razi St., Fayazbakhsh St., Kashmar
City
Kashmar
Province
Razavi Khorasan
Postal code
9671668618
Phone
+98 51 5522 7401
Email
moslehiali93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Moosa Sajjadi
Street address
Imam Khomeini St., Ghadir Sq., Gonabad Medical Sciences Headquarters
City
Gonabad
Province
Razavi Khorasan
Postal code
9671668618
Phone
+98 51 5722 3513
Fax
+98 51 5723 6160
Email
sajjadi1975@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Sadegh Moslehi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 15 Imam Khomeini St.
City
Kashmar
Province
Razavi Khorasan
Postal code
9671668618
Phone
+98 51 5524 0793
Email
moslehiali93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Sadegh Moslehi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 15 Imam Khomeini St.
City
Kashmar
Province
Razavi Khorasan
Postal code
9671668618
Phone
+98 51 5524 0793
Email
moslehiali93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Sadegh Moslehi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 15 Imam Khomeini St.
City
Kashmar
Province
Razavi Khorasan
Postal code
9671668618
Phone
+98 51 5524 0793
Email
moslehiali93@gmail.com
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about adherence to the treatment regimen of participants after undetectable
When the data will become available and for how long
Beginning of access period 3 months after printing
To whom data/document is available
Students and Professors of Medical Sciences
Under which criteria data/document could be used
After obtaining permission from the investigator
From where data/document is obtainable
moslehiali93@gmail.com
What processes are involved for a request to access data/document