Protocol summary

Study aim
Determining the effectiveness of cognitive-behavioral educational intervention of caregiver on promoting adherence to treatment behaviors in hemodialysis patients in Isfahan
Design
A Randomized experimental intervention (clinical trial) of pre-test-post-test type with control group
Settings and conduct
First, two centers were selected from hemodialysis centers under the auspices of Isfahan University of Medical Sciences by cluster sampling method and then randomly divided into two groups of intervention and comparison. Then, the participants were selected using a random number table. Patients enter the study after describing the objectives of the study and obtaining consent. The control group receives routine care and advice from hemodialysis patients at the center. In addition to receiving routine hemodialysis care, the intervention team will receive the "Training Program for Chronic Renal Failure and Hemodialysis" application. The researchers then explain to the intervention group how to receive training programs through the application. Evaluation in two stages, 1 month and 3 months after the end of the educational intervention, will be done by a questionnaire (in person, online) and then the data will be collected and analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Patients who undergo hemodialysis twice a week or more. Patients who have been on dialysis for at least three months. Exclusion criteria: 1. Patients who are hospitalized due to acute diseases. Patients with mental illness. 3. Patients on the kidney transplant list for the next six months.
Intervention groups
The intervention group will receive routine hospital training and the "Chronic Kidney Failure and Hemodialysis Training Program" application
Main outcome variables
Adherence to treatment behavior

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220504054737N1
Registration date: 2022-07-12, 1401/04/21
Registration timing: prospective

Last update: 2022-07-12, 1401/04/21
Update count: 0
Registration date
2022-07-12, 1401/04/21
Registrant information
Name
Mahin Nematollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3633 0177
Email address
nematollahimahin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Patient-Caregiver Cognitive-Behavioral Intervention on Promoting Adherence to Treatment Behaviors in Hemodialysis Patients in Isfahan
Public title
Investigating the Effect of Educational Program using Mobile Phone on the hHealth of hHemodialysis Patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients receiving Hemodialysis twice a Week or more Patients who have been on Dialysis for at least three Months
Exclusion criteria:
Patients who are hospitalized due to acute Illness Patients with Mental Illness Patients on the Kidney Transplant list for the next six Months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The current research is a randomized experimental intervention (clinical trial) of pre-test-post-test type with a control group. The sampling method in this research is multi-stage random cluster sampling: The first stage: Isfahan hemodialysis centers are identified, which includes 4 government hemodialysis centers: Al-Zahra, Farabi, Amin, Ali Asghar and 3 private hemodialysis centers: Zahra Marzieh, Hojjatiyeh and Abolfazl. These centers are almost similar to each other in terms of socio-economic characteristics, and each of them includes heterogeneous groups, and these centers can be considered as clusters. The number of 80 samples is required for the study. Then, the number of hemodialysis patients in each center is specified and the number of patients participating in the study will be determined based on the probability proportional to size (PPS) approach. The second step: simple random method with replacement is used to select patients participating in the study. The list of hemodialysis patients of each center is specified and a code is given to each patient. Each code is written on a sheet and placed inside the box, and then we take the papers one by one and write down the names of the patients and put the sheets back into the box, and this process continues until the desired sample volume is complete. This selection is done by lottery, which shows that it is a random sampling. This method will be implemented for all 7 centers to obtain 80 samples. The third step: 80 samples will be allocated in two control groups (40 samples) and intervention (samples) by simple random sampling method. Each sample is given a code and each code is written on a sheet and placed inside the box and the samples are selected by simple random sampling method and the first 40 samples will be placed in the intervention group and the second 40 samples will be placed in the comparison group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, blindness is one-way and the subjects do not know which intervention or control groups they are in.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs -Medical University of Isfahan
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St., Shiraz Gate, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-04-30, 1401/02/10
Ethics committee reference number
IR.MUI.RESEARCH.REC.1401.048

Health conditions studied

1

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

Primary outcomes

1

Description
Adherence to diet
Timepoint
Outcome variable is measured in three stages: before the intervention, one month and three months after the end of the educational intervention.
Method of measurement
End-Stage Renal Disease - Adherence Questionnaire (ESRD-AQ)

2

Description
Compliance with fluid restrictions
Timepoint
Outcome variable is measured in three stages: before the intervention, one month and three months after the end of the educational intervention
Method of measurement
End-Stage Renal Disease - Adherence Questionnaire (ESRD-AQ)

3

Description
Adherence to prescription drugs
Timepoint
Outcome variable is measured in three stages: before the intervention, one month and three months after the end of the educational intervention
Method of measurement
End-Stage Renal Disease - Adherence Questionnaire (ESRD-AQ)

4

Description
Regular attendance at hemodialysis sessions
Timepoint
Outcome variable is measured in three stages: before the intervention, one month and three months after the end of the educational intervention
Method of measurement
End-Stage Renal Disease - Adherence Questionnaire (ESRD-AQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: Hemodialysis patients enter the study after describing the study objectives and obtaining consent. In addition to receiving routine hemodialysis care, the intervention team will receive the "Training Program for Chronic Renal Failure and Hemodialysis" application. The researchers then explain to the intervention group how to receive training programs through the application. Also, how to use the application in the form of text and videos will be included in the application. Then the application will be installed on the mobile phone or tablet of the intervention group and how to use it will be explained. The duration of sending training programs is one month and the programs are in 4 sessions (one session every 7 days). ) Is sent to the intervention group through the application. The training programs of each session are divided and sent to the intervention group within seven days (one or more programs per day). Necessary trainings are given to the intervention group before the start of the program and at the beginning of each session through the application. At the end of each session, a simple and short test will be sent to users to measure their learning. Also, reminders for taking medicine and participating in dialysis sessions are embedded in this software that will help patients in managing the disease.
Category
Other

2

Description
Control group: Hemodialysis patients enter the study after describing the study objectives and obtaining consent. The control group will receive routine hospital training on chronic renal failure and hemodialysis, and no educational intervention will be performed for the control group by the researchers. The control group will receive the application "Educational program related to chronic kidney failure and hemodialysis" after the end of the educational intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hemodialysis centers under the auspices of Isfahan University of Medical Sciences
Full name of responsible person
Mahin Nematollahi
Street address
Department of Health Education, School of Health, Isfahan University of Medical Sciences, Shiraz Gate, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3239
Email
eeslami@hlth.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmadali Eslami
Street address
Department of Health Education, School of Health, Isfahan University of Medical Sciences, Shiraz Gate, Isfahan,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3239
Email
eeslami@hlth.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
50
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
Esfahan University of Medical Sciences
Full name of responsible person
Ahmadali Eslami
Position
Assistant Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education, School of Health, Isfahan University of Medical Sciences, Shiraz Gate, Isfahan,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
(+98)-31-3723239
Email
eeslami@hlth.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmadali Eslami
Position
Assistant Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education, School of Health, Isfahan University of Medical Sciences, Shiraz Gate, Isfahan,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
(+98)-31-3793239
Email
eeslami@hlth.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahin Nematollahi
Position
PhD student in health education
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education, School of Health, Isfahan University of Medical Sciences, Shiraz Gate, Isfahan,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3242
Email
nematollahimahin@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of information is one of the important ethical principles of our study
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
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