Protocol summary

Study aim
To assess the effect of face-to-face and distance training (Telenursing) versus control group on Self-efficacy of hemodialysis patients
Design
This is a randomized clinical trial, in which 180 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible hemodialysis patients referring to the Imam Reza Hospital in Kermanshah city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 65 years; Chronic renal failure; Under hemodialysis for at least 6 months; Literate; Access to phone call or cell phone; Exclusion criteria: Speech or hearing impairment; Hospitalization during stud period; Failure to answer the phone for 3 times
Intervention groups
Intervention group 1: Routine treatment plus face-to-face training (including encouraging the patient to study and exercise, energy conservation methods, side effects and symptoms of fluid accumulation in the body, nutritional management, restriction of taking sodium, potassium and fluids, signs and symptoms of hypertension, definition of fistula and how it works, how to control infection, and how to take medications) two 45-minute sessions weekly for 4 weeks Intervention group 2: Routine treatment plus distance training (Telenursing) (including encouraging the patient to study and exercise, energy conservation methods, side effects and symptoms of fluid accumulation in the body, nutritional management, restriction of taking sodium, potassium and fluids, signs and symptoms of hypertension, definition of fistula and how it works, how to control infection, and how to take medications) two 45-minute sessions weekly for 4 weeks Control group: Just routine treatment
Main outcome variables
Primary outcome: Self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N411
Registration date: 2021-12-09, 1400/09/18
Registration timing: prospective

Last update: 2021-12-09, 1400/09/18
Update count: 0
Registration date
2021-12-09, 1400/09/18
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of face-to-face and distance training (Telenursing) versus control group on Self-efficacy of hemodialysis patients: a randomized clinical trial
Public title
Effect of face-to-face and distance training (Telenursing) versus control group on Self-efficacy of hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years; Chronic renal failure; Under hemodialysis for at least 6 months; Literate; Access to phone call or cell phone;
Exclusion criteria:
Speech or hearing impairment; Hospitalization during stud period; Failure to answer the phone for 3 times
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1 and on two other sheets the name of the intervention 2 and on the third two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-11-27, 1400/09/06
Ethics committee reference number
IR.UMSHA.REC.1400.682

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
Z99.2
ICD-10 code description
Dependence on renal dialysis

Primary outcomes

1

Description
Self-efficacy
Timepoint
Before the intervention and 4 weeks after that
Method of measurement
Using Shere General Self-efficacy Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Routine treatment plus face-to-face training (including encouraging the patient to study and exercise, energy conservation methods, side effects and symptoms of fluid accumulation in the body, nutritional management, restriction of taking sodium, potassium and fluids, signs and symptoms of hypertension, definition of fistula and how it works, how to control infection, and how to take medications) two 45-minute sessions weekly for 4 weeks
Category
Other

2

Description
Intervention group 2: Routine treatment plus distance training (Telenursing) (including encouraging the patient to study and exercise, energy conservation methods, side effects and symptoms of fluid accumulation in the body, nutritional management, restriction of taking sodium, potassium and fluids, signs and symptoms of hypertension, definition of fistula and how it works, how to control infection, and how to take medications) two 45-minute sessions weekly for 4 weeks
Category
Other

3

Description
Control group: Just routine treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital in Kermanshah city
Full name of responsible person
Forouzan Ahmadi
Street address
Imam Reza Hospital, Zakaria Razi Ave.
City
Kermanshah
Province
Kermanshah
Postal code
8518465816
Phone
+98 81 3427 6301
Email
fr.ahmadi267@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Forouzan Ahmadi
Position
Bachlor of Nursery
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fr.ahmadi267@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Takarli
Position
Master of Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Tuiserkan Brunch, Hayaghoogh Nabi Ave.
City
Tuiserkan
Province
Hamadan
Postal code
8518465816
Phone
+98 81 3492 3288
Email
ftakarli2013@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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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