Protocol summary

Study aim
The effect of continuous nursing care based on Information, Knowledge, Attitude, and Practice (IKAP) theory on quality of life and lifestyle of hemodialysis patients
Design
A quasi-experimental study with control and intervention group, randomized, will be performed on 68 patients. Excel software will be used for randomization.
Settings and conduct
This quasi-experimental study with a control and intervention group will be performed randomly on 68 patients undergoing hemodialysis in the dialysis ward of Golestan Hospital in Ahvaz. In the intervention group, nursing care is performed by ICAP method during various training-care sessions and by establishing telephone communication and, if necessary, the Internet. But in the control group, nursing care will be done routinely.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Have the desire to participate in the present study, be literate, access to Smart phone. Exclusion criteria: the patient dies during the study, history of mental illness or hospitalization in a psychiatric hospital, the patient develops new physical problems that make him lose the ability to take care of himself and continue the training process.
Intervention groups
Intervention group: The intervention group receives continuous nursing care based on IKAP theory every 2 weeks for 20 to 30 minutes (four sessions in total for 8 weeks) along with routine nursing care. Control group: Control group receive only routine nursing care.
Main outcome variables
Lifestyle of hemodialysis patients; Quality of life of hemodialysis patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220106053644N1
Registration date: 2022-02-25, 1400/12/06
Registration timing: registered_while_recruiting

Last update: 2022-02-25, 1400/12/06
Update count: 0
Registration date
2022-02-25, 1400/12/06
Registrant information
Name
Ziya Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8383
Email address
ziya.azizi64@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of continuous nursing care based on Information, Knowledge, Attitude, and Practice (IKAP) theory on quality of life and lifestyle of hemodialysis patients
Public title
The effect of IKAP-based continuing nursing care on quality and lifestyle of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research Ability to read and write Ability to make direct telephone calls to the patient and active family member Ability to complete a questionnaire and participate in interviews cognitively Smartphone access
Exclusion criteria:
History of mental illness or hospitalization in a psychiatric hospital
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be selected by Simple randomization from hemodialysis patients. Randomization is done based on number Random table with Excel software and then Participants are divided into two groups of intervention and control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
No. 4; Ground Floor; Vice Chancellor for Research and Technology Development; Ahvaz Jundishapur University of Medical Sciences; Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2021-12-25, 1400/10/04
Ethics committee reference number
IR.AJUMS.REC.1400.596

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
Quality of life score of hemodialysis patients
Timepoint
before and three months after IKAP intervention
Method of measurement
Standard Quality of Life Questionnaire for Kidney Patients (KDQOL-SF)

2

Description
Lifestyle of hemodialysis patients
Timepoint
قبل و سه ماه بعد از مداخله IKAP
Method of measurement
Lifestyle Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group receives 20 to 30 minutes of continuous nursing based on IKAP theory every 2 weeks along with routine nursing care (4 sessions in total). When and how, while determining and agreeing on face-to-face / telephone appointments, mentioning goals and how communication is possible; They will take the course from this period and the two will be taken to the hospital. At the end, the patients will be received and the date of the next session will be announced. The sessions will be in the form of questions and answers (at the beginning of the session) and The presentation is then led by the researcher. At the end of each session, an educational booklet is provided to patients and they are asked questions about the topics of the previous session. Data collection takes 15-15 minutes, knowledge acquisition takes 10-15 minutes, and changes in patients' attitudes and performance are assessed after the intervention.
Category
Lifestyle

2

Description
Control group: Patients in the control group are provided with routine care that includes a hemodialysis training session (20-30 minutes). This includes information about the factors that affect the disease and make the condition of hemodialysis patients worse.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Neda Sayadi
Street address
Farvardin St., Golestan Blvd., Golestan Educational and Medical Center; Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6136835685
Phone
+98 61 3320 4501
Email
golestanhospital@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohamad Sadegh Salahshoor
Street address
Vice Chancellor for Finance; Ahwaz Jundishapur University; Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 7075
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ziya Azizi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Jundishapur University of Medical Sciences; Ahvaz Town
City
ابادان
Province
Khouzestan
Postal code
6131579457
Phone
0098 61 33738331
Email
ziya.azizi64@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ziya Azizi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Jundishapur University of Medical Sciences; Ahvaz Town
City
ابادان
Province
Khouzestan
Postal code
6131579457
Phone
+98 61 3373 8331
Email
ziya.azizi64@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ziya Azizi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University, School of Nursing and Midwifery
City
َAhvaz
Province
Khouzestan
Postal code
6131579457
Phone
+98 61 3373 8331
Email
ziya.azizi64@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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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