Determination effect of telenursing on self-care, readmission and psychological reactions of hemodialysis patients of Ali ibn Abitaleb hospital in Zahedan city, in 2018
Design
This clinical trial is community-based, pragmatic, non-blind with control group and 80 hemodialysis patients will be randomly assigned into two groups.
Settings and conduct
In the intervention group, telephone training will be conducted twice a week and the duration of the telephone training will be on average 15 minutes per training.In the control group, routine care has been performed and there will be no intervention in this group.In both groups, self-care questionnaires and DASS21 will be filled in before and after the study
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Beginning hemodialysis in the past year
2- Having a history of at least one hospitalization due to hemodialysis complications during the past three months
3- Have a cell phone to call Telenursing
4- Having ages 18 to 65 years
Exclusion criteria:
1-Not having at least reading and writing literacy
2- Inability to establish verbal communication
3- Presence of psychological disorders and treatment with antidepressants in the last 3 months
4- Reject to enter the study or non-cooperation at each stage of the research
5- Failure to respond to cell phone for 2 weeks in the first month and for 3 weeks in the second month.
6- Immigration or travel for more than 3 months.
7- The occurrence of new stressors (psychological and disease)
8- Kidney transplant
Intervention groups
In the intervention group, the telephone training will be conducted by the researcher for 12 weeks (3 months). In the control group, routine care has been performed and there will be no intervention in this group.
Main outcome variables
Self-Care, Readmission, Psychological problems
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171105037236N5
Registration date:2019-03-06, 1397/12/15
Registration timing:registered_while_recruiting
Last update:2019-03-06, 1397/12/15
Update count:0
Registration date
2019-03-06, 1397/12/15
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 33442481
Email address
askarihas77@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-28, 1397/11/08
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of telenursing on self-care, readmission and psychological reactions of hemodialysis patients
Public title
Training through telenursing for hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Beginning hemodialysis in the past year
Having a history of at least one hospitalization due to hemodialysis complications during the past three months
Having a cell phone to call Telenursing
Having ages 18 to 65 years
Exclusion criteria:
Not having at least reading and writing literacy
Inability to establish verbal communication
Presence of psychological disorders and treatment with antidepressants in the last 3 months
Reject to enter the study or non-cooperation at each stage of the research
Failure to respond to cell phone for 2 weeks in the first month and for 3 weeks in the second month
Immigration or travel for more than 3 months
The occurrence of new stressors (psychological and disease)
Kidney transplant
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
80 individuals will be randomly assigned to two groups. Block randomization based on permutation. Accordingly, 20 blocks will be allocated to patients, in each block 2 from study group and 2 from the control group will be placed.
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 Zahadan University of Medical Sciences
Street address
School Of Health, Zahedan University Of Medical Sciences, Jannat Blvd, Prof. Hesabi Sq, Zahedan, Iran. Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Approval date
2019-01-08, 1397/10/18
Ethics committee reference number
IR.ZAUMS.REC.1397.374
Health conditions studied
1
Description of health condition studied
Telephone follow up telenursing training
ICD-10 code
Z49.1
ICD-10 code description
Encounter for fitting and adjustment of extracorporeal dialysis catheter
Primary outcomes
1
Description
Self care: The score will be accounted of hemodialysis patients self care scale by participant and its scope is 0-72
Timepoint
Self-care measurements before and 12 weeks after study
Method of measurement
Self care questionnaire
2
Description
Readmission: Reception of patients until 30 days after discharge
Timepoint
Measurement of re-admission before and 12 weeks after the study
Method of measurement
the number of readmission using hospital HIS system.
3
Description
Stress:The score of stress in DASS21 questionnaire
Timepoint
Measurement of stress score before and 12 weeks after the study
Method of measurement
ِDASS21 questionnaire
4
Description
Depression: The score of depression in DASS21 questionnaire
Timepoint
Measurement of depression score before and 12 weeks after the study
Method of measurement
ِDASS21 questionnaire
5
Description
Anxiety: Anxiety Score in the DASS21 questionnaire
Timepoint
Measurement of anxiety score before and 12 weeks after the study
Method of measurement
ِDASS21 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group, the telephone training will be conducted by the researcher for 12 weeks (3 months). The telephone training will be conducted twice a week, and the duration of the telephone training will be 15 minutes per training on average. Patients will be trained in telephone conversations with diet, fluid intake, fistula care, skin care, exercise and rest, treatment follow-up, infection prevention, digestive problems, anxiety, stress and self-care education. Before and after the study, patients with self-care and DASS21 questionnaires will be examined
Category
Lifestyle
2
Description
Control group: In the control group, routine care has been taken and there is no intervention. Before and after the study, patients with self-care and DASS21 questionnaires will be examined
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abitaleb Hospital Zahedan
Full name of responsible person
Hasan Askari
Street address
School Of Health, Zahedan University Of Medical Sciences, Jannat Blvd, Prof. Hesabi Sq, Zahedan, Iran. Zahedan Sistan And Baluchestan Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3329 5572
Fax
+98 54 3329 5572
Email
askarihas77@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nor Muhammad Bakhsani
Street address
University of Medical Sciences and Health Services, Zahedan University of Medical Sciences, Dr. Hesabi - Persian Gulf Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Fax
+98 54 3329 5796
Email
bakhsani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Hasan Askari
Position
Nursing Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zahedan, Zahedan Nursing and Midwifery Faculty, Fellowship Square
City
Zahdan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
Askarihass77@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hasan Askari
Position
Nursing Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zahedan, Zahedan Nursing and Midwifery Faculty, Fellowship Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
Askarihass77@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hasan Askari
Position
Nursing Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zahedan, Zahedan Nursing and Midwifery Faculty, Fellowship Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
Askarihas77@yahoo.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
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
The Main Outcomes of the Participants are Public.
When the data will become available and for how long
6 months after the results .
To whom data/document is available
Researchers at Academic and Academic Institutions .
Under which criteria data/document could be used
Statistical Result .
From where data/document is obtainable
Nursing and Midwifery Faculty of Zahedan Phone and Fax: 05433442481 Zip Code: 9816913396 Address: Faculty of Nursing and Midwifery, Zahedan, Zahedan Nursing and Midwifery Faculty, Fellowship Square
What processes are involved for a request to access data/document