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Comparison of two interventions of promoting illness perception and self-care on adherence to treatment and adjustment to illness in patients undergoing peritoneal dialysis

Protocol summary

Study aim
Comparison of two interventions of promoting illness perception and self-care on adherence to treatment and adjustment to illness in patients undergoing peritoneal dialysis
Design
In this study, 60 patients undergoing peritoneal dialysis and entering the study were enrolled in two peritoneal dialysis centers of Imam Reza (AS) and Ghaem (AS) in Mashhad. At first, using the lottery, Imam Reza's center (AS) became the group of perception of the disease and the center of Qa'im (AS) as a self-care group. Then, the sampling was carried out in each group of 30 individuals purposefully.
Settings and conduct
Peritoneal Dialysis Centers in Imam Reza Hospitals and Ghaem Hospitals of Mashhad University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria were: • Diagnosis of ESRD by a specialist and registration in a medical record • At least three months have passed since the patient's first peritoneal dialysis • Age over 18 years • Reading and writing literacy • Not having mental disorder • Not having a wide field of illness based on a case and medical history
Intervention groups
Understanding of the disease: At first, the perception of the disease was evaluated using the BIPQ questionnaire. Then, in 4 sessions of 20 to 30 minutes, the patients received the perception of the disease intervention individually and weekly for two sessions. This intervention was based on five dimensions of perception of the disease. At the first session, introducing the researcher and familiarizing with the patient and completing the questionnaires, In the second session, the nature of the illness and physical and mental symptoms associated with the disease was described, as well as the outcomes and findings of the individual from the disease in terms of physical, psychological, economic and social effects. In the third session, individual beliefs about the causes of the disease were evaluated and corrected, and the individual's understanding of the duration of the disease was corrected and emphasized on the effectiveness of control and treatment, At the fourth session, a general assessment of the process was carried out. Self-care group: Patients in the self-care group received self-care intervention in 4 sessions of 20 to 30 minutes, individually and weekly in two sessions. The educational content included diet and nutrition, dietary restrictions and relative fluid limits, activity levels, dialysis procedures, peritoneal catheter care, and control and evaluation of perinatal conditions and peritoneum. Educational pamphlets and instructional materials and instructional films provided the patient with proper peritoneal dialysis.
Main outcome variables
Adherence to treatment and Psychosocial adjustment to illness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171219037949N1
Registration date: 2018-01-21, 1396/11/01
Registration timing: retrospective

Last update: 2018-01-21, 1396/11/01
Update count: 0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
Narges Sadeghi Zarmehri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3452 2228
Email address
sadeghizn921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-10-12, 1396/07/20
Actual recruitment end date
2017-12-26, 1396/10/05
Trial completion date
empty
Scientific title
Comparison of two interventions of promoting illness perception and self-care on adherence to treatment and adjustment to illness in patients undergoing peritoneal dialysis
Public title
The Effect of Two Methods of Education on Adherence to Treatment and Adaptation in Peritoneal Dialysis Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
ESRD diagnosis by a specialist and filed in a medical record At least three months have passed since the patient's first peritoneal dialysis Age older than 18 years Read and write
Exclusion criteria:
Not having a wide field of illness based on records and medical history having mental-psychiatric disorder
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
At first, using the lottery, Imam Reza's center (AS) became the group of perception of the disease and the center of Qa'im (AS) as a self-care group. Then, sampling in each group (30 people) was performed purposefully
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 Mashhad University of Medical Sciences
Street address
Ibn Sina Avenue, Doctora Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
95199-85845
Approval date
2017-01-21, 1395/11/02
Ethics committee reference number
IR.MUMS.REC.1395.523

Health conditions studied

1

Description of health condition studied
Peritoneal Dialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
Adherence to treatment
Timepoint
Start the study, three weeks after the intervention, six weeks after the intervention
Method of measurement
researcher-made questionnaire on Adherence to treatment in peritoneal dialysis patients

2

Description
Psychosocial adjustment to illness
Timepoint
Start the study, three weeks after the intervention, six weeks after the intervention
Method of measurement
Psychosocial Adaptation to Illness Survey (PAIS)

Secondary outcomes

empty

Intervention groups

1

Description
illness perception group: In this group, first, Preception of Illness was evaluated using the BIPQ questionnaire. Then, in 4 sessions of 20 to 30 minutes, the patients received the perception of the disease intervention individually and weekly for two sessions. This intervention was based on five dimensions of perception of the disease. At the first session, the introduction of a researcher and acquaintance with the patient and completion of the questionnaires, in the second session on the nature of the disease and the symptoms and physical and mental symptoms associated with the disease, as well as the expected outcomes and outcomes of the person from the disease in terms of physical, psychological, economic effects And social. At the third session, individual beliefs about the causes of the disease were evaluated and corrected, and the individual's understanding of the duration of the disease was corrected and the effectiveness of control and treatment was emphasized and a fourth assessment of the overall process was carried out. In fact, intervention was designed to change the misconception and negative perception that the patient might have about the disease
Category
Prevention

2

Description
self - care group: In this group, four sessions of 20 to 30 minutes received self-care intervention individually and weekly in two sessions. The educational content included diet and nutrition, dietary restrictions and relative fluid limits, activity levels, dialysis procedures, peritoneal catheter care, and control and evaluation of perinatal conditions and peritoneum. Educational pamphlets and instructional materials and instructional films provided the patient with proper peritoneal dialysis.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Peritoneal dialysis center of Imam Reza Hospital
Full name of responsible person
Narges Sadeghi Zarmehri
Street address
Taghi Abad. Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
95199-85845
Phone
+98 51 3802 2470
Email
sadeghizn921@mums.ac.ir

2

Recruitment center
Name of recruitment center
Peritoneal dialysis center of Imam Ghaem Hospital
Full name of responsible person
Narges Sadeghi Zarmehri
Street address
Ahmad abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
95199-85845
Phone
+98 51 3840 0000
Email
sadeghizn921@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafghadi
Street address
Doctora Crossroads, Daneshgah Street, Quraishi Building, Research Deputy
City
Mashhad
Province
Razavi Khorasan
Postal code
95199-85845
Phone
+98 51 3859 1511
Email
sadeghizn921@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hasanzadeh Farzaneh
Position
Faculty Member of Mashhad Nursing and Midwifery Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ibn Sina St, Doctora Crossroads, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
95199-85845
Phone
+98 51 3859 1511
Email
HasanzadehF@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Hasanzadeh
Position
Faculty Member of Mashhad Nursing and Midwifery Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Daneshgah Street, Doctora Crossroads, Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
95199-85845
Phone
+98 38591511
Email
HasanzadehF@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Narges Sadeghi Zarmehri
Position
MSC of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ibn-e Sina St., Chaharah Doktora Crossing
City
Mashhad
Province
Razavi Khorasan
Postal code
95199-85845
Phone
+98 51 3859 1511
Email
Sadeghizn921@mums.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
No - There is not a plan to make this available
Data Dictionary
Not applicable
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