The effect of home visit plan on the adherence to therapeutic regimen of patients undergoing hemodialysis in selected hospitals of Isfahan University of Medical Sciences in 2018
Effect of home visit plan on the adherence to treatment regimen of patients undergoing hemodialysis in selected hospitals of Isfahan University of Medical Sciences in 2018
Design
A clinical trial with a community-based control group, Pragmatic, Randomized, parallel groups
Settings and conduct
In this study, need assessment and sampling were performed in Khorshid and Alzahra hospitals in Isfahan and then 3-5 home visits were held in patients' home.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients who had had at least 3 months of onset of hemodialysis ,Patients treated with hemodialysis three times a week and 3-4 hours each,Patients who approved their initial consent and one of their family members to participate in the study,Patients who were able to speak and understand fully the Persian language, and at least to read and write literacy,Patients in the age range of 18-65 years,Patients who had not already received the home visit plan
Exclusion criteria:Patients with acute and chronic infections, inflammatory diseases, malignancy, and cognitive and psychological problems.
Intervention groups
In the intervention group, Training diet therapy_adherence behaviors to patient and families as 3-5 sessions of home education and in the routine control of hospital education.
Main outcome variables
Adherence to Therapeutic Regimen
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130801014242N2
Registration date:2019-10-04, 1398/07/12
Registration timing:retrospective
Last update:2019-10-04, 1398/07/12
Update count:0
Registration date
2019-10-04, 1398/07/12
Registrant information
Name
Maryam Shirazi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2904
Email address
m_shirazi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2018-10-23, 1397/08/01
Trial completion date
2019-02-20, 1397/12/01
Scientific title
The effect of home visit plan on the adherence to therapeutic regimen of patients undergoing hemodialysis in selected hospitals of Isfahan University of Medical Sciences in 2018
Public title
The effect of home visit plan on the adherence to therapeutic regimen of patients undergoing hemodialysis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who had had at least 3 months of onset of hemodialysis and had had an acute illness
Patients treated with hemodialysis three times a week and 3-4 hours each
Patients who approved their initial consent and one of their family members to participate in the study
Patients who were able to speak and understand fully the Persian language, and at least to read and write literacy.
Patients in the age range of 18-65 years
Patients who had not already received the home visit plan
Exclusion criteria:
Patients with acute and chronic infections.
Patients with malignancy.
Patients with cognitive and psychological problems.
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:
66
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign samples to the intervention and control groups, the researcher will write the names of the samples on small sheets after the completion of the sampling and place them in the box and begin to remove the sheets without inserting them from the box. Individuals (first, third, ...) will be assigned to the control group to the intervention group and the couple (second, fourth, and ...).
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 Isfahan University Of Medical Sciences
Street address
Hezarjirib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.MUI.REC.1396.3.870
Health conditions studied
1
Description of health condition studied
Dialysis
ICD-10 code
T81.502
ICD-10 code description
Unspecified complication of foreign body accidentally left in body following kidney dialysis
Primary outcomes
1
Description
Adherence to therapeutic regimen
Timepoint
Before, After and 1 month After The Prevention
Method of measurement
Renal adherence behavior Questionnaire ( RABQ)
Secondary outcomes
1
Description
Patient weight
Timepoint
Before, After and 1 month After The Prevention
Method of measurement
Weighing the patient and blood tests
Intervention groups
1
Description
"Intervention group:" Training on dietary behaviors including diet, medication and water and electrolyte restraint behaviors were given to the patient and their family during 3-5 sessions of at least 40-minute home visits and identified as existing It provides families with the opportunity to address it and improve adherence to their diet and improve community health and reduce medical costs.
Category
Lifestyle
2
Description
Control group: Questionnaires are filled in at intervals before, immediately and one month later and given to them after evaluation of educational booklets.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Selected Hospitals Of Isfahan University Of Medical Sciences
Full name of responsible person
Maryam Shirazi
Street address
Hezarjirib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7585
Email
m_shirazi@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahnaz Norouzi
Street address
Hezarjirib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7585
Email
norouzi@nm.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
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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Shirazi
Position
Academic Member, Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezarjirib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7585
Email
m_shirazi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Shirazi
Position
Academic Member, Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezarjirib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
13133437
Phone
+98 31 3792 7585
Email
m_shirazi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Shirazi
Position
Academic Member, Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezarjirib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7585
Email
m_shirazi@nm.mui.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