Effectiveness of education based on the collaborative care model on the adherence to treatment and laboratory indexes in the patients undergoing dialysis.
The effect of educational interventions based on Participatory Care Model on adherence to treatment and the level of laboratory index in the patients under hemodialysis
Design
A clinical trial with a sample size of 80 patients under dialysis
Settings and conduct
At first, The research samples are selected by convenience sampling based on inclusion criteria and then divided into two groups ( case and control ) based on Random Allocation Rule.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
1) - Consent to take part in the study
2)-At least 6 months have passed from under hemodialysis treatment
3) -Minimum and maximum age respectively 18 and 70 years’ old
4) -Not having an advanced underlying disease such as respiratory failure or malignant disease
5) -Mental health
6) -Attending in the training classes
7) -Having elementary Literacy
Exclusion Criteria
1) - Renal transplant
2)- Immigration
Intervention groups
In the intervention group:
The participatory care-based training program will be implemented based on four stages(motivation, involvement, participatory educational intervention, and follow-up participatory intervention), then will be followed for three months.
Main outcome variables
Adherence to treatment and average three-months of laboratory indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190303042900N2
Registration date:2019-08-25, 1398/06/03
Registration timing:registered_while_recruiting
Last update:2019-08-25, 1398/06/03
Update count:0
Registration date
2019-08-25, 1398/06/03
Registrant information
Name
Shahriyar Salehitali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3334 9321
Email address
sh.salehitali@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of education based on the collaborative care model on the adherence to treatment and laboratory indexes in the patients undergoing dialysis.
Public title
"The Effect of Collaborative Care Model on the Status of Chronic Kidney Failure Patients under dialysis "
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
consent to take part in the study
At least 6 months have passed from under dialysis treatment
Minimum and maximum age respectively 18 and 70 years old
don't have an advanced underlying disease such as respiratory failure or malignant disease
Mental health
Attend training classes
Elementary Literacy
Exclusion criteria:
Kidney transplant
Immigrate
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
First, the sample size was selected based on the inclusion criteria and easy sampling then the sampling selected divided two groups ( case and control ) base on random allocation rule
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 Shahrkord University Of Medical Sciences
Street address
University Of Medical Sciences, Rahmatie, Shahrkord Town
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2019-01-13, 1397/10/23
Ethics committee reference number
IR.SKUMS.REC.1397.255
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease, unspecified
Primary outcomes
1
Description
Adherence to treatment
Timepoint
At the beginning of the study and three months after the intervention
Method of measurement
questionnaire
2
Description
Albumin laboratory Index
Timepoint
At the beginning of the study and three months after the intervention
Method of measurement
laboratory finding
3
Description
calcium , potassium and phosphorus index
Timepoint
At the beginning of the study, one month, two months and three months after the intervention
Method of measurement
laboratory
4
Description
hemoglobin laboratory index
Timepoint
At the beginning of the study, one month, two months and three months after the intervention
Method of measurement
laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: educational intervention will be implemented based on the steps of participatory care that include (motivation, preparation, engagement, and evaluation) during eight sessions then intervention implemented followup for 3 months in the intervention group
Category
Treatment - Drugs
2
Description
Control group: Control group only receive routine care and treatment including hemodialysis and their medication.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital of SayyedAlshohada Lordegan
Full name of responsible person
Shahriar Salehi Tali
Street address
Lordegan، Hospital of Seyyed Alshohada
City
Lordegan
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8891635133
Phone
+98 38 3444 4441
Fax
+98 38 3444 4445
Email
sh_salehitali@yahoo.com
Web page address
http://sapp.ir/kashani_hospital_sh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Kamal Solati
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrkord.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Kamal_Solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Shahriar Salehi Tali
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences,Rahmatie,Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Sh.salehitali@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Shahriar Salehi Tali
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences,Rahmatie,Shahrekord.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Sh.salehitali@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Shahriar Salehi Tali
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Sh.salehitali@skums.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
Not applicable
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