Objectives: The aim of this study is to determine the effect of care plan based on the "Roy" adaptation model on the physiological parameters of chronic renal failure patients. Design: This study is a randomized clinical intervention. Methods: This study involved two group of 60 patients with chronic renal failure. Each group consist of 30 patients. Random allocation of samples will be done using block randomization. Intervention: An educational period of over two months on the physiological parameters such as nutrition, rest and activity will be done. Before and after intervention "Roy" questionnaire will be used to assess the effect of education. Inclusion criteria: Inclusion criteria included patients with complete consciousness, having six-months history of chronic renal disease, age older than 18 years and less than 60 years. Exclusion criteria: Exclusion criteria included lack of desire to continue cooperation, transfer to the others.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042627604N1
Registration date:2016-08-24, 1395/06/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-24, 1395/06/03
Registrant information
Name
Mandana Madani
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3822 6580
Email address
barzou@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Hamadan University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of care plan based on the model of consistency "Roy" on physiological parameters in patients with chronic renal failure
Public title
Nursing care in chronic kidney disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: complete consciousness; Having six-months history of chronic renal failure; Age over 18 years and less than 60 years.
Exclusion criteria: Lake of patient cooperation during study; Transfer to another center.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
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 Hamadan University of Medical Sciences
Street address
Fahmide Street-Hamadan University of Medical Sciences-Hamadan
City
Hamadan
Postal code
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.UMSHA.REC.1394.459
Health conditions studied
1
Description of health condition studied
kidney disease
ICD-10 code
N-18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Vomiting
Timepoint
Before and 2 months after intervention
Method of measurement
Roy questionnaire
Secondary outcomes
1
Description
Rest
Timepoint
Before and 2 months after intervention
Method of measurement
Roy questionnaire
Intervention groups
1
Description
Interventions 1: In the intervention group educational program in eight sessions in relation to physiological parameters such as nutrition, resting and activities for patients will be done during two months.
Category
Prevention
2
Description
Intervention 2: Will not be given any training in control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Mandana Madany
Street address
Fahmide Street-Hamadan University of Medical Sciences-Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Hamadan University of Medical Sciences
Full name of responsible person
Mandana Madani
Street address
Fahmide Street-Hamadan University of Medical Sciences-Hamadan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Reza Borzou
Position
PH.D
Other areas of specialty/work
Street address
Fahmide Street-Hamadan University of Medical Sciences- Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 1480
Fax
Email
barzou@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Reza Borzou
Position
PHD
Other areas of specialty/work
Street address
Fahmide Street-Hamadan University of Medical Sciences-Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 1480
Fax
Email
barzou@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Reza Borzou
Position
PHD
Other areas of specialty/work
Street address
Fahmide Street-Hamadan University of Medical Sciences- Hamadan
City
Hamadan
Postal code
Phone
Fax
Email
barzou@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)