Study objective is to determine the effect of diet training package on quality of life in pre-dialysis patients . Design of study is Non-randomized, single blind with control group with the usual care.Dietary components of training packages that will be presented to the patient group, the dominant service in the second training session Hour of personal training and group training to be the same, the contents of the manual training, the quality of life questionnaire Live, in person at monthly follow-up clinic and monthly tests and questions and answers between patient and researcher Based on patient needs and retraining will be necessary The study population are all non-dialysis patients with glomerular filtration rate 15 to 60. Main inclusion criteria is having a GFR between 15 to 60 and main exclusion criteria is the disease progresses as the patient may require dialysis. Sample size is 63 people. intervention study is diet training package. intervention is 3 months. The primary outcome of the study is the diet of training packages after 12 weeks improves , general and specific aspects of quality of life in non-dialysis patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203139289N1
Registration date:2012-04-16, 1391/01/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-16, 1391/01/28
Registrant information
Name
Mahsa Pourshaban Oushibi
Name of organization / entity
Faculty of Nursing and Midwifery of Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 4447 4535
Email address
m-pourshaban@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Univercity of Medical Sciences
Expected recruitment start date
2012-04-06, 1391/01/18
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of an Educational Package Related to a Diet on Quality of Llife Among nondialysis Patients
Public title
Effect of diet on quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclution criteria: age higher than 18 years old ,the ability for conversation and understanding persian language, glomeral fillteration rate=15-60 and ability for reading and Writing . exclusion criteria: patient's death,The disease progresses to dialysis, Mental illness or functional impairment of skeletal muscle, acute disease with the need for hospitalization and kidney transplant
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Universty of Medical Sciences Ethics Committee
Street address
Faculty of Nursing and Midwifery, Tohid sq.
City
Tehran
Postal code
Approval date
2012-03-14, 1390/12/24
Ethics committee reference number
90/د/130/2520
Health conditions studied
1
Description of health condition studied
chronic kidney disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
quality of life
Timepoint
Before and 3 months after intervention
Method of measurement
kidney disease quality of life questionairre
Secondary outcomes
1
Description
blood exam include: Na,k,CBC,Pr,BUN,Cr
Timepoint
First, second and third months of intervention
Method of measurement
Exposure levels, hemoglobin and urea, and sodium and potassium and protein in the normal range
Intervention groups
1
Description
Intervention group: 4-hour training manual training in patients with pre-dialysis diet, and individual 2-hour first session and second sessions of 2 hours and 5-person group
Category
Lifestyle
2
Description
Control group: usual care, including routine doctor visit
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Hasheminejad Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences. Faculty of Nursing and Midwifery
Full name of responsible person
Dr. Mehrdad
Street address
School of Nursing and Midwifery.Tohid Sq
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences. Faculty of Nursing and Midwifery
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
Faculty of Nursing and Midwifery
Full name of responsible person
Mahsa Pourshaban Oushibi
Position
MSc Of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery. Tohid sq.
City
Tehran
Postal code
Phone
+98 21 4447 4535
Fax
Email
m-pourshaban@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parsa Yekta Zohreh
Position
Phd of nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery. Tohid Sq.
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zparsa@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Pourshaban Oushibi Mahsa
Position
MSc of nursing
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
m-pourshaban@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)