This study aimed to determine the effect of continuous care model on the management weight and blood pressure in patients treated with dialysis. This study is a randomized clinical trial on patients suffering from chronic renal failure who referred to martyr Beheshti hospital (Abadan, Iran) hemodialysis center. After reviewing the characteristics of the samples in the research environment, among patients eligible for the study, 82 patients were randomly selected and each with a random block of two groups will be assigned. Demographic questionnaire for patients completed by investigator and record the exact weight vital signs between dialysis sessions will be performed in all cases; then three months continuous care model in intervention group will be implemented that including four orientation stage, making sensitive, control and evaluation. Inclusion criteria: all patients with chronic renal failure who are on specialist diagnosis; have a phone number; have the desire to participate in the study; the training must be physically and mentally and all samples have 18 years of age. Exclusion criteria: in case of critical situations; immigration; death and patient unwillingness to continue.
General information
Acronym
Continuous Care Model
IRCT registration information
IRCT registration number:IRCT2012072810416N1
Registration date:2013-03-04, 1391/12/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-04, 1391/12/14
Registrant information
Name
Batul Hosseini
Name of organization / entity
Jundi Shapur University, Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 77 2324 8218
Email address
hosseini_b@ymail.com
Recruitment status
Recruitment complete
Funding source
Jundi Shapur University, Ahvaz
Expected recruitment start date
2012-08-10, 1391/05/20
Expected recruitment end date
2012-11-10, 1391/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Continuous Care Model on weight control and blood pressure in hemodialysis patients
Public title
Effect of Continuous Care Model on weight control and blood pressure in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: all patients with chronic renal failure who are on specialist diagnosis; have a phone number; have the desire to participate in the study; the training must be physically and mentally and all samples have 18 years of age.
Exclusion criteria: in case of critical situations; immigration; death and patient unwillingness to continue.
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:
82
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
Jundi Shapur University, Ahvaz
Street address
Jundi Shapur University, Ahvaz
City
Ahvaz
Postal code
Approval date
2012-06-25, 1391/04/05
Ethics committee reference number
ETH-353
Health conditions studied
1
Description of health condition studied
chronic kidney failure
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Blood pressure
Timepoint
Once a month
Method of measurement
mmHg with a mercury manometer
2
Description
Weight
Timepoint
Once a month
Method of measurement
Kg weight
Secondary outcomes
empty
Intervention groups
1
Description
Continuous Care Model (Including orientation, sensitization, monitoring and evaluation) in the intervention group and measurements related to weight and blood pressure
Category
Lifestyle
2
Description
weight and blood pressure measured in the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Martyr Beheshti Hospital in Abadan
Full name of responsible person
Hemodialysis unit
Street address
Martyr Beheshti Hospital in Abadan
City
Abadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundi Shapur University, Ahvaz
Full name of responsible person
Dr. javaherizadeh hajir
Street address
Ahvaz
City
Jundi Shapur University, Ahvaz-school of medicine-reaserch assistance
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundi Shapur University, Ahvaz
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
jondi shapour University, Ahvaz
Full name of responsible person
Batou Hosseini
Position
Nursing master student
Other areas of specialty/work
Street address
Hospital Amiralmomenin Genaveh
City
Genaveh
Postal code
Phone
+98 77 2324 8218
Fax
Email
hosseini_b@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jondi shapour University, Ahvaz
Full name of responsible person
Soheila Sedaghat
Position
MS in Nursing
Other areas of specialty/work
Street address
School of Nursing
City
Abadan
Postal code
Phone
+98 63 1446 5495
Fax
Email
sedaghat1702@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jundi Shapur University, Ahvaz
Full name of responsible person
Batoul Hosseini
Position
Nursing master student
Other areas of specialty/work
Street address
Genaveh Amiralmomenin hospital
City
Genaveh
Postal code
Phone
+98 77 2324 8218
Fax
Email
hosseini_b@ymail.cim
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)