The aim of this study is to investigate the effect of continuous care model on adherence dialysis patients. This study is a parallel randomized clinical trial .Dialysis patients were randomly assigned to intervention and control group.Intervention is the continuous care model on adherence. Control group do not receive any training.
Adherence on treatment will be measured before intervention and one, two and three months after intervention in both groups . Finally all results will be compare .
Definition Adherence :
The rate of non-compliance of patient with recommended health behaviors or treatments .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012816400N1
Registration date:2014-07-01, 1393/04/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-01, 1393/04/10
Registrant information
Name
Saeid Hashemi
Name of organization / entity
Baghiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 464 3976
Email address
fazel@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Nephrology and Urology Research Center University of Medical Sciences Baghiytallah
Expected recruitment start date
2013-12-21, 1392/09/30
Expected recruitment end date
2014-03-19, 1392/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of continuous care model on treatment adherence in dialysis patients
Public title
Treatment of dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having ability of reading and writing; more than three months of hemodialysis; able to perform the actions described in the pamphlet ; 18 years and older patients
Exclusion criteria: lack of willingness or ability to cooperate during the study; diseases that can alter intervention (mental illness, etc.); having medical education, being medical staff either participants or their close relatives.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Morality Committee for Research University of Medical Sciences Baghiyatallah University of Medical S
Street address
Three way , Araj Square, Noubonyad,Tehran, University of Medical Sciences baghiyatallah
City
Tehran
Postal code
Approval date
2013-10-27, 1392/08/05
Ethics committee reference number
33
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.0
ICD-10 code description
Care involving dialysis
Primary outcomes
1
Description
Adherence
Timepoint
before the intervention then First, second , third months after intervention
Method of measurement
Questionnaire kim
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Do not receive any training.The questionnaire is filled at the end of the first, second and third months
Category
Lifestyle
2
Description
Intervention group:After performing the Continuous Care Model(process orientation, sensitization, Controlling and evaluation),the questionnaire is filled at the end of each month until the third month
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghiyatallah hospital
Full name of responsible person
Saeid hashemi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Baghiyatallah University of Medical Sciences
Full name of responsible person
Dr.Behzad eynollahi
Street address
Mollasadra Tree way, Vanak Squre,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Baghiyatallah 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
Baghiyatallah University of Medical Sciences
Full name of responsible person
Ali tayebi
Position
Faculty member
Other areas of specialty/work
Street address
Baghiyatallah University of Medical Sciences, Araj Three Way , Nobonyad Square,Tehran,
City
Tehran
Postal code
Phone
+98 21 8126 3294
Fax
Email
Tayybi.ali@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baghiyatallah University of Medical Sciences
Full name of responsible person
Behzad aynolahi
Position
Professor of Nephrology
Other areas of specialty/work
Street address
Baghiyatallah hospital, Mollasadra Three Ways, Vanak Square,Tehran
City
Tehran
Postal code
Tehran
Phone
+98 21 8126 4092
Fax
Email
Hashemi.saeid65@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baghiyatallah University of Medical Sciences
Full name of responsible person
Batoole nehrir
Position
Faculty member
Other areas of specialty/work
Street address
Araj Three way, Aghdasiyeh St.
City
Tehran
Postal code
Phone
+98 21 2228 9941
Fax
Email
rnehrir1739@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)