The purpose of this study was the comparison of the effect of individual multistages care with routine care on the treatment adherence among hemodialysis patients. This study was an experimental study with simple random allocation. The study population was consisted of hemodialysis patients at Hajar hospital in Shahrekord. Fifty-six patients were divided randomly in two intervention and control groups (each group 28 patients). Inclusion criteria were age higher than 18 years old, having reading and writing ability, to get dialysis treatment 3 times a week, and non-adherence to fluid and diet limitation according to treatment adherence questionnaire and laboratory findings. Exclusion criteria were background diseases such as cancer and lupus. The Patients in control group received routine care. The patients in intervention group participated in eight individual care intervention sessions (each session 1 hour) in addition to routine care. At the first and the end of the study, treatment adherence questionnaire was completed for patients in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012091710857N1
Registration date:2013-07-15, 1392/04/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-15, 1392/04/24
Registrant information
Name
Leila Rafiee Vardanjani
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 6900
Email address
rafiee_l@studentgoums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Golestan University of Medical Sciences, Gorgan, Iran
Expected recruitment start date
2013-03-19, 1391/12/29
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of individual care with routine care on the treatment adherence among hemodialysis patients
Public title
Comparison the effect of individual care with routine care on the treatment adherence among hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age higher than 18 years old, having reading and writing ability, to get dialysis treatment 3 times per week, and non-adherence to fluid and diet limitation according to treatment adherence questionnaire and laboratory findings.
Exclusion criteria:
Background diseases such as cancer and lupus.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
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 Golestan University of Medical Sciences
Street address
Kilometer 4 Gorgan-Sari Road, Initial of Shast Kolah Road, Golestan University of Medical Sciences, Gorgan
City
Gorgan
Postal code
Approval date
2013-03-17, 1391/12/27
Ethics committee reference number
356191122721
Health conditions studied
1
Description of health condition studied
Chronic kidney disease, stage 5
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease
Primary outcomes
1
Description
Treatment adherence
Timepoint
At the first and the end of the study
Method of measurement
Treatment adherence questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group:
Patients in control group received routine care.
Category
Behavior
2
Description
Intervention group:
Patients in the intervention group participated in eight personal intervention sessions in addition to routine care when they were under hemodialysis. The intervention was done by the researcher in step-by-step process with the aim of change in patient's behaviors.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Leila Rafiee Vardanjani
Street address
Hajar hospital, Parastar Street, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology, Golestan University of Medical Sciences
Full name of responsible person
Mohammad Jafar Golalipour
Street address
Kilometer 4 Gorgan-Sari Road, Initial of Shast Kolah Road, Golestan University of Medical Sciences, Gorgan
City
Gorgan
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 and technology, Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Leila Rafiee Vardanjani
Position
MSc Nursing Student
Other areas of specialty/work
Street address
Kilometer 4 Gorgan-Sari Road, Initial of Shast Kolah Road, Golestan University of Medical Sciences, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
Email
rafiee.leila@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Gholamreza Mahmoodi Shan
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Kilometer 4 Gorgan-Sari Road, Initial of Shast Kolah Road, Golestan University of Medical Sciences, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
+98 17 1442 5171
Email
mahmoodigh@yahoo.com
Web page address
www.Goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Leila Rafiee Vardanjani
Position
MSc Nursing Student
Other areas of specialty/work
Street address
Kilometer 4 Gorgan-Sari Road, Initial of Shast Kolah Road, Golestan University of Medical Sciences, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
Email
rafiee.leila@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)