This study aimed to evaluate the effect of care plan based on the Roy adaptation model on General health and life Satisfaction in hemodialysis patients. The study is a randomized, non-blinded. The study population includes all patients under hemodialysis in Semnan Kowsar Hospital and Garmsar Emam Hospital affiliated to Semnan University of Medical Sciences. Inclusion criteria: consent for participation in study; age between 40-80 years; diagnosed as CRF; Treatment with hemodialysis at least 2-3 times weekly; history of hemodialysis at least 6 month. Exclusion Criteria: having physical or mental disability; addiction; patients with cancer; hearing or visual impairment; experience of stressful events in recent 6 month; renal transplantation during study; patient's unwillingness to cooperate; refusing for continuing study and participation in teaching sessions. Sample size includes 70 patients. After getting informed consent in test group, they will complete general health, life satisfaction questionnaires and assessment form of Roy adaptation model. Maladaptive behaviors and their stimuli extract and care-plan based on the Roy adaptation model will implement for them. Finally, aforementioned questionnaires will complete for patients again. Control group is similar to test group but for this group we will not implement care-plan based on Roy adaptation model.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411198665N4
Registration date:2014-11-30, 1393/09/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-11-30, 1393/09/09
Registrant information
Name
Hassan Babamohamadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
babamohamadi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2015-01-05, 1393/10/15
Expected recruitment end date
2015-10-07, 1394/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of care plan based on the Roy adaptation model on General health and life Satisfaction in hemodialysis patients
Public title
Effect of Roy adaptation model on general health and life satisfaction in hemodialysis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria: consent for participation in study; age between 40-80 years; diagnosed as CRF; Treatment with hemodialysis at least 2-3 times weekly; history of hemodialysis at least 6 month.
Exclusion Criteria: having physical or mental disability; addiction; patients with cancer; hearing or visual impairment; experience of stressful events in recent 6 month; renal transplantation during study; patient's unwillingness to cooperate; refusing for continuing study and participation in teaching sessions.
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Vice Chancellor of Research and Technology, Basidj Blv, Semnan, Iran
City
Semnan
Postal code
3519899951
Approval date
2014-11-25, 1393/09/04
Ethics committee reference number
93/529209
Health conditions studied
1
Description of health condition studied
General Health
ICD-10 code
z10
ICD-10 code description
Routine general health check-up of defined subpopulation
2
Description of health condition studied
Life satisfaction
ICD-10 code
Y98
ICD-10 code description
Lifestyle-related condition
Primary outcomes
1
Description
General Health
Timepoint
At the first and end of study
Method of measurement
General Health Questionnaire (28 item)
2
Description
Life Satisfaction
Timepoint
At the first and end of study
Method of measurement
Satisfaction with Life scale questionnaire (SWLS)
Secondary outcomes
empty
Intervention groups
1
Description
After getting informed consent in control group, they will complete general health, life satisfaction questionnaires and assessment form of Roy adaptation model. But care-plan based on the Roy adaptation model will not implement for them and they will receive only routine nursing care during hemodialysis.
Category
Other
2
Description
After getting informed consent in test group, they will complete general health, life satisfaction and assessment form of Roy adaptation model questionnaires. Maladaptive behaviors and their stimuli extract and care-plan based on the Roy adaptation model will implemented for them. Finally, aforementioned questionnaires will complete for patients again.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan Kowsar Hospital
Full name of responsible person
Street address
Hemodialysis Department, Kowsar Hospital, Semnan
City
Semnan
2
Recruitment center
Name of recruitment center
Garmsar Emam Hospital
Full name of responsible person
Street address
Hemodialysis Department, Emam Hospital, Garmsar
City
Garmsar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidypour
Street address
Semnan University of Medical Sciences, Vice Chancellor of Research and Technology, Basidj Blv, Semnan, Iran
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing and Allied Health Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4299
Email
babamohamadi@semums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing and Allied Health Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4299
Email
babamohamadi@semums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing and Allied Health Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4299
Email
babamohamadi@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)