This research is a clinical trail study with two groups of experimental and control. The samples of 60 patients with moderate severity of rheumatoid arthritis in accordance with the American College of Rheumatology criteria which was confirmed by physician specialists and using the DAS28 for measuring the severity of rheumatoid arthritis.sampling method was convenience sampling and Assignment of samples in groups was random allocation.(30 patient in both intervention and control group).Information collecting tools were demographic information, pain, Performance and Satisfaction in activities of daily living scale. Method in this study hold 4 training sessions in two system of supportive educative and partly compensatory system according to questionnaire for need assessment based on Orem's Self-Care model, which was used in the test group, while the control group did not receive any intervention. Data from pain and activity daily living scale, were collected in three phases, first; before the intervention, second; one month after intervention and third; three months after intervention in test and control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014052517840N1
Registration date:2015-05-24, 1394/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-24, 1394/03/03
Registrant information
Name
Elahe sadat Saeedifar
Name of organization / entity
Tarbiat modares
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3554
Email address
elahe.saeedifar@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tarbiat Modares university
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the applying orem self-care model on level of activity daily living and pain in arthritis rheumatoid patient.
Public title
Applying model on level of activity daily living and pain in arthritis rheumatoid patient.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:60 patients with moderate severity of rheumatoid arthritis in accordance with the American College of Rheumatology criteria which was confirmed by physician specialists and using the DAS28 for measuring the severity of rheumatoid arthritis;the aged range between 20-60;At least Literacy
Exclusion criteria:In medical history, a history of cognitive problems such as dementia, psychosis, mental retardation؛ underlying diseases and disorders that are organic noticeable impact on performance.
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Tarbiat Modares University
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway, Nasr (Gisha) Bridge, Tehran, Iran
City
Tehran
Postal code
111-14115
Approval date
2013-10-27, 1392/08/05
Ethics committee reference number
52/4671د
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
Mo6.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
pain
Timepoint
before the intervention, second; one month after intervention and third; three months after intervention
Method of measurement
Numeric pain scale
2
Description
Activities of daily living
Timepoint
before the intervention, second; one month after intervention and third; three months after intervention.
Method of measurement
performance and satisfaction of Activities of daily living scale in Arthritis rheumatoid patient
Secondary outcomes
1
Description
Stress, anxiety and depression
Timepoint
before the intervention, second; one month after intervention and third; three months after intervention
Method of measurement
DASS-21 scale
2
Description
Quality of life
Timepoint
before the intervention, second?; one month after intervention and third?; three months after intervention
Method of measurement
Quality of Life Questionnaire SF36
Intervention groups
1
Description
Intervention group:Method in this study hold 4 training sessions in two system of supportive educative and partly compensatory system according to questionnaire for need assessment based on Orem's Self-Care model, which was used in the test group.
Category
Behavior
2
Description
Control group :This group did not receive any intervention and Just act according to their doctor's orders. Data from pain and activity daily living scale, were collected in three phases, first; before the intervention, second; one month after intervention and third; three months after intervention in test and control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of rheumatology
Full name of responsible person
Dr.Mohsen Ahkyani
Street address
Doctors Building 110,Beheshti street,shohada square,karaj.
City
karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tarbiat Modares University
Full name of responsible person
Saeed Mousavian
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway, Nasr (Gisha) Bridge, Tehran, Iran 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 of Tarbiat Modares University
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
Tarbiat Modares university
Full name of responsible person
Elahe Sadat saeedifar
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway, Nasr (Gisha) Bridge, Tehran, Iran
City
Tehran
Postal code
Phone
+98 936 606 8600
Fax
Email
elahe.saeedifar@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Robabe Memarian
Position
PhD in Nursing/Assistant Professor
Other areas of specialty/work
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway, Nasr (Gisha) Bridge, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8288 3554
Fax
Email
Memari_r@modares.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Elahe Sadat Saeedifar
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Nasr (Gisha) Bridge, Jalal Ale Ahmad Highway, Tehran, Iran, Tarbiat Modares University, Medical Scie
City
Tehran
Postal code
Phone
+98 26 3226 1141
Fax
Email
Elahe.saeedifar@Modares.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)