Protocol summary

Summary
The purpose of this study is the effect of "Chronic Disease Self-management Program" on Self efficacy skill, Depression, Compatibility with pain and Mobility in Rheumatoid arthritis patients. This study is an interventional study. Participants will be selected from Rheumatoid arthritis patients. The main inclusion criteria is Tabriz elderly resident suffering from rheumatoid arthritis and has a medical record at the Golgashte clinic and exclusion criteria include Elderly people who are suffering from cognitive disorders, Elderly people who are not able to attending meetings according to diagnosed by specialists, Elderly people who diseases's pattern or manage will change during the project. The sample size was obtained 40 persons for each group. After selecting the intervention and control groups, the data will be collected in two stages: The first phase of data collection will be before the intervention and the second stage 1 month after the intervention. Data will be collected using a questionnaire. In the stage before the intervention, the per-test will be done in both intervention and control groups ,and after holding training classes for the intervention group 1 session per week for 6 weeks the post-test will be done in both intervention and control groups. Outcomes of the study are Self efficacy Skill, Depression, Compatibility with pain and Mobility in Rheumatoid arthritis patients, before and after training.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015122425685N1
Registration date: 2016-02-01, 1394/11/12
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-02-01, 1394/11/12
Registrant information
Name
Nayer Anvar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3667 2380
Email address
majid.yousefi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectivness of "Chronic Disease Self-management Program" on reducing arthritis symptoms amongst elder women
Public title
The effect of self management program on elderly women with rheumatoid arthritis
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria: Elderly people with rheumatoid arthritis that live in Tabriz and has a medical record at the Golgashte clinic. The exclusion criteria: Elderly people who are suffering from cognitive disorders, Elderly people who are not able to attending meetings according to diagnosed by specialists, Elderly people who diseases's pattern or manage will change during the project.
Age
From 36 years old to 139 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Tabriz University of Medical Sciences
Street address
Ethics Committee, Third Floor, Central Building 2, Tabriz University of Medical Science, Golgashte street, Tabriz
City
Tabriz
Postal code
Approval date
2015-12-07, 1394/09/16
Ethics committee reference number
TBZMED.REC.1394.815

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
(M05, M06
ICD-10 code description
Seropositive rheumatoid arthritis-Other rheumatoid arthritis

Primary outcomes

1

Description
Self Management
Timepoint
Before the intervention and 1 month after interventio
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Self efficacy Skill
Timepoint
Before the intervention and 1 month after intervention
Method of measurement
Questionnaire

2

Description
Depression
Timepoint
Before the intervention and 1 month after intervention
Method of measurement
Questionnaire

3

Description
Mobility
Timepoint
Before the intervention and 1 month after intervention
Method of measurement
Questionnaire

4

Description
Compatibility with pain
Timepoint
Before the intervention and 1 month after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
The Intervention group: In this study the intervention will be holding the training sessions.
Category
Behavior

2

Description
The control group: Training in control groups is not but after the end of data collection in the end of study, educational pamphlets will be given to the control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Golgashte Clinic
Full name of responsible person
Anvar Nayer
Street address
Azadi Street, Tee Golgashte, Golgashte Clinic
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad-Reza Rashidi
Street address
Deputy for Research and Technology, Third Floor, Central Building 2, Tabriz University of Medical Sciences, Golgashte Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Nayer Anvar
Position
Geriatrics Health Student
Other areas of specialty/work
Street address
Department of Health Promotion and Education, Faculty of Health and Nutrition, Golgashte Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3667 2380
Fax
Email
majid.yousefi@ut.ac.iranvar.n60@gmail.comhm1349@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nayer Anvar
Position
Geriatrics Health Student
Other areas of specialty/work
Street address
Department of Health Promotion and Education, Faculty of Health and Nutrition, Golgashte Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3667 2380
Fax
Email
hm1349@gmail.com anvar.n60@gmail.com majid.yousefi@ut.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nayer Anvar
Position
Geriatrics Health Student
Other areas of specialty/work
Street address
Golgashte Street, Attar Street, Faculty of Health, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3667 2380
Fax
Email
anvar.n60@gmail.commajid.yousefi@ut.ac.irhm1349@gmail.comhm1349@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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