Protocol summary

Study aim
Determining the application of the theory of planned behavior in the preventive behaviors of knee arthritis (weight control, diet improvement, blood sugar control, exercise and smoking cessation) in the rural elderly of Bushehr province in 2022
Design
This clinical trial was designed as a single-group screening of 100 elderly people with osteoarthritis of the knee who were selected by random cluster sampling. They will be examined after three months of educational intervention.
Settings and conduct
This trial was conducted among the elderly over 60 years of age covered by the health services of the rural health centers of Bushehr province through random cluster sampling of 100 people. By referring to their homes, they first completed the questionnaire, then completed the training course designed for the intervention, and then again after three months. The questionnaire is completed for them. This intervention is a single group.
Participants/Inclusion and exclusion criteria
The inclusion criteria include age over 60 years, absence of cognitive (dementia and Alzheimer's) and mental disorders, willingness to participate in the study, and we will also examine patients with arthritis who have knee arthritis; For them, it has been diagnosed by a rheumatology specialist.The elderly who did not want to participate in the study and had cognitive and mental disorders were excluded from the study.
Intervention groups
A number of 100 elderly people over 60 years old with knee osteoarthritis based on the theory of planned behavior were subjected to educational intervention to increase the preventive behaviors of the subsequent complications of the disease.
Main outcome variables
attitude score; abstract norms; perceived behavior control; behavioral intention; preventive behaviors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221206056722N1
Registration date: 2022-12-12, 1401/09/21
Registration timing: prospective

Last update: 2022-12-12, 1401/09/21
Update count: 0
Registration date
2022-12-12, 1401/09/21
Registrant information
Name
Sara Alamdarbushehri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
saraalamdarbushehri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-26, 1401/10/05
Expected recruitment end date
2023-03-25, 1402/01/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on the theory of planned behavior on the increase of preventive behaviors of knee osteoarthritis in the elderly.
Public title
Investigating the effect of educational intervention based on the theory of planned behavior on increasing preventive behaviors of knee osteoarthritis complications in the elderly
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years Not having cognitive disorders (dementia and Alzheimer's) Definite diagnosis of osteoarthritis of the knee by a specialist Not having mental disorders
Exclusion criteria:
Reluctance to participate in the study
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand Ave.Shiraz University of Medical Sciences.Shiraz.Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-09-10, 1401/06/19
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1401.081

Health conditions studied

1

Description of health condition studied
KNEE OSTEOARTHRITIS
ICD-10 code
M17.0
ICD-10 code description
Bilateral primary osteoarthritis of knee

Primary outcomes

1

Description
Weight
Timepoint
The first day and three months after the educational intervention
Method of measurement
Theory of planned behavior questionnaire

2

Description
The rate of change in diet
Timepoint
The first day and three months after the educational intervention
Method of measurement
Theory of planned behavior questionnaire

Secondary outcomes

1

Description
Change in smoking
Timepoint
The first day and three months after the educational intervention
Method of measurement
Theory of planned behavior questionnaire

2

Description
Change in sports program
Timepoint
The first day and three months after the educational intervention
Method of measurement
Theory of planned behavior questionnaire

Intervention groups

1

Description
Intervention group: This clinical trial has an intervention group, 100 elderly people with osteoarthritis of the knee who were selected by random cluster sampling method. In the first round, after collecting and analyzing the data, with the cooperation of education specialists Health, Rheumatology and Physiotherapy educational program (2 workshops for 12 hours) will be designed and implemented to improve behavior. Educational program using lectures and questions and answers (two sessions of 45 minutes), educational film (two sessions of 20 minutes), practical demonstration (40 minutes), group discussion (two sessions of 30 minutes) and educational aids including pamphlets in 2 sessions of the educational workshop. It will be provided by rheumatology and physiotherapy specialists, who will be evaluated after three months of educational intervention
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rural health care centers of Bushehr province
Full name of responsible person
Hamid Habibinia
Street address
Valfajr Ave.Center Health Boushehr.Bushehr.Iran
City
Boushehr
Province
Boushehr
Postal code
7517685847
Phone
+98 77 3366 2516
Email
saraalamdarbushehri@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vahid Hossaini
Street address
Zand Ave-Shiraz university of medical sciences-Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 2559
Email
President_d@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Alamdarbushehri
Position
Univercity Student
Latest degree
Bachelor
Other areas of specialty/work
Family Health
Street address
Zand Ave-Shiraz university of medical sciences-Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 2559
Email
saraalamdarbushehri@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Alamdarbushehri
Position
Univercity Student
Latest degree
Bachelor
Other areas of specialty/work
Family Health
Street address
ZAND Ave-Shiraz university of medical sciences-Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
71348143336
Phone
+98 71 3235 2559
Email
saraalamdarbushehri@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Alamdarbushehri
Position
Univercity Student
Latest degree
Bachelor
Other areas of specialty/work
Family Health
Street address
ZAND Ave-Shiraz university of medical sciences-Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 2559
Email
saraalamdarbushehri@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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