Evaluation of the effect of self-management strategies training on life management skills and resilience in community-dwelling older adults
Design
Elders aged 60 and older eligible to participate, will randomly be assigned to one of the two intervention and control groups using the random numbers table. The sample size is estimated 60. The study will be double blind. Sampling in both intervention and control groups and interventions are carried out simultaneously and in parallel.
Settings and conduct
Setting of the study is Fatemeh College of Nursing. Participants in the intervention group participate in 16 sessions of the 90-minute self management education program. Participants in the control group do not receive intervention. The outcome assessor, data analyzer, and participants will be blinded to the randomization status.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged 60 year-old and older; Willingness to participate in the study. Exclusion criteria: Having reading and writing skills in Persian.
Intervention groups
Intervention group: Participants in the experimental group will participate in 8 90_minute sessions of self management education program that will be held twice a week.The first session will be devoted to the introduction and completion of questionnaires and the purpose of the study and the rules of the group. Next sessions are dedicated to self management education components. Control group: There is no intervention to participants in control group. The data from this group will be collected only for comparison with the intervention group.
Main outcome variables
Life management score; Resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120312009267N6
Registration date:2018-12-01, 1397/09/10
Registration timing:prospective
Last update:2018-12-01, 1397/09/10
Update count:0
Registration date
2018-12-01, 1397/09/10
Registrant information
Name
Giti Setoodeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
setoodeh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-20, 1398/01/31
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of self-management strategies training on life management skills and resilience in community-dwelling older adults
Public title
Effect of self-management strategies training on life management skills and resilience
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 60 year-old and older
Willingness to participate in the study
Having reading and writing skills in Persian
Exclusion criteria:
Mental and cognitive impairment
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will randomly assign to one of the two intervention and control groups with the help of a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are unaware of which groups they are allocated to. The research assistant will randomly divide the participants into the two groups; therefore, he is aware of the status of the participants. But the outcome assessor and data analyser are blinded to the randomization status.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Ethics Committee of Shiraz University of Medical Sciences, 7th floor, Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2018-09-11, 1397/06/20
Ethics committee reference number
IR.SUMS.REC.1397.656
Health conditions studied
1
Description of health condition studied
Life management
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Resilience
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Life management score in the Baltes' Selection, Optimization and Compensation questionnaire
Timepoint
Before intervention and 1 month after intervention
Method of measurement
Baltes' Selection, Optimization and Compensation questionnaire
2
Description
Resilience score on the Cannar-Davidson Resilience Scale
Timepoint
Before intervention and 1 month after intervention
Method of measurement
Cannar-Davidson Resilience Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in the experimental group will participate in 8 90_minute sessions of self management education program that will be held twice a week.The first session will be devoted to the introduction and completion of questionnaires and the purpose of the study and the rules of the group. Next sessions will be focused on self management components.
Category
N/A
2
Description
Control group: There is no intervention to participants in control group. The data from this group will be collected only for comparison with the intervention group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Senior Centers
Full name of responsible person
Giti Setoodeh
Street address
Shiraz Senior Centers, Kholdebarin Park, Besat Blvd.
City
Shiraz
Province
Fars
Postal code
7174775741
Phone
+98 71 3647 5010
Email
site@halyzendegy.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yunes Ghasemi
Street address
Research Deputy of Shiraz University of Medical Sciences, 7th floor, Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
ghasemiy@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
Giti Setoodeh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Room 57, Fatemeh College of Nursing & Midwifery, Namazi Square
City
Shiraz
Province
Fars
Postal code
7193666877
Phone
+98 71 3627 9983
Email
setoodeh@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Giti Setoodeh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Room 57, Fatemeh College of Nursing & Midwifery, Namazi Square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Email
setoodeh@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Giti Setoodeh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Room 57, Fatemeh College of Nursing & Midwifery, Namazi Square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Email
setoodeh@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only the main outcome data can be published.
When the data will become available and for how long
Access since 2021
To whom data/document is available
All health care researchers
Under which criteria data/document could be used
Use of data is permitted exclusively in scientific research.
From where data/document is obtainable
The responsible for the project must send an application to setoodeh@sums.ac.ir.
What processes are involved for a request to access data/document
The data will be submitted no later than 2 weeks after receiving the email.