Determine the effect of the family-centered self-care education on functional independence and life satisfaction among community- dwelling elderly adults
Design
Randomized clinical trial,with parallel group with 126 patients,blinded,sealed boxes for concealment
Settings and conduct
The community of study is all the elderly who refer to Tehran health care home.After getting the permission from Tehran University of Medical Science dignity committee,the expert will introduce yourself.Afterwards, 126 of older adults who are eligible will be chosen.
Participants/Inclusion and exclusion criteria
The older adults who live with their wives or children, Not participating in same educational classes,The possibility of participating of family members in classes,The ability to speak farsi. Exclusion criteria: Participating in same educational classes.
Intervention groups
Intervention group:self care education in all domains based on family-centered empowerment theory.This intervention will be held in defined educational classes which making speech and discussion will be adopted.
Control group:In the end,in one educational session,they will be educated and a booklet will be provided.
Main outcome variables
Functional independence,Life satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200824048499N1
Registration date:2020-09-14, 1399/06/24
Registration timing:registered_while_recruiting
Last update:2020-09-14, 1399/06/24
Update count:0
Registration date
2020-09-14, 1399/06/24
Registrant information
Name
Tannaz MehrabMohseni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 0951
Email address
sh-pashaeipour@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-10, 1399/06/20
Expected recruitment end date
2020-10-11, 1399/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the family-centered self-care education on functional independence and life satisfaction among community- dwelling elderly adults
Public title
The effect of the family-centered self care education on independence and life satisfaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The older adults who live with wives or children
The possibility of participating of family members in classes
Exclusion criteria:
Participating in same educational classes
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
The samples should be allocated to intervention and control groups.(Each group contain 63 samples). The randomized allocation is like this;researcher assumes intervention group as A and parallel group as B. The elderly will be grouped in four blocks that each of them are paired (AA is defined intervention group and BB is defined for parallel group).
Then,will be divided in 6 forms;1-AABB,2-ABAB,3-ABBA,4-BABA,5-BBAA,6-ABBA.
If the number 4 is appeared on the dice,it will be recorded as BABA,or if the number 5 is shown,it will be written as BBAA. This action will be repeated till this sample will be completed.In order to conceal the allocation,sealed and vague boxes which have numbers,will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study,the participants are aware of the participation,drawbacks and benefits of this study.After filling informed consent form, The participants and their families will be blind toward randomized allocation.Moreover, the researcher and the one who collects and analyzes the data will be blind too.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No 1,Poursina St,Qods St,Enghelab St
City
Tehran
Province
Tehran
Postal code
1415665881
Approval date
2020-08-24, 1399/06/03
Ethics committee reference number
IR.TUMS.FNM.REC.1399.091
Health conditions studied
1
Description of health condition studied
Functional independence,Life satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Functional independence
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Katz questionnaire
2
Description
Life satisfaction
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Life satisfaction Index-z Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention contains self care education in all domains,(physical,mental,social and spiritual) which focus on healthy and active life style ,(appropriate physical exercise,diet,the total hours of sleep and the balance between sleep and rest,positive self imagination,overcome the ineffectiveness and hopelessness and taking apart in social activities.) This study is based on family centered method.The classes will be held once a week six times for 1.5 hours based on making a speech,question and answer and discussion in small groups with an emphasis on active family participation (Role model and sharing opinions and experiences).
Category
Lifestyle
2
Description
Control group:This group will not be deprived of any health care of center. In the end,in one educational session,they will be educated about self care and a booklet will be provided.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
South Tehran Health Centre
Full name of responsible person
Dr. Mohamadreza Salmani
Street address
No 1178,Jeyhoon Ave,Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6687 7803
Email
fnm@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohamadali Sahraian
Street address
6th Floor,Central Building,Qods St,Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Tannaz MehrabMohseni
Position
Master degree student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 51,Marjan Ave,Daemi St,Fatemi
City
Tehran
Province
Tehran
Postal code
1415665881
Phone
+98 21 8897 0951
Email
tanaz.mohseni95@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
TannazMehrabMohseni
Position
Master degree student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 51,Marjan Ave,Daemi St,Fatemi
City
Tehran
Province
Tehran
Postal code
1415665881
Phone
+98 21 8897 0951
Email
tanaz.mohseni95@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
TannazMehrabMohseni
Position
Master degree student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 51,Marjan Ave,Daemi St,Fatemi
City
Tehran
Province
Tehran
Postal code
1415665881
Phone
+98 21 8897 0951
Email
tanaz.mohseni95@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
The letter of consent and the detail can be shared.
When the data will become available and for how long
This will be available 3 months after release.
To whom data/document is available
Nurses and Medical science experts.
Under which criteria data/document could be used
There is no specific occasion for observing the data.
From where data/document is obtainable
The best way to contact will be sending e-mail to address below:
tanaz.mohseni95@gmail.com
What processes are involved for a request to access data/document
Whenever the e-mail has been seen,the request will be defined and the response will be sent as soon as possible.