Determining the effect of education based on health literacy index on self-care ability in the elderly
Design
In this study, 68 elderly people are selected according to the
Inclusion criteria that are coming to the neighborhood of the 6th district of Tehran.Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
The research area is located in District 6 of Tehran Municipality.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Being aged 60 to 70 years;Having reading and writing skills ;Not having vision, hearing and cognitive impairments with self-declaration ;Not having physical and motor limitation
;Not a member of the health team;The inadequacy of the health literacy level is lower than the 50th by adult health literacy questionnaire HELIA
exclusion criteria:
Do not want to continue studying ;Absence in two consecutive sessions;Acute physical and psychological problems
Intervention groups
First, the control group and then the intervention on separate days were invited to participate in the briefing. The intervention group received 6 one-hour training sessions with content of self-care ability based on the health literacy index published on the basis of the latest sources. The instruments used in this study were Adult Functional Health Literacy Questionnaire (TOFHLA) and researcher-made Self-care Questionnaire, completed by the subjects before and 8 weeks after completion of the intervention. The control group received routine trainings for neighborhood students.
Main outcome variables
Self-care status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170912036150N1
Registration date:2018-05-23, 1397/03/02
Registration timing:registered_while_recruiting
Last update:2018-05-23, 1397/03/02
Update count:0
Registration date
2018-05-23, 1397/03/02
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 436 5110
Email address
rashkih@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-25, 1397/02/05
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on Health Literacy INDEX on self-care ability in elderly people
Public title
The effect of education on self-care of the elderly
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being aged 60 to 70 years
Having reading and writing skills
Not having vision, hearing and cognitive impairments with self-declaration
Not having Physical and motor limitation
Not a member of the health team
The inadequacy of the health literacy level is lower than the 50th by adult health literacy questionnaire HELIA
Exclusion criteria:
Do not want to continue studying
Absence in two consecutive sessions
Acute physical and psychological problems
Age
From 60 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size of this study is 68, and according to inclusion and exclusion criteria they are divided to two groups: control (34)and intervention (34). The sampling method is Randomized block design. In this design, the samples are selected by random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only participants were unaware of the allocation of study groups, as the coupled days were allocated to the intervention group and the individual days for the control group.
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
Nosrat St, District 6, Tehran, Tehran Province,
City
Tehran
Province
Tehran
Postal code
کد پستی : 1419733171
Approval date
2017-09-06, 1396/06/15
Ethics committee reference number
IR.TUMS.FNM.REC.1396.3392
Health conditions studied
1
Description of health condition studied
self care
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
self care
Timepoint
At the beginning of the study and 8 weeks after the end of the intervention
Method of measurement
Self-care questionnaire in the elderly
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For intervention group six self-care educational sessions based on health literacy index will be held in the Mahalleh houses for 4 weeks. Each session will be last one hour
Category
Lifestyle
2
Description
Control group: Traditional education in neighborhood
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Neighborhoods HOUSE in Tehran Municipality 6th District
Full name of responsible person
Hossein Rashki Ghaleh No
Street address
Nosrat St, District 6, Tehran, Tehran Province,
City
Tehran
Province
Tehran
Postal code
1419733171صندوق پستی
Phone
+98 21 6692 6355
Email
rashkih@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mrs. Cardan
Street address
Nosrat St, District 6, Tehran, Tehran Province,
City
Tehran
Province
Tehran
Postal code
کد پستی : 1419733171
Phone
+98 21 6692 6355
Email
rashkih@razi.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
Hossein Rashki Ghaleh No
Position
Masters student Geriatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery Tehran University of Medical Sciences Nosrat St., Tohid Sq., 1419733171 Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4208
Email
rashkih@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahzad Pashaeypoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat St, District 6, Tehran, Tehran Province,
City
Tehran
Province
Tehran
Postal code
کد پستی : 1419733171
Phone
+98 21 6105 4208
Email
pashaeypoor.sh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Rashki Ghaleh No
Position
Masters student Geriatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery Tehran University of Medical Sciences Nosrat St., Tohid Sq., 1419733171 Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4208
Email
rashkih@razi.tums.ac.ir
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