Designing, Implementing And Evaluating An Intervention Program To Improve The Behavior Of Using Rehabilitation Tools And Assistive Technologies And Functional Independence In The Elderly
Determining the effect of an intervention program to improve the behavior of using rehabilitation tools and assistive technologies and functional independence in the elderly.
Design
The clinical trial is a randomized controlled trial and was divided into two control groups and an intervention group, the randomization is based on the table of random numbers and the sample size in this study is 90 elderly people. Blinding was not done in this study.
Settings and conduct
The elderly referring to comprehensive health service centers in Hamedan city will receive the appropriate educational program in two groups of 45 people in a simple random manner.
Participants/Inclusion and exclusion criteria
inclusion criteria
1- elderly 60 years and older who have absolute or relative functional dependence in the descriptive-analytical stage
2- In case of non-communicable diseases, their disease should be under control
3- obtaining informed consent and willingness to cooperate in order to participate in the study
4- elderly whose information is registered in Sib system
5- Having at least basic literacy to answer the questions
6- Cognitive abilities (getting a score of 6 or higher in the Persian version of the short test of the cognitive status of the elderly)
exclusion criteria
Lack of cognitive abilities
Suffering from uncontrolled non-communicable diseases
Independent elderly
Intervention groups
This study includes an educational intervention program in the intervention group and this intervention program was designed to improve the behaviors of using rehabilitation tools and assistive technologies and functional independence in the elderly.
In the control group, there is no educational intervention program and this group only receives their routine training.
Main outcome variables
Improving the behavior of using rehabilitation tools and technologies
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220727055568N1
Registration date:2022-10-16, 1401/07/24
Registration timing:registered_while_recruiting
Last update:2022-10-16, 1401/07/24
Update count:0
Registration date
2022-10-16, 1401/07/24
Registrant information
Name
fataneh goodarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0063
Email address
f.goodarzi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing, Implementing And Evaluating An Intervention Program To Improve The Behavior Of Using Rehabilitation Tools And Assistive Technologies And Functional Independence In The Elderly
Public title
The Behavior Of Using Rehabilitation Tools And Assistive Technologies
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly 60 Year-Old Dependent And Semi-Dependent
In Case Of Non-Communicable Diseases, Their Disease Should Be Under Control
Obtaining Informed Consent And Willingness To Cooperate In Order To Participate In The Study
Elderly Whose Information Is Registered In Sib System
Having At Least Basic Literacy To Answer The Questions
Cognitive Abilities
Exclusion criteria:
Lack Of Cognitive Abilities
Suffering From Uncontrolled Non-Communicable Diseases
Independent Elderly
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
45
-
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible elderly who had moderate and severe level of functional status will assign to the intervention (n=45) and control (n=45) groups using a permuted block randomization with block sizes of 6. The block randomization list of the trial will generate using following website;
https://www.sealedenvelope.com/simple-randomiser/v1/lists
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences School
City
Hamadan
Province
Hamadan
Postal code
6517838687
Approval date
2022-07-06, 1401/04/15
Ethics committee reference number
IR.UMSHA.REC.1401.527
Health conditions studied
1
Description of health condition studied
Maintaining and promoting functional independence in the elderly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Improving the behavior of using technologies and services for rehabilitation
Timepoint
The outcome of interest would be evaluated in the baseline and 3 months after the intervention
Method of measurement
The questionnaires for evaluating behavior and use of technologies for rehabilitation will be completed by trained researchers in both groups before and 3 months after completion of the intervention.
Secondary outcomes
1
Description
Functional Independence
Timepoint
Before The Intervention And After The Intervention
Method of measurement
Functional Independence Questionnaire
Intervention groups
1
Description
Teaching the elderly about the acceptance and behavior of using rehabilitation assistive technologies will be based on the final structures of the model and on the basis of changes in the structures of the model. The educational content includes the introduction of assistive technologies and the advantages of using them (improving performance, reducing personal assistance, knowing the types of assistive technologies, improving the quality of life, reducing disability, overcoming injuries, promoting functional independence), providing an introduction to technology. rehabilitation aids and provide training on how to choose the appropriate rehabilitation assistive technologies. Then, in the follow-up phase, after the completion of the educational intervention, in order to remind the training given during the intervention period, a suitable educational message will be sent to the intervention group daily for one month through the formation of a group on social networks. The other intervention is in the form of a home visit, so that at this stage, the participants of the intervention group, in terms of the need to use rehabilitation assistive technologies, once before the intervention and once after the intervention through a home visit by the researcher, based on the checklist. Home visits (environmental checklist) are evaluated. Then the necessary training is given on encouraging the use of rehabilitation assistive technologies with an emphasis on cheap environmental modifications that suit the needs of the elderly.
Category
Behavior
2
Description
The controls will receive only usual care and not educational Intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health service centers
Full name of responsible person
Majid Barati
Street address
Hamadan University of Medical Sciences School
City
Hamadan
Province
Hamadan
Postal code
6517838687
Phone
+98 81 3838 0063
Email
majid.barati59@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Majid Barati
Street address
Hamadan University of Medical Sciences School
City
Hamadan
Province
Hamadan
Postal code
6517838687
Phone
+98 81 3838 0063
Email
m_baratimehr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Majid Barati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hamadan University of Medical Sciences School
City
Hamadan
Province
Hamadan
Postal code
6517838687
Phone
+98 81 3838 0063
Email
barati@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Majid Barati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hamadan University of Medical Sciences School
City
Hamadan
Province
Hamadan
Postal code
6517838687
Phone
+98 81 3838 0063
Email
majid.barati59@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fataneh Goodarzi
Position
University student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hamadan University of Medical Sciences School
City
Hamadan
Province
Hamadan
Postal code
6517838687
Phone
+98 81 3838 0063
Email
fataneh.goodarzi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
No - There is not 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
SPSS file data can be shared
When the data will become available and for how long
After printing the article
To whom data/document is available
The data will be available to researchers
Under which criteria data/document could be used
It can be used for secondary studies
From where data/document is obtainable
Correspond with fataneh.goodarzi@gmail.com
What processes are involved for a request to access data/document