Determining the impact of the training program of health volunteers to the ageing on ageing abuse
Design
A clinical trial study with a control group, with parallel groups, without blinding, randomized, on 80 ageing people, will use statistical consultant with SPSS software for randomization.
Settings and conduct
Education related to ageing abuse is first given by a researcher and nurse trained in this field to health volunteers in health community centers related to their field of activity, and then to health volunteers in comprehensive health centers related to the ageing themselves who have a history of elder abuse. They provide training in groups in two face-to-face sessions for one hour
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 60 years and older, understanding and speaking persian language, history or being subjected to elder abuse based on the score of the questionnaire (Vulnerability to Abuse Screening Scale (VASS-21), obtaining the score of cognitive ability based on the test Mental Status Assessment of Older Adults (Mini - Cog), obtaining individual independence score in the test (Activities of Daily Living (ADL).
Conditions of non-entry: Having a background of depression based on the test
Geriatric Depression Scale (GDS-15
Intervention groups
The intervention group includes elderly people who have a history of elder abuse, who receive the intervention of health liaison training on Ageing abuse.
The control group includes Ageing people who have a history of elder abuse who only receive routine training from community health centers and health liaisons.
Main outcome variables
Ageing Abuse
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191127045524N4
Registration date:2023-09-15, 1402/06/24
Registration timing:prospective
Last update:2023-09-15, 1402/06/24
Update count:0
Registration date
2023-09-15, 1402/06/24
Registrant information
Name
Amirheidar Bakhshiarab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3222 4816
Email address
bakhshiarab@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of the Training Program for Health Volunteers to the Ageing on Ageing Abuse: A Parallel Randomized Clinical Trial
Public title
The Effect of Training Health Volunteers on Ageing Abuse
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 years and older
understanding and speaking Persian language
history of or being abused by the elderly based on the Vulnerability to Abuse Screening Scale (VASS-21) questionnaire score
obtaining a cognitive ability score based on the Mental Status Assessment of Older Adults (Mini-Cog) test
obtaining an individual independence score on the Activities of Daily Living (ADL) test
Exclusion criteria:
Having a background of depression based on the Geriatric Depression Scale (GDS-15) test
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation sequence is obtained by the methodology consultant with the software. Eligible patients are registered by two people trained by the researcher. Allocation of participants to interventions is done by a trained nurse. In order to hide the random allocation, the names of the groups will be placed in a sealed envelope in the sequence of random allocation. Envelopes are numbered. People get a code in the order of their entry into the study, and an envelope is opened for each person and assigned to the desired group. It will be determined by SPSS software to create a random allocation sequence from the block method to quadruple volume. Patients will be selected based on the researcher's desired criteria and will be randomly placed in two groups A (test) and B (control group) based on the order determined by Spss software. The order of randomization will be done secretly; It means that there are 80 envelopes in the package, each of which contains code A and B. After obtaining informed consent and determining that the desired person participates in the study, the person trained by the researcher takes the desired envelope in the specified order and acts according to the group registered in the envelope.
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 in Research of Shahroud University of Medical Sciences
Street address
7th Square, Research and Technology, Shahroud University of Medical Science, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2023-09-04, 1402/06/13
Ethics committee reference number
IR.SHMU.REC.1402.080
Health conditions studied
1
Description of health condition studied
Ageing Abuse
ICD-10 code
Y07.9
ICD-10 code description
Unspecified perpetrator of maltreatment and neglect
Primary outcomes
1
Description
Investigation of Ageing Abuse with Vulnerability to Abuse Screening Scale (VASS-21) questionnaire
Timepoint
At the beginning of the study (before the intervention) and 4 weeks after the intervention
Method of measurement
The VASS-21Ageing Abuse Questionnaire and the cut point score of 3 and above indicates the potential risk of elder abuse.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first, related training such as the definition of ageing abuse, its recognition, its types, and prevention and notification strategies are given to the health volunteers by the researcher and a nurse trained by the researcher during a session, and then with the coordination of the health volunteers with During two face-to-face and group sessions for one hour, the elderly provide training on the issue of ageing abuse and its dimensions, as well as ways to prevent and report it. At the end of the second session, people will be given an educational pamphlet about ageing abuse. After selecting the people of the test group based on the entry criteria and obtaining informed consent, the trainings are conducted in the same comprehensive health service centers. Health volunteers in comprehensive health centers will talk to the ageing on a weekly basis through phone calls to investigate and answer their questions. After 4 weeks, the people of the test and control groups are again asked to be evaluated by a questionnaire related to ageing abuse.
Category
Other
2
Description
Control group: Ageing people who refer to community health centers receive care and routine training of the center.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers
Full name of responsible person
Amirheidar Bakhshiarab
Street address
7th Square, Research and Technology, Shahroud University of Medical Science, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3222 4816
Email
amirheidari770@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
7th Square, Research and Technology, Shahroud University Medical Science, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3222 4816
Email
amirheidari770@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Amirheidar Bakhshiarab
Position
Faculty of Shahroud University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
7th Square, Research and Technology, Shahroud University Medical Science, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3222 4816
Email
amirheidari770@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Amirheidar Bakhshiarab
Position
Faculty of Shahroud University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
7th Square, Research and Technology, Shahroud University Medical Science, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3222 4816
Email
amirheidari770@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Amirheidar Bakhshiarab
Position
Faculty of Shahroud University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
7th Square, Research and Technology, Shahroud University Medical Science, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3222 4816
Email
amirheidari770@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the patient's demographic information is shared after people have not been identified. All information related to measuring worry and blood pressure in patients can be shared after people have not been identified.
When the data will become available and for how long
Access starts 6 months after results are published
To whom data/document is available
Researchers and students of academic and scientific institutions
Under which criteria data/document could be used
Raw data for correlation studies
From where data/document is obtainable
amirheidari770@gmail.com
What processes are involved for a request to access data/document
Clear explanation of the reason for the need to access data and provide data after two weeks