Investigating the effect of empowerment interventions based on Pender's health promotion model in adopting a healthy lifestyle and self-efficacy of the elderly
Determining the effect of empowerment interventions based on the Pender health promotion model in adopting a healthy lifestyle and self-efficacy of the elderly
Design
A randomized controlled clinical trial on 70 elderly people
Settings and conduct
The study will be conducted on the elderly of Kermanshah city, and first two centers will be selected among the available health centers of Kermanshah city. After reviewing the case of the elderly, the elderly will be contacted and 70 people will be randomly selected. The intervention sessions will be conducted in the form of 6 group discussion sessions and 2 training sessions on their families in selected health centers.
Participants/Inclusion and exclusion criteria
The Inclusion criteria of the research include: having the ability to perform daily life activities, not suffering from severe diseases, interest in participating in the intervention.
Exclusion criteria include: admission to hospital, withdrawal from intervention and emigration from Kermanshah city
Intervention groups
The intervention group includes elderly people over 60 years old who receive the educational intervention.
The comparison group includes elderly people over 60 years old who do not receive any intervention.
Main outcome variables
Healthy lifestyle and self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230715058786N1
Registration date:2023-11-17, 1402/08/26
Registration timing:registered_while_recruiting
Last update:2023-11-17, 1402/08/26
Update count:0
Registration date
2023-11-17, 1402/08/26
Registrant information
Name
Mohsen Kazeminia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 4227 2023
Email address
mkazeminia69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of empowerment interventions based on Pender's health promotion model in adopting a healthy lifestyle and self-efficacy of the elderly
Public title
Empowering the elderly to adopt a healthy lifestyle and self-efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Interested in participating in the study
Full consciousness
Having the ability to perform activities of daily living
Not suffering from severe psychiatric diseases (such as Alzheimer's and dementia)
Not having serious emergency conditions
Not having hearing, vision and movement limitations
Living in Kermanshah for more than five years
Exclusion criteria:
being admitted to the hospital
Absence of more than three sessions in intervention sessions
Refusal to continue the intervention
Migration from Kermanshah city
Age
From 60 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization To apply randomization, the method of random blocks will be used with blocks of size four. The randomization unit will be individual. According to the sample size of 60 people, 24 quadruple blocks according to the statification factors including gender (male and female), age (less than 75 and 75 years and more) and literacy level (below diploma, diploma and above) using An online site (www.sealedenvelope.com) will be developed. Each sample is assigned a number that the researchers do not know about.For concealment, random allocation concealment will be used, which refers to the method used to implement a random sequence in the participants, so that the participant is unaware of his allocation in the study groups. For this purpose, based on the sequence created in the randomization software, each of the created sequences is recorded on a card, and the cards are placed inside sealed opaque envelopes, and to maintain the sequence on the outer surface of the envelopes, no. Placement is done in the same order. The lids of the envelopes are glued and placed in a box. Based on the order of entry of eligible participants to the study, the envelopes will be opened in order and the participant group will be revealed.
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 Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd., Medical Sciences Building No. 2
City
kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2023-07-16, 1402/04/25
Ethics committee reference number
IR.KUMS.REC.1402.145
Health conditions studied
1
Description of health condition studied
the old age
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Healthy lifestyle
Timepoint
Before and after the intervention
Method of measurement
Healthy lifestyle questionnaire
2
Description
Efficacy
Timepoint
Before and after the intervention
Method of measurement
Sharr self-efficacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The interventions will be focused on disease prevention behaviors, healthy nutritional behaviors, physical activity, stress management, and building healthy relationships with family, friends, and neighbors, and in the form of six educational intervention sessions for the elderly and the use of self-efficacy strategies, including taking steps to The behavior step and mastering the behavior, the use of verbal encouragement after the development of the desired behavior and the use of successful models of the elderly for behavioral modeling will be done. In addition, two educational intervention sessions will be held with their families. Pamphlets and educational videos will be used for training. Therefore, the content of the interventions is as follows: six training sessions based on Pender's health promotion model (one 2-hour session per week); The first session: teaching the patterns and behaviors of appropriate and adequate nutrition for the elderly, trying to change attitudes and health beliefs and convincing the people of the test group in terms of unhealthy nutritional habits in life, the second session: teaching the patterns and physical and sports activities appropriate for the elderly, increasing the sense of Self-efficacy, trying to change attitudes and health beliefs and convincing the people of the test group to physical activities suitable for the elderly, the third session: teaching the concept of communication, verbal and non-verbal communication methods, teaching problem solving style and conflict in social interactions and personal life of the elderly, session Fourth: Defining self-efficacy, teaching concepts and ways to increase the growth of self-efficacy in the elderly, helping the elderly in identifying and distinguishing between primary and secondary basic needs and valuing personal life priorities and goals, fifth session: Teaching concepts and ways to increase support in interpersonal relationships , paying attention to the present time and using 24 hours of daily life, teaching concepts and ways to increase responsibility in the field of healthy lifestyle in old age and the sixth session: teaching concepts of stress and ways to deal with it, identifying stressful life factors and learning emotional management techniques , the implementation of the post-exam stage. Also, two group discussion sessions with the families of the elderly (the first session: training on the effectiveness of implementing healthy lifestyle programs for the elderly at low risk of disease and the second session: training on increasing self-care of the elderly and having an active and healthy elderly) as well as presenting educational videos and pamphlets for the benefits It is understood that healthy behaviors are performed in the elderly.
Category
Lifestyle
2
Description
Control group: They did not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Mohsen Kazeminia
Street address
Habib Vand village
City
Sare-Pole-Zahab
Province
Kermanshah
Postal code
6775139177
Phone
+98 83 4227 2023
Email
mkazeminia69@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Cyrus Jalili
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Fax
+98 83 3838 6835
Email
research_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohsen Kaziminia
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Habib Vand village
City
Sare-Pole-Zahab
Province
Kermanshah
Postal code
6775139177
Phone
+98 83 4227 2023
Email
mkazeminia69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Jalali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nobahar
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
a_jalali@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohsen Kaziminia
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Habib Vand village
City
Sare-Pole- Zahab
Province
Kermanshah
Postal code
6775139177
Phone
+98 83 4227 2023
Email
mkazeminia69@gmail.com
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
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
Only a part of the data, such as the information related to the main outcome or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
All people
Under which criteria data/document could be used
For health research purposes
From where data/document is obtainable
Mohsen Kaziminia
What processes are involved for a request to access data/document