Determining the effect of health promotion training program on active aging in the elderly referring to health centers
Design
Superiority clinical trial with control group, with parallel group with blinded outcome assessment, randomized, on 60 elderly people referring to health center number one in Mashhad. The allocation will be random and block-type; In this way, first six blocks of four will be formed and then a lottery will be held once to arrange the blocks, and then the elderly will enter the intervention or control groups based on the codes of the blocks. Obviously, all six quadruple blocks will include 24 research units, so when the six blocks are completed, sampling will repeat the same six blocks until all units enter the research and sampling is completed.
Settings and conduct
The study population is the elderly referring to health centers number one in Mashhad.
Participants/Inclusion and exclusion criteria
1-Age over 60 years
2-Not having a debilitating disease
3. Having a file in the health center
Intervention groups
The health promotion program will be implemented in 6 sessions for the intervention group. Meetings are held at the Health Center - Park - Holy Shrine - Torqabeh or Shandiz, and the elderly will have a group discussion about the six dimensions of health-promoting behaviors and will share experiences. In addition, the training will take place in environments other than the health center. The control group will receive routine training, including integrated geriatric care, during this period. In addition, a summary of the training will be provided to the control group by the researcher during a lecture session.
Main outcome variables
Active Aging
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210308050639N1
Registration date:2021-08-21, 1400/05/30
Registration timing:prospective
Last update:2021-08-21, 1400/05/30
Update count:0
Registration date
2021-08-21, 1400/05/30
Registrant information
Name
Seyedeh Reyhane Davoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3224 7502
Email address
davoudir982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-16, 1400/06/25
Expected recruitment end date
2021-10-17, 1400/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an educational health promotion program on active aging in the elderly referring to health centers
Public title
The effect of an educational health promotion program on active aging in the elderly referring to health centers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Not having a debilitating disease
Having a file in the health center
Exclusion criteria:
Being too old like age over 80 years
Having a debilitating disease
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation and block type
Regarding the type of allocation of the elderly to the two groups, considering that the probability of information leakage between the elderly in this type; in this way, first six quadruple blocks will be formed and then a lottery will be held once to arrange the blocks, and then the elderly will enter the intervention or control groups based on the block codes. Obviously, all six quadruple blocks will include 24 research units, so when the six blocks are completed, sampling will repeat the same six blocks until all units enter the research and sampling is completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer goes blind so that the data he is analyzing does not know which group the data belongs to.
Placebo
Not used
Assignment
Parallel
Other design features
Unlike previous studies that have taught health-promoting behaviors in health centers, this study aims to teach these behaviors in cultural and recreational settings.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences., University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-06-15, 1400/03/25
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.034
Health conditions studied
1
Description of health condition studied
Active Aging
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Active aging
Timepoint
Assessment of active aging in the elderly is performed twice at the beginning of the study and before the intervention and the second time one month after the intervention.
Method of measurement
In the study of "The effect of health promotion program on the active aging of the elderly referring to health centers" the method of measuring the variable of active aging in the elderly, is the " MOHAMMDI et al. Active aging Questionnaire ".
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The health promotion program will be implemented in 6 sessions for the intervention group. The method of execution is as follows that first session will be discussed about nutrition and its role in the health of the elderly. The second session will be held in the park and along with the elderly walk, they will discuss physical activity and its role in old age. The third session will be held at the health center and will be discussed the impact of health responsibility on the elderly. The fourth session will be held in the park and in addition to walking, the elderly will perform appropriate exercises and they talk about stress and how to manage it and use each other's experiences. The fifth session will held in the park and will be presented the importance of communication and role-playing such as caring for grandchildren, etc. to the elderly and the last session will be held in the holy shrine or mosque and will discuss the impact of spiritual issues on the health of the elderly.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad number one health center
Full name of responsible person
Seyede reyhane Davoudi
Street address
between 66 and 60 Vakil Abad, Vakil Abad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3501 8011
Email
pr@mums.ac.ir.hc:
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zendetalab Hamid Reza
Street address
School of Nursing and Midwifery, Ibn Sinai St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
NMS.IT@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Zendehtalab
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sinai St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
zendehtalabhr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Zendehtalab
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sinai St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
zendehtalabhr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Zendehtalab
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sinai St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
zendehtalabhr@mums.ac.ir
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
No - There is not 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
Some data, such as information on active aging, can be shared.
When the data will become available and for how long
Access period starts 3 months after the results are published
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
If our data is used in other studies, it must be referenced.