Determining the impact of empowerment training on the quality of life of the elderly with type 2 diabetes
Design
It is a randomized clinical trial with a control group on 90 elderly patients with type 2 diabetes. Blocking of four is used for randomization.
Settings and conduct
The research population includes elderly people with type 2 diabetes who referred to the endocrinology clinic of ValiAsr Hospital in Qaem Shahr city and their disease was confirmed by a specialist doctor, and they have a medical record. Sampling is done in a convenience way. Blinding was done in such a way that the person who gives the questionnaires to the participants and the statistician during the data analysis do not know which is the intervention group and which is the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 60 years
Willingness to participate in the study
Ability to speak and communicate
Obtaining a score of 7-10 according to the short mental test questionnaire (AMT)
Obtaining a score of 11-14 according to the Instrumental Activities of Daily Living (IADL) questionnaire
Obtaining a score of 15-45 according to the quality of life questionnaire of diabetes patients (DQoL)
Exclusion criteria:
Having mental illness
Participating in courses and educational classes about diabetes in the last 6 months
Intervention groups
Before the intervention, they will complete the diabetic quality of life questionnaire. In addition to the previous treatments, the patients in the intervention group will participate in empowerment sessions. The sessions will last for one month and two sessions per week (8 sessions in total) and each session will last for 45. The method of implementing the empowerment program in this research is based on Anderson's empowerment program, which is implemented through speaking and giving pamphlets.
Main outcome variables
Quality of life of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180609040020N2
Registration date:2023-09-12, 1402/06/21
Registration timing:retrospective
Last update:2023-09-12, 1402/06/21
Update count:0
Registration date
2023-09-12, 1402/06/21
Registrant information
Name
Ali Hesamzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
a.hesamzadeh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-11, 1399/10/22
Expected recruitment end date
2021-06-12, 1400/03/22
Actual recruitment start date
2022-03-21, 1401/01/01
Actual recruitment end date
2023-02-20, 1401/12/01
Trial completion date
2023-03-11, 1401/12/20
Scientific title
Investigating the impact of empowerment program on the quality of life of elderly people with Diabetes type 2
Public title
Investigating the impact of empowerment program on the quality of life of elderly people with Diabetes type 2
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years
Willingness to participate in the study
Ability to speak and communicate
Being under the care and treatment of a doctor or a medical group
Obtaining a score of 7-10 according to the short mental test questionnaire (AMT)
Obtaining a score of 11-14 according to the Instrumental Activities of Daily Living (IADL) questionnaire
Obtaining a score of 15-45 according to the quality of life questionnaire of diabetes patients (DQoL)
Exclusion criteria:
Having mental illness
Participating in courses and educational classes about diabetes in the last 6 months
Age
From 60 years old
Gender
Both
Phase
4
Groups that have been masked
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
First, the samples will be placed randomly in blocks (of 4) in two control and test groups (45 people in each group). For random assignment, it will be done in such a way that each group is considered to be 4 states and therefore 6 different states can be occur: AABB-ABAB-ABBA-BAAB-BABA-BBAA. The number of people in each group is equal and this work is repeated for 90 patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
The intervention group and the control group are marked with the letters A and B, and the person who gives the questionnaires to the participants and the statistician during the data analysis do not know which is the test group and which is the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology Building, Moalem Sq., Moalem Blvd.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2020-08-26, 1399/06/05
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1399.057
Health conditions studied
1
Description of health condition studied
Low quality of life of the elderly with diabetes
ICD-10 code
Z72
ICD-10 code description
Problems related to lifestyle
Primary outcomes
1
Description
Quality of life score of patients with diabetes
Timepoint
Measuring the quality of life of patients with diabetes at the beginning of the study and 60 days after the intervention
Method of measurement
Quality of life questionnaire for patients with diabetes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before the intervention, they will complete the diabetic quality of life questionnaire. In addition to the previous treatments, the patients in the intervention group will participate in empowerment sessions. The sessions will last for one month and two sessions per week (8 sessions in total) and each session will last for 45. The method of implementing the empowerment program in this research is based on Anderson's empowerment program, which is implemented through speaking and giving pamphlets.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital of Qaemshahr
Full name of responsible person
Ali Hesamzadeh
Street address
Sari St.
City
Qaemshahr
Province
Mazandaran
Postal code
4851839661
Phone
+98 11 4203 2032
Email
a.hesamzadeh@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Mazandaran University of Medical Sciences
Street address
Moalem Sq.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Hesamzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh Faculty of Nursing and Midwifery, Vesal St., Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
+98 11 3336 7343
Email
a.hesamzadeh@mazums.ac.ir
Web page address
https://fnm.mazums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Hesamzadeh
Position
Assiatant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh Faculty of Nursing and Midwifery, Vesal St., Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
+98 11 3321 9437
Email
a.hesamzadeh@mazums.ac.ir
Web page address
https://fnm.mazums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Hesamzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh Faculty of Nursing and Midwifery, Vesal St., Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
+98 11 3321 9437
Email
a.hesamzadeh@mazums.ac.ir
Web page address
https://fnm.mazums.ac.ir/
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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main outcome 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
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
To conduct meta-analysis research
From where data/document is obtainable
Correspondence with email address: a.hesamzadeh@mazums.ac.ir
What processes are involved for a request to access data/document
Investigating the possibility of implementing the request by the responsible researcher and sending the document within less than a month