Determining the effect of telephone follow-up by a nurse on the quality of life and blood glycosylated hemoglobin in the elderly with diabetes hospitalized in hospitals affiliated to Shahid Beheshti University of Medical Sciences in 1401
Design
Semi-experimental study with control group, with parallel groups, randomized
Settings and conduct
People are randomly divided into intervention and control groups. The research tools will be a specific questionnaire for the quality of life of the elderly and a device for measuring glycosylated hemoglobin. Diet, exercise and drug therapy training will be given to the elderly in the hospital. People in the intervention group will be followed up by phone through a nurse for three months. The research tools will be completed immediately and one month after the intervention by the research units.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Ability to speak Persian
Confirmation of diabetes by a doctor
People over 60 years old
Telephone access at home
No speech and hearing problems
Glycosylated hemoglobin more than 7 and treated with oral hypoglycemic drugs
Not suffering from the advanced form of diseases of vital organs and known mental disorders
Non-entry criteria:
Insulin therapy
Suffering from diabetic ketoacidosis or hyperosmolar non ketonic hyperglycemic syndrome
Intervention groups
In the intervention group, trainings with the content of diet for diabetic patients, doing aerobic and stretching exercises, and drug therapy for the elderly will be conducted through lectures along with educational videos.
There will be no educational intervention in the control group.
Main outcome variables
Changes in the amount of glycosylated hemoglobin
Quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230217057440N1
Registration date:2023-03-23, 1402/01/03
Registration timing:registered_while_recruiting
Last update:2023-03-23, 1402/01/03
Update count:0
Registration date
2023-03-23, 1402/01/03
Registrant information
Name
Elahe Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8832 2352
Email address
www.elaheasadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-28, 1401/12/09
Expected recruitment end date
2023-07-02, 1402/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Telephone Nursing Follow-up on Quality of Life and HbA1C in Older People with Diabetes Referring to hospital
Public title
Telephone Nursing Follow-up on Quality of Life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have the ability to speak Persian
Their diabetes has been confirmed by an internist or endocrinologist
The age of people is more than 60 years
Willingness to participate in research.
Have access to a telephone at home
Do not have speech and hearing problems
have glycosylated hemoglobin more than 7 and be treated with oral hypoglycemic drugs
Absence of suffering from the advanced form of diseases of the vital organs of the body and known mental disorders
Exclusion criteria:
diabetes control to insulin therapy
Suffering from diabetic ketoacidosis or hyperglycemic hyperosmolar non-ketonic syndrome
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:
1
In this study, each person participating in the study is the same as the number of people included in the study, and each person provides a sample for the study.
Randomization (investigator's opinion)
Randomized
Randomization description
In this interventional study, all the centers covered by Shahid Beheshti University of Medical Sciences will be classified into four clusters based on geographical region, and one hospital will be randomly selected within the clusters. In this way, a total of four hospitals will be considered, two hospitals will be randomly assigned to select the samples of the intervention group (45 people) and two hospitals will be assigned to select the samples of the control group (45 people) (using cards lottery). Inside the hospitals, according to the characteristics of the research units, the samples will be selected by available sampling method. In other words, it will be a multi-stage cluster sampling method.
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 Shahid Beheshti University of Medical Sciences
Street address
No. 2661, College of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital, Vali Asr St., Niayesh Intersection, Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-09-06, 1401/06/15
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.119
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11.6
ICD-10 code description
Type 2 diabetes mellitus with other specified complications
Primary outcomes
1
Description
Glycosylated hemoglobin change rate
Timepoint
Measurement of glycosylated hemoglobin at the beginning of the study and three months after the beginning of the training
Method of measurement
Measuring Glycosylated Hemoglobin Using Blood Sample with High Performance Liquid Chromatography Method
2
Description
The Quality of life score
Timepoint
The Quality of life score at the beginning of the study and three months after the beginning of the training
Method of measurement
Measuring the Quality of Life Score with a Specific Questionnaire for Measuring the Quality of Life of the Elderly
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At the beginning of the study, completion of the quality of life questionnaire for the elderly, training on the content of the diet of diabetic patients, aerobic and stretching exercises and drug therapy for the elderly in the form of lectures along with educational videos, telephone follow-up for 12 weeks (in the first month of each week Twice and once a week during the second and third months), one month after the end of the last telephone follow-up, the people of the intervention group will complete a special questionnaire measuring the quality of life of the elderly.
Category
Lifestyle
2
Description
Control group: No educational intervention was done
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Selected centers related to Shahid Beheshti University of Medical Sciences in Tehran
Full name of responsible person
Abbas Abbaszadeh
Street address
No. 2661, College of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital, Vali Asr St., Niayesh Intersection, Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
aabaszadeh@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Abbaszadeh
Street address
No. 2661, College of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital, Vali Asr St., Niayesh Intersection, Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
elaheasai@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Deputy of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Abbaszadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nursery
Street address
No. 2661, College of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital, Vali Asr St., Niayesh Intersection, Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
aabaszadeh@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Abasszadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nursery
Street address
No. 2661, College of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital, Vali Asr St., Niayesh Intersection, Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
aabaszadeh@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Abbaszadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nursery
Street address
Vali Asr St., Niayesh Intersection, Tehran, in front of Shahid Rajaee Heart Hospital, College of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
aabaszadeh@sbmu.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
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
The information related to the main outcome, including the quality of life score and the change in the amount of glycosylated hemoglobin in the blood, 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
Study data will be available to researchers working in academic and scientific institutions and people who are also engaged in industry.
Under which criteria data/document could be used
Secondary analyzes are performed on the primary data of the present study by the groups requesting the study data.
From where data/document is obtainable
Corresponding author and research team
aabaszadeh@sbmu.ac.ir
ADDRESS: Vali Asr St., Niayesh Intersection, Tehran, in front of Shahid Rajaee Heart Hospital, College of Nursing and Midwifery
What processes are involved for a request to access data/document
Through correspondence with the responsible author, within three working days, the data will be provided to the requesting person via email.