The results of this study can be predicted and used in the geriatric care system and increase the sleep quality of the elderly and teach methods to improve sleep quality and control insomnia in the elderly.
Design
A clinical trial with a control group, a blind strain, with entry and exit criteria and randomized is performed on 64 patients.
Settings and conduct
diabetes clinic in Gorgan city
Participants/Inclusion and exclusion criteria
Age over 65 years; Literacy for reading and writing; Ability to communicate; Patients with diabetes referred to Deziani Specialized Clinic in Gorgan, who have had at least one year of diagnosis and history of drug treatment and have an active case file in the clinic; Not having known progressive chronic diseases such as cancer and lupus; Obtaining low and medium scores from the sleep quality questionnaire; Willingness to participate in the study; Absence of psychiatric problems based on the file and self report
Intervention groups
Diabetic patients referred to diabetes clinic in Gorgan city
Main outcome variables
The effectiveness of the intervention of using education and continuous care on the sleep quality of patients with diabetes
General information
Reason for update
Acronym
TSDE
IRCT registration information
IRCT registration number:IRCT20220411054493N1
Registration date:2022-07-30, 1401/05/08
Registration timing:retrospective
Last update:2022-07-30, 1401/05/08
Update count:0
Registration date
2022-07-30, 1401/05/08
Registrant information
Name
ghazale mazraie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 727 0160
Email address
ghazallmazraie@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-10, 1401/03/20
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sleep health education on improving sleep quality in the elderly with diabetes
Public title
The effect of sleep health education on diabetic elderly
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 65 years
Beeing literate
Ability to communicate
Diabetic patients referred to Deziani specialized clinic in Gorgan who have at least one year after the diagnosis and history of drug treatment are confirmed and have an active file in the clinic
Not being diagnosed with known progressive diseases such as cancer and lupus
Obtaining low and medium scores from the sleep quality questionnaire
Willingness to participate in the study
Do not have psychiatric problems based on the file and self-report
Exclusion criteria:
The death of the elderly
Not attending the class for more than one session
Elder moving to another city or country
absence of the elder due to illness that leads to hospitalization
Withdrawal of the patient to continue participation in the study
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Considering that at the beginning of the study, the quality of sleep of the elderly is measured as a criterion for inclusion in the study, the score obtained from the questionnaire is arranged from small to large and placed in 2 blocks (one letter A and one letter B) and allocated as Classified will be executed.
First, we will form a random sequence of 64 letters in double blocks as follows:
BA-AB-AB-BA-AB-BA-AB-AB-BA-AB-BA-BA-AB-AB-BA-AB- BA-AB-AB-BA-AB-BA-AB-AB-BA-AB-BA- BA-AB-AB-BA-AB
In this random sequence, there will be 32 of each letter A and B. According to the above block, 64 envelopes will be prepared and in each envelope, the letter A or B will be placed and will be numbered from 1 to 64.
The person delivering the envelopes to the patients does not know what is inside. The production of a random sequence is done by a statistics and methodology consultant who does not have access to patients and only he knows what is in each envelope.
Patients who received the letter A will be in the intervention group and patients who received the letter B will be in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyst does not know the names of the patients and how to complete the questionnaire and the scores of the people.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan university of medical sience
Street address
Shastkola Street
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2022-06-01, 1401/03/11
Ethics committee reference number
IR.GOUMS.REC.1401.066
Health conditions studied
1
Description of health condition studied
diabet
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
The effectiveness of the intervention of using education and continuous care on the sleep quality of patients with diabetes
Timepoint
one month and tow months after intervention
Method of measurement
Petersburg questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 32 elderly people who meet the entry criteria will be given a sleep health training program during 3 sessions. Then one month and two months after the intervention, sleep quality is measured.
Category
Lifestyle
2
Description
Control group: We select 32 elderly people who meet the entry criteria as a control group. Then one month and two months later, we measure the quality of sleep.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Gorgan Diabetes Clinic
Full name of responsible person
Fateme maghsoudloo
Street address
Shahid beheshti street
City
Gorgan
Province
Golestan
Postal code
4916679191
Phone
+98 17 3226 3060
Email
ghazallmazraie@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Golestan university og medical sience
Street address
Shastkola Street
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0310
Email
info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Ghazale Mazraie
Position
Master sudent if nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Baharan street, 1st baharan
City
Gorgan
Province
Golestan
Postal code
4916797447
Phone
+98 938 727 0160
Fax
Email
ghazallmazraie@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Ghazale Mazraie
Position
Master sudent if nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Baharan street, 1st baharan
City
Gorgan
Province
Golestan
Postal code
4916797447
Phone
+98 938 727 0160
Fax
Email
ghazallmazraie@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Ghazaleh mazraie
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
baharnarenj , baharan street
City
Gorgan
Province
Golestan
Postal code
4916797447
Phone
+98 17 3216 2680
Email
ghazallmazraie@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
"No more information"
When the data will become available and for how long
"No more information"
To whom data/document is available
"No more information"
Under which criteria data/document could be used
"No more information"
From where data/document is obtainable
"No more information"
What processes are involved for a request to access data/document