Evaluation the nurse follow - up plan and its effect on self-care and metabolic control indices in diabetic patients
Design
Clinical trial with control group, with parallel groups, randomized, on 65 patients
Settings and conduct
This study will be performed in Allameh Behlool Gonabadi Hospital as follows:
In the intervention group:
According to the ministry checklist, the patient's number will be called 3 to 7 days after discharge.
The frequency of follow-up is determined as follows:
1. Green area: Follow the frequency of fish twice.
2. Yellow area: Frequency of follow-up once a week.
3. Red area: While advising to go to the hospital emergency department immediately, a follow-up by phone should be done up to 6 hours later. Follow-up of these patients is done twice a week after discharge from the hospital until they are in the green area.
The control group will receive routine hospital training and follow-up. Of course, in order to maintain ethics, a normal follow-up will be done at least once in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Definitive diagnosis of diabetes by a specialist
Discharged from the hospital and referred to the hospital self-care and follow-up unit
Age over 18 years
Informed consent
Access to phone or mobile
Lack of speech, hearing and vision disorders and the ability to understand and answer questions
Resident of Gonabad city
No history of mental illness
Intervention groups
In the intervention group, the follow-up nurse project will be carried out.
The control group will receive routine hospital care.
Main outcome variables
Self-care; Metabolic control indices of diabetic patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130428013152N3
Registration date:2021-05-22, 1400/03/01
Registration timing:prospective
Last update:2021-05-22, 1400/03/01
Update count:0
Registration date
2021-05-22, 1400/03/01
Registrant information
Name
reza noori
Name of organization / entity
university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 3513
Email address
noori.r@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the nurse follow - up plan and its effect on self-care and metabolic control indices in diabetic patients
Public title
Evaluation the nurse follow - up plan and its effect on self-care and metabolic control indices in diabetic patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of diabetes by a specialist doctor
Discharged from the hospital and referred to the self-care and follow-up unit of the hospital
Age over 18 years
Informed consent
Access to phone or mobile
No speech, hearing and vision disorders and the ability to understand and answer questions
Resident of Gonabad city
No history of mental illness
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by stratified random replacement blocks. Classes are based on three age groups (less than or equal to 45 years, 46 to 64 years, 65 years and more) and gender (male and female) that are created in a set of 6 classes. Randomization within each floor is done in the style of random replacement blocks with sizes 2 and 4. The list will be determined by the web analytics.
In order to privatize the properties, opaque envelopes will be stamped using a random sequence
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The follow-up nurse project is being piloted at two medical universities.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Parastar Ave, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793918
Approval date
2021-05-08, 1400/02/18
Ethics committee reference number
IR.GMU.REC.1400.013
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Self-care
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Diabetes Self-Care Questionnaire (F-SCODI)
2
Description
Fasting blood sugar
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Laboratory Kit
3
Description
Cholesterol
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Laboratory Kit
4
Description
Triglyceride
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Laboratory Kit
5
Description
Glycosylated hemoglobin
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Laboratory Kit
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Routine hospital care including discharge from the hospital and training during discharge by the patient nurse and return to the self-care clinic after 3 months
Category
N/A
2
Description
Intervention group: Follow-up nurse care plan including: performing safe discharge steps, introducing the patient to the follow-up nurse and sending his case summary. The patient's number is called the day after discharge. After contacting the patient and introducing yourself, based on the relevant checklist, the necessary follow-up is done and in any case where the patient needed further and supplementary training, recommendations are given. Also, if the patient needs support resources such as diabetes clinic, hospital self-care clinic, health centers, psychologist, addiction and smoking cessation centers, nutrition counselor and home care centers and referral until complete reassurance, the necessary follow-ups are done with the mentioned institutions. Frequency of follow-up is determined based on the severity of the disease and danger signs according to the instructions from three days to one year after discharge as follows: 1. Green area: Follow-up frequency of patients in the green area should be done twice as a fish. 2. Yellow area Frequent follow-up of patients in the yellow area should be done once a week. Red area: While advising to go to the hospital emergency room immediately, a follow-up should be done by phone up to 6 hours later. Follow-up of these patients is done twice a week after discharge from the hospital until they are in the green area.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Behlool Gonabadi Hospital
Full name of responsible person
Elham Saberi Noghabi
Street address
Parstar Ave., Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
rnoori68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosravan
Street address
Parstar Ave., Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
rnoori68@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Elham Saberi Noghabi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Parstar Ave., Gonabad University of Medical Sciences
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
saberi.e@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Elham Saberi Noghabi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Parstar St., Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
009685157223028
Email
saberi.e@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Reza Noori
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Parstar St., Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
Rnoori68@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
Undecided - It is not yet known if there will be 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
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
All data related to the main consequences can be shared.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Data will be available to all researchers
Under which criteria data/document could be used
The data will be usable for further studies and improving patient care
From where data/document is obtainable
Elham Saberi Noghabi
saberi.e@gmu.ac.ir
What processes are involved for a request to access data/document
6 months after the publication of the results of the study, the applicant can submit a valid letter of introduction from an organization to the e-mail of Ms. Elham Saberi Noghabi and can request the data and the data file will be provided to her within two weeks.