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Investigating the Effect of Implementing the Family Health Nurse Model on Self-management and Glycosylated Hemoglobin of Middle-aged Women with Type 2 Diabetes

Protocol summary

Study aim
Determining the effect of implementing the family health nurse model on self-management and glycosylated hemoglobin of middle-aged women with type 2 diabetes
Design
A clinical trial with a control group, with parallel groups, without blinding, without randomization, on 84 patients.
Settings and conduct
The research population of middle-aged women with type 2 diabetes was covered by the centers of Isfahan city, and the control and intervention center was selected through lottery and the subjects were selected by systematic method. For the test group, a self-management program is implemented in the form of a localized family health nurse model.
Participants/Inclusion and exclusion criteria
Inclusion criteria: suffering from diabetes during the last year, not controlling HbA1c according to the opinion of the attending physician of the center Exclusion criteria: unwillingness to continue cooperation, failure to complete questionnaires and tests, death of the affected person
Intervention groups
Intervention group: For the test group, a self-management program is implemented in the form of a localized family health nurse model. This model includes 3 stages before intervention, intervention, and evaluation, in the pre-intervention stage, preparations are made and in the intervention stage, home visits and identification are carried out. The patient's problems are presented with the service package of the localized family health model. Evaluation is done in 3 stages during, immediately, and 3 months after the intervention Control group: they receive the center's routine care.
Main outcome variables
Diabetes self-management; Glycosylated hemoglobin level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230522058256N1
Registration date: 2023-07-26, 1402/05/04
Registration timing: prospective

Last update: 2023-07-26, 1402/05/04
Update count: 0
Registration date
2023-07-26, 1402/05/04
Registrant information
Name
Tayebeh Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7509
Email address
tkarimi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-08, 1402/05/17
Expected recruitment end date
2023-11-08, 1402/08/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Implementing the Family Health Nurse Model on Self-management and Glycosylated Hemoglobin of Middle-aged Women with Type 2 Diabetes
Public title
Investigating the effect of implementing the Family Health Nurse Model on Self-management and Glycosylated Hemoglobin
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have an active file in the center At least one year has passed since the diagnosis of their disease There should be no restrictions on entering the house and visiting the house. HbA1C should be considered uncontrolled according to the patient's medical record and the doctor's opinion Willingness and informed consent to participate in the research Have Iranian nationality
Exclusion criteria:
Suffering from chronic and advanced complications of diabetes such as nephropathy, proliferative retinopathy, amputation Suffering from cognitive problems including mental retardation or known psychological disorders Failure to complete HBA1c questionnaires and tests or their incomplete completion
Age
From 30 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, School of Nursing and Midwifery
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-07-08, 1402/04/17
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.055

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.00
ICD-10 code description
Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC)

Primary outcomes

1

Description
Diabetes self-management score in the Schmitt diabetes self-management questionnaire
Timepoint
Before, immediately and 3 months after the intervention
Method of measurement
Diabetes Self-Management Questionnaire

2

Description
The percentage of people who have glycosylated hemoglobin above 7.7
Timepoint
Before and 3 months after the intervention
Method of measurement
Glycosylated hemoglobin blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For this group, the steps of the localized family health nurse model, which was developed by Kishori et al. in 2013 under the title "Explaining the process of providing health services to families covered by rural health centers in Isfahan City: Designing a suitable model for providing family health care" It has been designed and will be implemented. This model will include three stages (before intervention, intervention, and evaluation). The pre-intervention stage included two preliminary stages and the first meeting with the samples, during the preliminary stage, the necessary measures were taken to meet the people with diabetes, and in the first meeting with the samples, after completing the relevant questionnaires, their initial evaluation in The home visit center and time will be coordinated with them. In the intervention stage, which includes (home visits, implementation in the center and provision of a localized family health model service package, formation of self-help groups, and follow-up for 3 months), at least during two home visit sessions and the selection of a family health ambassador, with Use the relevant forms to assess the educational needs of the family with the help of family members and after identifying the identified problems of the patient, based on the nursing diagnoses, plan nursing care for the affected person with the help of the family and a localized model package that includes (counseling Individual, educational booklet and holding training sessions, referral to the doctor, follow-up of internal referrals made by the doctor (to a psychiatrist, nutritionist, internal specialist) and follow-up of external referrals) will be provided according to the needs and problems of each patient. Then, for 3 months, in the form of self-help group meetings and monthly care, and fasting blood sugar control, he will follow up with the affected people. The evaluation stage of this model will be done in 3 stages (during the intervention, immediately after the intervention, and 3 months after the intervention by diabetes self-management questionnaire and glycosylated hemoglobin test).
Category
Treatment - Other

2

Description
Control group:Control group: In this study, the control group after being called to the center, performing the initial assessment, glycosylated hemoglobin test, and completing the relevant questionnaires, will be referred to the health care providers and will receive the center's routine care for 3 months, and after 3 months, the questionnaires will be re-administered. Completion and testing of their glycosylated hemoglobin will be done
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan comprehensive health service centers
Full name of responsible person
Tayyaba Karimiج
Street address
Esfahan, Ibn Sina St., next to Amin Hospital, Health Vice District
City
Esfahan
Province
Isfehan
Postal code
81486-53374
Phone
+98 31 3441 6060
Fax
Email
health@mui.ac.ir
Web page address
https://phc.mui.ac.ir/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Headquarters, Research and Technology Vice-Chancellor of the University, 1st Floor
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Web page address
https://tech.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Tayebeh Karimi
Position
Assistant professor, member of the faculty of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, Nursing and Midwifery College
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Fax
Email
tkarimi@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tayyaba Karimi
Position
Assistant professor, member of the faculty of nursing and midwifery in Isfahan
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, Nursing and Midwifery College
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
tkarimi@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tayebeh Karimi
Position
Assistant professor, member of the faculty of nursing and midwifery in Isfahan
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, Nursing and Midwifery College
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
tkarimi@nm.mui.ac.ir

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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