The survey on the effect of implementing an intervention based on the family health nurse model on glycemic and anthropometric indicators in middle-aged people with pre-diabetes
Determining the effect of implementing an intervention based on the family health nurse model on glycemic and anthropometric indicators in middle-aged people with prediabetes covered by selected comprehensive health service centers in Isfahan city in 1402
Design
Clinical trial with control group, with parallel groups, without randomization, on 72 patients.
Settings and conduct
The research population is middle-aged people with pre-diabetes under the comprehensive health service centers of Isfahan city, who were selected using systematic sampling method. One center will be randomly selected from among centers No. 1 in Isfahan, where social medicine is located, and in order for the control group to be homogenous in terms of social and economic conditions with the subjects of the intervention center, one center will be selected as the control group by lottery among the comprehensive health service centers that are located in the vicinity of the center of the intervention group, which will be implemented for the test group in a self-management program in the form of a localized family health nurse model.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Willingness and informed consent to participate in the research.
Exclusion criteria:
Unwillingness to continue cooperation
Failure to complete the questionnaire or its incomplete completion
Disease progression and diabetes
Intervention groups
The intervention group includes people with prediabetes who receive educational intervention.
The comparison group includes people with prediabetes who receive routine interventions from health care providers.
Main outcome variables
prediabetes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230516058206N1
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
Atefe Afshari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 222 7796
Email address
afshar.atefe@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-08, 1402/05/17
Expected recruitment end date
2023-11-09, 1402/08/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey on the effect of implementing an intervention based on the family health nurse model on glycemic and anthropometric indicators in middle-aged people with pre-diabetes
Public title
Investigating the effect of the family health nurse model on glycemic and anthropometric indicators
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
For the client, the diagnosis of pre-diabetes has been registered in the Sib system by the doctor of the center in the last one-month through the Hba1c test.
Have the desire and informed consent to participate in the research.
Having consent for home visit.
Farsi speaking.
Be between the ages of 30 and 59.
Have minimum reading and writing literacy.
Exclusion criteria:
Reluctance to continue cooperation
Not completing the questionnaire or completing it incompletely
Disease progression to diabetes
Death of the patient or caregiver or causing problems in such a way that the patient and caregiver are unable to continue participating in the study.
Age
From 30 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Research Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan University of
Street address
Hezar Jerib street, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-07-08, 1402/04/17
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.054
Health conditions studied
1
Description of health condition studied
prediabetes
ICD-10 code
R73.01
ICD-10 code description
Impaired fasting glucose
Primary outcomes
1
Description
HbA1c
Timepoint
At the beginning of the study and after the end of the intervention and 3 months after the end of the intervention
Method of measurement
HbA1c test
Secondary outcomes
1
Description
Anthropometric indexes
Timepoint
Begin, at the end of intervention, 3 months after intervention
Method of measurement
meter
Intervention groups
1
Description
Intervention group: For this group, the steps of the localized family health nurse model, which was designed by Keshvari 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", will be implemented. This model will include three stages (pre-intervention, intervention, evaluation). The pre-intervention stage includes two preliminary stages and the first meeting with the samples, during the preliminary stage, the necessary measures will be taken to meet the people with pre-diabetes and in the first meeting with the samples, after completing the relevant questionnaires, their initial assessment will be done at the center and the time of the home visit will be coordinated with them. In the intervention stage, which includes (home visit, implementation at the center and presentation of the service package of the localized family health model, formation of self-help groups and follow-up for 3 months), during at least two home visit sessions and the selection of a family health ambassador, using the relevant forms to assess the family's educational needs with the help of family members, and after identifying the identified problems of the patient, based on the nursing diagnoses, planning nursing care for the affected person with the help of the family, and the localized model package, which includes individual counselling, training booklets and holding training sessions, is referred to The doctor will follow up the internal referrals made by the doctor to the psychiatrist, nutritionist, specialist doctor and follow up the external referrals according to the needs and problems of each patient. Then, for 3 months, in the form of holding self-help group meetings and conducting monthly care and blood sugar control, he will follow up the affected people. The evaluation stage of this model will also be done during 3 stages (during the intervention, immediately after the intervention, 3 months after the intervention) by measuring blood sugar.
Category
Prevention
2
Description
Control group: In this study, the control group after being called to the center, performing an initial assessment, measuring blood sugar and completing related questionnaires, were referred to health care providers and received routine care at the center for 3 months, including monthly follow-up and fasting blood sugar checks. They will receive referrals to nutrition and psychological experts, and after 3 months, the questionnaires will be completed again and their blood sugar will be measured again.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
kerd abad Comprehensive health service center
Full name of responsible person
zohreh changanian
Street address
Shahid Rezaei Alley, kerd ababd square, Mahdieh Street,J Street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3529 0370
Email
m.azadmanesh19@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
atefe afshari
Street address
isfahan university of medical science, hezar jarib ave, isfahan
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 222 7796
Email
afshar.atefe@yahoo.com
Grant name
Grant code / Reference number
340292
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
Mohammad Azadmanesh
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan Province, Isfahan, Hazarjarib St., Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 911 410 8703
Fax
Email
m.azadmanesh19@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atefe Afshari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Isfahan Province, Isfahan, Hazarjarib St., Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 222 7796
Fax
Email
afshar.atefe@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atefe Afshari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Isfahan Province, Isfahan, Hazarjarib St., Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 222 7796
Fax
Email
afshar.atefe@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available