Investigating the effect of the implementation of the family health nurse model on Hypertension self-management of elders
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized on 76 patients, random number table was used for randomization.
Settings and conduct
The research population is elderly with high blood pressure covered by comprehensive health service centers in Isfahan City, who were selected using a random number table. Among the number 1 centers of Isfahan where social medicine is located, one center will be randomly selected and one base will be selected as an intervention center and one base will be selected as a control center. The localized model of the family health nurse is implemented.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Elderly aged 60-74 years
Willingness to participate in the study
Suffering from high blood pressure above 140/90 for at least 6 months
Resident of Isfahan
The presence of an active person in the elderly home
Farsi language
No mental disorders
Criteria for not entering the study:
Having chronic diabetes
Having untreated hypothyroidism
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. The evaluation is done in 3 stages during, immediately, and 3 months after the intervention. The control group: receives the center's routine care.
Main outcome variables
Hypertension self-management
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190806044449N2
Registration date:2023-07-23, 1402/05/01
Registration timing:prospective
Last update:2023-07-23, 1402/05/01
Update count:0
Registration date
2023-07-23, 1402/05/01
Registrant information
Name
Maryamsadat Shahshahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7585
Email address
shahshahani@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 the implementation of the family health nurse model on self-management of high blood pressure in the elderly
Public title
Investigating the effect of implementing the family health nurse model on Hypertension self-management
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly aged 60-74 years
Willingness to participate in the study
Patients with high blood pressure above 140/90
Living in Isfahan city
Diagnosis of high blood pressure for at least 6 months
Not suffering from mental disorders
Farsi speaking participants
Doing daily activities independently
The presence of an active person in the elderly home (family health ambassador based on ambassador criteria)
Exclusion criteria:
Having chronic diabetes that leads to cardiovascular disorders.
Having untreated hypothyroidism
Age
From 60 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in two stages. At first, referring to Isfahan Health Network 1, a center will be selected as the intervention group by lottery, and then, for the control group to be homogeneous with the subjects of the intervention center in terms of social and economic conditions, 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. In the second stage, in the centers selected by the researcher, through the Sib system, the head of the center will prepare a list of all the people who meet the entry criteria and systematically select the subjects, in such a way that the total number of the research population is divided by the required number of subjects to get the K number. Then randomly, the first number below ten is obtained, which is called n. Then the numbers N+K, N+2K, N+3K,... will be selected until the last subject
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
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Ave., Azadi Square
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-07-08, 1402/04/17
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.056
Health conditions studied
1
Description of health condition studied
hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
High blood pressure self-management score in the Stanford Self-Management Questionnaire
Timepoint
Before, immediately and 3 months after the intervention
Before, immediately and 3 months after the intervention
Method of measurement
Mercury sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: For this group, the steps of the localized family health nurse model, which was developed 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" 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 high blood pressure, and in the first meeting with the samples, after completing the relevant questionnaires, an initial assessment was carried out. They will be done at the center and the home visit 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 nursing diagnoses, nursing care for the affected person is planned with the help of the family and a localized model package that includes individual counseling. , educational booklets and holding training sessions, referral to a doctor, follow-up of internal referrals made by a doctor to a psychiatrist, nutritionist, or specialist doctor, 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 holding self-help group meetings and conducting monthly care and blood pressure control, he will follow up with the affected people. The evaluation stage of this model will also be done during 3 stages (during the intervention, immediately after the intervention, and 3 months after the intervention) by means of the Stafford Chronic Disease Self-Management Questionnaire and blood pressure measurement.
Category
Treatment - Other
2
Description
Control group: In this study, the control group after being called to the center, performing initial assessment, measuring blood pressure, and completing relevant questionnaires referred to health care providers and receive routine care at the center for 3 months, and after 3 months they complete the questionnaires and Their blood pressure will be measured again.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan comprehensive health service centers
Full name of responsible person
Hamid Galeh dari
Street address
Health Vice District, next to Amin Hospital, Ibn Sina St, Esfahan
City
Esfahan
Province
Isfehan
Postal code
81486-53374
Phone
+98 31 3441 6060
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
1st Floor, Research and Technology Vice-Chancellor of the University, Headquarters Building No. 4, Isfahan University of Medical Sciences and Health Care Services, Hazar Jarib St.
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
Zohreh Noorollahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Department of Community Health, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Street, Azadi Square, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
Zohreh.noorollahi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Sadat Shahshahani
Position
Faculty Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
shahshahani@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Sadat Shahshahani
Position
Member of the faculty of nursing and midwifery in Isfahan
Latest degree
Master
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
shahshahani@nm.mui.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Results from demographic data, questionnaires and blood tests can be shared anonymously. The study protocol will be announced.
When the data will become available and for how long
Start access period after printing results
To whom data/document is available
According to the research title, all interested people will have access to the results.
Under which criteria data/document could be used
The results will be published in scientific journals and in addition ; the researchers' emails will be available
From where data/document is obtainable
he way to communicate is emails:
shahshahani@nm.mui.ac.ir
zohreh.noorollahi@gmail.com
What processes are involved for a request to access data/document
It will be answered at least 1 week after request.
Comments
Only the results and study protocol will be presented.