The effect of self management education based on Pender's health promotion model on clinical findings of patients with brucellosis
Design
Patients will be divided into two groups of test and control each of them 4 patients will be divided using 4 permutation blocks method and in both groups the valid and reliable questionnaire will be filled and clinical findings will be recorded and the control group will receive routine care in the self management training group based on Pender's model and then again the questionnaire and clinical findings will be measured after the intervention and the information will be analyzed.
Settings and conduct
Randomized clinical trial and research community of all patients with brucellosis will have inclusion criteria under the cover of community health centers in Gonabad city.
Participants/Inclusion and exclusion criteria
The patient with a diagnosis of brucellosis and in the acute stage and in the first two weeks of drug treatment.All or a number of clinical signs and symptoms of fever and pain, fatigue, sweating and anorexia have a burn or kom 1.80 burn or 2ME test equal to or greater than 1.40.40. Have access to a phone or internet at home and be literate about women not breastfeeding and pregnancy
Exclusion criteria:
Not participating in online or in person training group. Stop taking medication for medical reasons
Dissatisfaction with cooperation in the continuation of the study inpatient. hospitalization during the study simultaneous. participation in similar educational groups
Intervention groups
Self management training is based on Pender's model by lecture method and based on the pre-organizer model.The control group does not receive training
Main outcome variables
Self-management education based on Pender's health promotion model
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220205053940N1
Registration date:2022-02-16, 1400/11/27
Registration timing:prospective
Last update:2022-02-16, 1400/11/27
Update count:0
Registration date
2022-02-16, 1400/11/27
Registrant information
Name
Maryam Tavazoi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 2606
Email address
tavazoim1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-01, 1400/12/10
Expected recruitment end date
2022-08-08, 1401/05/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self management training based on Pender's health promotion model on clinical findings of patients with brucellosis
Public title
The effect of self management training based on Pender's model on clinical findings of patients with brucellosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has brucellosis according to the diagnosis and in the acute stage (less than 3 months from the onset of symptoms)
be at most in the first two weeks of drug treatment
All or a number of clinical signs and symptoms have fever and pain, fatigue, sweating and anorexia
The headline of Wright or Coombs Wright is equal to or greater than 1/80, or the 2ME test is equal to or greater than 1/40
Be under drug treatment in accordance with the national guidelines for controlling brucellosis
Lack of mental illnesses according to the client's history and ability to self care
Willingness to participate in this study. Capable of speaking, being able to hear and communicate
He has not previously attended self management training on brucellosis.
Have access to the phone and preferably the Internet at home (if the program is implemented online) and have read and write literacy
Not about women in breastfeeding and pregnancy
Exclusion criteria:
Not participating in online or in person training group (absence of more than one session)
Discontinuation of drug use for medical reasons
Dissatisfaction with cooperation in the continuation of the study
Client's hospitalization during study
Simultaneous participation in similar educational groups
Age
From 16 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of the sample begins in an access to the study by preparing a list of patients with the conditions of participation in the study, and then random allocation of the subjects to the experimental and control groups will be done using the four point permutation block method.
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 Committee of Gonabad University of Medical Sciences
Street address
Mahdi zadeh Next to the Asian Road, Deputy for Research, Gonabad University of Medical Sciences, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2022-01-30, 1400/11/10
Ethics committee reference number
IR.GMU.REC.1400.187
Health conditions studied
1
Description of health condition studied
brucellosis
ICD-10 code
A23
ICD-10 code description
Brucellosis
Primary outcomes
1
Description
Fever, pain, fatigue, appetite
Timepoint
At the beginning of work in both experimental and control groups, measurement of fever, pain, fatigue, appetite, Sweating and 8 weeks later and after the end of drug treatment, reassessment.
Method of measurement
Fever with thermometer, Appetite from the first 3 questions of the questionnaire (ADTA), Sweating with the patient's self expression, Pain with visual analog scale (VAS), Fatigue with visual fatigue intensity scale (VAFS)
Secondary outcomes
empty
Intervention groups
1
Description
We have an intervention group.Intervention Group Self management training based on Pender's model, which first determines how self management behavior and its deficiencies before the intervention, then using the constructs of personal factors, perceived benefits, perceived barriers, perceived self efficacy, and interpersonal influencers to why self management behavior in patients with brucellosis will be achieved and then the training program will be performed in 4 sessions for the intervention group.
Category
Other
2
Description
Control group:According to the instructions of the health deputy of patients with brucellosis, routine and routine care of visits and treatment of medication and self care is done by the physician.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Deputy of Health, Gonabad University of Medical Sciencesof Medical Sciences
Full name of responsible person
Dr. Javad Sadeghi Nasab
Street address
Gonabad University of Medical Sciences , Deputy of Health, Corner of Nasir Khusraw 15, Gonabad, Nasir Khusraw, Street Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 9012
Fax
+98 51 5722 3815
Email
info@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosravan
Street address
Education Deputy of Gonabad University of Medical Sciences, Asian Road Margin, Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 9025
Email
sdh@gmu.ac.ir
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
Dr. Shahla Khosravan
Position
Vice Chancellor for Research, Gonabad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Education Deputy of Gonabad University of Medical Sciences, Asian Road Margin, Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
khosravan@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosrowan
Position
Faculty of Gonabad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Education Deputy of Gonabad University of Medical Sciences, Asian Road Margin , Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
khosravan@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosrowan
Position
Faculty of Gonabad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Education Deputy of Gonabad University of Medical Sciences, Asian Road Margin , Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
khosravan@gmu.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
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
Undecided - It is not yet known if there will be 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