Protocol summary

Study aim
Determining the effect of education based on social cognitive theory in health ambassadors on preventive behaviors of cutaneous leishmaniasis in ambassadors and covered families in rural areas of Mashhad.
Design
A randomized, single-blind, randomized controlled clinical trial was performed on 220 participants selected by stepwise cluster sampling.
Settings and conduct
Internal medicine in the field of education for the prevention of leishmaniasis in health ambassadors in the intervention village is done through the Internet cyberspace and the presentation of educational texts based on social cognitive theory. Then the result of the intervention on the behavior of rural household members before, after, and 3 months after the intervention will be determined and analyzed. When entering information into the software, the information identifying the intervention and control group is hidden so that the analyst is blind to their findings.
Participants/Inclusion and exclusion criteria
Join as a health ambassador - Informed consent - Confirmation of disability or physical disability - Health Ambassador over the age of 15 - Not participating in health ambassadors training classes - Family members with the ability to read and write - Age between 15 to 40 years of family members Exclusion criteria: - Reluctance to cooperate
Intervention groups
Educational intervention to improve leishmaniasis prevention behaviors is performed for the experimental group in the intervention village. During the intervention, the control group did not receive training. But after the intervention, the training package is presented to the control group.
Main outcome variables
Preventive behaviors against leishmaniasis Scores of structures of self-efficacy, self-control, social support, outcome expectations, self-efficacy of overcoming obstacles, environmental perception, emotional adjustment, and outcome value.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200615047784N1
Registration date: 2020-09-02, 1399/06/12
Registration timing: registered_while_recruiting

Last update: 2020-09-02, 1399/06/12
Update count: 0
Registration date
2020-09-02, 1399/06/12
Registrant information
Name
Mahmoud Fakhar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3847 4911
Email address
fakharm2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on social cognitive theory in health volunteers on preventive behaviors of cutaneous leishmaniosis in volunteers and covered households
Public title
The effect of educational intervention on social cognitive theory in health ambassadors on the preventive behaviors of cutaneous leishmaniasis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Health ambassadors and their parents have informed consent. Health ambassadors must be over 15 years old Health ambassadors do not have a confirmed disability or physical disability. Have not attended health ambassadors training classes.
Exclusion criteria:
Not able to read and write. Family members covered by health ambassadors must be over 40 years old.
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 220
Randomization (investigator's opinion)
Randomized
Randomization description
With a multi-stage cluster method of comprehensive rural health service centers and health houses affiliated to Mashhad city health center number one, which consists of 51 rural centers and health houses in three clusters (clusters based on their geographical location relative to the city health center) Mashhad number one is considered) First, a cluster will be selected randomly by lottery method. Each health house will be given a number and by drawing a health house for the experimental group (individual number) and a health house It is assigned to the control group (even number). Then, in each of the selected health centers, the list of registered health ambassadors is extracted and according to the Word criteria, individuals are included in the study and sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the study analysts are kept blind to the information of the intervention and control groups by assigning an unspecified title (for example, by titles of groups 1 and 3).
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences Ethics Committee
Street address
No. 16، Daneshgah Street، School of Health. Postal Code: 9137673119
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Approval date
2019-10-13, 1398/07/21
Ethics committee reference number
IR.MUMS.REC.1398.198

Health conditions studied

1

Description of health condition studied
Leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis

Primary outcomes

1

Description
Score of self-control.
Timepoint
Before the intervention - immediately after the intervention - 3 months after the intervention
Method of measurement
questionnaire

2

Description
Scores of structures of self-efficacy.
Timepoint
Before the intervention - immediately after the intervention - 3 months after the intervention
Method of measurement
questionnaire

3

Description
Scores of structures of social support.
Timepoint
Before the intervention - immediately after the intervention - 3 months after the intervention
Method of measurement
questionnaire

4

Description
Scores of structures of outcome expectations.
Timepoint
Before the intervention - immediately after the intervention - 3 months after the intervention
Method of measurement
questionnaire

5

Description
Scores of structures of barrier self efficacy.
Timepoint
Before the intervention - immediately after the intervention - 3 months after the intervention
Method of measurement
questionnaire

6

Description
Scores of structures of environmental perception.
Timepoint
Before the intervention - immediately after the intervention - 3 months after the intervention
Method of measurement
questionnaire

7

Description
Scores of structures of emotional adjustment.
Timepoint
Before the intervention - immediately after the intervention - 3 months after the intervention
Method of measurement
questionnaire

8

Description
Scores of structures of outcome experiences.
Timepoint
Before the intervention - immediately after the intervention - 3 months after the intervention
Method of measurement
questionnaire

9

Description
Score of preventive behavior of leishmaniasis.
Timepoint
Before the intervention - immediately after the intervention - 3 months after the intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
demographic variables
Timepoint
At one stage, preferably 3 months after training
Method of measurement
questionnaire

Intervention groups

1

Description
This study will be performed quasi-experimentally with a control group. First, a descriptive study is performed to determine the factors related to the preventive behaviors of leishmaniasis. In the second stage, intervention studies of before and after type are performed with a randomized control group. Based on the education of leishmaniasis and based on cognitive-social theory on preventive behaviors of leishmaniasis through health ambassadors will be performed on rural households in Mashhad 1. Training programs between 6 to 8 sessions; 2 face-to-face sessions (60 m) and other virtual sessions (via social media) will be held over a period of one month. The educational content will be in the form of pamphlets, tracts, educational videos, and slides. In 3 stages, the researcher-made questionnaire will be completed immediately after the training, immediately after the training, and 3 months after the training. The data will be analyzed with SPSS software. The teaching method should be measured.
Category
Behavior

2

Description
Control group: Health ambassadors and members of their families do not receive training in the control group, but after the intervention, they will be given a training package.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
No. 1. Mashhad Health Center
Full name of responsible person
Mahmoud fakhar
Street address
No. 16, Daneshgah St., School of Health
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3819 2206
Fax
+98 51 3852 2775
Email
fakharm2@mums.ac.ir
Web page address
https://ch-mashhad1.mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
No. 16، Daneshgah Street، Ghoreyshi, Mashhad, Korasan Razavi. Postal Cod: کد پستی : 13944-91388
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
presidentoffice@mums.ac.ir
Web page address
https://www.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahmoud Fakhar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No 16. Daneshghah street, Mashhad, Khorasan-Razavi. Postal Cod: 9137673119
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3189 2206
Email
Fakharm2@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehrsadat Mahdizadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
No.16, Daneshgah street, School of health, Mashhad, Khorasan razavi. Postal Cod: 9137673119
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3854 4633
Fax
Email
Mahdizadehtm@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahmoud Fakhar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 16, Daneshghah street, School of health, Mashhad, Khorasan Razavi. Postal Cod: 9137673119
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3847 4911
Email
Fakharm2@mums.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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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