Protocol summary

Study aim
Determining the Effectiveness of Self-Care Training with Network Method Virtual on the quality of life of HIV positive patients in Tehran
Design
40 subjects in control group and 40 patients in intervention group will be divided into quasi-random method. The grouping will be based on the file number. It will first draw between the couple's number and the individual. The first group will be intervention group and the second group will be control group.
Settings and conduct
The study population was HIV positive patients referred to Behavioral Disease Counseling Centers in Tehran. 5 Behavioral Counseling Centers in Tehran will be selected. The study is single-blind and the participants are blinded.
Participants/Inclusion and exclusion criteria
Entry requirement: 1. A definitive diagnosis of HIV and having a file at the counseling center 2. Not having severe cognitive impairments such as mental retardation 3. Access to smartphone and internet 4. Age range from 18 to 45 years 5. Having informed consent 6. Minimum literacy skills 7. No addiction 8. No chronic diseases such as hepatitis, tuberculosis, etc.
Intervention groups
The intervention and control groups will complete the MQOL-HIV questionnaire. The intervention group will then receive audio and text files of virtual self-care skills training. Training will be for 4 weeks. The questionnaire will be completed again by the participants 2 weeks after the training and the information will be analyzed.
Main outcome variables
Quality of life of HIV-positive patient

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190924044872N1
Registration date: 2019-10-04, 1398/07/12
Registration timing: prospective

Last update: 2019-10-04, 1398/07/12
Update count: 0
Registration date
2019-10-04, 1398/07/12
Registrant information
Name
Anna Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4431 4148
Email address
anna.amini@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-05, 1398/07/13
Expected recruitment end date
2019-10-12, 1398/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual self-care education on quality of life in HIV positive patients
Public title
The effect of virtual self-care education on quality of life in HIV positive patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1.A definitive diagnosis of HIV and having a file at the counseling center 2.Not having severe cognitive disorders, such as mental retardation 3. Smartphone and Internet access 4. Age range 18 to 45 years 5. Having informed consent 6. Minimum literacy 7. No addiction 8. Lack of other chronic diseases such as hepatitis, tuberculosis, etc.
Exclusion criteria:
Lack of continuous communication with the researcher
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of medical school of Islamic Azad University of Tehran
Street address
No. 6, Block 16, Kanoon Ave., Share Ziba Blvd., ayatollah kashani, Tehran
City
Tehran
Province
Tehran
Postal code
1487953186
Approval date
2018-10-30, 1397/08/08
Ethics committee reference number
IR.IAU.TMU.REC.1397.227

Health conditions studied

1

Description of health condition studied
HIV
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease

Primary outcomes

1

Description
The quality of life of HIV-positive patients is measured by the standard MQOL-HIV questionnaire.
Timepoint
Questionnaires will be completed before intervention and 2 weeks after training.
Method of measurement
MQOL-HIV

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 40 HIV positive patients will complete the questionnaire. The group will then receive audio and text files for 4 weeks of self-care virtual training. The questionnaire will be completed again by this group within 2 weeks of completion of training.
Category
N/A

2

Description
Control group: 40 HIV-positive patients who did not receive education. This group will also be provided with training to follow ethics.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
مركز مشاوره بيماري‏هاي رفتاري والفجر
Full name of responsible person
Dr. Lesan Pezashki
Street address
West Shahid Dastgheib, Ostad Moein Boulevard, Azadi Ave.
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 6603 8920
Email
whc@iums.ac.ir

2

Recruitment center
Name of recruitment center
شبکه بهداشت و درمان شمیرانات
Full name of responsible person
بهرخ محمود زاده
Street address
at the beginning of Shariati Street, Qods Square
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 2223 0370
Email
Shemiranat@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Akram Peyman
Street address
School of Nursing, University of Science and Research, University Square, Simon Bolivar Ave.
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
akrampeyman@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad university
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
Islamic Azad University
Full name of responsible person
Anna Amini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 6, Block 16, Kanoon Ave., Share Ziba Blvd., Ayatollah Kashani
City
Tehran
Province
Tehran
Postal code
1487953186
Phone
+98 21 4431 4148
Email
anna.amini@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Anna Amini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 6, Block 16, Kanoon Ave., Share Ziba Blvd., Ayatollah Kashani
City
Tehran
Province
Tehran
Postal code
1487953186
Phone
+98 21 4431 4148
Email
anna.amini@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Anna Amini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 6, Block 16, Kanoon Ave., Share Ziba Blvd., Ayatollah Kashani
City
Tehran
Province
Tehran
Postal code
1487953186
Phone
+98 21 4431 4148
Email
anna.amini@yahoo.com

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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Clinical reports will be presented in paper form.
When the data will become available and for how long
Since 1399
To whom data/document is available
Researchers and students in academic institutions
Under which criteria data/document could be used
Any kind of ethical statistical analysis is allowed
From where data/document is obtainable
anna.amini@yahoo.com
What processes are involved for a request to access data/document
Send request and full justification for use of information to researcher
Comments
Loading...