Protocol summary

Study aim
Investigating the Impact of a Self-Care Navigator Application on Physical and Spiritual Health Behaviors
Design
This is a randomized, single-blind, parallel-group, controlled clinical trial involving 80 volunteers. The intervention group will be provided with a self-care application, while the control group will receive a pamphlet. Health behaviors will be assessed in both groups before and after the educational intervention.
Settings and conduct
Eligible individuals referring to Taleghani Hospital in Tehran will be enrolled in the study after completing informed consent and will be randomly assigned to the control and intervention groups. The researcher, outcome collector, and data analyst will be blinded to the allocation of participants to the study groups.
Participants/Inclusion and exclusion criteria
They must be over 18 years of age, willing to install the self-care app on their mobile phones, and not suffer from an illness requiring hospitalization.
Intervention groups
The intervention group receives a self-care application—a mobile-based program featuring educational content on health behaviors. The control group receives instruction via a pamphlet containing educational content on health behaviors.
Main outcome variables
Health behaviors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210131050189N20
Registration date: 2026-10-18, 1405/07/26
Registration timing: registered_while_recruiting

Last update: 2026-10-18, 1405/07/26
Update count: 0
Registration date
2026-10-18, 1405/07/26
Registrant information
Name
Raziyeh Ghafouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 4520
Email address
ghafouri@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-17, 1405/07/25
Expected recruitment end date
2027-10-22, 1406/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of a Self-Care Navigator Application on Physical and Spiritual Health Behaviors
Public title
Impact of a Self-Care Navigator Application
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to use a smartphone. Being literate (able to read and write).
Exclusion criteria:
Contracting an illness requiring hospitalization
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of participants to two intervention and control groups will be done with the help of statistical randomization software using simple randomization methods and in parallel. Before the intervention, the study is registered in the Study Randomizer web application software, available at (https://www.studyrandomizer.com). The research information, including the number of 80 participants, two intervention groups, and random and parallel allocation to the two groups, is given to the software. After registering the study, by clicking on the participant entry option, the software randomly enters the individual into one of the two groups and gives him a code. 80 samples are entered into the software in the same way, and a random sequence is prepared with the software from 1 to 80. To conceal the random sequence, 80 sealed envelopes are then prepared, and the envelopes are numbered from 1 to 80. Then, the random sequence prepared by the software is placed in the envelopes in the intervention groups from 1 to 80 in order. Then, as each person enters the study, their envelope is opened, and they are placed in one of two study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this way, researcher A makes the allocation and the results are recorded by researcher B, who is unaware of the group allocation. The data analyst will also be unaware of the grouping of participants.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of School of Pharmacy and Nursing & Midwifery- SBMU
Street address
SBMU School of Pharmacy and Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2026-09-15, 1405/06/24
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1405.179

Health conditions studied

1

Description of health condition studied
Unhealthy lifestyle
ICD-10 code
Z72
ICD-10 code description
Problems related to lifestyle

Primary outcomes

1

Description
Health behaviors
Timepoint
One week before the intervention, two weeks after the completion of the educational intervention.
Method of measurement
Health Behavior Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group is provided with a self-care application. This application is mobile-based software containing educational content and information on health behaviors.
Category
Lifestyle

2

Description
Control group: In the control group, education is provided via a pamphlet containing educational content on health behaviors.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
(Ayatollah) Taleghani Educational Hospital
Full name of responsible person
Raziyeh Ghafouri
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2303 1100
Email
taleghani@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zargi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh ghafouri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shareable after de-identifying individuals
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
More research
From where data/document is obtainable
By email to the corresponding author: raziehghafouri@gmail.com
What processes are involved for a request to access data/document
By email to the corresponding author: raziehghafouri@gmail.com
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