Determining the effect of remote health program on health literacy and self-care behaviors in patients with high blood pressure at risk of peripheral artery disease.
Design
This study is a randomized controlled clinical trial using remote communication technology
Settings and conduct
The current research will be conducted on patients aged 45 to 95 years with high blood pressure diagnosed by a cardiologist at Shahid Rahimi Hospital in Khorramabad.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Has a record of hospitalization in Shahid Rahimi Hospital
Information and written consent to participate in the study (30)
Participants are at risk of peripheral artery diseases based on a special nomogram (minimum initial blood pressure increase of 140/90) (5).
Have a smart phone or laptop
Age between 45 and 95 years based on nomogram (36)
The patient or caregiver should be literate (37)
Have the ability to use smart phones and social networks (39)
Diagnosis of high blood pressure by a cardiologist
Exit criteria:
Reluctance to continue cooperation in the study (39)
Death of the patient (40)
Having hearing and speech problems (12)
Participation in other educational and rehabilitation programs (40)
Hospitalization during the study (38)
Suffering from other vascular diseases such as Raynaud's, lupus or vasculopathy
Existence of psychiatric diseases (28)
Absence of more than one meeting (14)
Having chronic diseases and limitations in self-care ability (38)
Changing mobile phone number and not informing (37)
Having a blood pressure crisis (110/180)
The need for vascular reconstruction through surgery Aortic aneurysm or vascular thrombosis
Intervention groups
Hypertensive patients at risk of peripheral artery disease
Main outcome variables
Increasing health literacy and self-care behaviors in hypertensive patients at risk of peripheral artery disease
General information
Reason for update
Acronym
اموزش سواد سلامت و رفتارهای خودمراقبتی از راه دور
IRCT registration information
IRCT registration number:IRCT20230409057867N1
Registration date:2025-06-04, 1404/03/14
Registration timing:retrospective
Last update:2025-06-04, 1404/03/14
Update count:0
Registration date
2025-06-04, 1404/03/14
Registrant information
Name
Farhad Falah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3326 3663
Email address
farhadfalah1367@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-10, 1402/02/20
Expected recruitment end date
2023-07-11, 1402/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Telehealth program on health literacy and self-care behaviors in patients with hypertension at risk of peripheral artery diseases
Public title
The effect of Telehealth program on health literacy and self-care behaviors in patients with hypertension at risk of peripheral artery diseases
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with hypertension
Has a record of being admitted to Shahid Rahimi Hospital in Khorram Abad
Exclusion criteria:
Age less than 45 years
Unwillingness to participate in the study
Age
From 45 years old to 95 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
More than 1 sample in each individual
Number of samples in each individual:
1
Each person or person caring for the patient was considered as a sample
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples in study groups is done by random block method. Then, by random block method, they are placed in 2 study groups in a balanced way. It should be noted that the volume of each block is 4 items, so that 6 different combinations of 4 blocks (AABB, ABAB, BBAA, BAAB, ABBA, BABA) are created and randomly selected by placing the blocks. are selected
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
Ethics Committee of Lorestan University of Medical Sciences and Health Services
Street address
University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moalem St., Lorestan, Khorram Abad
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2023-04-09, 1402/01/20
Ethics committee reference number
IR.LUMS.REC.1400.22510
Health conditions studied
1
Description of health condition studied
Peripheral artery disease
ICD-10 code
(I00-I99)
ICD-10 code description
IX Diseases of the circulatory system
Primary outcomes
1
Description
Increasing health literacy and self-care ability in patients with arterial vascular disease and the presence of risk factors such as blood pressure, smoking, improper diet and low activity
Timepoint
Before studying and after studying
Method of measurement
with Montazeri et al.'s health literacy questionnaire and Han et al.'s self-care questionnaire
Secondary outcomes
1
Description
Increasing patient self-care
Timepoint
Before and after study
Method of measurement
The 20-item instrument has 4-point Likert responses: always (score 4), often (score 3), sometimes (score 2) and rarely or never (score 1), with the total score varying between 20 and 80, and obtaining a higher score means more self-care. Is. Items 12 and 13 have reverse scoring
Intervention groups
1
Description
Control group:During the training period, this group was independent from the intervention group and will only receive routine treatment according to the previous roll
Category
Lifestyle
2
Description
Intervention group: This group will receive training on health literacy and self-care behaviors continuously and in two months through the remote network.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahimi Khorramabad Hospital
Full name of responsible person
Farhad Falah
Street address
Phase 2 of Army Coy, Shahab 5 East
City
Khorramabad
Province
Lorestan
Postal code
4736814949
Phone
+98 916 669 7718
Email
farhadfalah1367@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
tahare toulabi
Street address
University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moalem St., Lorestan, Khorram Abad
City
khorramabad
Province
Lorestan
Postal code
6813833946
Phone
Email
publicrelation@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Medical Sciences
Proportion provided by this source
1
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
Khoram-Abad University of Medical Sciences
Full name of responsible person
farhad falah
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Khorram Abad Lorestan, Phase 2 Army Quarter, Shahab 5 East
City
Khorram Abad
Province
Lorestan
Postal code
6814949473
Phone
+98 66 3330 0661
Email
toulabi_t@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
tahare toulabi
Position
college professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moalem St., Lorestan, Khorram Abad
City
khorram abad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
toulabi_t@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
farhad falah
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Phase 2 of Koi Artesh, Shehab 5 East
City
khorram abad
Province
Lorestan
Postal code
6814949473
Phone
+98 66 3330 0661
Email
farhadfalah1367@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To protect the privacy of the participants
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data will be stored in a file and the results will be published at the end of the study
When the data will become available and for how long
4 months
To whom data/document is available
Research team
Under which criteria data/document could be used
With the aim of improving and making patients aware of health-threatening conditions and lifestyle changes
From where data/document is obtainable
Research team
What processes are involved for a request to access data/document
After conducting the study and statistical analysis and recording the data, I will publish the data with the privacy of the participants and the consent of the groups