Protocol summary
-
Study aim
-
Determining the effect of mobile educational application on adherence to treatment and its consequences on blood pressure in the elderly with hypertension of the Retired Cultural Center
-
Design
-
This study is a randomized clinical trial with a control group that was conducted to determine the effect of mobile educational application on adherence to treatment and its consequences on blood pressure in 54 elderly people with hypertension in the retired cultural center of Neishabour. In order to randomly assign individuals to the two groups and ensure the balance of the number of individuals in the groups, the block randomization method was used.
-
Settings and conduct
-
The research took place in the Neishabour Cultural Retirees Education Center, which includes an organization in Neishabour city.
-
Participants/Inclusion and exclusion criteria
-
Elderly 70 to 60 years according to WHO guidelines
No history of psychological disorders based on AMT questionnaire
No history of attending similar training sessions for at least 6 weeks
Take anti-hypertensive drugs based on your doctor's diagnosis
Member of Neishabour Retired Cultural Association
Has a smartphone with Android operating system
The ability to use mobile phones and educational applications that were objectively examined by the researcher in the first session.
Primary hypertension based on physician diagnosis for at least 6 weeks
-
Intervention groups
-
Intervention group: Patients with hypertension referred to the Neishabour Cultural Retirees Center who were trained.
Control group: The patient with hypertension referred to the Cultural Retirees Center of Neishabour city who met the inclusion criteria.
-
Main outcome variables
-
Adherence to treatment; Hypertension
General information
-
Reason for update
-
Due to presence of some mistakes in the initial registration of information and re-examination by the supervisors, we decided to correct them.
Inclusion criteria: The reason for updating the information in this section was the misspelling of some inclusion conditions.
Total sample size: The reason for updating this section was a mistake in recording study information.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200618047824N1
Registration date:
2020-11-29, 1399/09/09
Registration timing:
retrospective
Last update:
2021-03-24, 1400/01/04
Update count:
2
-
Registration date
-
2020-11-29, 1399/09/09
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-06-06, 1399/03/17
-
Expected recruitment end date
-
2020-08-05, 1399/05/15
-
Actual recruitment start date
-
2020-06-06, 1399/03/17
-
Actual recruitment end date
-
2020-08-05, 1399/05/15
-
Trial completion date
-
2020-08-05, 1399/05/15
-
Scientific title
-
The effect of mobile educational application on adherence to treatment and blood pressure in the elderly with hypertension
-
Public title
-
The effect of mobile educational application on adherence to treatment and blood pressure in the elderly
-
Purpose
-
Health service research
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Elderly 60 to 70 years according to WHO guidelines
No history of psychological disorders based on AMT questionnaire
No history of attending similar training sessions for at least 6 weeks
Take anti-hypertensive drugs based on your doctor's diagnosis
Member of Neishabour Retired Cultural Association
Has a smartphone with Android operating system
The ability to use mobile phones and educational applications that were objectively examined by the researcher in the first session.
Primary hypertension based on physician diagnosis for at least 6 weeks
Exclusion criteria:
Having vision, hearing or any illness that prevents the use of smartphones
Having a history of psychological disorders based on AMT questionnaire
-
Age
-
From 60 years old to 70 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
54
Actual sample size reached:
54
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Samples were selected consecutively from the retirees of the Neyshabour Cultural Association based on the inclusion criteria. In order to randomly assign people to two groups and ensure the balance of the number of people in the groups, the block randomization method was used. In this study, blocks with quadruple sizes were created. Random sequences were generated using the www.sealedenvelope.com website. Dark envelopes were used to conceal the allocation. Equivalent to the calculated sample size (n = 54), a dark envelope was prepared and the envelopes were numbered from 1 to 54 and the name of the desired group (control or intervention) was placed inside each envelope according to the random sequence created.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-02-12, 1398/11/23
-
Ethics committee reference number
-
IR.TUMS.FNM.REC.1398.175
Health conditions studied
1
-
Description of health condition studied
-
Hypertension
-
ICD-10 code
-
I10
-
ICD-10 code description
-
Essential (primary) hypertension
Primary outcomes
1
-
Description
-
Adherence to treatment
-
Timepoint
-
At the beginning of the study (before the intervention) and after the end of the study (after the last session of the intervention)
-
Method of measurement
-
40-item questionnaire on adherence to treatment in chronic diseases developed by Madanloo et al. (2013)
Secondary outcomes
1
-
Description
-
Hypertension
-
Timepoint
-
At the beginning of the study (before the intervention) and after the end of the study (after the last session of the intervention)
-
Method of measurement
-
Use a sphygmomanometer
Intervention groups
1
-
Description
-
Intervention group: The intervention for the intervention group was performed in the form of 6 absentee sessions: The first session: stating the objectives, explaining the mobile health training program, the content of the training sessions (training chart), how to communicate with the researcher to answer questions and resolve ambiguity. Session 2: Definition of hypertension, symptoms, complications and methods of treatment and control. Session 3: Lifestyle and include proper diet for hypertensive patients. Session 4: Lifestyle and include adequate exercise, sleep and rest for hypertensive patients. Session 5: Lifestyle and includes the effect of stimulants such as tea, caffeine and coffee on blood pressure and the harms of smoking and alcohol consumption for hypertensive patients. Session 6: Lifestyle and stress management in hypertensive patients.
-
Category
-
Lifestyle
2
-
Description
-
Control group: Patients with hypertension referred to the Cultural Retirees Center of Neishabour city who met the inclusion criteria. This group is not specially trained by researchers.
-
Category
-
Treatment - Other
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Tehran 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
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
-
The data obtained from this project will eventually be reported as standard and general, and reporting personal information by individuals does not seem necessary.
-
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
-
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
-
Demographic information and information about the main outcome of this project can be shared.
-
When the data will become available and for how long
-
Start of access period 1 year after printing the results
-
To whom data/document is available
-
The data of this project can be shared by all aspiring researchers working in academic and scientific institutes.
-
Under which criteria data/document could be used
-
Appropriate scientific use of the data of this study in order to improve the quality of similar studies is unimpeded.
-
From where data/document is obtainable
-
The data of the present research is possible by announcing the request via email Nikpeyma@yahoo.com and also danial.baghei@gmail.com.
-
What processes are involved for a request to access data/document
-
After confirming the eligibility of the person requesting the information, the data will be sent as soon as possible via the above emails.
-
Comments
-