Determining effect of mobile health on self-care in older people with myocardial infarction
Design
The clinical trial has two parallel groups of intervention and control and block randomization is used. The sample size is 128 people
Settings and conduct
This study will be performed in the heart clinic of Boo Ali Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 60 years old and older; history of myocardial infarction for at least the last 6 months; education level at least a diploma; has the mental capacity to communicate; patient consent to participate in the study; having a smartphone (Android).
Exclusion criteria: catching Heart failure; hearing or speech impairment that prevents communication; cognitive impairment such as Alzheimer's and amnesia; having debilitating diseases such as stroke and neurological diseases, etc.; occurrence of severe stressful event during the study or 3 months before; loss of smartphone; dissatisfaction with continuing the study.
Intervention groups
First, the health mobile application is installed on the phones of the intervention group and they are taught how to use it. Prior to the intervention, the baseline level of self-care will be assessed using the Self-care of Coronary Heart Disease Inventory (SC-CHDI) questionnaire uploaded to the health companion program.
Health intervention includes two parts: monitoring and training. During this period, the control group will receive the usual care of Qazvin Heart Center (Bouali Hospital), which includes a low-fat low-fat diet educational pamphlet, a visit to a heart clinic two weeks after discharge, as well as advice not to consume salt and not to have sex for two weeks.
Main outcome variables
Level of self-care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210327050782N1
Registration date:2021-08-15, 1400/05/24
Registration timing:prospective
Last update:2021-08-15, 1400/05/24
Update count:0
Registration date
2021-08-15, 1400/05/24
Registrant information
Name
Arash Ghiasvand mohammad khani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3367 4024
Email address
a.ghiasvand@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-21, 1400/05/30
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mobile health on self-care in older people with myocardial infarction
Public title
The effect of mobile health on self-care in older people with myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 years old and older
A history of myocardial infarction for at least the last 6 months
Has the mental capacity to communicate
Patient consent to participate in the study
Having a smartphone (Android)
Have minimum ability to read and write
Exclusion criteria:
Catching Heart failure
Hearing or speech impairment that prevents communication
Cognitive impairment such as Alzheimer's and amnesia
Having debilitating diseases such as stroke and neurological diseases, etc.
Occurrence of severe stressful event during the study or 3 months before
Loss of smartphone
Dissatisfaction with continuing the study
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization method will be used in this study to randomize the samples. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers in cases where intermediate analyzes are needed during the sampling process. Number of samples Equal to each of the study groups. The size of all the blocks is equal and we will have 6 groups of 6 blocks (including 3 participants in the intervention group and 3 participants in the control group) in this two-group experiment.
Random allocation software is also used for randomization tools. In addition to simple randomization, these random sequence generation software is able to generate random sequences by blocking method. To hide us from Allocation concealment
We use the method used to perform a random sequence on the study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with random sequence Sequentially numbered, sealed, opaque envelopes in
This method records each of the random sequences created on a card and the cards are placed in the letter envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
First, the health mobile application is installed on the phones of the intervention group and they are taught how to use it. Prior to the intervention, the baseline level of self-care will be assessed using the Self-care of Coronary Heart Disease Inventory (SC-CHDI) questionnaire uploaded to the accompanying health program.Health intervention includes two parts: monitoring and training. The monitoring section includes self-monitoring of the patient in the areas of drug use, examination of cardiac symptoms and nutrition, etc. The interactive and automated capability of this software is such that it provides reminders for timely consumption in the drug consumption section. In case of cardiac symptoms, patients can first receive a recommendation to go to the emergency room, stop the activity, etc. by entering their symptoms in the program. If there is a problem in the areas or have questions in these areas or training programs, they can refer to the question and answer section and send their question to the facilitators and receive the answer.The trainings provided in the health companion program are daily for 4 weeks. Educational content is provided to the elderly using specialized resources after simplification in the form of multimedia, Persian animations, text and audio in the accompanying health program. Different parts of this software help the user in various areas of self-care and receive the necessary information from the user in the form of artificial intelligence and forms and questionnaires. During this period, the control group will receive the usual care of Qazvin Heart Center (Bouali Hospital), which includes a low-fat low-salt diet educational pamphlet, a visit to the heart clinic two weeks after discharge, as well as advice not to consume salt and not to have sex for two It is the week.Immediately after the intervention and 1 month after, the software automatically measures the level of self-care of the participants and sends the results online to the software server and we access the data.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Qazvin University of Medical Sciences
Street address
Beheshti Blvd.
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Approval date
2021-08-03, 1400/05/12
Ethics committee reference number
IR.QUMS.REC.1400.200
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Self-care
Timepoint
(Before the intervention) and 30, 60 days after the intervention
Method of measurement
Self-care Questionnaire of Coronary Heart Disease Inventory (SC-CHDI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: first, the health mobile application is installed on the phones of the intervention group and they are taught how to use it. Prior to the intervention, the baseline level of self-care will be assessed using the Self-care of Coronary Heart Disease Inventory (SC-CHDI) questionnaire uploaded to the accompanying health program.Health intervention includes two parts: monitoring and training. The monitoring section includes monitoring the patient in the areas of medication use, cardiac symptoms, and nutrition. The interactive and automated capability of this software is such that in the drug consumption section, it provides reminders for timely use to the patient. In the event of cardiac symptoms, patients can first receive a recommendation to go to the emergency room, stop the activity or reduce the activity by entering their symptoms in the program. If there is a problem in the proposed areas or have a question in the same areas or training programs, they can refer to the question and answer section and send their question to the facilitators and receive the answer.The trainings provided in the health companion program are daily for 4 weeks. Educational content is provided to the elderly using specialized resources after simplification in the form of multimedia, Persian animations, text and audio in the accompanying health program. Different parts of this software help the user in various areas of self-care and receive the necessary information from the user in the form of artificial intelligence and forms and questionnaires.Immediately after the intervention and 1 month after, the software automatically measures the level of self-care of the participants and sends the results online to the software server and we access the data.It should be noted that the intervention group will also receive the usual care of the heart center.
Category
Lifestyle
2
Description
Control group: control group will receive the usual care of Qazvin Heart Center (Bouali Hospital), which includes a low-fat low-salt diet educational pamphlet, a visit to a heart clinic two weeks after discharge, as well as advice not to consume salt and not to have sex for up to two weeks.Immediately after participating in this study and one month later, the level of self-care will be asked of them and will be examined with other data.