The study of the effect of family-centered care by short message service method on life expectancy, quality of life and self-efficacy in drug compliance in patients with acute myocardial infarction
Determining the effect of family-centered interventions by send message service on quality of life, life expectancy and effective self-efficacy on drug compliance in patients with acute myocardial infarction
Design
Clinical trial was randomized. sampling is easy and was done based on inclusion criteria. According to the sample size formula, 32 individuals were included in each sample, which increased to 40, including 10% sample loss. Samples were assigned to the control and intervention groups based on randomized random sampling software. Study is one blind
Settings and conduct
A randomized clinical trial study was conducted in Hajar Hospital and Kashani Hospital in Shahrekord. The samples are not know how classified in the control and test groups.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
• The willingness of the patient and family member to participate in the study, Not having hearing؛ speech and vision problems؛ New diagnosis of acute myocardial infarction by the physician؛ Being an active member of the family to read and write short messages and complete questionnaire؛ Having a mobile phone and the ability to use it to answer the phone؛ receive؛ read؛write and send messages to the active member of the family
Exit criteria:
Unwillingness of the patient or family member to co-operate؛ stage two or more of the disease
Intervention groups
intervention method in intervention group:
In the intervention group, for a period of 12 weeks and 4 times a week, a text message will be sent with the content of the time, the amount of the drug and the necessary care.
Patients in the control group receive routine hospital intervention.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180127038530N1
Registration date:2018-09-29, 1397/07/07
Registration timing:retrospective
Last update:2018-09-29, 1397/07/07
Update count:0
Registration date
2018-09-29, 1397/07/07
Registrant information
Name
Leila Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3226 4221
Email address
st-ebrahimi.l@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-10, 1396/10/20
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effect of family-centered care by short message service method on life expectancy, quality of life and self-efficacy in drug compliance in patients with acute myocardial infarction
Public title
Send Message Service self efficacy and quality of life and life expectancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's desire and the active participation of the family to participate in the study
Not having hearing, speech and vision problems
New diagnosis of acute myocardial infarction by a physician
Being an active member of the family to read and write short messages
Having a mobile phone and the ability to use it to answer the phone, receive, read, write and send SMS messages to the active member of the family
Not having any confirmed mental illness in the patient and active member of the family
The patient has no other illness other than a cardiovascular disease
An active member of a family member of the patient who has the opportunity to receive text-lessons and transfer materials to the patient, and the patient has a chance to hear him.
Exclusion criteria:
Unwillingness of the patient or family member to continue cooperation
stage two or more of the disease
Age
From 25 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was done in a convenient way and based on the inclusion criteria of patients referred to the heart department and CCU of Hajar Hospital and Kashani Hospital. According to the researcher's daily visit to the hospital, on the first day and the first appointment with the patient, he will select him as a research unit according to the conditions of entry. The samples were assigned randomly in two groups A and B respectively in the intervention and control groups based on the statistical software of the game.
Blinding (investigator's opinion)
Single blinded
Blinding description
To conduct the research a trained medical emergency specialist for acute myocardial infarction justified by the main executor for the purpose of the work, was used as a research associate for the researcher. The researcher's assistance after sampling and completion of the questionnaires a questionnaire it is delivered to the researcher and the researcher imports the samples in the control and sample groups based on the random distribution. Therefore, the patients are blinded to the distribution of samples in two groups of control and intervention. Only the completion of the questionnaire is done by the researcher.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Kashani Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818843519
Approval date
2018-01-30, 1396/11/10
Ethics committee reference number
1396.234.IR.SKUMS.Rec
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Quality Of Life
Timepoint
Before the intervention and 90 days after the intervention began
Method of measurement
Mac New Questionnare
2
Description
Self Afficacy in medical adherence
Timepoint
Before the intervention and 90 days after the intervention began
Method of measurement
Self-Efficacy for Appropriate Medication Use Scale
3
Description
Life Expectancy
Timepoint
Before the intervention and 90 days after the intervention began
Method of measurement
Schneider hope Questionnare
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group for twelve weeks, 48 mobile SMS messages are sent every week to four educational short messages related to the diet, quality of life and life expectancy.
Category
Behavior
2
Description
Control group: Hospital routine intervention (drug delivery and training during clearance)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Fereshte Aein
Street address
Parastar Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818843519
Phone
+98 38 3334 6691
Email
fereahteaein@yahoo.com
2
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Fereshte Aein
Street address
Parastar Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818843519
Phone
+98 38 3334 6691
Email
fereahteaein@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University Medical sciense
Full name of responsible person
Research Deputy
Street address
Kashani Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
fereshtehaein@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University Medical sciense
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Fereshteh Aein
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rahmatiye
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 5648
Email
fereshtehaein@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Fereshteh Aein
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 5648
Email
fereshtehaein@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Leila Ebrahimi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 1, Alley 38, Namjoo Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818843519
Phone
+98 38 3226 4221
Email
leilaebrahimi1394@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
Only in condition of reviewer's need for data, the data will be send for them