1. Home
  2. Approved trials
  3. » فارسی

Assessment of the effect of patient education and follow up with short massage on adherence to therapeutic regimen of the patients with acute coronary syndrome after discharge of coronary care units.

Protocol summary

Study aim
Determination of the effect of patient education and fallow up with short massage on adherence to therapeutic regimen with acute coronary syndrome after discharge
Design
This is a parallel clinical trial, pragmatic, community based with two intervention and a control group. The subjects will allocate to each group through a random block approach. Each block have a sample of each group. Then, each block randomly will be selected of one of the six possible state. In this study, blindness is not possible.
Settings and conduct
In the clinical trial study, 111 patients with acute coronary syndrome who hospitalized in the coronary intensive care units, 5th of Azar and Sayyad Shirazi in Gorgan; Amiralmomenin in Kordko city and Al-Jalil in Ahgala city will be selected through convenient sampling and then, will be designated randomly into three groups. The first and second groups will be educated through a booklet about adherence of treatment by the researcher. Then they will receive the booklet.  The second group will be followed by short message after discharge for 2 months. The control group will only receive routine pre-discharge training. Two months after the discharge, the adherence questionnaire will be completed for each patient in the heart clinic or patient home. In the study blinding is not possible.
Participants/Inclusion and exclusion criteria
Inclusion criteria: subjects' age between 25 - 75 years, confirming patients' acute coronary syndrome by a Cardiologist, having an active Mobile and SMS program (short message service). Exclusion criteria : Not having sensory perception or mental retardation Not having advanced disease such as censer.
Intervention groups
Group1: Training booklet group2: Training, Booklet and Follow-up Group3: Control
Main outcome variables
Treatment regimen adherence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180911041002N1
Registration date: 2019-01-22, 1397/11/02
Registration timing: registered_while_recruiting

Last update: 2019-01-22, 1397/11/02
Update count: 0
Registration date
2019-01-22, 1397/11/02
Registrant information
Name
Zoleikha Ghoreishi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3242 6900
Email address
ghoreishi.z@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of patient education and follow up with short massage on adherence to therapeutic regimen of the patients with acute coronary syndrome after discharge of coronary care units.
Public title
Effect of patient education and follow up with short massage on patient's therapeutic adherence with heart disease.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 25 to 75 years old Acute coronary syndrome diagnosis approved by a cardiologist physician Ability to speak and understanding Persian language by patient or relatives Ability to using mobile by patient or relatives Having active mobile and ability to send SMS by patient or relatives Achieving adherence score less than 50%
Exclusion criteria:
Not having other advanced disease, such as cancer, diabetes Not having diagnosed mental disorder Unwillingness to participate in research by patient or relatives Lack of access to the patient after discharge
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 111
Randomization (investigator's opinion)
Randomized
Randomization description
We have three groups in this study. Group A = training with booklet, Group B = training with booklet and follow-up with SMS, and Group C = Control group. In this study, we have 111 samples, each of which contains 37 patients. For block randomization, the simplest and smallest production block will be 3 blocks (3 = the number of groups under investigation). Therefore, we have 6 states including 1. ABC, 2. CAB, 3. CAB, 4. BCA, 5. BAC, 6. ABC. To execute, we will use a regular hexagon (6 sided dice) that each side of dice is attributed to one of the 1 to 6 above states. So, by each throwing a dice, one of these situations arises. By 37 throwing the dice, we have 37 triple block that randomly created. Example: ABC, BAC, BAC, CBA, ABS, CAB, ........ = 37 Triple Block
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 Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, Shast-Kola Road, Saari Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2018-09-03, 1397/06/12
Ethics committee reference number
IR.GOUMS.REC.1397.102

Health conditions studied

1

Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified

Primary outcomes

1

Description
Adherence to the treatment regimen
Timepoint
At the beginning of the study and 2 months after the patient's discharge
Method of measurement
Adherence to treatment questionnaire-self report

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group will be educated about adherence the drug orders, the type of medications used by the patient, the importance of adherence of medication orders, unwanted side effects of drugs, considering doses of medication, taking on time, emergency medicines, diet and permitted exercise. The second group: In addition to teaching the above, short message will be sent about the times and drug using, attention to dosage, diet, and mobility are at the acceptable level. These training take place in two sessions and each session about 45 minutes.
Category
Behavior

2

Description
Second intervention group: training, booklet, Follow-up reminder short messages Patients are trained in the ward on the patient's bedside for a half to an hour before discharge by the researcher. The booklet has been prepared by a researcher and confirmed by a cardiologist and dietitian. Within two months after the discharge, 3 times a week, a reminder message will be sent to the patient. Two months after discharge the adherence questionnaire, researcher at the Patient's Home or Heart Clinic will complete the face-to-face interview.
Category
Behavior

3

Description
Control group will receive only routine training before discharge of the ward. Two months after discharge of the patients, they will complete the adherence questionnaire in their home or in clinical heart disease department through face-to-face interview by researcher.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sayyad Shirazi hospital in Gorgan
Full name of responsible person
Zoleikha Ghoreishi
Street address
Shahid Sayyad Shirazi hospital, Shahid Sayyid Shirazi Blvd.
City
Gorgan
Province
Golestan
Postal code
4917867439
Phone
+98 17 3215 1502
Fax
+98 17 3226 1175
Email
infosayyad@goums.ac.ir

2

Recruitment center
Name of recruitment center
5 Azar hospital
Full name of responsible person
Zoleikha Ghoreishi
Street address
5 Azar street
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Email
pr-5azar@goums.ac.ir

3

Recruitment center
Name of recruitment center
Amir Almomenin Kordkoy hospital
Full name of responsible person
Zoleikha Ghoreishi
Street address
Forest Avenue
City
Kordkoy
Province
Golestan
Postal code
4881899441
Phone
+98 17 3432 5769
Fax
Email
h.kordkoy@goums.ac.ir

4

Recruitment center
Name of recruitment center
Al Jalil Aq Qala Hospital
Full name of responsible person
Zoleikha Goreishi
Street address
Aqqala Bandar Turkman Road
City
Aqqala
Province
Golestan
Postal code
4931313946
Phone
+98 17 3452 6767
Email
alejalil-H@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Street address
Golestan University of Medical Sciences, Sari Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 6900
Fax
+98 17 3245 5171
Email
Honarvar@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Gholam Reza Mahmoodi-shan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Golestan University of Medical Sciences, Sari Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17324551660
Fax
+98 17 3242 1657
Email
mahmoodigh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Zoleikha Ghoreishi
Position
Critical Care Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
Golestan University of Medical Sciences, Sari Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17324551660
Fax
Email
ghoreishi.z@goums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Zoleikha Ghoreishi
Position
Critical care nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
Golestan University of Medical Sciences, Sari Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3245 1660
Fax
+98 17 3245 5171
Email
ghoreishi.z@goums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
Results of the study will be published as an article. The ethical principle will be respected during preparation of the article for publishing.
When the data will become available and for how long
Accessibility of the data can be started 6 months after publishing the results of the study as an article.
To whom data/document is available
Only for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The results could be used for scientific purposes with citing to the article published.
From where data/document is obtainable
4918936316 TEL_01732451660 Fax_4421657, Golestan University of Medical Sciences, Sari Road, Gorgan, IRAN
What processes are involved for a request to access data/document
Scholar valid documents and the title of study must be sent and the study must be about adherence of therapeutic regime in patient with acute coronary syndrome.
Comments
Loading...