Protocol summary

Study aim
Determining the effect of cardiac rehabilitation of home-based guidance nurse on adherence to treatment in patients with myocardial infarction
Design
Randomized clinical trial,Parallel، one-way blind, with control group, eligible individuals (78 people) and in each group randomly block with four blocks of random allocation will be performed using Excel software
Settings and conduct
Patients are selected from the heart ward of Shariati Hospital based on the inclusion criteria and the rehabilitation of the supervising nurse is performed with the necessary coordination in the patient's home and using the means of communication. All participants believe they were involved in the intervention, even though some did not. We send a written consent and an online questionnaire to all participants with a description of the research.Then the necessary coordination is done with the test group Placed.
Participants/Inclusion and exclusion criteria
Patients between 40-65 years 6-12 months with myocardial infarction - Has not participated in the training program - Apart from the underlying diseases, the cause of myocardial infarction is not a disease or a cognitive problem. Failure to respond to a home visit more than once Acute disease with the need for hospitalization and surgery
Intervention groups
For the test group (39 people) 4 sessions once a week, and for questions and answers until the post-test, continuous communication will be used using communication tools. The control group will receive routine care in the hospital and then, they will be provided with an educational booklet on the topic of following treatment for myocardial infarction.
Main outcome variables
Adherence to treatment, diligence in treatment, willingness to participate in treatment, ability to adapt, integration of treatment with life, clinging to treatment, commitment to treatment, tact in implementing treatment

General information

Reason for update
Acronym
HBCR
IRCT registration information
IRCT registration number: IRCT20201006048953N1
Registration date: 2020-12-24, 1399/10/04
Registration timing: prospective

Last update: 2020-12-24, 1399/10/04
Update count: 0
Registration date
2020-12-24, 1399/10/04
Registrant information
Name
Zohreh Parsaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2201 6435
Email address
zohrehparsaeian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-04, 1399/10/15
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of home based nurse- led cardiac rehabilitation on adherence to therapeutic regiments in patients with myocardial infarction
Public title
The effect of home based nurse- led cardiac rehabilitation on patients with myocardial infarction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The definitive diagnosis of myocardial infarction is based on the opinion of a cardiologist for 6-12 months. Literacy Speaking Persian Lack of communication and cognitive problems No other underlying diseases (except diseases that lead to myocardial infarction), Resides in Tehran Age between 40-65 years
Exclusion criteria:
Failure to respond to a home visit more than once Acute disease with the need for hospitalization and surgery
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Given the four classes (women under 50, women equal to or older than 50, men under 50 and men equal to or older than 50) each class will use a quadruple random block (in each The following four states may occur: (I = Intervention & C = control) 1- (IICC) 2- (ICIC), 3- (ICCI), 4- (CICI), 5- (CCII), 6- (CIIC) The order in which each of the above blocks is placed will be determined by the software, then the cards will be sorted according to the specified order and the entry row (according to the order of entry) and the type of assigned group will be covered. Each person's entry into the study of the assigned group will be determined by removing the cover from each intervention or control group card. It should be noted that on the cover of each card, a row of cards is written (meaning that this is the second person in the desired category to enter the study) and before opening the cover, another researcher checks the entry row of the person in the floor with the check tables. And then the cover of the card will be opened and the type of individual group (intervention group or control group) will be specified.
Blinding (investigator's opinion)
Single blinded
Blinding description
All participants thought they were involved in the intervention, even though some did not. The researcher sends a written consent and an online questionnaire to all participants and it is explained to them that they participate in the research. After random allocation and selection of the test group, the necessary coordination is done with the test group Placed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Floor 5، Number 30، Zeinab Alley، Mohry Alley، Valiasr Street، Tehran
City
Tehran
Province
Tehran
Postal code
1966765664
Approval date
2020-08-24, 1399/06/03
Ethics committee reference number
IR.TUMS.FNM.REC.1399.092

Health conditions studied

1

Description of health condition studied
Myocardial Infraction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Primary outcomes

1

Description
Adherence to therapeutic regiments
Timepoint
Beginning of research and after 3 months from the start of research
Method of measurement
Madanlu Treatment Adherence Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Cardiac rehabilitation of a guiding nurse at home in 4 sessions with lifestyle modification topics in the field of stress management, healthy nutrition and exercise that is done by the researcher and patients are followed for 3 months and patients' weight and blood pressure control is done and educational pamphlet in It is at the disposal of the patients. Patients in 4 sessions of one and a half hours at home and through virtual educational topics on heart function, blood pressure and heart attack, the effects of exercise and walking on weight control and better heart function, healthy and unhealthy stress management, DASH diet (including vegetables , Sausages, sprouts, whole grain breads and white meat protein) and instructional videos. Patients walk 30 minutes a day and do health meditation, are followed up electronically within two months of training, and patients' questions are answered during this time. Weight and blood pressure are controlled. At the beginning and end of this course, patients take an online questionnaire of demographic information and adherence to Madanlu treatment.
Category
Rehabilitation

2

Description
Control group: They receive only the usual care (Includes medication, doctor visits and tests) after discharge from the hospital and at the end, an educational pamphlet is provided to the patients.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariatee Hospital
Full name of responsible person
Dr. Mehrpour Mohammadabadi
Street address
Tehran, North Kargar Street, Jalal Al-Ahmad Three Ways
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Web page address
http://shariati.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehrnaz Granmayeh
Street address
Tehran, Tohid Square, Tehran School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4207
Email
pajoheshyar@sina.tums.ac.ir
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

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zohreh Parsaeian
Position
Nurse، Bedside Instructor، Technical Assistant
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Floor 5، Number 30، Zeinab Alley، Mohry Alley، Valiasr Street، Tehran t
City
Tehran
Province
Tehran
Postal code
1966765664
Phone
+98 21 2201 6435
Email
zohrehparsaeian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zohreh Parsaeian
Position
Nurse، Technical Assistant، Bedside Instructor
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 30, 5th Floor, Zeinat Alley, Mohri Alley, Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1966765664
Phone
+98 21 2201 6435
Email
zohrehparsaeian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zohreh Parsaeian
Position
Nurse, Technical Officer, Clinical Instructor
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 30, 5th Floor, Zeinat Alley, Mohri Alley, Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1966765664
Phone
+98 21 2201 6435
Email
zohrehparsaeian@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
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not 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
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