1. Home
  2. Approved trials
  3. » فارسی

Investigating the effectiveness of telenursing based on self-care program on self-efficacy and medication adherence in patients with myocardial infarction

Protocol summary

Study aim
Determining the effect of telenursing based on self-care program on self-efficacy and medication adherence in patients with myocardial infarction
Design
In the clinical trial, 62 patients will be selected using the available method, then will be divided into intervention and control groups equally (ratio 1:1) using block randomization method with the size of 4 and 6 blocks. The online randomization service of Sealed Envelope Ltd will be used to generate the randomization list
Settings and conduct
The statistical population of this research is the patients with heart attack hospitalized in the cardiology department, PCCU and CCU of Dr. Heshmat Rasht specialized and sub-specialized hospital; The telenursing method is telephone and SMS follow-up.
Participants/Inclusion and exclusion criteria
Entry: having minimum reading and writing literacy, having a phone, diagnosis of heart attack by a cardiologist Exclusion includes: death of the patient, non-cooperation
Intervention groups
In the intervention group, in addition to the routine training, a one-on-one face-to-face training session is given in the hospital about heart anatomy and physiology in simple language, MI pathophysiology and the duties and avoidances that the patient must do, after discharge, telephone follow-up for one It will be done twice a week for 20 minutes, and educational items will be sent to them via SMS after the phone call. During the phone call, appropriate training will be given based on the patient's needs regarding diet, fluid intake, physical activity and rest, sexual activity, treatment follow-up, anxiety and stress reduction, and adherence to medication regimen. In the control group, no intervention will be applied by the researcher and they will receive the routine interventions of the ward.
Main outcome variables
Efficacy Adherence to medication

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240416061511N1
Registration date: 2024-05-23, 1403/03/03
Registration timing: registered_while_recruiting

Last update: 2024-05-23, 1403/03/03
Update count: 0
Registration date
2024-05-23, 1403/03/03
Registrant information
Name
Arian Mobasheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4263 2274
Email address
arian.mobasheri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of telenursing based on self-care program on self-efficacy and medication adherence in patients with myocardial infarction
Public title
Investigating the effectiveness of telenursing on myocardial infarction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Entry criteria include: having minimum literacy Lack of speech and hearing problems Not suffering from psychological diseases Having a landline and mobile phone to establish telenursing Willingness to participate in the study Having a myocardial infarction Diagnosis of the disease by a cardiologist
Exclusion criteria:
death of the patient Unwillingness to continue cooperation Simultaneous participation in other studies
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected using available sampling method. Then, all eligible patients will be divided equally (1:1 ratio) into intervention and control groups using the block randomization method with the size of blocks of 4 and 6.
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 Gilan University of Medical Sciences
Street address
Shahid Beheshti Blvd., next to Jaber Rad Health Network
City
Langrud
Province
Guilan
Postal code
4471655513
Approval date
2024-05-01, 1403/02/12
Ethics committee reference number
IR.GUMS.REC.1403.032

Health conditions studied

1

Description of health condition studied
myocardial infarction
ICD-10 code
I23.8
ICD-10 code description
Other current complications following acute myocardial infarction

Primary outcomes

1

Description
Self-efficacy score in Sullivan questionnaire
Timepoint
Self-efficacy measurement at the beginning of the study (before the start of the intervention) and after four weeks from the last contact
Method of measurement
Sullivan self-efficacy questionnaire

2

Description
The score of adherence to drug treatment in Morisky questionnaire
Timepoint
Measurement of adherence to drug treatment at the beginning of the study (before the start of the intervention) and after four weeks from the last contact
Method of measurement
Questionnaire of compliance with Moriski's drug treatment

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, in addition to the routine training, a face-to-face training session is given in the hospital individually about the anatomy and physiology of the heart in simple language, the pathophysiology of MI and the obligations and avoidances that the patient must do, and the patient's questions are also answered; This meeting will be held for half an hour and then, after the discharge, telephone follow-up for one month will be conducted twice a week by the researcher based on the needs of each patient and his questions for 10 to 20 minutes and the cases In order not to forget the patient, training is sent to them in the form of a text message after the phone call. During the phone call, appropriate training is provided based on the patient's needs regarding diet, fluid intake, physical activity and rest, sexual activity, treatment follow-up, reduction Anxiety and stress and adherence to medication regimen will be given (45). Also, the phone number of the researcher will be provided to the patients to answer their questions. At the end, after four weeks from the last contact in the intervention and control group, Moriski et al.'s MMAS-8 medication regimen compliance questionnaire and Sullivan's self-efficacy questionnaire will be completed again with the coordination of the patient over the phone.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Heshmat hospital
Full name of responsible person
Arian Mobasheri
Street address
next to Gilan Province Management and Planning Organization- Khordad 15 St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 9064
Email
heshmat@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Parand Pourghane
Street address
Eastern Gilan School of Nursing, Midwifery and Paramedicine- Shahid Yaqoub Sheikhi Street - Laila Koh Road
City
langrud
Province
Guilan
Postal code
4477166595
Phone
+98 13 4256 5059
Email
pourghanep@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Arian Mobasheri
Position
Geriatrics master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Jaber Rod dormitory- next to the health network -Shahid Beheshti Boulevard
City
Langrud
Province
Guilan
Postal code
4471655513
Phone
+98 13 4255 3961
Email
Arian.mobasheri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Parand Pourghane
Position
PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Eastern Gilan School of Nursing, Midwifery and Paramedicine-Shahid Yaqoub Sheikhi Street - Laila Koh Road
City
Langrud
Province
Guilan
Postal code
4477166595
Phone
+98 13 4256 5059
Email
pourghanep@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Arian Mobasheri
Position
Geriatrics master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Jaber Rod dormitory- next to the health network -Shahid Beheshti Boulevard
City
Langrud
Province
Guilan
Postal code
4471655513
Phone
+98 13 4255 3961
Email
Arian.mobasheri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in research work
From where data/document is obtainable
Arian mobasheri Arian.mobasheri@gmail.com
What processes are involved for a request to access data/document
They will then provide a full explanation of what they are doing.
Comments
Loading...