Protocol summary

Study aim
Determining the effect of remote nursing (online courses) on inner strength and resilience of elderly patients after acute myocardial infarction
Design
Since the current study is a randomized controlled trial, elderly patients diagnosed with myocardial infarction who are discharged from cardiac departments will be randomized into the control and intervention groups. In the pre-test between both intervention and control groups, standard questionnaires of internal strength and resilience are provided to them. Despite the available sampling, the allocation of samples in groups is done randomly and by random block method. Therefore, first, 14 blocks of 2 people for two intervention and control groups are designed and arranged inside the blocks, and the blocks are numbered, then according to the table of random numbers, the block number is selected and the samples are placed in the intervention or control group based on the arrangement of the blocks. The experimental group is subjected to remote nursing care sessions (remote nursing) online (online trainings), while the control group receives training and routine follow-ups.
Settings and conduct
The statistical population is all elderly people with MI in Khorram Abad city.Only the data analyst in our study will be blinded.
Participants/Inclusion and exclusion criteria
• Elderly patients with MI during discharge and after discharge • Elderly or caregiver access to a cell phone • Not having a debilitating disease • Age 60 years and older • Having the ability to answer the phone and talk • Seniors with family caregivers
Intervention groups
Distance education in cardiac rehabilitation of elderly patients with myocardial infarction after discharge
Main outcome variables
Inner strength; resilience

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220530055029N1
Registration date: 2023-07-20, 1402/04/29
Registration timing: prospective

Last update: 2023-07-20, 1402/04/29
Update count: 0
Registration date
2023-07-20, 1402/04/29
Registrant information
Name
Farzad Farzanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3333 0278
Email address
farzadfarzanpour.nurse@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesing The Effect Of Telenursing on Inner Strength and Resilence in Elder Patients After Acute Myocardial Infarction
Public title
Investigating the impact of remote nursing
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly patients with MI during discharge and after discharge Elderly or caregiver access to a cell phone No debilitating disease Age 60 years and older Having the ability to answer the phone and talk Seniors with family caregivers
Exclusion criteria:
Addiction to drugs due to non-compliance with recommendations Impaired vision and hearing Having a cognitive problem according to the Cognitive Assessment Scale
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
People who enter the study will be assigned to one of the intervention and control groups by random block method as follows: In a random block arrangement with blocks of 4, there are 6 possible situations in order to place 4 people in each block (2 people in the intervention group and two people in the control group). To randomize the samples in each group, we need to randomly select one of the blocks each time and place people based on it until the sample size we have is completed. We will have 56 samples, there are 4 people in each block, so we have to randomly select 14 blocks from these 6 blocks to complete the sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, there will be no possibility of blinding and only the data analyst will be unaware of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
nursing and midwifery faculty, Lorestan University of Medical Sciences, Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Approval date
2022-01-21, 1400/11/01
Ethics committee reference number
IR.LUMS.REC.1401.025

Health conditions studied

1

Description of health condition studied
Myocardial Infarction
ICD-10 code
121.3
ICD-10 code description
Acute transmural myocardial infarction of unspecified site

Primary outcomes

1

Description
Resilience
Timepoint
One month after the intervention
Method of measurement
Questionnaire

2

Description
Inner strength
Timepoint
One month after the intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, after the patient's discharge, the researcher will contact the patients in two sessions every week for one month according to the previous coordination between 4 and 7 pm and the necessary training and support will be given online. The contact time of the researcher can be changed depending on the desire of the patient or his supervisor in order to get a better answer for each patient and will be determined by the patient himself, and if necessary, the patient will be consulted. During the online communication, if a potential problem is observed, the patient's doctor will be informed and the patient will be guided for immediate care and referral to the emergency room or to contact the doctor. If the internet is available with suitable quality, video calls will be used through existing applications (WhatsApp, etc.). In case of video chat connection failure. The training session will be repeated again. It should be mentioned that in order to fully fulfill the supporting role of the nurse, the communication channel with the patient will be open and the patient will call in case of a specific problem outside of the necessary training and the need for re-consultation, and the researcher will investigate the solution of the patient's problem or the session. He will arrange an extension or consult the patient over the phone. Also, the contact number of the researcher will be given to the patient and his caregiver in case of a problem. Patients will be able to have a phone call with the researcher from 8 am to 8 pm, in addition to a call by the nurse.
Category
Rehabilitation

2

Description
Control group: The control group did not receive online counseling and will only receive the same regular care at the time of discharge.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani and Shafa hospitals
Full name of responsible person
Shahin Salarvand
Street address
Nursing and Midwifery Faculty, Lorestan University of Medical Sciences, Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0140
Fax
+98 66 3312 0140
Email
salarvand60@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr. Bahram Rasoulian
Street address
Research and Technology Vice-Chancellor, Lorestan University of Medical Sciences, kilometer 3 Broujerd road, Kamalvand campus, 3 th floor
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0172
Fax
+98 66 3312 0173
Email
research@ lums.ac.ir
Web page address
http://research.lums.ac.ir/
Grant name
0
Grant code / Reference number
0
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Shahin Salarvand
Position
Assistant Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Lorestan University of Medical Sciences, Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0140
Fax
+98 66 3312 0140
Email
salarvand60@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Shahin salarvand
Position
Assistant prof.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery faculty, Lorestan University of Medical Sciences, Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0410
Fax
+98 66 3312 0410
Email
salarvand60@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Shahin salarvand
Position
Assistant Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery faculty, Lorestan University of Medical Sciences, Iran
City
Khorramabad
Province
Lorestan
Postal code
68114993165
Phone
+98 66 3312 0140
Fax
+98 66 3312 0140
Email
salarvand60@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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