Protocol summary

Study aim
Determining the Effect of Heart Rehabilitation Program Using Mobile App on ;activity tolerance; Fatigue, Dyspnea, Patients After Acute Myocardial Infarction.
Design
00 samples were randomly assigned to the intervention and control groups. Each sample was given a 3-digit code, referring to the table. The starting point was selected based on adjacent digit numbers moving along rows or columns. Ignore first digit number less than 100 as first sample of larger number control group Continue to 50 samples selected for control group to continue to 50
Settings and conduct
The researcher referred to the Hajar and Kashani hospitals of Shahrekord, selected patients who were included in the study and At the beginning of the intervention, the patients were evaluated for their dyspnea fatigue, and endurance. The intervention group received software installed on the patient's mobile phone and was given the necessary training in this area. They received cardiac routine, and after 8 weeks of evaluation, fatigue was again assessed dyspnea and activity tolerance were measured
Participants/Inclusion and exclusion criteria
log in Acute myocardial infarction; patient consent to participate; no psychotropic drugs; age range 35-75 years; no learning difficulties; Lack of hearing and vision impairment; Consent of one patient's family to cooperate with the plan; Patient and mobile dating; Family members' residence in the patient's place of residence, ability to communicate with patient and co-worker after discharge Exit Not having a sick and companion Android phone; over 75; not reading or writing about a patient or companion Learn to pronounce
Intervention groups
The control and test groups, the app test and installation group, and the control group, the routine training of the hospital, such as pamphlets, etc.
Main outcome variables
activity tolerance; fatigue ; dyspnea

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190511043560N1
Registration date: 2019-10-22, 1398/07/30
Registration timing: retrospective

Last update: 2019-10-22, 1398/07/30
Update count: 0
Registration date
2019-10-22, 1398/07/30
Registrant information
Name
Zahra Esmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3232 2713
Email address
st-esmaeili.za@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-05, 1397/11/16
Expected recruitment end date
2019-06-06, 1398/03/16
Actual recruitment start date
2019-02-05, 1397/11/16
Actual recruitment end date
2019-06-05, 1398/03/15
Trial completion date
2019-06-15, 1398/03/25
Scientific title
Assessment the effects of implementation cardiac rehabilitation program using a mobile application on activity tolerance, fatigue and dyspnea of patients after acute myocardial infraction
Public title
Assessment the effects of implementation cardiac rehabilitation program using a mobile application on activitytolerance, fatigue and dyspnea of patients after acute myocardial infraction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has an acute stroke The patient is willing to cooperate Not treated by a psychiatrist. Age over 35 and less than 75 Can not communicate and have difficulty learning There is no communicative problem such as hearing impairment and vision. At least one member of the patient's family is willing to cooperate with the research At least they are familiar with using the patient's mobile and one of the family members One family should know the status of the patient and have the power to make decisions. The residence of the family members is at the place where the patient lives or is near him. Possibility to communicate with members and patient after discharge
Exclusion criteria:
Not having a sick or mobile patient on your Android mobile phone Age over 75 Lack of education in reading or writing about the patient himself or herself
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The patients with inclusion criteria were divided into two intervention and control groups by random allocation method. In this way 100 patients were selected. Each of the individuals given a three-digit code 001 and 002 ...... 100 then referred to the table. Smaller than 100 was selected as the first sample and ignored larger numbers than 100 and this continued until 50 were selected as the intervention group and 50 as the control group.
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 Shahrekord University of Medical Sciences
Street address
Ayatollah Kashani Boulevard
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2019-02-05, 1397/11/16
Ethics committee reference number
IR.SKums.REC.1397.264

Health conditions studied

1

Description of health condition studied
MYOCARDIAL INFRACTION
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
activity tolerance score in the RAPA questionnaire and dyspenea score in the berg questionnaire and fatigue score in Fss questionnaire.
Timepoint
Before you start the intervention and after 8 weeks after using the app
Method of measurement
Using RAPA questionnaire for measuring activity tolerance and berg questionnaire for measuring dyspenea and Fss questionnaire for measuring fatigue

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, the software was installed on a mobile phone or a patient, and for 8 weeks, the patients in the control group were evaluated
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
kashani and hajar haspital
Full name of responsible person
zahra esmaeili
Street address
No215.alley45.leader blvd.mahdie-shahrekord
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816664353
Phone
+98 38 3232 2713
Email
zahra.e.nurse@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
dr seayad kamal solati
Street address
Shahrekord-Ayatollah Kashani Blvd.-University of Science and Technology-Building No.2 Vice-Chancellor for Researc
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Fax
Email
kamal-solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
zahra esmaeili
Position
master of student nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahr-e-Kher, Mahdieh Boulevard, Leader of Alley 45, Plain 215
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816664353
Phone
+98 38 3232 2713
Email
zahra.e.nurse@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
zahra esmaeili
Position
master of student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahr-e-Kher, Mahdieh Boulevard, Leader of Alley 45, Plain 215
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816664353
Phone
+98 38 3232 2713
Email
zahra.e.nurse@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
zahra esmaeili
Position
master of student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahr-e-Kher, Mahdieh Boulevard, Leader of Alley 45, Plain 215
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816664353
Phone
+98 38 3232 2713
Email
zahra.e.nurse@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
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
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