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General information
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35
35
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2019-12-21, 1398/09/30
2019-12-21 00:00:00
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2021-01-07, 1399/10/18
2021-01-07 00:00:00
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2021-04-07, 1400/01/18
2021-04-07 00:00:00
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Project progress and status updates
Project progress and status updates
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تغییرات مربوط به اتمام طرح
تغییرات مربوط به اتمام طرح
Protocol summary
Study aim
The effect of self-management education videocasts on quality of life, readmission rates and self-care behaviors in elder with heart failure
Design
The randomized controlled trial with a intervention and control group, with parallel groups, single-blind, the sample of this research is a total of 38 people.
Settings and conduct
This study is a randomized clinical trial study.Samples will be selected from among Elder with heart failure. This study will be carried out at the Imam Khomeini Hospital. Self-management education videocasts will be provided to eligible patients, and finally, quality of life, readmission rates and self-care behaviors in Participation will be measured. This study will be single-blind. data from two groups will be coded and delivered to the statistical analyst.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of New York Heart Association class II, III, Having age of 60 to 75 years Having mental stability, Trading in Persian and ability to read and write, Having a Personal computer, smartphone or tablet and the ability to use it or presence of a companion who lives with elder person and has these facilities, Patient Satisfaction to Participate in the Study.
Exclusion criteria: Cognitive problems in medical history (impairment of short term memory or dementia), previous training in the field of self-management Over the past year, Hearing and visual impairment, disabilities and limitations, using psychosocial drugs,Change in the patient's functional class to higher class before the end of the intervention or Hospitalization during the intervention, Patient died or unwillingness to continue the program.
Intervention groups
After pre test for both groups, 4 Self-management education videocasts will send to intervention group weekly for 1 month and the control group will receive the usual care.
Main outcome variables
self-care behaviors
General information
Reason for update
Project progress and status updates
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044249N1
Registration date:2019-09-01, 1398/06/10
Registration timing:prospective
Last update:2021-11-28, 1400/09/07
Update count:1
Registration date
2019-09-01, 1398/06/10
Registrant information
Name
Sarina Ramtin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
sarinaramtin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-04, 1398/06/13
Expected recruitment end date
2020-03-03, 1398/12/13
Actual recruitment start date
2019-12-21, 1398/09/30
Actual recruitment end date
2021-01-07, 1399/10/18
Trial completion date
2021-04-07, 1400/01/18
Scientific title
The Effect of Self-Management Education Videocasts on Quality of Life, Readmission Rates and Self-Care Behaviors in Elder with Heart Failure
Public title
The Effect of Self-Management Education Videocasts on Quality of Life, Readmission Rates and Self-Care Behaviors in Elder with Heart Failure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of New York Heart Association class II, III
Having age of 60 to 75 years
Having mental stability
Trading in Persian and ability to read and write
Having a Personal computer, smartphone or tablet and the ability to use it or presence of a companion who lives with elder person and has these facilities
Patient Satisfaction to Participate in the Study
Exclusion criteria:
cognitive problems in medical history (impairment of short term memory or dementia)
previous training in the field of self-management Over the past year
Hearing and visual impairment
disabilities and limitations
using psychosocial drugs
Change in the patient's functional class to higher class before the end of the intervention or Hospitalization during the intervention
patient died
unwillingness to continue the program
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Actual sample size reached:
35
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation will include three steps: Random sequence generation, allocation concealment and doing a random allocation process. Four random blocks are used to generate random sequences. Random sequence generation by block method will be done using Random Allocation Software. To ensure that random sequence is not predictable for the researcher who will perform the sampling, allocation concealment will be performed using numbered, sealed, opaque envelopes. These two steps are taken by the supervisor and the student who performs the sampling will not be involved in these two phases.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be single blind. Data from two groups will be coded and delivered to the statistical analyst.
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
Sixth floor, Central Office of Tehran University of Medical Sciences, Corner of Quds St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-06-02, 1398/03/12
Ethics committee reference number
IR.TUMS.VCR.REC.1398.213
Health conditions studied
1
Description of health condition studied
Congestive heart failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
Self-Care Behaviors
Timepoint
Before and Two month after the intervention.
Method of measurement
Self-care behaviors in heart failure
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before and two month after the intervention.
Method of measurement
Minnesota Questionnaire
2
Description
Readmission
Timepoint
two month after the intervention.
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: For the test group, the intervention will take place for one month. 4 Self-management education videocasts will send to intervention group weekly and after sending of each videocast researcher will answer to their quesions by phone call.
Category
Lifestyle
2
Description
Control group: The control group will benefit from routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
sarina ramtin
Street address
Imam Khomeini Hospital Complex, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Negarandeh
Street address
Sixth floor, Central Office of Tehran University of Medical Sciences, Corner of Quds St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
rmo@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
Sarina Ramtin
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Nosrat St., Tohid Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6642 1685
Email
sarinaramtin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Negarandeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery Care Research Center, School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Square
City
تهران
Province
Tehran
Postal code
1419733171
Phone
+98 21 6642 1685
Email
negarandeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
sarina ramtin
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Nosrat St., Tohid Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6642 1685
Email
sarinaramtin@gmail.com
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
Undecided - It is not yet known if there will be 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
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
Some of the information, such as a sample demographic profile form without personal information of individuals, as well as some information on the primary consequences (primary and secondary), can be shared.
When the data will become available and for how long
Data will be released when the results are published.
To whom data/document is available
All people will have access to published data.
Under which criteria data/document could be used
Data can be used for people who intend to write systematic review and meta-analysis.
From where data/document is obtainable
To receive the data, you can send an email to the following address:
sarinaramtin@gmail.com
What processes are involved for a request to access data/document
After reviewing the request, the data will be sent by email.