Protocol summary
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Study aim
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The effect of self-management education videocasts on quality of life, readmission rates and self-care behaviors in elder with heart failure
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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self-care behaviors
General information
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Reason for update
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Project progress and status updates
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Acronym
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IRCT registration information
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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
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Registration date
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2019-09-01, 1398/06/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-09-04, 1398/06/13
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Expected recruitment end date
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2020-03-03, 1398/12/13
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Actual recruitment start date
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2019-12-21, 1398/09/30
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Actual recruitment end date
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2021-01-07, 1399/10/18
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Trial completion date
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2021-04-07, 1400/01/18
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Scientific title
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The Effect of Self-Management Education Videocasts on Quality of Life, Readmission Rates and Self-Care Behaviors in Elder with Heart Failure
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Public title
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The Effect of Self-Management Education Videocasts on Quality of Life, Readmission Rates and Self-Care Behaviors in Elder with Heart Failure
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 60 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
38
Actual sample size reached:
35
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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This study will be single blind. Data from two groups will be coded and delivered to the statistical analyst.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-02, 1398/03/12
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.213
Health conditions studied
1
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Description of health condition studied
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Congestive heart failure
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ICD-10 code
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I50.9
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ICD-10 code description
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Heart failure, unspecified
Primary outcomes
1
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Description
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Self-Care Behaviors
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Timepoint
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Before and Two month after the intervention.
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Method of measurement
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Self-care behaviors in heart failure
Secondary outcomes
1
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Description
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Quality of Life
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Timepoint
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Before and two month after the intervention.
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Method of measurement
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Minnesota Questionnaire
2
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Description
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Readmission
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Timepoint
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two month after the intervention.
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Method of measurement
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questionnaire
Intervention groups
1
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Description
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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.
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Category
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Lifestyle
2
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Description
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Control group: The control group will benefit from routine care.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Data will be released when the results are published.
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To whom data/document is available
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All people will have access to published data.
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Under which criteria data/document could be used
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Data can be used for people who intend to write systematic review and meta-analysis.
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From where data/document is obtainable
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To receive the data, you can send an email to the following address:
sarinaramtin@gmail.com
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What processes are involved for a request to access data/document
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After reviewing the request, the data will be sent by email.
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Comments
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