Education and Counseling Program on Patients With CIEDs and Low HL
Primary Purpose
Arrhythmias, Cardiac, Heart Failure, Health Knowledge, Attitudes, Practice
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education and Counseling Program
Sponsored by
About this trial
This is an interventional supportive care trial for Arrhythmias, Cardiac
Eligibility Criteria
Inclusion Criteria: no communication problems in Turkish implanted any type of CIED for the first time having low score of HLS EU Q16 willingness to participate in the study Exclusion Criteria: Not literate having vision or hearing problem having psychiatric and cognitive impairment
Sites / Locations
- Merve ErunalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patients who receive education and counseling program
Patients who receive clinical routine care
Arm Description
Patients with CIEDs and low health literacy received education and counseling program by researchers.
Patients with CIEDs and low health literacy received only clinical routine care.
Outcomes
Primary Outcome Measures
Baseline knowledge level
CIEDs knowledge scale score of patients
Change in knowledge level
CIEDs knowledge scale score of patients
Change in knowledge level
CIEDs knowledge scale score of patients
Change in knowledge level
CIEDs knowledge scale score of patients
Baseline daily life activities
Duke Activity Index score of patients
Change in daily life activities
Duke Activity Index score of patients
Change in daily life activities
Duke Activity Index score of patients
Change in daily life activities
Duke Activity Index score of patients
Baseline health literacy level
Health Literacy Survey European Questionnaire 16 score of patients
Change in health literacy level
Health Literacy Survey European Questionnaire 16 score of patients
Change in health literacy level
Health Literacy Survey European Questionnaire 16 score of patients
Change in health literacy level
Health Literacy Survey European Questionnaire 16 score of patients
Secondary Outcome Measures
Full Information
NCT ID
NCT05636956
First Posted
November 16, 2022
Last Updated
November 24, 2022
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT05636956
Brief Title
Education and Counseling Program on Patients With CIEDs and Low HL
Official Title
The Effect of Education and Counseling Program on Patients With Cardiac Implantable Electronic Devices and Low Health Literacy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this RCT (randomized controlled trial) is to investigate the effect of education and counseling program that researches developed on patients with cardiac implantable electronic devices (CIEDs) and low health literacy.
The main questions are; Is there a difference between the health literacy scores of intervention and control groups after education and counseling program? Is there a difference between the CIEDs knowledge scores of intervention and control groups after education and counseling program? Is there a difference between the daily life activity scores of intervention and control groups after education and counseling program?
Researches offer an education and counseling program about living with CIEDs to patients that having CIEDs for the first time. Participants answers questions in Health Literacy Survey European Questionnaire 16, cardiac implantable electronic devices knowledge scale (researches developed) and Duke Activity Index before education and counseling program, at first month, third month and sixth month after implantation.
Reseraches compare scores between intervention and control groups, also different times in same groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac, Heart Failure, Health Knowledge, Attitudes, Practice
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients who receive education and counseling program
Arm Type
Experimental
Arm Description
Patients with CIEDs and low health literacy received education and counseling program by researchers.
Arm Title
Patients who receive clinical routine care
Arm Type
No Intervention
Arm Description
Patients with CIEDs and low health literacy received only clinical routine care.
Intervention Type
Other
Intervention Name(s)
Education and Counseling Program
Other Intervention Name(s)
Education and counseling program about living with CIEDs.
Intervention Description
Researches created an education and counseling program. In this context, patients receive an one hour education. Education program consist of face-to-face informing and teach-back method. At the end of the face-to-face informing, researchers give a comicbook about instructions of living with CIEDs as a written material. After discharge, researches follow-up patients with phone calls. In the context of phone calls researches continue to informing patients, remind related instructions for that time and answer questions of patients. Patients are allowed to reach reserarches any time if they have any concern or question. This program lasts for six months.
Primary Outcome Measure Information:
Title
Baseline knowledge level
Description
CIEDs knowledge scale score of patients
Time Frame
Before education
Title
Change in knowledge level
Description
CIEDs knowledge scale score of patients
Time Frame
At first month after education
Title
Change in knowledge level
Description
CIEDs knowledge scale score of patients
Time Frame
At third month after education
Title
Change in knowledge level
Description
CIEDs knowledge scale score of patients
Time Frame
At sixth month after education
Title
Baseline daily life activities
Description
Duke Activity Index score of patients
Time Frame
Before education
Title
Change in daily life activities
Description
Duke Activity Index score of patients
Time Frame
At first month after education
Title
Change in daily life activities
Description
Duke Activity Index score of patients
Time Frame
At third month after education
Title
Change in daily life activities
Description
Duke Activity Index score of patients
Time Frame
At sixth month after education
Title
Baseline health literacy level
Description
Health Literacy Survey European Questionnaire 16 score of patients
Time Frame
Before education
Title
Change in health literacy level
Description
Health Literacy Survey European Questionnaire 16 score of patients
Time Frame
At first month after education
Title
Change in health literacy level
Description
Health Literacy Survey European Questionnaire 16 score of patients
Time Frame
At third month after education
Title
Change in health literacy level
Description
Health Literacy Survey European Questionnaire 16 score of patients
Time Frame
At sixth month after education
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
no communication problems in Turkish
implanted any type of CIED for the first time
having low score of HLS EU Q16
willingness to participate in the study
Exclusion Criteria:
Not literate
having vision or hearing problem
having psychiatric and cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merve Erünal
Phone
+905544635942
Email
erunalmm@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hatice Mert
Phone
+092324124786
Email
hatice.mert@deu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merve Erünal
Organizational Affiliation
Dokuz Eylul University Faculty of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hatice Mert
Organizational Affiliation
Dokuz Eylul University Faculty of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Merve Erunal
City
Balçova
State/Province
İzmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merve Erunal, MSc
Phone
+905544635942
Email
erunalmm@gmail.com
12. IPD Sharing Statement
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Education and Counseling Program on Patients With CIEDs and Low HL
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