Investigate of effectiveness of follow up care program on self efficacy and short term outcomes in patients with an Implantable Cardioverter Defibrillator.
Design
Randomized, blinded, shame controlled clinical trial, with a blinded, Parallel group design of 154 patients
Settings and conduct
Implanting Cardioverter Defibrillator is the popular treatment of patients suffering from cardiac arrhythmia. The research is performed in the electrophysiology sector of Shaheed Rajaie's Cardiovascular Medical and Research Center and after the approval of the ethical committee. Patients that need Implantable Cardioverter Defibrillator (ICD) were identified and after gaining their written satisfaction, sampling is performed. After they discharge, the researcher trains them face to face but the patients are not aware of their group. The researcher is not the part of the staff and the staff does not participate in the intervention.
Participants/Inclusion and exclusion criteria
Patients 20 to 80 years old who being able to read, write, and speak Persian, and have received Implantable Cardioverter Defibrillator can participate in the study; they are excluded from study if they have a Commorbidity that prevent their discharge from the hospital, or suffering from cognitive disorders.
Intervention groups
Patients in the control group are discharged after receiving routine care, including a booklet recognizing the device and its care; patients in the intervention group receive a follow-up care program in addition to routine care, including two 1.5 hour training sessions and An instruction book featuring other patients' experiences and weekly follow ups for up to 12 weeks..
Main outcome variables
Self-efficacy Expectations and Out come Expectations score; Anxiety score; Referral out of plan to Medical center; Number of received shock.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100725004443N24
Registration date:2018-12-29, 1397/10/08
Registration timing:prospective
Last update:2018-12-29, 1397/10/08
Update count:0
Registration date
2018-12-29, 1397/10/08
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Shaheed Rajaei's Cardiovascular Medical and Rresearch Center
Expected recruitment start date
2018-12-31, 1397/10/10
Expected recruitment end date
2019-01-30, 1397/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of continues care program on self efficacy and outcomes in patients with Implantable Cardioverter Defibrillator
Public title
Effectiveness of continues care program on self efficacy and outcomes in patients with cardiac shocker
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being 20 to 80 years old
Being ability to read, write, and speak in Persian
Accessing phone call
Implanting Cardioverter Defibrillator for the first time
Exclusion criteria:
Suffering from Cognitive Disorders
Suffering from Commorbidity results in hospitalization
Participation in other intervention program
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
154
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients in two groups of test and control was done by Block Balanced Randomization (BBR) method. The Randomization Sequence was generated with using the free web site at http://www.randomization.com.
Blinding (investigator's opinion)
Single blinded
Blinding description
When discharging the patient, the researcher trains on the research and its method. However, he does not make the patient aware of his group and the researcher is not the member of the staff and the hospital staff does not participate in the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic commitee of Shaheed Rajaie's Cardiovascular Medical and Rresearch Center
Street address
Shaheed Rajaie's Cardiovascular Medical and Rresearch Center, Niayesh Blvd., Vali-Asr Ave.
City
Tehran
Province
Tehran
Postal code
199691-1151
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
RHC.AC.IR.REC.1395.31
Health conditions studied
1
Description of health condition studied
The patient with an Implantable Cardioverter Defibrillator
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-efficacy
Timepoint
Before the intervention, immediately after ending the intervention
Method of measurement
Self-efficacy questionnaire
Secondary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, immediately after ending the intervention
Method of measurement
Speil-berger State-Trait Anxiety Inventory
2
Description
Number of received shocks
Timepoint
Immediately after ending the intervention
Method of measurement
patient report
3
Description
Referrals outside of the plan to Medical centers
Timepoint
Immediately after ending the intervention
Method of measurement
patient report
Intervention groups
1
Description
Control group:This patients do not receive any intervention from the researcher and are discharged after receiving regular care at the facility.
Category
Other
2
Description
Intervention group: The intervention includes two training sessions for 1.5 hours by the researcher and one month later, they go to the health-care center. In these sessions, the researcher trains the patients about the ability to take care of oneself after received shock, the way to register the shocks, the performance of the Device, their feeling when evacuating the energy and the required changes in lifestyle, the warning and follow-up and their relationship with the family members is explained. The researcher tells about the ways of reducing stress such as praying, relaxation, listening to music and distraction of mind and describes the solution based on the patient's will. After the second session,a training book is given to the patients including two parts. The first part explains the performance and equipment and the second part is about the experience of patients with Implantable Cardioverter Defibrillator. Finally, the patient's phone number is taken and the patient is followed from 8 am to 8 pm for 10 to 20 minutes based on the patient's need, verbal encouragement, responsiveness of the patient's questions, their current concerns, behavioral techniques to be consistent with the living conditions with heart shocker and relaxation in the book. In addition to phone follow-up, the participants in the intervention can access the researcher from morning to night and ask their questions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Rajaie's Cardiovascular Medical and Research Center
Full name of responsible person
Zakerimoqhadam Masoumeh
Street address
Shaheed Rajaie's Cardiovascular Medical and Research Center, Niayesh Blvd., Vali-asr Ave.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
Zakerimo@sina.tums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shaheed Rajaie's Cardiovascular Medical and Research Center
Full name of responsible person
Maleki Majid
Street address
Shaheed Rajaie's Cardiovascular Medical and Research Center, Niayesh Blvd., Vali-asr Ave.
City
Tehran
Province
Tehran
Postal code
199691-1151
Phone
+98 21 2392 2193
Fax
+98 21 2266 3217
Email
majid33@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shaheed Rajaie's Cardiovascular Medical and Research Center
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
Zakerimoghadam Masoumeh
Position
Assistant professor and Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery College of Tehran University, Easte Nosrat St., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed Rajaie's Cardiovascular Medical and Rresearch Center
Full name of responsible person
Haghjoo Majid
Position
Professor, Scientific Faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Internal Heart Adult
Street address
Shaheed Rajaie's Cardiovascular Medical and Rresearch Center, Niayesh Blvd., Vali-Asr Ave.,
City
Tehran
Province
Tehran
Postal code
1996911151
Phone
+98 21 2392 2358
Fax
+98 21 2392 2340
Email
majid.haghjoo@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zakerimoqhadam Masoumeh
Position
Assistant professor, Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Callege of Tehran University of Medical Sienses, Eastern Nosrat street, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
Zakerimo@sina.tums.ac.ir
Web page address
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