The aim of this study was to determine the effectiveness of applying the support group based on Roy’s Model on the adaptation of patients with implantable cardioverter-defibrillators.
Design
In this clinical trial study, patients are assigned to the intervention and control groups using randomization blocks of 4 according to the gender (male and female) and left ventricular ejection fraction (lower and higher 35%). The number of the patients in each of groups will be 30 persons.
Settings and conduct
The study will be conducted in Farshchian Heart Hospital of Hamadan. Patients randomly assigned to the intervention and control groups. In the intervention group, patients participate in support group. For all patients at least two support groups will be held. Before and one and a half months after the intervention, adaptation of patients will be assessed by nursing assessment and recognition form.
In the control group patients will receive only routine care.
Participants/Inclusion and exclusion criteria
Patients with implantable cardioverter-defibrillator are selected as study samples. The inclusion criteria are age of 60 years and lower, able to hearing and speaking, lack of diagnosed mental disease, implanting cardioverter-defibrilator for at least six months. Patients with failure to complete the nursing assessment and recognition form were excluded from the study.
Intervention groups
In the experimental group, patients participate in support group. In this groups, educational topics and psychological counseling are presented. In the control group patients will receive only routine care.
Main outcome variables
The primary variables include the number of adjusted behaviors related to the health of patients, which are assessed by assessment and recognition form of the Roy nursing model before and one and a half months after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180826040874N1
Registration date:2020-03-13, 1398/12/23
Registration timing:registered_while_recruiting
Last update:2020-03-13, 1398/12/23
Update count:0
Registration date
2020-03-13, 1398/12/23
Registrant information
Name
Mohammadreza Razavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 1145
Email address
m.razavi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of applying the support group based on Roy’s Model on the adaptation of patients with implantable cardioverter-defibrillators
Public title
The effectiveness of the support group based on Roy’s Model on the adaptation of patients with implantable cardioverter-defibrillators
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
maximum age of 60 years
Hearing and speaking ability
lack of diagnosed mental disease
Patients with cardiac defibrillator implantation for at least six months
Exclusion criteria:
Failure to complete the nursing assessment and recognition
Age
To 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals referred to therapeutic center and with inclusion criteria to the study will selected by convenience sampling method and were randomly divided into intervention and control groups. In this study, individuals were divided into two groups using randomization blocks of 4 method. In this method, A represents the individual receiving the intervention and B represents the individual in the control group. Then codes will indicate as Code 1: AABB, code 2: ABAB, code 3: ABBA, code 4: BAAB, code 5: BBAA and code 6: BABA. After that, the starting point is randomly selected using the random number table. Given the sequence of table numbers, each number that is assigned will be determined a code. For example, if the first three numbers of the random number table are 2, 1 and 6, the order of assigning the first 12 patients in groups of the study will be ABABAABBBABA, respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Ave, Pajohesh Squ., Hamadan city
City
Hamadan
Province
Hamadan
Postal code
6517765178
Approval date
2020-02-09, 1398/11/20
Ethics committee reference number
IR.UMSHA.REC.1398.999
Health conditions studied
1
Description of health condition studied
Cardiovascular disease
ICD-10 code
Z95.810
ICD-10 code description
Presence of automatic (implantable) cardiac defibrillator
Primary outcomes
1
Description
Adaptation of patients
Timepoint
before and 1.5 months after intervention.
Method of measurement
Adaptation is measured using assessment and recognition form of Roy nursing model.
Secondary outcomes
1
Description
In this study, secondary outcome is level of social adaptation.
Timepoint
Level of social adaptation is measured at before and 1.5 months after intervention.
Method of measurement
Level of social adaptation is measured using Bell adaptation questionnaire.
Intervention groups
1
Description
Intervention group: patients participate in support group. Selecting the educational topics and content of each support group as well as the patients' health status are identified based on the assessment and recognition form of Roy nursing model. Support group members will include patients with better health status, patients with poor health status, and a family member who is responsible for caring them, as well as a psychologist and researcher. the duration of each session will vary depending on the patients' educational needs. For all patients, two support groups is held at least in one month. The content of these groups included discussions about their past, present and future of illness, actions required after receiving shock, questions and answers to device and illness, suggestions for daily living activities, lifestyle changes and doing sports activities, providing information about phantom shock, driving, marrying, and supporting family members. One and a half months after participating in the support group, patients are reassessed by the assessment and recognition form of Roy nursing model.
Category
Behavior
2
Description
Control group: In the control group patients will receive only routine care that includes an educational pamphlet provided by the health center.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Hamadan Unoversity of Medical Sciences
Street address
Shahid Fahmideh Aven, Pajohesh Squ., Hamadan city
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1740
Email
hcvc@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Vice chancellor for research & technology, Hamadan University of medical Sciences
Street address
Shahid Fahmideh Ave., Pajohesh Squ,. Hamadan City
City
Hamadan
Province
Hamadan
Postal code
6517765178
Phone
+98 81 3838 0717
Email
Fanavari@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammadreza Razavi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Ave., Pajohesh Squ., Hamadan City
City
Hamadan
Province
Hamadan
Postal code
6517765178
Phone
+98 81 3827 1145
Email
mrerazavi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammadreza Razavi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Ave., Pajohesh Squ., Hamadan City
City
Hamadan
Province
Hamadan
Postal code
6517765178
Phone
+98 81 3827 1145
Email
mrerazavi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammadreza Razavi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Ave., Pajohesh Squ,. Hamadan city
City
Hamadan
Province
Hamadan
Postal code
6517765178
Phone
+98 81 3827 1145
Email
mrerazavi@yahoo.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