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Trial registered on ANZCTR


Registration number
ACTRN12617000451303
Ethics application status
Approved
Date submitted
28/01/2017
Date registered
27/03/2017
Date last updated
12/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nursing Intervention for the Acceptance of the Patient to the Cardioverter
Scientific title
Nursing Intervention for the Acceptance of the Patient to the Cardioverter
Secondary ID [1] 290988 0
Nil Known
Universal Trial Number (UTN)
U1111-1191-7711
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acceptance of patient to cardiac device 301747 0
cardiac arrhythmias 301748 0
Condition category
Condition code
Cardiovascular 301444 301444 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Nursing Intervention APECC “Acceptance In People With Cardiac Stimulation Cardioverter” is a direct attention treatment, based on the knowledge and clinical judgment, that the nurse performs independently in the pre-implantation period, to help the person to Accept the cardiac stimulation device Cardioverter, in response To the physical, psychological and social needs that can appear from the implantation to the performance of the daily functions.
The intervention is proposed from the Social Learning Theory for behavior modeling, these are developed through three components, the first corresponds to an educational component provided by the nurse who is the person that has the knowledge to address the main issues of the implantation and that have been reported in the evidence, such as:
1 What is a cardio-defibrillator, how it acts, how the implantation is performed, what are the indications
2 Physical consequences of implantation to the device: wound care, physical activity, body image change, what can I expect and how can I act?
3 Social Consequences: Changes in the job, family and social role, sexual activity, driving limitations, activities of daily living, What can I expect and how can I act?
4 Psychological Consequences: primary emotions (fear, apprehensiveness, anger, sadness) and Anxiety and Depression. What is normal and how can I act?
The second component refers to the modeling of behavior through the peers or people with similar conditions, so those two people who have a cardiodesfibrilador express their experience of living with the device, its advantages and disadvantages and how they settle their difficulties. Through 15 minutes video of two people who have had an implant talking about their experiences is watched in the session.
Finally, the last component is an exercise in relaxation that will allow the implanted person to practice it in their moments of anxiety or stress. Are 15 minutes of video with images, music and instructions for the relaxation of body and mind, is watched in the session.
The Nursing intervention will be delivered by the nurse face to face, in a single moment with a duration of approximately 60 minutes for the session, be supported using tools such as the educational flipchart designed for this study contains illustrative images to explain the educational content of physical, psychological, social changes and the use of a DVD designed for this study, which contains three small videos of 15 minutes duration, with the components educational, experiences and exercise in relaxation, the study participants can take home, for your consultation anytime you require it.
note: The participants will be assigned one by one to each group
30 participants to intervention group 1, persons receiving intervention before to device implantation.
30 participants to intervention group 2, people receiving the intervention once the device is implanted and before clinical discharge.
30 participants to the control group, people receiving standar care.
Intervention code [1] 296944 0
Lifestyle
Intervention code [2] 296945 0
Treatment: Other
Comparator / control treatment
Intervention Group 2: The intervention will be delivered the day after the implantation of the device and before clinical discharge.
the comparator group received standard care: Brief explanation of the surgical procedure and delivery of the brochure of the marketing house of the device.
Control group
Active

Outcomes
Primary outcome [1] 300834 0
Evaluate the effects of the nursing intervention in the preimplantation period of the Cardiodesfibrilador, in the acceptance to the device in the people implanted.

Will be evaluated through Florida Patient Acceptance Survey with corresponding statistical analyzes between intervention and control groups., It has been estimated a significance of alpha equal or less to 0.05
Timepoint [1] 300834 0
at 4 weeks after intervention commencement
Secondary outcome [1] 332016 0
None
Timepoint [1] 332016 0
None

Eligibility
Key inclusion criteria
-Being over 18 years until 90 years old
-Persons with the first time indication of implantation of cardiac stimulation therapy with defibrillation.
note: The Participants should not have received the device to be elected for enrolment in this trial.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-People with cognitive disabilities
-People with device complications in the post-implant period.
-Persons who are not implanted with the Cardioverter device.

Clarifying Note: Exclusion criterion number two is established taking into account that people who are implanted with the device can have serious complications that might require additional treatment, a condition that would not allow to continue in the process of the study, since all the Acceptance level measurements should be performed after the implant.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical hypothesis

1. Null Hypothesis: The nursing intervention applied in the pre-implantation has no effect on the person's acceptance to the Cardioverter.H0: p=0
Alternative Hypothesis: The nursing intervention applied in the pre-implantation has positive effects on the person's acceptance to the Cardioverter.H1: p=<0

2. Null Hypothesis: The nursing intervention applied in the pre-implantation does not decreases the adjustment time in people with cardioverter. H0: p=0
Alternative Hypothesis:The nursing intervention applied in the pre-implantation decreases the adjustment time in people with cardioverter.H1: p=<0

3.Null Hypothesis: The nursing intervention applied in the pre-implantation does not decreases the physical, psychological and social consequences in people with cardioverter. H0: p=0
Alternative Hypothesis:The nursing intervention applied in the pre-implantation decreases the physical, psychological and social consequences in people with cardioverter.H1: p=<0

SAMPLE SIZE
The calculation of the sample size will be made for the purpose of judging the hypotheses of the investigation and for which the following elements will be taken into account:
1) Error Type I or Alpha: is the error that is committed when the investigator does not accept or reject the null hypothesis, being this true, which is set at p = <0.05
2) Error type II or Beta: is the error that is committed when the investigator accepts the null hypothesis being false, confidence intervals calculate a 95%.

The sample size to support the comparisons between the experimental group and its respective control group is based on the adjustment to the Gaussian model and in this case they are independent samples. To support the conclusions to be drawn from the statistical analysis is required a non-probabilistic global random sample.Therefore, this sample size is calculated by the following mathematical expression:

n=2{raiz cuadrada de (x_(1-alfa)^2 (k-1)-(K-2) )+Z_(1-beta) }^2+(sigma/Delta )^2+1

Values established for the validity of the sample:
alfa=0.05
Beta=0.01
Delta= Sigma

Taking into account these precisions, the required sample size is 90 People, each group will have 30 participants, according to the inclusion criteria established

DATA ANALYSIS
Descriptive Analysis: Descriptive statistics are used to detail and synthesize the data, allows to characterize the behavior of the sociodemographic variables, a frequency distribution is proposed for these data, taking into account the nature of each variable.

Inferential Analysis: It will be done based on the hypothesis and the question of the study. For this study, we used comparison tests that consider the presence of a given factor in one of them, while in the other the opposite occurs. For the inferential analysis it is used, Student T for Related Samples to test the hypothesis that the scores of a variable differ over time for the same subjects. This type of before-after design is measured twice for the same individuals between the applications of the tests. This test requires the normal distribution of the data, otherwise a nonparametric test such as Friedman can be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/03/2017
Date of last participant enrolment
Anticipated
30/06/2017
Actual
15/09/2017
Date of last data collection
Anticipated
30/06/2017
Actual
15/10/2017
Sample size
Target
90
Accrual to date
Final
72
Recruitment outside Australia
Country [1] 8603 0
Colombia
State/province [1] 8603 0
Bogota

Funding & Sponsors
Funding source category [1] 295406 0
Government body
Name [1] 295406 0
COLCIENCIAS
Country [1] 295406 0
Colombia
Primary sponsor type
Individual
Name
Diana Marcela Castillo Sierra
Address
Universidad Nacional de Colombia
Faculty of Nursing
Carrera 30 No 45-03 edificio 228
Country
Colombia
Secondary sponsor category [1] 294228 0
Individual
Name [1] 294228 0
Renata Virginia Gonzalez Consuegra
Address [1] 294228 0
Universidad Nacional de Colombia
Faculty of Nursing
Carrera 30 No 45-03 edificio 228
Country [1] 294228 0
Colombia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296739 0
Ethics committee in research of the faculty of nursing
Ethics committee address [1] 296739 0
carrera 30 No. 45-03 edificio 228 Universidad Nacional de Colombia
Ethics committee country [1] 296739 0
Colombia
Date submitted for ethics approval [1] 296739 0
23/05/2016
Approval date [1] 296739 0
08/08/2016
Ethics approval number [1] 296739 0
AVAL - 042 - 16

Summary
Brief summary
This research it is proposed to design and apply a nursing intervention, to improve the level of acceptance to device in daily life, Approaching the physical, psychological and social consequences caused by the implantation of the ICD, with the goal that the implanted people achieve the greater benefit of the device, in years of quality survival. The knowledge generated will provide evidence for nursing professionals in relation to the effects of the intervention applied in the pre-implant period and provides new tools for nursing practice in relation to the care of this population group.

Hypothesis
A Structured Nursing Intervention with two components: educational and relaxation strategies, applied in the pre-implantation period, provides the person the necessary tools to achieve acceptance of the device, reducing the physical, psychological and social consequences of the implantation of the Cardioverter, Allowing the integration of technology into life.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1400 1400 0 0
/AnzctrAttachments/372218-PROTOCOLO PARA LA APLICACIÓN DE LA INTERVENCION DE ENFERMERIA.pdf (Protocol)
Attachments [2] 1401 1401 0 0
/AnzctrAttachments/372218-AVAL-042-2016 DIANA MARCELA CASTILLO.pdf (Ethics approval)
Attachments [3] 1402 1402 0 0
/AnzctrAttachments/372218-Consentimientos Informados .pdf (Participant information/consent)

Contacts
Principal investigator
Name 71930 0
Mrs Diana Marcela Castillo Sierra
Address 71930 0
Universidad Nacional de Colombia
Faculty of Nursing
Carrera 30 No 45-03 edificio 228
Country 71930 0
Colombia
Phone 71930 0
+573013641570
Fax 71930 0
Email 71930 0
dmcastillos@unal.edu.co
Contact person for public queries
Name 71931 0
Diana Marcela Castillo Sierra
Address 71931 0
Universidad Nacional de Colombia
Faculty of Nursing
Carrera 30 No 45-03 edificio 228
Country 71931 0
Colombia
Phone 71931 0
+573013641570
Fax 71931 0
Email 71931 0
dmcastillos@unal.edu.co
Contact person for scientific queries
Name 71932 0
Diana Marcela Castillo Sierra
Address 71932 0
Universidad Nacional de Colombia
Faculty of Nursing
Carrera 30 No 45-03 edificio 228
Country 71932 0
Colombia
Phone 71932 0
+573013641570
Fax 71932 0
Email 71932 0
dmcastillos@unal.edu.co

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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