Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients with an Implanted Cardiac Defibrillator (ICD) have less risk of death from cardiac arrhythmias (irregular heartbeat). However, there are many concerns about this device, including ICD shocks, which may result in increased anxiety and limitation in performing everyday activities. Due to these emotional reactions and behavioural changes patients may not accept this device. The purpose of this study was to find the feasibility, acceptability and initial effectiveness of an individualized nursing intervention aimed at improving device acceptance and performance in everyday activities and decreasing anxiety in patients with newly implanted ICDs.

Who can participate?
Adult patients with a first-time ICD implanted can take part in the study.

What does the study involve?
For all participants, data are collected at the start and 1 month after hospital discharge. Patients are randomly allocated to two groups. Those in the experimental group received three interventions, with the first being a face-to-face encounter before hospital discharge, followed by two subsequent telephone interventions at 7 and 14 days post-discharge. Those in the control group received usual care in the hospital.

What are the possible benefits and risks of participating?
There are no known risks to the participants. However, time is needed for face-to-face encounters (for those in the experimental group) and to respond to questionnaires for participants in both groups.

Where is the study run from?
Montreal Heart Institute, Canada.

When is study starting and how long is it expected to run for?
The recruitment started in June 2011 and ended in April 2012, including a one month follow-up.

Who is funding the study?
Quebec’s Ministry of Education, Recreation and Sports, Canada.

Who is the main contact?
Mrs Mélanie Charchalis

Trial website

Contact information



Primary contact

Mrs Melanie Charchalis


Contact details

Montreal Heart Institute Research Centre
Belanger street
H1T 1C8
+1 514 376 3330 ext.3069

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Evaluation of a caring and cognitive behavioural nursing intervention on device acceptance in patients with newly implanted cardiac defibrillators



Study hypothesis

The purpose of this randomized controlled pilot study was to evaluate the feasibility, acceptability and preliminary efficacy of an individualized nursing intervention on device acceptance in patients with newly implanted cardiac defibrillators.

The study hypothesis was that at one month post hospital discharge patients who received the intervention would demonstrate better device acceptance and performance of everyday activities, as well as less defibrillator shock and general anxiety compared to the control group.

Ethics approval

Ethics Committee of the Montreal Heart Institute, 11/05/2011, ref: 11-1294

Study design

Randomized pilot study – two groups

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Patients with Newly Implanted Cardiac Defibrillators


Experimental intervention (three encounters):
At the start of each encounter, the nurse encouraged the patient to express their major concerns/worries about the ICD. Then the research nurse proposed an individualized intervention, based on Human Caring theory and a cognitive behavioural approach. From the reported concerns, the nurse focused the intervention on the patient’s dysfunctional beliefs that can lead to anxiety and avoidance behaviours.
The research nurse undertook this assessment-intervention process three times:
1. Face-to-face encounter before hospital discharge, after ICD implantation;
2. By telephone 7 ± 2 days following discharge, and;
3. By telephone 14 ± 2 days following discharge.

Control group:
The control group continued to benefit from usual hospital care and follow-up.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Acceptability and feasibility of the intervention and the methodological aspects of the study

Secondary outcome measures

1. Device acceptance - Florida Patient Acceptance Survey (FPAS), Burns, Serber, Keim, & Sears, 2005.
2. Performance in everyday activities - Functional Performance Inventory (FPI)- Short Form, Leidy, 1999; Leidy & Knebel, 2010.
3. Defibrillator shock anxiety - Florida Shock Anxiety Survey (FSAS), Kuhl, Dixit, Walker, Conti, & Sears, 2006.
4. General anxiety - Hospital Anxiety and Depression (HAD) Scale (anxiety sub-scale only), Zigmond & Snaith, 1983.

Data were collected at baseline and 1 month after hospital discharge.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Aged 18 years or older, no upper age limit and either sex
2. Patients with first-time implantable cardiac defibrillators (ICD)
3. Speak, read and understand French
4. Physical and cognitive capabilities to participate
5. Hospital length of stay of two weeks or less after ICD implantation
6. Returning home after hospital discharge (not to long-term care, rehabilitation or other health care facilities)

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Having a regular and specialized follow-up (e.g., every week or every month) in a Heart Failure Clinic or an Adult Congenital Heart Center
2. Participate in another clinical research project, or regular follow-up by a specialist such as a psychiatrist or nurse practitioner, to avoid doubling the interventions by different professionals
3. Being referred or followed in palliative care or similar, or being in end-stage heart failure [New York Heart Association (NYHA) class IV]

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Montreal Heart Institute Research Centre
H1T 1C8

Sponsor information


Montreal Heart Institute Research Center (Canada)

Sponsor details

c/o Gilles Lefebvre
Belanger Street
H1T 1C8
+1 514 376 3330

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Quebec Interuniversity Nursing Intervention Research Group [Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec (GRIISIQ)] (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Quebec’s Ministry of Education, Recreation and Sports [Ministère de l’Éducation, du Loisir et du Sport (MELS)] (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 protocol - Charchalis, M., & Cossette, S. (2010). Description of informational and follow-up preferences expressed by new carriers of implantable cardiac defibrillators [Abstract- N002]. The Canadian Journal of Cardiology, 26, suppl. D, 149D.
2. 2011 protocol - Charchalis, M., Cossette, S., Frasure-Smith, N., Martorella, G., Verville, A., & Guertin, M.-C. (2011). Development and evaluation of an individualized nursing intervention to increase the acceptance of implantable cardiac defibrillators by new carriers of these devices [Abstract- NP015]. The Canadian Journal of Cardiology, 27, 5S, S363.
3. 2012 protocol - Charchalis, M., Cossette, S., Frasure-Smith, (2012). Feasibility and acceptability of an individualized nursing intervention aimed at increasing adaptation among patients with newly implanted cardiac defibrillators: A pilot randomized clinical trial [Abstract- N043]. The Canadian Journal of Cardiology, 28, 5S, S433.

Publication citations

Additional files

Editorial Notes