Evaluation of the PROCARE nursing intervention on device acceptance in patients with newly implanted cardiac defibrillators
| ISRCTN | ISRCTN95996799 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95996799 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/01/2013
- Registration date
- 30/01/2014
- Last edited
- 19/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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?
Quebecs Ministry of Education, Recreation and Sports, Canada.
Who is the main contact?
Mrs Mélanie Charchalis
melanie.charchalis@umontreal.ca
Contact information
Scientific
Montreal Heart Institute Research Centre
S-2490
5000, Belanger street
Quebec
Montreal
H1T 1C8
Canada
| Phone | +1 514 376 3330 ext.3069 |
|---|---|
| melanie.charchalis@umontreal.ca |
Study information
| Study design | Randomized pilot study two groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of a caring and cognitive behavioural nursing intervention on device acceptance in patients with newly implanted cardiac defibrillators |
| Study acronym | PROCARE |
| Study objectives | 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(s) | Ethics Committee of the Montreal Heart Institute, 11/05/2011, ref: 11-1294 |
| Health condition(s) or problem(s) studied | Patients with Newly Implanted Cardiac Defibrillators |
| Intervention | 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 patients 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 | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/06/2011 |
| Completion date | 01/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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) |
| Key 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] |
| Date of first enrolment | 01/06/2011 |
| Date of final enrolment | 01/04/2012 |
Locations
Countries of recruitment
- Canada
Study participating centre
H1T 1C8
Canada
Sponsor information
Hospital/treatment centre
c/o Gilles Lefebvre
5000, Belanger Street
Montreal
H1T 1C8
Canada
| Phone | +1 514 376 3330 |
|---|---|
| gilles.lefebvre@icm-mhi.org | |
| Website | http://www.icm-mhi.org/en/index.html |
"ROR" |
https://ror.org/03vs03g62 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 01/10/2010 | No | No | ||
| Abstract results | 01/09/2011 | No | No | ||
| Abstract results | 01/09/2012 | No | No |
