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Evaluation of the PROCARE nursing intervention on device acceptance in patients with newly implanted cardiac defibrillators

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95996799
Enrollment
30
Registered
2014-01-30
Start date
2011-06-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Newly Implanted Cardiac Defibrillators Circulatory System

Interventions

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
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.

Sponsors

Montreal Heart Institute Research Center (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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]

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026