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Trial registered on ANZCTR
Registration number
ACTRN12612000971831
Ethics application status
Approved
Date submitted
22/08/2012
Date registered
10/09/2012
Date last updated
10/09/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of a nurse-led educational clinic for patients within 5-7 days post-discharge from hospital following percutaneous coronary intervention (PCI).
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Scientific title
A RandomisEd Controlled Clinical TriAL Of A Post-DIscharge Educational IntervenTion to Reduce Anxiety and Enhance Self-Efficacy (SE) In Percutaneous CoronarY Intervention (PCI) Patients WitHin Five to SEven Days Post-DisCharge.
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Secondary ID [1]
280949
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Nil
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Universal Trial Number (UTN)
U1111-1133-1638
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Trial acronym
The 'REALITY CHEC' Project
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anxiety
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Coronary heart disease
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Condition category
Condition code
Mental Health
287373
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0
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Anxiety
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Cardiovascular
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0
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Study Intervention Group (n=110)
Intervention: Post-PCI nurse-led educational clinic.
Clinic: Post-discharge period education and support tailored to PCI patients including: cardiac rehabilitation [CR] referral and attendance; medication knowledge, education and adherence; post-discharge period cares, complication identification and management, including access site management; chest pain identification and management.
Intervention to be administered in a 45-60 minute single visit at day 5-7 post-discharge from hospital.
Visit times (i.e. 45-60 minutes) will vary on a case by case basis. For example one participant may have more questions/concerns than others and therefore require slightly more time to have these addressed.
Telephone follow-up for intervention group participants will occur at 1 and 3 months post-discharge.
Data collection: self-report standardised tools; and salivary cortisol.
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Intervention code [1]
285394
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Treatment: Other
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Intervention code [2]
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Rehabilitation
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Intervention code [3]
285396
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Behaviour
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Comparator / control treatment
Standard Care Group (n=110)
Participants will receive Hospital standard care and telephone follow-up by the principal researcher to collect post-discharge period data after undergoing PCI. Telephone follow-up for standard care group data collection will only occur once at each timepoint.
Hospital standard care involves participants receiving in-patient procedural and post-procedural education from nursing and cardiac rehabilitation (CR) teams up until the day of discharge from hospital using standardised pathways. Follow-up outpatient appointments are made with the CR team and cardiologist.
Data collection: Psychosocial and physical health assessment using self-report standardised tools; and salivary cortisol. After baseline assessment, data collection will occur via telephone at 5-7 days, 1 month and 3 months post-discharge from hospital. Participants in the standard care group will not return for any follow-up at day 5-7 post-discharge and will only be contacted via telephone for data collection purposes.
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Control group
Active
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Outcomes
Primary outcome [1]
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To reduce anxiety as measured by the State Trait Anxiety Inventory (STAI).
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Assessment method [1]
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Timepoint [1]
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(Once only collection at each timepoint): Baseline (day of hospital discharge), 5-7 days, 1 month and 3 months post-discharge from hospital.
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Primary outcome [2]
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To reduce anxiety as measured by salivary cortisol levels.
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Assessment method [2]
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Timepoint [2]
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(Once only collection at each timepoint): Baseline (day of hospital discharge) and 1 month post-discharge from hospital.
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Primary outcome [3]
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To enhance Self-Efficacy as measured by the Cardiac Self-Efficacy Questionnaire (CSE).
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Assessment method [3]
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Timepoint [3]
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(Once only collection at each timepoint): Baseline (day of hospital discharge), 5-7 days, 1 month and 3 months post-discharge from hospital.
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Secondary outcome [1]
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To identify depression in participants in the early post-discharge period as measured by the Cardiac Depression Scale (CDS).
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Assessment method [1]
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Timepoint [1]
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(Once only collection at each timepoint): Baseline (day of hospital discharge), 5-7 days, 1 month and 3 months post-discharge from hospital.
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Secondary outcome [2]
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To reduce symptoms of depression in PCI patients in the early post-discharge period as measured by the Cardiac Depression Scale (CDS).
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Assessment method [2]
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Timepoint [2]
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(Once only collection at each timepoint): Baseline (day of hospital discharge), 5-7days, 1 month and 3 months post-discharge from hospital.
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Secondary outcome [3]
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To achieve one-hundred percent referral and attendance to a cardiac rehabilitation (CR) program as measured by participant self-report and CR clinic follow-up.
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Assessment method [3]
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Timepoint [3]
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(Once only collection at each timepoint): Baseline (day of hospital discharge), 5-7days, 1 month and 3 months post-discharge from hospital.
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Secondary outcome [4]
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Early identification and prevention of post-discharge complications.
Post-operative complications and methods of assessment are identified below:
1. Chest pain/discomfort: Chest pain assessment pathway, clinical assessment and Electrocardiogram
2. Haematoma: Clinical assessment
3. Bleeding: Clinical assessment
4. Bruising: Clinical assessment (Documentation on wound
care pathway)
5. Wound site infection: Wound care assessment pathway and clinical assessment
6. Psudoaneurysm: Clinical assessment (auscultation for bruit using stethoscope)
7. Neurovascular complications: Neurovascular assessment tool and clinical assessment
8. Suspected medication complications/interactions/
allergies: Clinical assessment, participant interview
9. Contrast induced pyrexia: Clinical assessment using thermometer.
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Assessment method [4]
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Timepoint [4]
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(Once only collection at each timepoint): Baseline (day of hospital discharge), 5-7days, 1 month and 3 months post-discharge from hospital.
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Eligibility
Key inclusion criteria
Age of 18 years and above; informed consent for primary or elective PCI signed by patient and cardiologist; undergone a primary or elective PCI; understand or speak English; and post-discharge telephone access (mobile phone and/or landline).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Children and/or young people (i.e. < 18 years); inability to understand or speak English; overseas resident and unable to be followed-up due to return to home country; on vacation in Australia for < 12 months; suffering from a mental illness/cognitive impairment and unable to legally consent; pregnancy; in existing dependent or unequal relationship(s); highly dependent on medical care; and no telephone communication access.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be identified through collaboration with ward staff at the hospital sites.
The recruitment process - Day of hospital discharge:
1. Consultation with the nurse unit manager (NUM);
2. Consultation with the nurse in charge of the shift; and
3. Consultation with the nurse caring for the patient.
Participants will be approached by their nurse, advised of the study and asked if they wish to speak with the principal researcher regarding potential participation. If participants agree, the principal researcher will offer a participant information and consent form (PICF) in the presence of their nurse and be given time to review the documents. If the patient wishes to speak with the principal researcher to seek clarification or to sign the consent form, they may advise their nurse, who will contact the researcher. Participants, if agreeable, will be consented to the study. Baseline data will be collected, and participants will be randomly assigned to a study group.
The allocation sequence will be concealed from the hospital sites and participants. Envelopes containing random numbers for participant selection are opaque, aluminium lined and sealed. The aluminium lining will ensure the envelope is impermeable to intense light. Envelopes are only to be opened after the enrolled participants complete all baseline assessments.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
9/08/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
220
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
5580
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4000
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Recruitment postcode(s) [2]
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4102
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Queensland University of Technology
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Address [1]
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Victoria Park Rd, Kelvin Grove Campus, Kelvin Grove, Brisbane, QLD, 4059
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Country [1]
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Australia
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Funding source category [2]
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Self funded/Unfunded
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Name [2]
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Katina M Corones
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Address [2]
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Queensland University of Technology, School of Nursing, Victoria Park Rd, Kelvin Grove Campus, Kelvin Grove, Brisbane, QLD, 4059
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Country [2]
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Australia
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Primary sponsor type
University
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Name
Queensland University of Technology
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Address
Victoria Park Rd, Kelvin Grove Campus, Kelvin Grove, Brisbane, QLD, 4059
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Metro South Health Service District Human Research Ethics Committee
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Ethics committee address [1]
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Ipswich Road
Woolloongabba, Brisbane, Queensland, 4102
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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05/03/2012
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Ethics approval number [1]
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HREC/11/QPAH/526
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Ethics committee name [2]
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UnitingCare Health Human Research Ethics Committee
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Ethics committee address [2]
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PO BOX 499, Toowong, Brisbane, QLD, 4066
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Ethics committee country [2]
287751
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Australia
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Date submitted for ethics approval [2]
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Approval date [2]
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07/03/2012
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Ethics approval number [2]
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1125
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Ethics committee name [3]
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Queensland University of Technology Human Research Ethics Committee
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Ethics committee address [3]
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Research Ethics Unit, Office of Research
Level 4, 88 Musk Avenue, Kelvin Grove, Brisbane, Queensland
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Ethics committee country [3]
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Australia
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Date submitted for ethics approval [3]
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Approval date [3]
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16/07/2012
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Ethics approval number [3]
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1200000332
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Ethics committee name [4]
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St Andrew's Medical Institute
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Ethics committee address [4]
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457 Wickham Terrace, Spring Hill QLD, Brisbane, 4000
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Ethics committee country [4]
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Australia
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Date submitted for ethics approval [4]
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Approval date [4]
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26/04/2012
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Ethics approval number [4]
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1125
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Summary
Brief summary
This study evaluates the effectiveness of a nurse-led educational clinic offered to patients within 5-7 days after having a procedure on their heart. The main aim of the clinic is to reduce patient anxiety after discharge from hospital. This study also aims to reinforce education on post-operative cares, risk and lifestyle modification, and encouraging medication adherence whilst improving access to secondary prevention programs. Through the provision of nurse-led clinical follow-up, support and education in the early post-discharge period, it is hoped that patients can achieve confidence and independence in their health-management, resulting in improvements in psychosocial and physical well-being.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ms Katina M Corones
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Address
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Queensland University of Technology, School of Nursing, Victoria Park Rd, Kelvin Grove Campus, Kelvin Grove, Brisbane, QLD, 4059
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Country
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Australia
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Phone
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+617 3138 8208
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Fax
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+ 61 7 3138 3814
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Katina M Corones
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Address
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Queensland University of Technology, School of Nursing, Victoria Park Rd, Kelvin Grove Campus, Kelvin Grove, Brisbane, QLD, 4059
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Country
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Australia
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Phone
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+617 3138 8208
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Fax
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+ 61 7 3138 3814
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Email
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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