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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).
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.
Secondary ID [1] 280949 0
Nil
Universal Trial Number (UTN)
U1111-1133-1638
Trial acronym
The 'REALITY CHEC' Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 287045 0
Coronary heart disease 287046 0
Condition category
Condition code
Mental Health 287373 287373 0 0
Anxiety
Cardiovascular 287374 287374 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 285394 0
Treatment: Other
Intervention code [2] 285395 0
Rehabilitation
Intervention code [3] 285396 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 287655 0
To reduce anxiety as measured by the State Trait Anxiety Inventory (STAI).
Timepoint [1] 287655 0
(Once only collection at each timepoint): Baseline (day of hospital discharge), 5-7 days, 1 month and 3 months post-discharge from hospital.
Primary outcome [2] 287656 0
To reduce anxiety as measured by salivary cortisol levels.
Timepoint [2] 287656 0
(Once only collection at each timepoint): Baseline (day of hospital discharge) and 1 month post-discharge from hospital.
Primary outcome [3] 287722 0
To enhance Self-Efficacy as measured by the Cardiac Self-Efficacy Questionnaire (CSE).
Timepoint [3] 287722 0
(Once only collection at each timepoint): Baseline (day of hospital discharge), 5-7 days, 1 month and 3 months post-discharge from hospital.
Secondary outcome [1] 298590 0
To identify depression in participants in the early post-discharge period as measured by the Cardiac Depression Scale (CDS).
Timepoint [1] 298590 0
(Once only collection at each timepoint): Baseline (day of hospital discharge), 5-7 days, 1 month and 3 months post-discharge from hospital.
Secondary outcome [2] 298715 0
To reduce symptoms of depression in PCI patients in the early post-discharge period as measured by the Cardiac Depression Scale (CDS).
Timepoint [2] 298715 0
(Once only collection at each timepoint): Baseline (day of hospital discharge), 5-7days, 1 month and 3 months post-discharge from hospital.
Secondary outcome [3] 298716 0
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.
Timepoint [3] 298716 0
(Once only collection at each timepoint): Baseline (day of hospital discharge), 5-7days, 1 month and 3 months post-discharge from hospital.
Secondary outcome [4] 298775 0
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.
Timepoint [4] 298775 0
(Once only collection at each timepoint): Baseline (day of hospital discharge), 5-7days, 1 month and 3 months post-discharge from hospital.

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5580 0
4000
Recruitment postcode(s) [2] 5581 0
4102

Funding & Sponsors
Funding source category [1] 285745 0
University
Name [1] 285745 0
Queensland University of Technology
Country [1] 285745 0
Australia
Funding source category [2] 285746 0
Self funded/Unfunded
Name [2] 285746 0
Katina M Corones
Country [2] 285746 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Rd, Kelvin Grove Campus, Kelvin Grove, Brisbane, QLD, 4059
Country
Australia
Secondary sponsor category [1] 284571 0
None
Name [1] 284571 0
Address [1] 284571 0
Country [1] 284571 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287750 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 287750 0
Ethics committee country [1] 287750 0
Australia
Date submitted for ethics approval [1] 287750 0
Approval date [1] 287750 0
05/03/2012
Ethics approval number [1] 287750 0
HREC/11/QPAH/526
Ethics committee name [2] 287751 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [2] 287751 0
Ethics committee country [2] 287751 0
Australia
Date submitted for ethics approval [2] 287751 0
Approval date [2] 287751 0
07/03/2012
Ethics approval number [2] 287751 0
1125
Ethics committee name [3] 287752 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [3] 287752 0
Ethics committee country [3] 287752 0
Australia
Date submitted for ethics approval [3] 287752 0
Approval date [3] 287752 0
16/07/2012
Ethics approval number [3] 287752 0
1200000332
Ethics committee name [4] 287753 0
St Andrew's Medical Institute
Ethics committee address [4] 287753 0
Ethics committee country [4] 287753 0
Australia
Date submitted for ethics approval [4] 287753 0
Approval date [4] 287753 0
26/04/2012
Ethics approval number [4] 287753 0
1125

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34516 0
Address 34516 0
Country 34516 0
Phone 34516 0
Fax 34516 0
Email 34516 0
Contact person for public queries
Name 17763 0
Ms Katina M Corones
Address 17763 0
Queensland University of Technology, School of Nursing, Victoria Park Rd, Kelvin Grove Campus, Kelvin Grove, Brisbane, QLD, 4059
Country 17763 0
Australia
Phone 17763 0
+617 3138 8208
Fax 17763 0
+ 61 7 3138 3814
Email 17763 0
k.corones@student.qut.edu.au
Contact person for scientific queries
Name 8691 0
Ms Katina M Corones
Address 8691 0
Queensland University of Technology, School of Nursing, Victoria Park Rd, Kelvin Grove Campus, Kelvin Grove, Brisbane, QLD, 4059
Country 8691 0
Australia
Phone 8691 0
+617 3138 8208
Fax 8691 0
+ 61 7 3138 3814
Email 8691 0
k.corones@student.qut.edu.au

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.