Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001104347
Ethics application status
Approved
Date submitted
24/07/2017
Date registered
28/07/2017
Date last updated
30/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Transitioning from hospital to reality:
Do newly diagnosed heart failure patients benefit from a heart failure clinical nurse specialist providing focused education at discharge?
Scientific title
What effects does a brief intervention emphasising self-checks for weight changes, oedema or breathing changes prior to discharge have on adherence to medication, ongoing symptom monitoring and management
Secondary ID [1] 292513 0
Nil Known
Universal Trial Number (UTN)
U1111-11997579
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 304153 0
Condition category
Condition code
Cardiovascular 303486 303486 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People who are admitted to a metropolitan hospital and newly diagnosed with heart failure and referred to the heart failure clinical nurse specialist clinic will be invited to participate in the study. Recruitment period will be over a three month period. Non-probability sampling will be used for this research. This research will be conducted in a metropolitan hospital in New Zealand.
The educational intervention will be a one off educational session prior to discharge from hospital. The session will take place in inpatient wards where patients with heart failure are admitted to and being assessed, diagnosed, educated, referred and discharged home. The post discharge questioning will take place over the telephone once participants have discharged home within 48 hours from the researcher’s office and at an outpatient clinic at two weeks following discharge. .
Participants recruited to the educational intervention will be given additional education by the heart failure clinical nurse specialist (researcher). An appropriate time will be made with the participants, family members and researcher to go and provide a brief focused educational session on heart failure self-monitoring. Each session will take approximately between 10 to 20 minutes. The session will include focusing on the National Heart Foundation of New Zealand weight diary resource given to patients and the researcher will explain the importance of daily weighing, monitoring for changes in breathing and checking for any oedema.
The participants will be advised that the heart failure clinical nurse specialists will be in phone contact with them (both groups) within 48 hours following discharge and booked into the heart failure clinic at two weeks following discharge (both groups). Participants will also able to ask any questions at that time.
The collection tool intended for use for this study will be a heart failure phone questionnaire. The questionnaire includes initial referral information including if patients have already received heart failure self-management education and if they have received the heart failure resources. A set of 10 questions will be asked based on self-management principles and NYHA functional classification at a 48 hour and two week time intervals. The questionnaire is in the form of a yes/no tick box in each time interval section. This questionnaire will be used to reflect the aims of the study. Participants recruited to the control or usual care groups will be followed up and questioned at time intervals by other heart failure clinical nurse specialist other than the researcher to avoid any bias

Reference for weight diary.
National Heart Foundation of New Zealand (2017). Heart Failure Action Plan and daily checks. [Brochure]. Retrieved from http://assets.heartfoundation.org.nz/shop/heart-healthcare/non-stock-resources/my-heart-failure-action-plan.pdf
Intervention code [1] 298697 0
Lifestyle
Intervention code [2] 298721 0
Treatment: Other
Comparator / control treatment
Participants recruited to the control group or usual care, will be given discharge education by the ward nurses prior to discharge home. This involves basic heart failure education on furosemide diuretic education, giving patients the Heart Foundation of New Zealand weight diary and ensuring patients can self-manage including monitoring daily weights and changes in breathing. This session may take approximately 10-30 minutes. Patients are then given a pack that includes information about heart failure and referred to the outpatient heart failure clinical nurse specialist clinic. Participants in the control comparator group will be followed at timely intervals and questioned as is the intervention group at 48 hour and at the two week clinic appointment.
Control group
Active

Outcomes
Primary outcome [1] 302854 0
To measure the effect of discharge education on heart failure self-monitoring at 48 hours post discharge on a telephone call.
This will be measured by checking if participants have monitored their symptoms via the Heart Foundation of New Zealand weight diary and on the researchers checklist questionnaire in regards to their NYHA functional classification and checking for self-monitoring..
Timepoint [1] 302854 0
Educational intervention to be done prior to discharge and then time points for questioning will be a telephone call 48 hours following discharge.
Primary outcome [2] 302885 0
To measure the effect of discharge education on heart failure self-monitoring at a two week clinic follow up.
This will be measured by checking if participants have monitored their symptoms via the Heart Foundation of New Zealand weight diary and on the researchers checklist questionnaire in regards to their NYHA functional classification and checking for self-monitoring.
Timepoint [2] 302885 0
Outpatient clinic review at two weeks following discharge.
Secondary outcome [1] 337252 0
To measure the effect of discharge education on heart failure functional classification (NYHA).
This will be assessed by using the researchers questionnaire to obtain what functional class participants are and if participants have any heart failure symptoms.
Timepoint [1] 337252 0
48 hours post discharge and two week clinic visit post discharge

Eligibility
Key inclusion criteria
Patients who are admitted during the three month recruitment period to a metropolitan hospital, treated and newly diagnosed with heart failure meet the initial criteria for recruitment.. Patients need to be inpatients, referred by a cardiology team as an inpatient, classed as having low co-morbidity. Recruited participates needto be accessible by telephone and able to attend the heart failure clinic.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes, patients who have a known diagnosis of heart failure and known to the heart failure clinical nurse specialist clinic previously and patients who are recruited to other heart failure research.

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)
The sample will be sourced from the referrals made to the metropolitan hospital’s heart failure clinical nurse specialist clinic. Patients who meet the criteria will be given an information sheet about the study and invited to participate by the researcher. The researcher will make a time to go back to see patients and obtain written consent. Once consent is obtained participates will be randomised into the control or intervention groups. The researcher’s medical secretary will have 40 envelopes which will have either intervention or control group labelled once opened. The medical secretary will hand an envelope to the researcher and the researcher will open the envelope at the bedside with the consenting participants. If participants are recruited to the control group no further information will be provided by the researcher during the discharge process until the post discharge questioning at 48 hours. If participants are recruited to the intervention group, another time will be made with the participants for the researcher to commence the bedside education.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization will be used for this study. Once participants are consented, a computer generated system will assist in randomizing participants to one of two groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on the number of current referrals the heart failure CNS clinic receives a target of 40 participates was recruited for this study who met the inclusion and exclusion criteria.

Descriptive statistical analysis describes and produces raw data and shows trends and patterns. Data will be condensed and summarised into meaningful units to show mode, medians and means of questionnaire answers. Data will be presented in the form of percentages and raw figures and to allow variables to be analysed were in a measurable form of numbers and scores. Nominal measurement will be used to classify answers into categories and frequency distribution to group answers

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/08/2017
Actual
28/08/2017
Date of last participant enrolment
Anticipated
27/11/2017
Actual
27/11/2017
Date of last data collection
Anticipated
25/12/2017
Actual
4/12/2017
Sample size
Target
40
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 9084 0
New Zealand
State/province [1] 9084 0

Funding & Sponsors
Funding source category [1] 297085 0
Government body
Name [1] 297085 0
Canterbury District Health Board
Country [1] 297085 0
New Zealand
Primary sponsor type
Individual
Name
Emma Reeves
Address
Cardio-Respiratory Integrated Specialist Services (CRISS)
5th Floor, Riverside Block
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 296091 0
Individual
Name [1] 296091 0
Professor Bob Marshall
Address [1] 296091 0
Eastern Institute of Technology (EIT)
501 Gloucester street
Private Bag 1201 Hawkes Bay Mail centre
Napier 4142
New Zealand
Country [1] 296091 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298263 0
Health and Disability Ethics Committees (HDEC) 19th July 2017
Ethics committee address [1] 298263 0
Ministry of Health
133 Molesworth Street
PO BOX 5013
Wellington
New Zealand 6011
Ethics committee country [1] 298263 0
New Zealand
Date submitted for ethics approval [1] 298263 0
27/06/2017
Approval date [1] 298263 0
19/07/2017
Ethics approval number [1] 298263 0
17/STH/114

Summary
Brief summary

This research will determine if a focused educational session by a heart failure clinical nurse specialist prior to discharge has any significance on the patient’s self-adherence to medications, self-monitoring and any change to their condition. Data collected will be able to be used by clinicians working in areas of heart failure and highlight areas where heart failure patients may require more specific education during the delivery of education at discharge. This research may assist in the development or teachings required for health professionals working in areas of heart failure in order to promote heart failure patient outcomes.
Trial website
Trial related presentations / publications
Public notes
Please note provisionally approved upon registering this study on a clinical trial registry.
Attachments [1] 1906 1906 0 0
/AnzctrAttachments/373364-Research Consent Form version 2.docx (Participant information/consent)
Attachments [2] 1907 1907 0 0
/AnzctrAttachments/373364-Letter of Information for Participants-final.docx (Participant information/consent)
Attachments [3] 1908 1908 0 0
/AnzctrAttachments/373364-protocol work doc.docx (Protocol)
Attachments [4] 1909 1909 0 0
/AnzctrAttachments/373364-HDEC Letter 17STH114 Prov App EXP Application.pdf (Ethics approval)

Contacts
Principal investigator
Name 76514 0
Ms Emma Reeves
Address 76514 0
Cardio- Respiratory Integrated Specialist Services
5th Floor Riverside, Christchurch Hospital
Private Bag 4710
Christchurch 8140
New Zealand
Country 76514 0
New Zealand
Phone 76514 0
+ 64 3 3640167
Fax 76514 0
+ 64 3 3640849
Email 76514 0
[email protected]
Contact person for public queries
Name 76515 0
Ms Emma Reeves
Address 76515 0
Cardio- Respiratory Integrated Specialist Services
5th Floor Riverside, Christchurch Hospital
Private Bag 4710
Christchurch 8140
New Zealand
Country 76515 0
New Zealand
Phone 76515 0
+ 64 3 3670167
Fax 76515 0
+ 64 3 3640849
Email 76515 0
[email protected]
Contact person for scientific queries
Name 76516 0
Prof Bob Marshall
Address 76516 0
Eastern Institute of Technology
501 Gloucester Street, Taradale, Napier
Private Bag 1201 Hawkes Bay Mail Centre Napier 4142
Country 76516 0
New Zealand
Phone 76516 0
+ 64 6 9748000
Fax 76516 0
+ 64 6 9748974
Email 76516 0
[email protected]

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.