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Trial registered on ANZCTR


Registration number
ACTRN12616001190493p
Ethics application status
Not yet submitted
Date submitted
23/08/2016
Date registered
30/08/2016
Date last updated
30/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Device to aid in the administration of glyceryl tri-nitrate sublingual spray for patients with angina and impaired manual dexterity.
Scientific title
Adaptive study of prototype assistive angina spray device for patients with angina and a coexisting arthritic, neuromuscular or other disability.
Secondary ID [1] 289996 0
None
Universal Trial Number (UTN)
U1111-1178-9034
Trial acronym
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Cardiac rehabilitation 300004 0
Angina 300038 0
Arthritis 300039 0
Neuromuscular disability 300040 0
Condition category
Condition code
Musculoskeletal 299901 299901 0 0
Other muscular and skeletal disorders
Neurological 299931 299931 0 0
Other neurological disorders
Cardiovascular 299932 299932 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The device used to facilitate the GTN spray has been called the GT'NHaler. The device is used to assist with the administration of glyceryl tri-nitrate sublingual spray in patients with angina and impaired manual dexterity caused by arthritic, neuromuscular or other disability. The device consists of a tube into which the GTN spray canister is inserted. A l lever attached .to the top of the device is used by the patient to provide downwards pressure to the top of the canister thereby activating administration of the GTN spray. The device will be used every time the participant's standard care glyceryl tri-nitrate sublingual spray is administered over the 1 month period of the study. The patient's use of the device and their opinions on its effectiveness and ease of use will be recorded in a questionnaire booklet.
Intervention code [1] 295699 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299383 0
Satisfaction with the device, assessed by a questionnaire designed specifically for this study.
Timepoint [1] 299383 0
One month after starting using the device
Primary outcome [2] 299417 0
Difficulty using the device during the 1 month period of the study, assessed by a questionnaire designed specifically for this study.
Timepoint [2] 299417 0
One month after starting using the device
Secondary outcome [1] 326997 0
Proportion of participants who report not being able to use the device adequately, An inability to use the device will be defined as failure to use the device on two consecutive administrations of GTN spray in any given day. The number of consecutive failures over the 30 days of the trial will be counted.
Timepoint [1] 326997 0
1 month after the start of using the device

Eligibility
Key inclusion criteria
Angina
Impaired manual dexterity that hinders administration of angina spray
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability or unwillingness to use the spray device

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Phase 0
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analysis of patient written responses in questionnaire. No statistical power calculations were carried out as the study is a qualitative assessment of the GTN device, making statistical assumptions difficult to construct. The number of 20 subjects with 30 days of responses/observations (600 data points) was considered adequate to provide information that could be used to adapt or modify the GTN device. .

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8120 0
New Zealand
State/province [1] 8120 0
Canterbury

Funding & Sponsors
Funding source category [1] 294367 0
Government body
Name [1] 294367 0
Via Innovations,
Address [1] 294367 0
4th floor, 32 Oxford Tce
Christchurch 8011
Country [1] 294367 0
New Zealand
Primary sponsor type
Government body
Name
Via Innovations,
Address
4th floor, 32 Oxford Tce
Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 293210 0
None
Name [1] 293210 0
None
Address [1] 293210 0
Not applicable
Country [1] 293210 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 295784 0
Health Disability Ethics Committee
Ethics committee address [1] 295784 0
Ministry of Health
Freyberg Building
20 Aitken St
PO Box 5013
wellington 6011
Ethics committee country [1] 295784 0
New Zealand
Date submitted for ethics approval [1] 295784 0
29/08/2016
Approval date [1] 295784 0
Ethics approval number [1] 295784 0

Summary
Brief summary
This is an adaptive study. The objective is to field test a device for assisting with the administration of angina spray in patients who have difficulty using proprietary GTN spray devices and evolve the prototype based on this experience so that a final version can be produced. Firstly patients will be selected for the study because they have expressed difficulty using the proprietary GTN spray devices. Alternatively they will have been observed to be experiencing difficulty using the devices. The Christchurch Hospital cardiac rehabilitation programme or Arthritis Society will provide useful settings for these patients to be identified. The cardiac rehabilitation programme provides aftercare for patients who have been in hospital having experienced a cardiac event for example myocardial infarction. It is hoped that sufficient patients will be identified in this manner for a meaningful trial of the device to be undertaken. If insufficient numbers of patients are identified an alternative avenue would be through General Practice. Once identified, patients will be shown and instructed in the use of the device, and if they are interested in becoming part of the trial will be given a prototype device to use. Patients will be followed up to obtain their feedback about the use of the device, with information being sought on the ease of administration, durability, ease of changing to a new spray once expired or used up, and other issues that may arise. Modifications to the device can then be made based upon feedback obtained..
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 68478 0
Dr Arthur Collins
Address 68478 0
Travis Medical Centre
225 Travis Road
Christchurch 8083
Country 68478 0
New Zealand
Phone 68478 0
+64 27 3394095
Fax 68478 0
+64 3 3289223
Email 68478 0
cobrastarno@gmail.com
Contact person for public queries
Name 68479 0
Ms Ruth Davison
Address 68479 0
Department of Cardiology
Christchurch Hospital
2 Riccarton Ave
Christchurch Central 4710
Country 68479 0
New Zealand
Phone 68479 0
+64 3 3641093 Ext 81093
Fax 68479 0
Email 68479 0
ruth.davison@cdhb.health.nz
Contact person for scientific queries
Name 68480 0
Dr Arthur Collins
Address 68480 0
Travis Medical Centre
225 Travis Road
Christchurch 8083
Country 68480 0
New Zealand
Phone 68480 0
+64 27 3394095
Fax 68480 0
Email 68480 0
cobrastarno@gmail.com

No information has been provided regarding IPD availability
Summary results
No Results