Device to aid in the administration of glyceryl tri-nitrate sublingual spray for patients with angina and impaired manual dexterity.

Adaptive study of prototype assistive angina spray device for patients with angina and a coexisting arthritic, neuromuscular or other disability.

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001190493

Enrollment

Registered

2016-08-30

Start date

2016-11-01

Completion date

2017-08-01

Last updated

2020-01-13

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

Conditions

None listed

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..

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Angina Impaired manual dexterity that hinders administration of angina spray

Exclusion criteria

Inability or unwillingness to use the spray device

Outcome results