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Trial registered on ANZCTR


Registration number
ACTRN12617001175369
Ethics application status
Approved
Date submitted
4/08/2017
Date registered
10/08/2017
Date last updated
28/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring whether pill-swallowing aids make it easier to swallow tablets whole
Scientific title
Exploring whether pill-swallowing aids make it easier to swallow tablets whole by people who self-report disliking swallowing them
Secondary ID [1] 292577 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Swallowing difficulties in relation to solid oral dosage form 304242 0
Condition category
Condition code
Oral and Gastrointestinal 303596 303596 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions are products that offer different approaches to making tablets/capsules easier to swallow. Each participant will be required to swallow three placebo tablets (microcellulose tablets) using three of the following seven randomly allocated interventions:

(i) Pilgo (Registered Trademark)
Description: A pill swallowing cup with a mouth piece that is angled back away from the user to assist individuals in pill swallowing. Its design allows thorough mixing of the pill and liquid before reaching the oral cavity and reduces tilting of the head for a more comfortable motion.
Instruction of use: Swallow a whole tablet using this pill swallowing cup filled with water to the indicator according to the manufacturer's instruction.

(ii) Medi-Straw (Registered Trademark)
Description: A pill swallowing straw with a shelf inside for the pill to rest on. It suspends the pill in liquid as it enters the mouth. It allows the head to remain level and provides a flow of liquid to carry the pill into the mouth. The sucking action also triggers the swallowing reflex, which avoids the gag response.
Instruction of use: Drink water through this pill swallowing straw with a whole tablet pre-placed on the shelf inside the straw (a cup containing 200-250 mL is provided).

(iii) Pill Glide (Registered Trademark)
Description: A non-prescription, water-based, flavored mouth/throat lubricating spray to facilitate pill swallowing by creating a slippery surface on the tongue and throat and masking unpleasant bitter taste of pills. It does not contain any active ingredients.
Instruction of use: Spray 2-4 sprays in the mouth according to manufacturer's instructions and then swallow a whole tablet with water (a cup containing 200-250 mL is provided).

(iv) MedCoat (Registered Trademark)
Description: A disposable pill coating device designed to facilitate pill swallowing by coating the entire pill with a slippery layer and stimulating saliva production, which makes pills easier to swallow. It does not contain any active ingredients.
Instruction of use: Swallow a whole tablet coated using this device with water (a cup containing 200-250 mL is provided).

(v) Gloup (Registered Trademark)
Description: A thick, slippery lubricating gel that makes pills easier to swallow. It is capable of effectively moistening the mouth and throat. It does not contain any active ingredients.
Instruction of use: Swallow a whole tablet encased in a heaped tablespoon of this lubricating gel. If the participants need it, they may follow this with water (a cup containing 200-250 mL is provided).

(vi) Ensure Original Pudding (Registered Trademark)
Description: A nutritious alternative to other snacks or desserts that is suitable for individuals on consistency-modified diets or with swallowing difficulties. It does not contain any active ingredients.
Instruction of use: Swallow a whole tablet encased in a heaped tablespoon of this pudding. If participants need it, they may follow this with water (a cup containing 200-250 mL is provided).

(vii) Water
Description: Water is a commonly recommended as the liquid when swallowing pill.
Instruction of use: Swallow a whole tablet with water (a cup containing 200-250 mL is provided).

There is no minimum duration of break between each swallowing aid and participants may take as much time as they require to break between each swallowing aid.

All interventions will be delivered face-to-face by healthcare professionals with expertise in the field of medication and/or swallowing difficulties.
Intervention code [1] 298785 0
Treatment: Devices
Intervention code [2] 298819 0
Treatment: Other
Comparator / control treatment
Asking participants to swallow a sip of water before commencing the swallowing task will be used to calibrate the ease of swallowing rating for each of the randomly allocated pill-swallowing aid. The perceived ease of swallowing whole tablets using the intervention will be compared against other interventions being investigated.
Control group
Active

Outcomes
Primary outcome [1] 302953 0
The perceived ease of swallowing whole tablets when using different pill-swallowing aids. This will be measured using a 150mm visual analogue scale.
Timepoint [1] 302953 0
The visual analogue scale is completed by all eligible participants enrolled in the study following the use of the randomly allocated swallowing aids.
Secondary outcome [1] 337548 0
Reasons why people dislike swallowing tablets whole. This will be assessed using a questionnaire specifically designed for the study.
Timepoint [1] 337548 0
After enrolling into the study.
Secondary outcome [2] 337549 0
Types of information sources about difficulties swallowing pills. This will be assessed using a questionnaire specifically designed for the study.
Timepoint [2] 337549 0
After enrolling into the study.
Secondary outcome [3] 337550 0
Strategies use to make pill easier to swallow. This will be assessed by using a questionnaire specifically designed for the study.
Timepoint [3] 337550 0
After enrolling into the study.

Eligibility
Key inclusion criteria
Inclusion criteria:
(i) males or females aged 18 years or over
(ii) self-reported dislike of swallowing tablets whole
(iii) ability to provide independent informed consent to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
(i) self-reported or diagnosed difficulties swallowing food and/or drink
(ii) presence of a neurological disorder or uncontrolled diabetes or has a history of surgery or radiation in the head and neck region
(iii) have never swallowed a tablet or capsule whole
(iv) have allergies to the ingredients or preservatives being used in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2017
Actual
3/10/2017
Date of last participant enrolment
Anticipated
30/06/2018
Actual
25/05/2018
Date of last data collection
Anticipated
30/06/2018
Actual
25/05/2018
Sample size
Target
210
Accrual to date
Final
210
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 297154 0
University
Name [1] 297154 0
Queensland University of Technology
Country [1] 297154 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George Street, Brisbane QLD 4000
Country
Australia
Secondary sponsor category [1] 296174 0
None
Name [1] 296174 0
Address [1] 296174 0
Country [1] 296174 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298321 0
University Human Research Ethics Committee (Queensland University of Technology)
Ethics committee address [1] 298321 0
Ethics committee country [1] 298321 0
Australia
Date submitted for ethics approval [1] 298321 0
Approval date [1] 298321 0
26/07/2017
Ethics approval number [1] 298321 0
1700000509

Summary
Brief summary
The objective of the study is to explore the perceived ease of swallowing whole tablets, when using different pill-swallowing aids, by people who self-report disliking swallowing them. This study consists of two parts: a questionnaire and a tablet swallowing task. Participants will be enrolled into the study once they meet the inclusion and exclusion criteria.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76710 0
Mr Yew-Mun Simon Wong
Address 76710 0
Queensland University of Technology
Level 5, Q Block, 2 George Street
Brisbane QLD 4000
Country 76710 0
Australia
Phone 76710 0
+61 7 3138 1490
Fax 76710 0
Email 76710 0
[email protected]
Contact person for public queries
Name 76711 0
Esther Lau
Address 76711 0
Queensland University of Technology
Level 9, Q Block, 2 George Street
Brisbane QLD 4000
Country 76711 0
Australia
Phone 76711 0
+61 7 3138 1490
Fax 76711 0
Email 76711 0
[email protected]
Contact person for scientific queries
Name 76712 0
Yew-Mun Simon Wong
Address 76712 0
Queensland University of Technology
Level 5, Q Block, 2 George Street
Brisbane QLD 4000
Country 76712 0
Australia
Phone 76712 0
+61 7 3138 1490
Fax 76712 0
Email 76712 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

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