ASSIST Study: Investigation of a digital health solution providing real-time inhaler technique guidance
| ISRCTN | ISRCTN14411274 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14411274 |
| IRAS number | 312455 |
| Secondary identifying numbers | CPMS 52693, IRAS 312455, Grant codes: NIHR202884 |
- Submission date
- 01/06/2022
- Registration date
- 08/06/2022
- Last edited
- 27/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Most medicines for asthma are given by inhaler so that medicine can directly reach the lungs and work better. However, we know it’s difficult to use an inhaler properly and mistakes are often made. Poor inhaler technique has been linked to increased asthma symptoms, hospital admission and the need for more asthma medicines. To be certain patients are using their inhaler correctly, it is necessary for patients to be trained regularly; showing someone once is not enough! However, patients and their health care professionals are busy and opportunities to check and refresh inhaler technique are often limited.
Clip-Tone is a small device fitted to the top of the patients’ inhaler which makes a very quiet whistle when used properly. This is used with the Clip-Tone Buddy app which detects the specific sound of the Clip-Tone along with the sound of the inhaler being pressed and provides real time feedback on the screen on how to improve inhaler technique. Together the device and app are known as the Clip-Tone System, CTS.
The study aim is to assess whether a new tool can help people to learn how to use their asthma inhaler better.
Who can participate?
People in England or Wales with asthma aged 16 or above who are regularly prescribed one of the following brands of inhaler and has been using it for at least 1 month:
1. Fostair pMDI (100 mcg Beclometasone/ 6 mcg Formoterol per dose; 200 mcg Beclometasone/ 6mcg Formoterol per dose); Chiesi Ltd
2. Clenil Modulite pMDI (50 mcg, 100 mcg, 200 mcg or 250 mcg Beclometasone per dose); Chiesi Ltd
3. Trimbow pMDI (87 mcg Beclometasone, 5 mcg Formoterol, 9 mcg Glycopyrronium per dose); Chiesi Ltd
4. Seretide Evohaler pMDI (50 mcg Fluticasone/Salmeterol 25 mcg per dose; 125 mcg Fluticasone/Salmeterol 25 mcg per dose; 250 mcg Fluticasone/ Salmeterol 25 mcg per dose); GSK UK Ltd
5. Flixotide Evohaler pMDI (50 mcg Fluticasone per dose; 125 mcg Fluticasone per dose; 250 mcg Fluticasone per dose); GSK UK Ltd
What does the study involve?
This study will compare the CTS with the usual care asthmatics receive. Once in the study, participants will be allocated to one of the two groups (to receive either usual care or the Clip-Tone System), with an equal chance of being in either group (like tossing a coin). The study will take place remotely via video consultations allowing easy access to the study. The inhaler technique will be assessed in both groups at 1, 3 and 6 months and compared. Asthma symptoms will also be assessed. Participants can keep the CTS at the end of the study and those in the “usual care” group will be given the CTS at the end of the 6-month study period as a “thank-you”.
What are the possible benefits and risks of participating?
Benefits:
1. A Greater understanding of correct inhaler use
2. Reinforcement of effective inhaler technique
3. An opportunity to contribute to innovative technology development
Participating in the study is not likely to cause discomfort or expose you to any additional risks.
Participants will continue to use their medication as usual. Those in the intervention group will be asked to use the Clip-Tone system as often as they can when they take their inhaler as prescribed.
Where is the study run from?
The University of Manchester (UK), although visits are able to be held remotely meaning that anyone from England or Wales is able to participate
When is the study starting and how long is it expected to run for?
October 2020 to April 2024
Who is funding the study?
The National Institute for Health and Care Research (UK)
Who is the main contact?
Prof Clare Murray, clare.murray@manchester.ac.uk
Miss Naomi Brooke, Naomi.brooke@manchester.ac.uk
Contact information
Principal Investigator
University of Manchester
2nd floor, ERC Building
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
 ORCID ID |
0000-0002-8961-8055 |
|---|---|
| Phone | +44 (0)1612915876 |
| clare.murray@manchester.ac.uk |
Public
Wythenshawe Hospital
2nd Floor ERC
Manchester
M23 9LT
United Kingdom
| ORCID ID |
0000-0001-9870-8282 |
|---|---|
| Phone | +44 (0)7774472243 |
| Naomi.brooke@manchester.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | 41862_PIS_v2_15May22.pdf |
| Scientific title | Assessment of an electronic system of the impact on inhaler skills and technique |
| Study acronym | ASSIST |
| Study hypothesis | Participants using the Clip-Tone System will improve inhaler technique scores more than those receiving care as usual. |
| Ethics approval(s) |
Approved 20/05/2022, North West - Greater Manchester East Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8009; gmeast.rec@hra.nhs.uk), ref: 22/NW/0137 |
| Condition | Asthma |
| Intervention | Current interventions as of 08/02/2023: The main aim of the study is to establish whether the use of the Clip-Tone System (CTS) improves and maintains inhaler technique in asthmatic patients over a 6-month period compared with those receiving “usual care” alone. Other aims include: 1. To assess the use of the CTS in asthmatic patients (> 16 years) and its effects on asthma control and unscheduled clinical visits over a period of 6-months 2. To develop an understanding of how patients use CTS in a real-world setting 3. To develop an understanding of what frequency of use of CTS is desirable The Clip-Tone System technology consists of two parts: 1. Clip-Tone - a small plastic retrofit device available in two variants (developed and manufactured by commercial partner Clement Clarke International; both CE marked, Class I medical devices available on prescription from May 2021) 1.1. Clip-Tone E fits GSK-manufactured Evohalers (Ventolin, Flixotide, Seretide brands) 1.2. Clip-Tone F fits Chiesi-manufactured inhalers (Fostair, Trimbow, Clenil brands) 2. Clip-Tone Buddy app - class I medical device accessory (CE marked), available on Apple and Google app stores. Both parts of the system are independently protected by patents (granted and pending) - a collaboration agreement is in place clearly delineating background and foreground IP ownership. We will carry out a randomised controlled study comparing inhaler techniques in those using Clip-Tone System (CTS) with standard care (the “usual care” group) over a 6-month period. Potential recruits will attend an online baseline visit where formal consent to participate will be taken and eligibility criteria checked. The initial inhaler technique will be assessed using a formal inhaler technique score. An asthma control questionnaire will be completed (a validated asthma questionnaire to detect the level of asthma symptom control). Some baseline questions will be asked about their asthma e.g. medication, exacerbations, and HCP involved. We plan to randomise 126 participants, half to CTS and half to usual care. At the beginning of the study, an online computer programme will be used to generate 150 numbers in random order. At the point of randomisation, the researcher will allocate the next available number to the participant. When this number is an even number the participant will be allocated to the care as usual group. When this number is odd, they will be allocated to the intervention group. Those allocated to the CTS group will have the Clip-Tone posted to them along with a code for the Clip-Tone Buddy App and a short virtual visit will be arranged the following week to ensure the participant knows how to use the device and the features of the app. Participants will all attend 3 further follow-up visits in 1, 3 and 6 months from the baseline visit. All of the visits will be online remote visits as a default, although those local to the University of Manchester may request a face-to-face visit if preferred. At each visit, the inhaler technique will be assessed using the formal inhaler technique score. An asthma control questionnaire will be completed and a few questions will be asked about asthma healthcare utilisation since the previous visit. Previous interventions: The main aim of the study is to establish whether the use of the Clip-Tone System (CTS) improves and maintain inhaler technique in asthmatic patients over a 6-month period compared with those receiving “usual care” alone. Other aims include: 1. To assess the use of the CTS in asthmatic patients (> 16 years) and its effects on asthma control and unscheduled clinical visits over a period of 6-months 2. To develop an understanding of how patients use CTS in a real-world setting 3. To develop an understanding of what frequency of use of CTS is desirable The Clip-Tone System technology consists of two parts: 1. Clip-Tone - a small plastic retrofit device available in two variants (developed and manufactured by commercial partner Clement Clarke International; both CE marked, Class I medical devices available on prescription from May 2021) 1.1. Clip-Tone E fits GSK manufactured Evohalers (Ventolin, Flixotide, Seretide brands) 1.2. Clip-Tone F fits Chiesi manufactured inhalers (Fostair, Trimbow, Clenil brands) 2. Clip-Tone Buddy app - class I medical device accessory (CE marked), available on Apple and Google app stores. Both parts of the system are independently protected by patents (granted and pending) - a collaboration agreement is in place clearly delineating background and foreground IP ownership. We will carry out a randomised controlled study comparing inhaler technique in those using Clip-Tone System (CTS) with standard care (the “usual care” group) over a 6 month period. Potential recruits will attend a baseline visit where formal content to participate will be taken and eligibility criteria checked. Initial inhaler technique will be assessed using a formal inhaler technique score. Asthma control questionnaire will be completed (a validated asthma questionnaire to detect level of asthma symptom control). Some baseline questions will be asked about their asthma e.g. medication, exacerbations, HCP involved. We plan to randomise 126 participants, half to CTS and half to usual care. At the beginning of the study a online computer programme will be used to generate a 150 numbers in a random order. At the point of randomisation the researcher will allocate the next available number to the participant. When this number is an even number the participant will be allocated to the care as usual group. When this number is odd, they will be allocated to the intervention group. Those allocated to the CTS group will have the Clip-Tone posted to them along with a voucher code for the Clip-Tone Buddy App and a short virtual visit will be arranged the following week to ensure the participant knows how to use the device and the features of the app. Participants will all attend 3 further follow-up visits in 1, 3 and 6 months from the baseline visit. At each inhaler technique will be assessed using the formal inhaler technique score. Asthma control questionnaire will be completed and a few questions will be asked about asthma health care utilisation since the previous visit. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Clip-Tone System |
| Primary outcome measure | Current primary outcome measure as of 07/02/2024: Inhaler technique measured using inhalation time at baseline and 6 months and an inhaler technique checklist score (based on UK Inhaler Group standards) at baseline, 1 month, 3 months, and 6 months Previous primary outcome measure: Inhaler technique measured using an inhaler technique checklist (based on UK Inhaler Group standards) at baseline, 1 month, 3 months, and 6 months |
| Secondary outcome measures | 1. Asthma control measured using the validated Asthma Control Questionnaire (ACQ) at baseline, 1 month, 3 months, and 6 months. 2. Frequency and pattern of use of the Clip-Tone System measured using usage data within the app at baseline, 1 month, 3 months, and 6 months. 3. Data on unscheduled healthcare visits measured through self-reported questionnaires at baseline, 1 month, 3 months, and 6 months. |
| Overall study start date | 01/10/2020 |
| Overall study end date | 30/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 126; UK Sample Size: 126 |
| Total final enrolment | 126 |
| Participant inclusion criteria | 1. Provision of signed and dated informed consent 2. Willingness to comply with the study procedures and confirmed availability for the study duration 3. Aged ≥16 years 4. Self-reported asthma diagnosis and currently receiving treatment 5. Regularly prescribed one of the following brands of inhaler and has been using it for at least 1-month prior to enrolment: 5.1. Fostair pMDI (100 mcg Beclometasone/ 6 mcg Formoterol per dose; 200 mcg Beclometasone/ 6mcg Formoterol per dose); Chiesi Ltd 5.2. Clenil Modulite pMDI (50 mcg, 100 mcg, 200 mcg or 250 mcg Beclometasone per dose); Chiesi Ltd 5.3. Trimbow pMDI (87 mcg Beclometasone, 5 mcg Formoterol, 9 mcg Glycopyrronium per dose); Chiesi Ltd 5.4. Seretide Evohaler pMDI (50 mcg Fluticasone/Salmeterol 25 mcg per dose; 125 mcg Fluticasone/Salmeterol 25 mcg per dose; 250 mcg Fluticasone/ Salmeterol 25 mcg per dose); GSK UK Ltd 5.5. Flixotide Evohaler pMDI (50 mcg Fluticasone per dose; 125 mcg Fluticasone per dose; 250 mcg Fluticasone per dose); GSK UK Ltd 6. Access to a smartphone or tablet device and willingness to use it to regularly assess inhaler technique for the study duration |
| Participant exclusion criteria | 1. Using a spacer to assist with using their inhaler 2. Prescribed oral steroids for asthma in the preceding 1-month 3. Medication is not self-administered 4. Previous treatment for acute asthma in an ICU |
| Recruitment start date | 01/11/2022 |
| Recruitment end date | 01/09/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centre
Oxford Road
Manchester
M13 9PT
United Kingdom
Sponsor information
University/education
2nd Floor, Christie Building
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 (0)1612755436 |
|---|---|
| clinicaltrials@manchester.ac.uk | |
| Website | http://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | The study outcomes are intended to be presented at relevant respiratory sector conferences and publication in a peer reviewed journal is planned. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 15/05/2022 | 08/06/2022 | No | Yes |
| Protocol file | version 2.0 | 16/05/2022 | 04/01/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 4.0 | 16/01/2024 | 07/02/2024 | No | No |
| Protocol file | version 5.0 | 11/03/2024 | 27/03/2024 | No | No |
Additional files
Editorial Notes
27/03/2024: Uploaded protocol V5 (not peer reviewed).
07/02/2024: The following changes have been made:
1. The primary outcome measure was changed.
2. Uploaded protocol (not peer reviewed).
02/01/2024: The overall study end date has been changed from 31/01/2024 to 30/04/2024 and the plain English summary updated accordingly.
02/10/2023: The following changes have been made:
1. The recruitment end date has been changed from 31/10/2023 to 01/09/2023.
2. The final enrolment number has been added.
14/02/2023: A public contact was added.
08/02/2023: The following changes have been made and the plain English summary has been updated accordingly:
1. The public title was changed from "Investigation of a digital health solution providing real-time inhaler technique guidance" to "ASSIST Study: Investigation of a digital health solution providing real-time inhaler technique guidance".
2. The overall trial end date has been changed from 01/01/2024 to 31/01/2024.
3. The interventions have been changed.
4. Wales has been added as a country of recruitment.
04/01/2023: Uploaded protocol (not peer-reviewed) as an additional file.
10/08/2022: The recruitment start date has been changed from 01/08/2022 to 01/11/2022.
01/06/2022: Trial’s existence confirmed by the National Institute for Health and Care Research (NIHR).
