CFHealthHub Data Observatory
| ISRCTN | ISRCTN14464661 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14464661 |
| IRAS number | 216782 |
| Secondary identifying numbers | IRAS 216782 |
- Submission date
- 26/07/2017
- Registration date
- 02/08/2017
- Last edited
- 02/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Cystic Fibrosis (CF) is an inherited disease affecting 10000 people in the UK with an average age at death of 28 years in 2012. The lungs of people with CF (PWCF) are prone to infections. Daily physiotherapy and inhaled medications are needed to stay healthy. Around £30 million is spent annually on inhaled therapy but average adherence has been shown to be only 36%. Data suggest that adherence is better in younger children but of the most of the PWCF are now adults. PWCF who collect less than 50% of their medication cost the healthcare system significantly more than PWCF who collect more than 80% and most of the additional cost results from unscheduled emergency care and hospital admission. This unscheduled emergency care is distressing for PWCF and their families. Current research investigating whether adult PWCF can build successful, self-management, treatment habits using dose-counting nebulisers to collect adherence data, displaying this data on a website (CFHealthHub) and using a behaviour change toolkit, supported by a health professional, is ongoing. The aim of this study and the CFHealthHub is to help facilitate quality improvement projects using data from CFHealthHub about participants adherence and participant's relationship with the team. The study also aims to build an understanding of the process of implementing CFHH into routine practice.
Who can participate?
Adults aged 16 and older who are diagnosed with CF and use a nebuliser.
What does the study involve?
Participants receive a new chipped nebuliser, or have their existing nebuliser adapted to communicate with CFHealthHub. They are given a log in to the CFHealthHub system and shown how to use their device and the CFHealthHub website, by a member of their care team. This includes how to turn on and off data sharing with their clinical team. Participants are then able to use their nebuliser as normal, with the support of CFHealthHub. CFHealthHub automatically collects data on the participants' use of their chipped nebuliser, specifically the time of use and duration of inhalation. The data is stored in the secure CFHealthHub server. To provide a tailored CF toolkit participants will periodically complete a questionnaire about the challenges of taking their medication.
What are the possible benefits and risks of participating?
Participants may benefit from participating as the data could lead to changes in their CF care at their own health centre. Participants may find feedback available in the CFHealthHub useful to understand their condition or form habits to take their medication. Participants may benefit from the treatment or therapy offered. There are no notable risks with participants, however, participants may have to give up some time to complete the consent visit.
Where is the study run from?
This study is being run by the University of Sheffield (UK) and takes place across seventeen hospitals in the UK.
When is the study starting and how long is it expected to run for?
January 2017 to March 2025
Who is funding the study?
NHS England CQUIN (UK)
Who is the main contact?
1. Sophie Farrell
sophie.farrell3@nhs.net
2. Dr Martin Wildman
martin.wildman3@nhs.net
Contact information
Public
Clinical Trials Research Unit
ScHARR (School of Health and Related Research)
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
| Phone | +44 114 222 4027 |
|---|---|
| sophie.farrell3@nhs.net |
Scientific
Honorary Senior Clinical Lecturer Health Services Research, ScHARR, University Sheffield
Clinical Lead in Service Improvement
Consultant Respiratory Medicine & Adult CF
Sheffield Adult CF Centre
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
Public
Sheffield Clinical Trials Research Unit, ScHARR
The University of Sheffield
Room 2.15, Innovation Centre
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
 ORCID ID |
0000-0003-4900-7695 |
|---|---|
| Phone | +44 (0)114 222 0843 |
| i.davids@sheffield.ac.uk |
Study information
| Study design | Current study design as of 11/02/2020: A pragmatic development study which consists of an observational cohort study and a platform for quality improvement projects across the NHS. A mixed-methods process evaluation that will be repeated yearly from 2018 to 2020 and will follow MRC process evaluation guidelines to explore the activities and outputs documented on the logic model, specifically to identify the barriers and pathways to implementation. Previous study design: A pragmatic development study which consists of an observational cohort study and a platform for quality improvement projects across the NHS. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Available to download from the study website https://www.sheffield.ac.uk/scharr/sections/dts/ctru/cfhealthhub/dataobservatoryfolder/dataobservatory |
| Scientific title | CFHealthHub Data Observatory: A Quality Improvement project and Trials within Cohort platform for Cystic Fibrosis |
| Study hypothesis | Current study hypothesis as of 11/02/2020: The aim of CFHealthHub data observatory is to explore the use of adherence data for quality improvement and as behavioural data within a cohort for future CF studies. The study also aims to build an understanding of the process of implementing CFHealthHub into routine clinical practice. Previous study hypothesis: The aim of CFHealthHub data observatory is to explore the use of adherence data for quality improvement and as behavioural data within a cohort for future CF studies. |
| Ethics approval(s) | London-Brent Research Ethics Committee, 06/04/2017, ref: 17/LO/0032 |
| Condition | Cystic Fibrosis |
| Intervention | CFHealthHub is an online portal which displays adherence data and provides behaviour change resources and tools for people with Cystic Fibrosis (PWCF), these tools used alongside trained CF health professionals support changes in patient self-management (nebuliser adherence). It is available on-line via computers, tablets or mobile phones. Previous research has focused on the development of an adherence intervention for PWCF (CFHealthHub) and is subject to ongoing evaluation. These work packages have been supported by an NIHR applied programme grants (Reference RP-PG-1212-20015). The Data Observatory facilitates quality improvement projects, which act as an intervention within the CF team. These QI projects utilise the Clinical Microsystem methodology developed by the Dartmouth Institute, USA (Nelson, Bataldan and Godfrey 2007) and adopted by the Sheffield Microsystem Coaching Academy (MCA). The Sheffield MCA (http://www.sheffieldmca.org.uk) approach advocates that complex health systems can be reduced to smaller building blocks called ‘microsystems’ where multidisciplinary teams deliver healthcare to patients. At each microsystem a number of QI projects may occur but the implementation requires the completion of four phases; Assessment, Diagnose, Treatment and Standardise, where tools such as assessment using the 5 P’s (Purpose, Patients, Professionals, Processes, Patterns) process mapping, time series measurements, Plan Do Study Act (PDSA) cycles are utilised until the change idea has been adapted or has become embedded into the microsystem. Participants who consent to take part in the study will receive a new chipped nebuliser, or have their existing nebuliser adapted to communicate with CFHealthHub. They will be given a log in to the CFHealthHub system and shown how to use their device and the CFHealthHub website, by a member of their care team. This includes how to turn on and off data sharing with their clinical team. Participants will then be able to use their nebuliser as normal, with the support of CFHealthHub. CFHealthHub automatically collects data on the participants use of their chipped nebuliser, specifically the time of use and duration of inhalation. The data is stored in the secure CFHealthHub server. To provide a tailored CF toolkit participant's periodically complete a questionnaire about the challenges of taking their medication, which is entered by a member of staff into CFHealthHub, at a clinic appointment or review. Members of the CF team will be able to view the adherence data for participants who have data sharing switched on, and identify if any participants could benefit from the behavioural intervention that is currently being tested in an RCT. The Data Observatory will not be measuring the effectiveness of this intervention. Instead, CFHealthHub will help facilitate quality improvement projects using data from CFHealthHub about participants adherence and participant's relationship with the team. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 11/02/2020: Objective nebuliser adherence measured using adherence information stored in the CFHealthHub system. Three-monthly and annual adherence for each individual will be calculated as unadjusted adherence, normative adherence (Hoo, 2016) and total nebuliser used per week. Previous primary outcome measure: Sophisticated normative adherence as defined by Hoo (2016) |
| Secondary outcome measures | Current secondary outcome measures as of 13/02/2020: 1. Lung function assessed by FEV1 captured on CFHealthHub at baseline and every clinical encounter 2. Process data (prescription checks, duration of inhalation) is measured using data recorded on CFHealthHub at baseline and every clinical encounter 3. The rate of consent as measured by the number of completed consent forms. Rate of follow up is measured by the number of completed follow-up questionnaires, data sharing is available by extracting the number of participants with data sharing switched on or off on the CFHealthHub system. Previous secondary outcome measures as of 11/02/2020: 1. Lung function assessed by FEV1 on spirometry 2. Process data (prescription checks, duration of inhalation) is measured using data recorded on CFHealthHub 3. The rate of consent as measured by the number of completed consent forms. Rate of follow up is measured by the number of completed follow-up questionnaires, data sharing is available by extracting the number of participants with data sharing switched on or off on the CFHealthHub system. Previous secondary outcome measures: 1. Unadjusted adherence is measured using adherence information stored in the CFHealthHub system 2. Simple normative adherence is measured using the CFHealthHub system 3. Process data (prescription checks, duration of inhalation) is measured using data recorded on CFHealthHub 4. The rate of consent as measured by the number of completed consent forms. Rate of follow up is measured by the number of completed follow-up questionnaires, data sharing is available by extracting the number of participants with data sharing switched on or off on the CFHealthHub system. |
| Overall study start date | 09/01/2017 |
| Overall study end date | 31/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | To date, there are seventeen confirmed CQUIN (2019/2020) centres across England taking part in the CFHealthHub Learning Health System. Across such CF centres, 899 patients are providing real-time objective adherence data, with the intention that there could be as many as 2000 patients accessing adherence support and contributing data for quality improvement and medicines optimisation projects. As a long-term recruitment goal, it is anticipated that all patients using nebulisers with electronic monitoring capabilities will eventually join the data observatory resulting in 5000 to 6000 adults with CF to be included. |
| Participant inclusion criteria | 1. Diagnosed with CF and with data within the CF registry 2. Aged 16 years and above 3. Taking inhaled mucolytics or antibiotics via a chipped nebuliser (e.g. eTrack or I-Neb) or able and willing to take via eTrack or I-Neb |
| Participant exclusion criteria | Lacking in capacity to give informed consent |
| Recruitment start date | 25/05/2017 |
| Recruitment end date | 31/03/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Northern General Hospital
Herries Rd
Sheffield
S5 7AU
United Kingdom
Nottingham University Hospitals NHS Trust City Hospital campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
level C
West Wing
Southampton General Hospital
Tremona Rd
Southampton
SO16 6YD
United Kingdom
Portsmouth Rd
Frimley
Camberley
GU16 7UJ
United Kingdom
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Queen Victoria Rd
Newcastle upon Tyne
NE1 4LP
United Kingdom
East Block
Level 3
Norfolk and Norwich University Hospitals NHS Foundation Trust
Colney Lane
Norwich
NR4 7UY
United Kingdom
Children's Outpatients Department
University Hospitals of North Midlands NHS Trust
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
Ward 5D
Level 5
John Radcliffe Hospital
Headley way
Headington
Oxford
OX3 9DU
United Kingdom
Cystic Fibrosis Unit
Department of Respiratory Medicine
4th Floor
KGV Building
West Smithfield
London
EC1A 7BE
United Kingdom
Royal Cornwall Hospitals NHS Trust
Treliske
Truro
TR1 3LQ
United Kingdom
Level 2
Royal Devon and Exeter Hospital NHS Foundation Trust
Barrack Road
Exeter
EX2 5DW
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Bordesley
Green East
Birmingham
B9 5SS
United Kingdom
Zone B501
University Hospitals Bristol NHS Foundation Trust
Marlborough Street
Bristol
BS2 8HW
United Kingdom
University Hospitals of Leicester NHS Foundation Trust
Groby Rd
Leicester
LE3 9QP
United Kingdom
Level 6
University Hospitals Plymouth NHS Trust
Plymouth
PL6 8DH
United Kingdom
University Hospital of Wales
Penlan Road
Llandough
Cardiff
CF64 2XX
United Kingdom
York Teaching Hospital NHS Foundation Trust
Wigginton Road
York
YO31 8HE
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
England
United Kingdom
"ROR" |
https://ror.org/018hjpz25 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 11/02/2020: Planned publication in a high-impact peer-reviewed journal. Additional documentation is available to download from the study website: https://www.sheffield.ac.uk/scharr/sections/dts/ctru/cfhealthhub/dataobservatory |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Martin Wildman (Chief Investigator), martin.wildman3@nhs.net. The data-sets are available throughout the duration of the Data Observatory. Data available will include real-time adherence data. At present the study team are refining what information will be helpful for future research, therefore contacting the study team to discuss any requests is advised. Data will only be available from participants who have consented to participate in the trials within cohorts platform. All future research using the Data Observatory platform must be ethically approved. The Data Observatory is suitable for future randomised controlled trials. However, there are two levels of consent for the trials within cohorts platform, consent to: 1. Pseudonymised data within CFHealthHub to be used for future research related to CF which has been ethically approved 2. Be included for selection in future research studies which have been ethically approved. If the participant meets the desired characteristics for the study they may be selected by chance to receive a new treatment. If they are not selected to receive the new treatment then they consent to sharing pseudonymised data without further notification. If they are selected to receive the new treatment they understand that they will be contacted and will have the opportunity to decline participation in the new study. Previous publication and dissemination plan: Planned publication in a high-impact peer reviewed journal. Additional documentation is available to download from the study website https://www.sheffield.ac.uk/scharr/sections/dts/ctru/cfhealthhub/dataobservatory IPD sharing statement: The datasets generated during and/or analysed during the current study will be available upon request from Dr Martin Wildman (Chief Investigator), martin.wildman@sth.nhs.uk. The data-sets are available throughout the duration of the Data Observatory. Data available will include real-time adherence data. At present the study team are refining what information will be helpful for future research, therefore contacting the study team to discuss any requests is advised. Data will only be available from participants who have consented to participate in the trials within cohorts platform. All future research using the Data Observatory platform must be ethically approved. The Data Observatory is suitable for future randomised controlled trials. However, there are two levels of consent for the trials within cohorts platform, consent to: 1. Pseudonymised data within CFHealthHub to be used for future research related to CF which has been ethically approved 2. Be included for selection in future research studies which have been ethically approved. If the participant meets the desired characteristics for the study they may be selected by chance to receive a new treatment. If they are not selected to receive the new treatment then they consent to sharing pseudonymised data without further notification. If they are selected to receive the new treatment they understand that they will be contacted and will have the opportunity to decline participation in the new study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v9.0 | 19/03/2020 | 01/06/2020 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN14464661_Protocol_v9.0_19Mar2020.pdf
- Uploaded 01/06/2020
Editorial Notes
02/04/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2024 to 31/03/2025.
2. The public contact was changed.
03/06/2020: A public contact has been added.
01/06/2020: Uploaded protocol Version 9.0 19 March 2020 (not peer reviewed) and the protocol version number removed from the protocol/serial number field.
13/02/2020: The following changes have been made:
1. The IRAS number has been added.
2. The secondary outcome measure has been updated.
11/02/2020: The following changes have been made:
1. The protocol number has been changed from "v2_06Mar2017" to "V8.0 18Oct2019".
2. The study hypothesis has been updated.
3. The study design has been updated.
4. The participant information sheet has been changed from "Available to download from the study website https://www.sheffield.ac.uk/scharr/sections/dts/ctru/cfhealthhub/dataobservatory"; to "Available to download from the study website https://www.sheffield.ac.uk/scharr/sections/dts/ctru/cfhealthhub/dataobservatoryfolder/dataobservatory";.
5. The primary outcome measure has been updated.
6. The secondary outcome measures have been updated.
7. The target number of participants has been changed from "We hope to recruit 400 PWCF across 3 centres until 2019. When the RCT is completed in 2019 patients from the 20 RCT centres will be invited to join the data observatory with the possibility that all patients using nebulisers with electronic monitoring capabilities’ will eventually join the data observatory resulting in between 5000 to 6000 adults with CF included." to "To date, there are seventeen confirmed CQUIN (2019/2020) centres across England taking part in the CFHealthHub Learning Health System. Across such CF centres, 899 patients are providing real-time objective adherence data, with the intention that there could be as many as 2000 patients accessing adherence support and contributing data for quality improvement and medicines optimisation projects. As a long-term recruitment goal, it is anticipated that all patients using nebulisers with electronic monitoring capabilities will eventually join the data observatory resulting in 5000 to 6000 adults with CF to be included.".
8. The total target enrolment has been changed from 400 to 2000.
9. The publication and dissemination plan has been updated.
10. The trial participating centres "Frimley Park Hospital", "The Royal Victoria Infirmary", "Norfolk and Norwich University Hospital", "Royal Stoke University Hospital", "John Radcliffe Hospital", "Royal Cornwall Hospital", "Royal Devon and Exeter Hospital", "St Bartholomew’s Hospital", "Birmingham Heartlands Hospital", "Bristol Royal Infirmary", "Glenfield Hospital", "Derriford Hospital", "University Hospital of Wales" and "York Teaching Hospital" have been added.
11. The plain English summary has been updated to reflect the changes above.
13/12/2017: Carla Girling replaced Kimberley Horspool as the public trial contact.
