Adherence to treatment in adults with cystic fibrosis
| ISRCTN | ISRCTN13076797 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13076797 |
| Secondary identifying numbers | 20849 |
- Submission date
- 18/05/2016
- Registration date
- 07/06/2016
- Last edited
- 10/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Genetic Diseases
Plain English summary of protocol
Background and study aims
Cystic fibrosis (CF) is an inherited condition which causes the lungs and digestive system to become blocked with mucus. It is caused by a faulty gene, which is responsible for controlling the movement of water and salts in and out of cells. This leads to a buildup of sticky mucus which clogs the lungs and airways causing breathing difficulties and lung infections, and the digestive system which affects the way food travels through and the ability to absorb nutrients from it. Most people with CF experience problems with lung function and usually are treated with a combination of physiotherapy and inhaled medications to prevent lung infections and the buildup of mucus that causes damage. Around £30 million is spent every year on inhaled therapy but average adherence has been shown to be only 36%. Data suggest that adherence is better in younger children (71% in under-12s, falling to 50% in teenagers) but of the 10000 UK people with CF (PWCF) almost 6000 are now adults. PWCF who collect less than 50% of their medication cost the healthcare system significantly more in terms of unscheduled emergency care and hospital admission. This study is looking at a new programme which has been designed to help adults with CF to monitor their medication usage, by using dose-counting nebulisers to collect data and send it to a website where it can be displayed. The aim of this study is to find out whether a large-scale study looking at the whether this program is feasible and acceptable to PWCF.
Who can participate?
Patients aged 16 years and over with CF who are within a CF registry and are taking medication via a chipped nebulizer.
What does the study involve?
Participants are randomly allocated to one of two groups. Both groups have a short period of two to four weeks when data is collected through their nebulisers and fed back to the website. Following this, those in the first group are given access to their data so that they can manage their treatment habits. This involves a combination of at least three face-to-face/telephone/email contact sessions with trial staff and using the program independently over five months. Those in the second group continue as normal, whilst having their usage data recorded continually. At the start of the study and after five months, the health and medication usage and behaviour patterns of participants in both groups are determined using the data collected by the dose-counting nebulisers.
What are the possible benefits and risks of participating?
Participants with access to the program may benefit from improvements to the way they take their medication. There are no notable risks involved with participating.
Where is the study run from?
1. Wessex Adult Cystic Fibrosis Service - Poole (UK)
2. Wessex Adult Cystic Fibrosis Service - Southampton (UK)
3. Nottingham University Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
May 2016 to April 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Miss Chin Maguire
c.maguire@sheffield.ac.uk
Contact information
Public
Clinical Trials Research Unit
University of Sheffield
30 Regent Street
Sheffield
S1 4DA
United Kingdom
 ORCID ID |
0000-0002-9397-7608 |
|---|---|
| Phone | +44 114 222 0717 |
| c.maguire@sheffield.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Prevention, Process of Care, Education or Self-Management, Device, Psychological & Behavioural, Complex Intervention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Development and evaluation of an intervention to support Adherence to treatment in adults with cystic fibrosis: A feasibility study comprised of an external pilot randomised controlled trial and process evaluation (WP 3.1) |
| Study acronym | ACtiF |
| Study objectives | The aim of the study is to determine the feasibility of conducting a full-scale randomised controlled trial investigating the acceptability of the CFHealthHub intervention. |
| Ethics approval(s) | REC London - Brent Research Ethics Committee, 11/03/2016, ref: 16/LO/0356 |
| Health condition(s) or problem(s) studied | Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Other diseases of the respiratory system |
| Intervention | Study participants will be randomised to either the intervention arm (CFHealthHub) or control arm (usual care). Participants in both groups will contribute adherence data to CFHealthHub but only those randomised to the intervention arm will have access to interact with CFHealthHub to manage their treatment habits. This will be via a combination of face to face (or telephone/email contact sessions) with the trial interventionists and using CFHealthHub as a tool independently between sessions. Although it is anticipated that there will be a minimum of 3 sessions during the follow up period, further sessions will be tailored to each participants individual needs. |
| Intervention type | Other |
| Primary outcome measure | Number of pulmonary exacerbations of cystic fibrosis is measured using the modified Fuchs Criteria at baseline and 5 (+/- 1) months |
| Secondary outcome measures | 1. Generic health status is measured using the EQ5D5L at baseline and 5 (+/- 1) months 2. Assessment of patient knowledge, skill, and confidence for self-management is measured using the Patient Activation Measure -13 at baseline and 5 (+/- 1) months 3. Life chaos is measured using the Confusion, Hubbub And Order Scale -6 at baseline and at 5 +/- 1 months 4. Habit-based behaviour patterns are measured using the Self-Reported Behavioural Automaticity Index at baseline and 5 (+/- 1) months 5. Disease specific health-related quality of life is measured using the Cystic Fibrosis Questionnaire-Revised at baseline and 5 (+/- 1) months 6. Depressive disorder severity is measured using the Patient Health Questionnaire depression scale -8 at baseline and 5 (+/- 1) months 7. Medication adherence is measured using the Medication Adherence Data -3 at baseline and 5 (+/- 1) months 8. Anxiety severity is measured using the General Anxiety Disorder -7 at baseline and 5 (+/- 1) months 9. Perceived necessities and concerns for nebuliser treatment are measured using the Capability Opportunity Motivation–Beliefs about Medicines Questionnaire at baseline and 5 (+/- 1) months 10. Resource use data is collected using the resource use form developed for the study at 5 (+/- 1) months 11. Acceptability of the intervention is determined through qualitative interviews with patients and members of the multidisciplinary CF team at 5 (+/- 1) months 12. Condition severity is measured using FEV1/FVC at routine clinic visits from baseline to study end |
| Overall study start date | 02/05/2016 |
| Completion date | 30/04/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 64; UK Sample Size: 64 |
| Total final enrolment | 61 |
| Key inclusion criteria | 1. Diagnosed with CF and within 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) |
| Key exclusion criteria | 1. Post-lung transplant 2. People on the active lung transplant list 3. Patients receiving palliative care, with palliative intent, for whom trial participation could be a burden 4. Participants who lack capacity to give informed consent 5) Participants using dry powder devices to take antibiotics or mucolytics |
| Date of first enrolment | 13/06/2016 |
| Date of final enrolment | 30/09/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Tremona Road
Southampton
SO16 6YD
United Kingdom
Longfleet Road
Poole
BH15 2JB
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Hospital/treatment centre
D Floor
Clinical Research Office
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
England
United Kingdom
"ROR" |
https://ror.org/018hjpz25 |
|---|
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 | 30/04/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. The main study report will be published within the NIHR Journals Library (Programme Grants for Applied Research) 2. Other study publications will be published in peer-reviewed journals |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 18/09/2018 | 18/09/2018 | No | No | |
| Results article | results | 01/02/2019 | 08/05/2019 | Yes | No |
| Results article | results | 06/10/2020 | 24/07/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol (other) | 11/04/2019 | 10/07/2023 | No | No | |
| Results article | 01/10/2021 | 10/07/2023 | Yes | No | |
| Results article | 27/10/2020 | 10/07/2023 | Yes | No | |
| Results article | 11/04/2019 | 10/07/2023 | Yes | No |
Additional files
- ISRCTN13076797_BasicResults_18Sep18.pdf
- Uploaded 18/09/2018
Editorial Notes
10/07/2023: Publication references and protocol added.
24/07/2020: Publication reference added.
08/05/2019: Total final enrolment and publication reference were added.
18/09/2018: The basic results of this trial have been uploaded as an additional file.
