Condition category
Respiratory
Date applied
17/07/2017
Date assigned
12/10/2017
Last edited
22/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Cystic Fibrosis (CF) is a genetic condition that causes the lungs and digestive system to be clogged with mmucus. It affects 10000 people in the UK. The lungs of people with CF (PWCF) are prone to infections and require daily medication to stay healthy. Average adherence to medication has been shown to be only 36%. Poor adherence is associated with poor clinical outcomes including distressing unscheduled hospitalisations. Researchers have designed an intervention that will feedback adherence data to PWCF using chipped nebulisers displaying real time treatment use on smartphones and the website (CFHealthhub). Feedback is a powerful support to habit formation and the use the CFHealthHub and a behaviour change manual to support PWCF in building successful treatment habits. The aim of this study is to assess whether use of the CFHealthHub intervention, which includes the toolkit and website, reduces the amount of unscheduled emergency care PWCF require compared to those receiving standard care.

Who can participate?
Aged 16 and older who are diagnosed with CF and are willing to take inhaled mucolytics or antibiotics via a chipped nebuliser.

What does the study involve?
Participants are randomly allocated to groups. Those in the first group receive their usual care. Those in the second group receive the CFHealthHub and behaviour change manual to support them to build successful treatment habits. Participants are followed for 12 months and data is collected about their exacerbations and their adherence in treatment.

What are the possible benefits and risks of participating?
Participants may benefit from being able to access their CFHealthhub group and a record of their nebuliser use. Participants may find feedback treatment useful in making treatments a regular and routinue part of life. The main risk/disadvantage to participation is giving up time to attend the appointments. Appointments will vary from 10 minutes (over the phone) to up to one hour where more data is collected.

Where is the study run from?
This study is being run by the University of Sheffield (UK) and takes place in hospitals in the UK.

When is the study starting and how long is it expected to run for?
January 2019 to December 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mrs Chin Maguire
c.maguire@sheffield.ac.uk

Trial website

http://www.sheffield.ac.uk/scharr/sections/dts/ctru/actif

Contact information

Type

Public

Primary contact

Mrs Chin Maguire

ORCID ID

http://orcid.org/0000-0002-9397-7608

Contact details

Clinical Trials Research Unit
University of Sheffield
Scharr
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 0114 222 0717
c.maguire@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33345

Study information

Scientific title

Development and evaluation of an intervention to support Adherence to treatment in adults with Cystic Fibrosis: A randomised controlled trial and parallel process evaluation

Acronym

ACtiF

Study hypothesis

The aim of this study is to assess whether use of the CFHealthHub intervention, which includes the toolkit and website, reduces the amount of unscheduled emergency care PWCF require compared to those receiving standard care.

Ethics approval

REC London - Brent Research Ethics Committee, 02/03/2017, ref: 17/LO/0035

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Congenital Disorders/ Congenital malformations of the respiratory system

Intervention

The study is a mixed method study comprising a Quantitative component (parallel group, open labelled, external RCT) and a Qualitative component (audio recordings of consultations and interviews). Both quantitative and qualitative data will contribute to the process evaluation. The main aims of the study are to determine whether the intervention offers any benefit over usual care in adult patients with CF.

Once consent and eligibility for the study have been determined, study participants are randomised to either the intervention arm (CFHealthHub) or control arm (usual care) via the Sheffield Clinical Trials Research Unit web randomisation system. Participants in both groups contribute adherence data to CFHealthHub but only those randomised to the intervention arm have access to interact with CFHealthHub to manage their treatment habits. This is done 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.

The mean number of Pulmonary Exacerbations (PE) per patient in the 12-month post-consent follow-up as determined by the Fuch’s criteria is assessed. Each participant is followed up for 12 months. Research data is collected at a number of time points including baseline, standard clinic visits, during intervention sessions and at 12 months. Exacerbation data is collected at each point of an exacerbation. Data relating to intervention delivery are also collated during the course of the trial. Qualitative data are collected during interviews with interventionists and intervention arm participants to determine the acceptability of CFHealthHub. Audio recordings from each intervention delivery session are used to assess the fidelity of the intervention.

Beyond the 12 month visit, participants continue to contribute adherence data to CFHealthHub till 30/6/2019. During this period, those in the intervention arm can continue to receive support from the interventionists or use CFHealthHub independently.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Number of exacerbations are measured based on the modified Fuch's criteria and determined by a combination of hospital and participant input at baseline to June 2019.

Secondary outcome measures

1. Patient knowledge, skills, and confidence for self-management is measured using Patient Activation Measure (PAM-13) at baseline and 12 months
2. Life chaos is measured using Assessment of routine at baseline and 12 months
3. Generic health status is measured using the EuroQuol (EQ5d-5L) at baseline, 12 months and around points of exacerbations
4. Habit based behavioural patterns are measured using Self-Report Behavioural Automaticity Index (SRBAI) at baseline and 12 months
5. Disease specific quality of life is measured using Cystic Fibrosis Questionnaire-Revised (CFQ-R) at baseline and 12 months
6. Depression severity is measured using the Patient Health Questionnaire depression scale (PHQ-8) at baseline and 12 months
7. Medication adherence is measured using MAD (Medication Adherence Data-3 items) at baseline and 12 months
8. Anxiety severity is measured using the General Anxiety Disorder 7-item anxiety scale (GAD-7) at baseline and 12 months
9. Beliefs about medication (specifically nebuliser use) is measured using The Capability Opportunity Motivation Behaviour Beliefs Questionnaire (COM-BMQ) at baseline and 12 months
10. Behaviour is measured using Behavioural question and questionnaire at baseline and 12 months
11. Clinical measures is measured using Medical adherence questions, BMI FEV1/FVC at baseline to end of study
12. Resource use is measured using questionnaire at 12 month visit

Overall trial start date

01/09/2017

Overall trial end date

30/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosed with CF and with data within the CF registry
2. Aged 16 years and above
3. Willing and able to take inhaled mucolytics or antibiotics via a chipped nebuliser (e.g. eTrack)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 566; UK Sample Size: 556

Participant 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

Recruitment start date

02/10/2017

Recruitment end date

30/05/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Frimley Park Hospital
Portsmouth Road Frimley
Camberley
GU16 7UJ
United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

Royal Stoke University Hospital
Newcastle Road Staffordshire
Stoke-on-Trent
ST4 6QG
United Kingdom

Trial participating centre

Papworth Hospital
Papworth Everard
Cambridge
CB23 3RE
United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

St Bartholomew's Hospital
W Smithfield
London
EC1A 7BE
United Kingdom

Trial participating centre

Bristol Royal Infirmary
Upper Maudlin Street
Bristol
BS2 8HW
United Kingdom

Trial participating centre

King's College Hospital
Denmark Hill Brixton
London
SE5 9RS
United Kingdom

Trial participating centre

Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom

Trial participating centre

Royal Brompton Hospital
Sydney Street Chelsea
London
SW3 6NP
United Kingdom

Trial participating centre

Derriford Hospital
Derriford Road Crownhill
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom

Trial participating centre

Cardiff and Vale University Health Board
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Western General Hospital
Crewe Road S
Edinburgh
EH4 2XU
United Kingdom

Trial participating centre

Birmingham Heartlands Hospital
Bordesley Green E
Birmingham
B9 5SS
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Royal Cornwall Hospital
Treliske
Truro
TR1 3LQ
United Kingdom

Trial participating centre

York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom

Trial participating centre

Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Trial participating centre

Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NSH Foundation Trust

Sponsor details

Sheffield Teaching Hospitals NHS Foundation Trust
D Floor
Clinical Research Office
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The main study report will be published within the NIHR Journals Library (Programme Grants for Applied Research). Other study publications will be published in peer-reviewed journals.
The CFHealthHub RCT website has links to the Protocol and PIS
https://www.sheffield.ac.uk/scharr/sections/dts/ctru/cfhealthhub

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from (Amanda Loban, Data Manager, a.loban@sheffield.ac.uk). A formal request will need to be submitted and reviewed by the Study Trial Management group. The group will consider, at the time of the request, the type of data, any restrictions on this and the mechanism by which this will be shared on a case-by-case basis.

Intention to publish date

31/01/2021

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

22/11/2017: The target number of participants has been updated from 688 to 556. 24/10/2017: Internal review. 12/10/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.