Condition category
Genetic Diseases
Date applied
18/05/2016
Date assigned
07/06/2016
Last edited
07/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

https://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
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 114 222 0717
c.maguire@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20849

Study information

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)

Acronym

ACtiF

Study hypothesis

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

REC London - Brent Research Ethics Committee, 11/03/2016, ref: 16/LO/0356

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: 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

Phase

Drug names

Primary outcome measures

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 trial start date

02/05/2016

Overall trial end date

30/04/2017

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 64; UK Sample Size: 64

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

13/06/2016

Recruitment end date

30/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wessex Adult Cystic Fibrosis Service (Southampton)
University Hospital Southampton NHS Foundation Trust Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Wessex Adult Cystic Fibrosis Service (Poole)
Poole Hospital NHS Foundation Trust Longfleet Road
Poole
BH15 2JB
United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
City Hospital campus Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust

Sponsor details

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

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

Intention to publish date

30/04/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes