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CFHealthHub Data Observatory

CFHealthHub Data Observatory: A Quality Improvement project and Trials within Cohort platform for Cystic Fibrosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14464661
Enrollment
2000
Registered
2017-08-02
Start date
2017-05-25
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis Respiratory Cystic Fibrosis

Interventions

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 pro
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

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Lacking in capacity to give informed consent

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

England, United Kingdom, Wales

Contacts

Public ContactSophie;India Farrell;Davids

;

sophie.farrell3@nhs.net;i.davids@sheffield.ac.uk+44 114 222 4027;+44 (0)114 222 0843

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026