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NCT07780201
Feasibility, Acceptability, and Implementability of I-IMPACT for ILD
Conditions: Interstitial Lung Disease (ILD)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: University Hospitals, Leicester
Summary
This is a single-centre, two-arm randomised controlled feasibility trial comparing I-IMPACT, an asynchronous digital rehabilitation programme, with conventional centre-based pulmonary rehabilitation (usual care) in adults with Interstitial Lung Disease (ILD). The study will be conducted at the University Hospitals of Leicester NHS Trust, and Glenfield Hospital is the central site for participant recruitment, baseline and longitudinal assessments, and delivery of the in-person usual care arm.
This is a feasibility study; therefore, the primary outcome is feasibility (recruitment, attrition, adherence, and acceptability), and the secondary outcomes comprise preliminary clinical and safety parameters. Outcomes will be assessed through a mixed-methods approach, involving both ILD patients and staff (healthcare professionals) participants.
Eligibility Criteria
Inclusion Criteria:
Patient participants:
* Age: ≥ 18 years
* Consent: willing and able to provide informed consent to participate in the study
* Diagnosis: physician-confirmed diagnosis of ILD of any subtype
* Clinically stable: no ILD exacerbation or respiratory-related hospitalisation in the preceding four weeks.
* Digital access: able to access and use the internet and an internet-enabled device to engage with I-IMPACT.
* Language: able to read and write in English to complete the programme and study assessments.
* Randomisation: willing to be randomised to either arm
Staff participants:
* Consent: willing and able to provide informed consent to participate in the study
* Professional role: a qualified healthcare professional involved in delivering ILD care and/or pulmonary rehabilitation (PR) at the UHL NHS Trust or another healthcare organisation.
* Employment duration (UHL staff only): must have been employed by the UHL NHS Trust for at least two years.
* Language: able to read and write in English to complete the acceptability questionnaire and optional interview.
Exclusion Criteria:
Patient participants:
* Recent or concurrent PR: concurrent enrollment or recent completion of a PR programme within the 12-months preceding enrollment.
* Contraindications to exercise: presenting with exercise-related contraindications (unstable cardiovascular disease; hypertension, etc., a full list is described by the American College of Sports Medicine and is routinely deployed).
Source: ClinicalTrials.gov (NCT07780201). StuddyBuddy aggregates publicly available trial information.