Feasibility, Acceptability, and Implementability of I-IMPACT for ILD (I-IMPACT ILD)
Feasibility, Acceptability, and Implementability of an Asynchronous Digital Pulmonary Rehabilitation Programme (I-IMPACT) Compared With Centre-Based Pulmonary Rehabilitation in Adults With Interstitial Lung Disease.
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Pulmonary rehabilitation (PR) is a recommended treatment for people living with long-term lung conditions such as Interstitial Lung Disease (ILD). The programme helps improve physical ability, symptom management, the ability to carry out everyday activities and mood. Standard programmes are typically delivered twice a week for 6-8 weeks at a hospital or community centre and include tailored exercise and education.
However, attending twice-weekly in-person sessions can be challenging for some individuals due to their symptoms, travel difficulties, or other commitments. To improve access, the University Hospitals of Leicester NHS Trust has developed a digital rehabilitation programme called I-IMPACT, which enables people to participate in rehabilitation from home using a computer, smartphone, or tablet. The platform includes a patient-facing website and an administrative website.
The I-IMPACT patient website includes:
- Health information
- Exercise resources with step-by-step video demonstrations
- Symptom trackers
- Goal-setting features
- Support from the clinical and IT team
The study aims to assess whether it is feasible (practical and acceptable) to compare I-IMPACT with a traditional in-person PR programme for people with ILD. In addition, health outcomes, including physical ability, breathlessness, quality of life, mood and safety, will be evaluated.
Participants will be randomly assigned to either I-IMPACT or an in-person programme and will complete assessments at baseline, immediately after the programme, and at six months. Participants will also have the opportunity to take part in two optional interviews.
Healthcare professionals will be invited to complete a questionnaire and an optional interview exploring their views on digital PR and I-IMPACT.
The findings will help determine whether a larger study can be conducted and whether I-IMPACT could be a safe and effective alternative to traditional in-person PR programmes.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Enya Daynes, PhD
- Número de telefone: 0116 250 2759
- E-mail: e.daynes@nhs.net
Estude backup de contato
- Nome: Duha Azwai, BSc Biomedical Science
- Número de telefone: 0116 250 2758
- E-mail: da356@leicester.ac.uk
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Cuidados usuais
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An outpatient pulmonary rehabilitation programme delivered at the UHL NHS Trust.
This is an 8-week, twice-weekly supervised programme at Glenfield Hospital.
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Experimental: I-IMPACT
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I-IMPACT (Individualised self-Management ProgrAmme for long-term CondiTions) is a digital self-management rehabilitation programme developed by the UHL NHS Trust. The programme is designed for individuals recovering from acute illness and those living with chronic respiratory and cardiac conditions. For this study, the programme will be set so that each participant's primary diagnosis is ILD. I-IMPACT delivers physical and psychological support through a comprehensive set of features. Participants allocated to the I-IMPACT programme will be able to:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Feasibility of the programme and conducing the RCT
Prazo: Patients: Recruitment monitored over a 12-month recruitment phase. Attrition, adherence and acceptability assessed at baseline, week 8 and 6 months. Staff: Acceptability assessed at any single time-point during the study.
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The primary objective is to determine the feasibility of delivering I-IMPACT and of conducting this RCT, with primary endpoints including patient recruitment, attrition, adherence and programme acceptability evaluated from both patient and healthcare professional (HCP) perspectives
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Patients: Recruitment monitored over a 12-month recruitment phase. Attrition, adherence and acceptability assessed at baseline, week 8 and 6 months. Staff: Acceptability assessed at any single time-point during the study.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Functional Exercise Capacity - Incremental Shuttle Walk Test (ISWT)
Prazo: Baseline, Week 8, and 6-month follow-up
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Functional exercise capacity will be assessed using the Incremental Shuttle Walk Test (ISWT). Unit of Measure: Distance (metres) |
Baseline, Week 8, and 6-month follow-up
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Functional Exercise Capacity - 1-Minute Sit-to-Stand Test (1-MSTST)
Prazo: Baseline, Week 8, and 6-month follow-up
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Functional exercise capacity will also be assessed using the 1-Minute Sit-to-Stand Test (1-MSTST). Unit of Measure: Number of completed repetitions |
Baseline, Week 8, and 6-month follow-up
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Functional Exercise Capacity - Endurance Shuttle Walk Test (ESWT)
Prazo: Baseline, Week 8, and 6-month follow-up
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Functional exercise capacity will also be assessed using the Endurance Shuttle Walk Test (ESWT). Unit of Measure: Time (seconds) |
Baseline, Week 8, and 6-month follow-up
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Dyspnoea
Prazo: Baseline, Week 8, and 6-month follow-up
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Dyspnoea will be assessed using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ). Unit of Measure: Total score (0-120) |
Baseline, Week 8, and 6-month follow-up
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Health-Related Quality of Life - King's Brief Interstitial Lung Disease Questionnaire (K-BILD)
Prazo: Baseline, Week 8, and 6-month follow-up
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Health-related quality of life will be assessed using the King's Brief Interstitial Lung Disease Questionnaire (K-BILD). Unit of Measure: Total score (0-100) |
Baseline, Week 8, and 6-month follow-up
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Health-Related Quality of Life - Chronic Airways Assessment Test (CAAT)
Prazo: Baseline, Week 8, and 6-month follow-up
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Health-related quality of life will also be assessed using the Chronic Airways Assessment Test (CAAT). Unit of Measure: Total score (0-40) |
Baseline, Week 8, and 6-month follow-up
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Health-Related Quality of Life - EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Prazo: Baseline, Week 8, and 6-month follow-up
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Health-related quality of life will also be assessed using the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L). Unit of Measure: Index Value |
Baseline, Week 8, and 6-month follow-up
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Psychological Health - Patient Health Questionnaire-9 (PHQ-9)
Prazo: Baseline, Week 8, and 6-month follow-up
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Psychological health will be assessed using the Patient Health Questionnaire-9 (PHQ-9). Unit of Measure: Total score (0-27) |
Baseline, Week 8, and 6-month follow-up
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Psychological Health - Generalised Anxiety Disorder-7 (GAD-7)
Prazo: Baseline, Week 8, and 6-month follow-up
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Psychological health will also be assessed using the Generalised Anxiety Disorder-7 questionnaire (GAD-7). Unit of Measure: Total score (0-21) |
Baseline, Week 8, and 6-month follow-up
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Physical Activity
Prazo: Baseline, Week 8, and 6-month follow-up
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Physical activity will be assessed using a wrist-worn GENEActiv accelerometer provided to participants at each assessment visit. Unit of Measure: Average daily physical activity |
Baseline, Week 8, and 6-month follow-up
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Incidence and Nature of Adverse Events
Prazo: Baseline through 6-month follow-up
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The incidence and nature of adverse events will be recorded throughout the study. Participants will be asked about adverse events at the Week 8 and 6-month follow-up assessments and can report events directly to the research team throughout the study. Participants allocated to the I-IMPACT arm will also receive fortnightly telephone check-ins during which safety events may be reported. Hospital records will be reviewed, where appropriate, to verify reported events. Unit of Measure: Incidence and nature of adverse events |
Baseline through 6-month follow-up
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Outros números de identificação do estudo
- 370102
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