Feasibility Randomised Controlled Trial Exploring Implementation of the Compassionate Mindful rEsilience pRogram for People With pUlmonaRY Fibrosis: The MERcURY Study (MERcURY)
Pulmonary fibrosis (PF) is a chronic lung condition in which scar tissue gradually forms, impairing oxygen transfer and causing breathlessness. Individuals with PF frequently experience anxiety and depression, yet supportive care remains underdeveloped, and few evidence-based psychological interventions exist for this population, representing a critical gap in care.
This feasibility randomised controlled trial (RCT) evaluated the Compassionate Mindful Resilience (CMR) programme, a 4-week online, nurse-led mindfulness-based intervention designed to improve psychological outcomes in people living with PF.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Background: Pulmonary fibrosis is a progressive, irreversible fibrotic lung disease that requires long-term treatment. People with a diagnosis of pulmonary fibrosis are known to have reduced health-related quality of life, furthermore, it is common for such individuals to experience anxiety and depression. Therefore, interventions to support these individuals are essential to improve their psychological health. Mindfulness is increasing in popularity but retention in these programmes can be challenging. Condensed programmes have great potential but require statistical and individual evaluation. The Compassionate Mindful Resilience Program is a 4-week course that teaches simple, effective, evidence-based practices, skills and techniques.
Methods: This study aims to establish the feasibility of a randomised controlled trial to evaluate the effectiveness of the Compassionate Mindful Resilience Program in improving the psychosocial well-being of people with a diagnosis of pulmonary fibrosis. The trial will be conducted to test procedures, outcomes and validated tools; estimate recruitment and attrition rates; and calculate the sample size required for a future definitive multi-centre randomised controlled trial. The study will also utilise qualitative methods to explore the acceptability of the intervention to the study population. In keeping with CONSORT guidelines. The SPIRIT guidelines and checklist will be utilised to report the study.
Discussion: This study will implement a four-week mindfulness intervention and its utility for people with Pulmonary Fibrosis. The investigators aim to increase equitable access to evidence-based mindfulness practices with the potential to improve the lives of people impacted by this condition. If the study demonstrates the practicability of delivering the online 4-week Compassionate Mindful Resilience program with adequate recruitment, the investigators will be able to determine the feasibility of progression to a randomised controlled clinical trial to increase equitable access to evidence-based mindfulness practices with the potential to improve the lives of people impacted by Pulmonary Fibrosis.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Please Select
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Belfast, Please Select, Zjednoczone Królestwo, BT7 1NN
- Queen's University Belfast
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- have a confirmed diagnosis of PF
- be aged 18 years or older
- reside in the UK or Ireland
- have the capacity to provide informed consent
- demonstrate a commitment to attend all four CMR sessions (demonstrated through discussion with the mindfulness teacher during screening)
- have access to an internet-enabled device.
Exclusion Criteria:
- No diagnosis of PF
- under 18 years old
- live outside of UK or Ireland
- no capacity to provide informed consent
- not willing to attend all four CMR sessions
- no access to an internet-enabled device.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Intervention group
CMR is an internationally accredited 4-week programme with 2-hour online sessions delivered via Microsoft Teams
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It is an internationally accredited 4-week programme with 2-hour online sessions delivered via Microsoft Teams
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Brak interwencji: Waitlist group
This group did not receive the CMR intervention until all intervention groups had completed CMR.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Feasibility of the intervention
Ramy czasowe: From enrollment until the follow up interview was completed (up to 10 weeks)
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Adherence
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From enrollment until the follow up interview was completed (up to 10 weeks)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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The feasibility of collecting data on anxiety, depression, well-being, mindfulness, resilience, and self-compassion
Ramy czasowe: Baseline (week 1), post-CMR (week 4), and four-week follow-up (week 8)
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These were measured via online surveys at baseline, post-CMR, and four-week follow-up
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Baseline (week 1), post-CMR (week 4), and four-week follow-up (week 8)
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
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Feasibility of recruitment and retention
Ramy czasowe: From recruitment until the end of the study (up to 5 months)
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Measured against pre-defined recruitment and retention targets
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From recruitment until the end of the study (up to 5 months)
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Mc Veigh C, Reid J, Larkin P, Porter S, Hudson P. Palliative care for people with non-malignant respiratory disease and their carers: a review of the current evidence. J Res Nurs. 2019 Sep;24(6):420-430. doi: 10.1177/1744987119840066. Epub 2019 Apr 29.
- Mc Veigh C, Reid J, Larkin P, Porter S, Hudson P. The experience of palliative care service provision for people with non-malignant respiratory disease and their family carers: An all-Ireland qualitative study. J Adv Nurs. 2018 Feb;74(2):383-394. doi: 10.1111/jan.13453. Epub 2017 Nov 27.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- MHLS 24_139
- SB\ZA\101010662\980079 (Inny numer grantu/finansowania: The Burdett Trust)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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