- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04466020
SELF - BREATHE for Chronic Breathlessness
A Self -Guided, Internet -Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): an Interview Study.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
STUDY OVERVIEW
Full title:
A self -guided, internet -based intervention for patients with chronic breathlessness (SELF-BREATHE): an interview study.
Objective:
To understand the key factors that would enable / facilitate patients with chronic breathlessness to use an online breathlessness support intervention (SELF-BREATHE).
Study type:
Qualitative interview study
Methods:
Semi-structured qualitative interviews will be conducted to achieve maximum variation in approx 20 patients with chronic breathlessness (a purposive sample: age sex, diagnoses, and presence of caregiver).
The interview will explore and identify:
Patients' views/experiences of internet-based activities, e.g. digital apps, shopping online; Patients' understanding, preferences, values and motivations that would influence uptake of SELF-BREATHE; Potential barriers to the development and use of SELF-BREATHE; Facilitators to usage of SELF-BREATHE, such as the ability to self-monitor progress etc...
These topics cover areas of uncertainty in order to optimise the SELF - BREATHE intervention.
Inclusion criteria:
Adult patients >18 years of age, with the ability to read, converse in English and able to provide informed consent
Chronic breathlessness on exertion and or rest (MRC dysponea score >2)
Advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or interstitial lung disease (ILD), where the underlying disease is deemed to be optimally medically managed by the referring clinician / allied health professional / clinical nurse specialist
Exclusion criteria:
Breathlessness of unknown cause
A primary diagnosis of chronic hyperventilation syndrome
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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London, Det Forenede Kongerige, SE5 9RS
- King's College Hospital NHS Foundation Trust
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Adult patients >18 years of age, with the ability to read, converse in English and able to provide informed consent
- Chronic breathlessness on exertion and or rest (MRC dyspnea score >2)
- Advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or interstitial lung disease (ILD), where the underlying disease is deemed to be optimally medically managed by the referring clinician / allied health professional / clinical nurse specialist
Exclusion Criteria:
- Breathlessness of unknown cause
- A primary diagnosis of chronic hyperventilation syndrome
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Andet
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Patients with Chronic Breathlessness
|
None.
Qualitative research interviews to be conducted
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Descriptive qualitative analysis of patients' preferences, values and motivations that would influence the use of an online self - management intervention for chronic breathlessness (SELF-BREATHE).
Tidsramme: 12 months
|
Qualitative data
|
12 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Charles C Reilly, PhD,MSc,BSc, King's College Hospital NHS Trust
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KCH20-056
- ICA-CL-2018-04-ST2-001 (Andet bevillings-/finansieringsnummer: HEE/NIHR Integrated Clinical Academic Programme)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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