COPDNCT04466020
SELF - BREATHE for Chronic Breathlessness
An observational study of COPD and Cancer, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Semi-structured qualitative interviews will be conducted to understand key factors that would enable / facilitate patients with chronic breathlessness to potentially use an online breathlessness intervention (SELF-BREATHE). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COPD, Cancer, Heart Failure
- What is being tested?
- Qualitative research interviews to be conducted
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jun 2020to 11 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD, Cancer, Heart Failure, Interstitial Lung disease, Dyspnea
Who may be able to join
- 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
Who cannot join
- Breathlessness of unknown cause
- A primary diagnosis of chronic hyperventilation syndrome
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, SE5 9RS
About this study
Official title: A Self -Guided, Internet -Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): an Interview Study.
Semi-structured qualitative interviews will be conducted to understand key factors that would enable / facilitate patients with chronic breathlessness to potentially use an online breathlessness intervention (SELF-BREATHE).
Read the detailed description
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
- Conditions
- COPD, Cancer, Heart Failure, Interstitial Disease, Dyspnea
- Being tested
- Qualitative research interviews to be conducted
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Neoplasms, Heart Failure, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative research interviews to be conductedOther
None. Qualitative research interviews to be conducted
| Study group | Role | What they receive |
|---|---|---|
| Patients with Chronic Breathlessness | Patients with Chronic Breathlessness Receives: Other: Qualitative research interviews to be conducted |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Qualitative data
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start3 Jun 2020
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Charles C Reilly, PhD,MSc,BSc, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466020
- Sponsor's protocol ID
- KCH20-056
- Other IDs
- ICA-CL-2018-04-ST2-001
- Status last verified
- Sep 2021
- First submitted
- 7 Jul 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self -Guided, Internet -Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): an Interview Study.
- ClinicalTrials.gov ID
- NCT04466020
- Acronym / sponsor ID
- KCH20-056
- Conditions
- COPD, Cancer, Heart Failure, Interstitial Disease, Dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Semi-structured qualitative interviews will be conducted to understand key factors that would enable / facilitate patients with chronic breathlessness to potentially use an online breathlessness intervention (SELF-BREATHE).
Detailed description
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Chronic Breathlessness | – | Other: Qualitative research interviews to be conductedPatients with Chronic Breathlessness |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD, Cancer, Heart Failure, Interstitial Lung disease, Dyspnea
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Breathlessness of unknown cause
- A primary diagnosis of chronic hyperventilation syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative research interviews to be conductedNone. Qualitative research interviews to be conducted | Other | Patients with Chronic Breathlessness |
Primary outcome
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).
Time frame: 12 months
Qualitative data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles C Reilly, PhD,MSc,BSc principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Cancer, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.