SELF-BREATHE RCT for Chronic Breathlessness

NCT ID: NCT04574050

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-11

Study Completion Date

2022-01-30

Brief Summary

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A feasibility RCT comprising two groups:

1. Intervention (SELF-BREATHE in addition to standard NHS care)
2. Control group (standard / currently available NHS care)

Detailed Description

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Conditions

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Cancer COPD Asthma Bronchiectasis Adult Interstitial Lung Disease Cystic Fibrosis Chronic Heart Failure Sickle Cell Disease Renal Failure Liver Failure Post COVID-19 Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A feasibility RCT comprising two groups:

1. Intervention (SELF-BREATHE in addition to standard NHS care)
2. Control group (standard / currently available NHS care)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Single blind

Study Groups

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SELF-BREATHE

Access to a self -guided, internet -based intervention for patients with chronic breathlessness known as SELF-BREATHE

Group Type EXPERIMENTAL

SELF-BREATHE

Intervention Type OTHER

A self -guided, internet -based intervention for patients with chronic breathlessness

Control

standard / currently available NHS care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SELF-BREATHE

A self -guided, internet -based intervention for patients with chronic breathlessness

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults ≥ 18 years of age, with the ability to read and type in English
* Access to a computer, or tablet or smart phone, with internet access and the ability to email
* Chronic breathlessness (CB) defined as; breathlessness that persists (\>3months) despite optimal pharmacological treatment of the underlying disease including cancer, chronic obstructive pulmonary disease (COPD),asthma, interstitial lung disease (ILD), bronchiectasis, cystic fibrosis (CF) chronic heart failure (CHF), sickle cell disease, chronic renal/ liver failure or post COVID-19
* Chronic breathlessness at rest or on exertion; MRC dysponea score \>2
* Willing to engage with short-term self-guided internet-based breathlessness intervention (SELF-BREATHE)
* Able to provide informed consent

Exclusion Criteria

* Breathlessness of unknown cause
* A primary diagnosis of chronic hyperventilation syndrome
* Currently participating in a rehabilitation programme, e.g. pulmonary/cardiac rehabilitation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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King's College Hospital NHS Foundation TRUST

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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20/LO/1108

Identifier Type: OTHER

Identifier Source: secondary_id

IRAS 285303

Identifier Type: -

Identifier Source: org_study_id

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