SELF-BREATHE RCT for Chronic Breathlessness

Sponsor

King's College Hospital NHS Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT04574050

Collaborator

King's College London (Other)

Enrollment

Location

Arms

29.6

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A feasibility RCT comprising two groups:

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

Condition or Disease	Intervention/Treatment	Phase
Cancer COPD Asthma Bronchiectasis Adult Interstitial Lung Disease Cystic Fibrosis Chronic Heart Failure Sickle Cell Disease Renal Failure Liver Failure Post COVID-19 Dyspnea	Other: SELF-BREATHE	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A feasibility RCT comprising two groups: Intervention (SELF-BREATHE in addition to standard NHS care) Control group (standard / currently available NHS care)A feasibility RCT comprising two groups:Intervention (SELF-BREATHE in addition to standard NHS care) Control group (standard / currently available NHS care)

Masking:

Single (Outcomes Assessor)

Masking Description:

Single blind

Primary Purpose:

Treatment

Official Title:

A Self - Guided, Internet - Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): Feasibility Randomised Controlled Trial

Actual Study Start Date :

Jan 11, 2020

Anticipated Primary Completion Date :

Apr 4, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SELF-BREATHE Access to a self -guided, internet -based intervention for patients with chronic breathlessness known as SELF-BREATHE	Other: SELF-BREATHE A self -guided, internet -based intervention for patients with chronic breathlessness
No Intervention: Control standard / currently available NHS care

Arm

Intervention/Treatment

Experimental: SELF-BREATHE

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

Other: SELF-BREATHE

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

No Intervention: Control

standard / currently available NHS care

Outcome Measures

Primary Outcome Measures

Feasibility: the number of patients recruited into this study over a 12-month period [12 months]
The number of patients recruited into this study over a 12-month period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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