FAB study: Fan, Activity and Breathlessness: assessing the fan’s capacity to increase physical activity in patients with breathlessness and reducing carer anxiety

Phase 2

Active, not recruiting

• Conditions: Breathlessness; Physical activity; Self management; Self-efficacy - care givers; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12614000525684
• Lead Sponsor: The University of Notre Dame Australia,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Over 18

Able to provide verbal or written consent to take part in the study

Living in the community with or without a carer

Intractable breathlessness from all causes, for whom all reversible components of breathlessness have been addressed

Level 3 or higher on the modified Medical Research Council (mMRC) Dyspnoea scale; and

Have not used the hand held fan for breathlessness during the past week.

Exclusion Criteria

Too breathless to participate in study in the opinion of investigator and/or patient

Cognitively impaired and unable to understand the study

Medical Research Council (MRC) Dyspnoea scale < 3

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be activity levels over 7 days, measured by the activPAL (Trademark) monitor. [Change in total physical activity over 7 days from prior to randomisation (Day -8 till Day 0) to Day 21-28 (the week prior to study end).]

Secondary Outcome Measures

Name	Time	Method
Change in intensity of breathlessness (0-10 numerical rating scale, 0 = none; 10 worst imaginable)[Symptom assessment at Baseline, Day 7, Day 14, Day 21 and Day 28];Changes in Function, as measured by 6 Minute Walk Test (6MWT) and Life-Space Assessment<br>[Changes in function, at Baseline and Day 28.];Change in unpleasantness of breathlessness on a (0-10 numerical rating scale, 0 = none; 10 worst imaginable)<br><br>[Symptom Assessment at Baseline, Day 7, 14, 21 and 28];Changes in patient self-efficacy as measured by COPD Self Efficacy Scale and General Self Efficacy Scale (GSES), Patient questionnaire regarding fan use<br>[Patient self efficacy at Baseline and Day 28];Carer self efficacy and carer burden as measured by General Self Efficacy Scale and Zarit Care Giver Burden short form<br>[Carer self efficacy and burden at Baseline and Day 28];Health Service Utilisation[Health Service Utilisation at Baseline, Day 7, Day 14, Day 21 and Day 28, recorded via patient verbal report and via patient medical records]