The Relating Experienced To Recalled Breathlessness Observational Study

NCT03468205 | Completed

• 1 other identifier: RETRO
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Breathlessness is common through a range of chronic and life limiting diseases, such as chronic pulmonary disease and congestive hearth failure. There is a lack of knowledge concerning the understanding of the experience of breathlessness such as the relation between predicted, experienced and recalled breathlessness. Method: Questions on breathlessness intensity will be asked to participants with breathlessness several times daily through a mobile application installed on the users own cellphone. The mean experienced breathlessness will be related to the predicted and the recalled breathlessness as well as to background factors.

Conditions

Breathlessness; Dyspnea

Keywords

breathlessness; dyspnea; measurement

Outcome Measures

Primary Outcomes (1)

• Actual breathlessness.

  Intensity of breathlessness on a 0-10 Numerical Rating scale. 0 being no breathlessness and 10 being the worst imaginable breathlessness.

  Up to one week. Starting from installation of application.

Secondary Outcomes (4)

• Recalled breathlessness

  Up to one week. Starting from installation of application.

• Multidimensional dyspnea profile (MDP)

  Up to one week. Starting from installation of application.

• Predicted intensity of breathlessness on a 0-10 numerical rating scale

  Up to one week. Starting from installation of application.

• Perceived self-efficacy regarding breathlessness

  Up to one week. Starting from installation of application.

Study Arms (2)

Main Cohort

Main cohort of patients meeting all of the eligibility criteria enrolled through newspaper adds, flyers and via non personal recruitment.

Subgroup

Smaller group of patients, meeting eligibility criteria for the main study, enrolled through clinical visits. These patients will be followed more closely and also be recorded in a logbook in order for later review. Some of the participants in this group will be interviewed in a semi-qualitative interview about their experiences of breathlessness.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified by clinical and research staff at the centers of the participating investigators (see Research Team below) including primary care and internal medicine/cardiology departments in Blekinge, Örebro, and Skane University Hospital (Lund/Malmö). Participants will also be recruited through advertisements in national and local newspapers and magazines including those of the Swedish Respiratory Society, the Swedish Heart-Lung Foundation and the Heart-Lung Association, and on web-portals/sites, discussion forums and blogs.

You may qualify if:

• Age ≥ 18 years
• Self-reported overall breathlessness intensity ≥ 3 on a 0-10 numerical rating scale (NRS) during the prior 2 weeks, that was not entirely caused by an acute infection such as a cold or pneumonia
• Able to walk without personal aid (rollator allowed)
• Can use a device (smart phone/pad) with Internet access regularly
• Ability to read and complete data entry at baseline
• Clinical stability with no expected need for hospital admission within one week
• Have not participated before in the present study

Sponsors & Collaborators

• Skane University Hospital: lead

Study Sites (1)

Örebro University Hospital

Örebro, SE-70185, Sweden

Location

Related Publications (13)

• Gronseth R, Vollmer WM, Hardie JA, Olafsdottir IS, Lamprecht B, Buist AS, Gnatiuc L, Gulsvik A, Johannessen A, Enright P. Predictors of dyspnoea prevalence: results from the BOLD study. Eur Respir J. 2014 Jun;43(6):1610-20. doi: 10.1183/09031936.00036813. Epub 2013 Oct 31.

  PMID: 24176991 BACKGROUND

• Lopez Varela MV, Montes de Oca M, Halbert RJ, Muino A, Perez-Padilla R, Talamo C, Jardim JR, Valdivia G, Pertuze J, Moreno D, Menezes AM; PLATINO Team. Sex-related differences in COPD in five Latin American cities: the PLATINO study. Eur Respir J. 2010 Nov;36(5):1034-41. doi: 10.1183/09031936.00165409. Epub 2010 Apr 8.

  PMID: 20378599 BACKGROUND

• Bowden JA, To TH, Abernethy AP, Currow DC. Predictors of chronic breathlessness: a large population study. BMC Public Health. 2011 Jan 12;11:33. doi: 10.1186/1471-2458-11-33.

  PMID: 21226957 BACKGROUND

• Lansing RW, Gracely RH, Banzett RB. The multiple dimensions of dyspnea: review and hypotheses. Respir Physiol Neurobiol. 2009 May 30;167(1):53-60. doi: 10.1016/j.resp.2008.07.012. Epub 2008 Jul 25.

  PMID: 18706531 BACKGROUND

• Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.

  PMID: 22336677 BACKGROUND

• Laviolette L, Laveneziana P; ERS Research Seminar Faculty. Dyspnoea: a multidimensional and multidisciplinary approach. Eur Respir J. 2014 Jun;43(6):1750-62. doi: 10.1183/09031936.00092613. Epub 2014 Feb 13.

  PMID: 24525437 BACKGROUND

• Mead J. Dysanapsis in normal lungs assessed by the relationship between maximal flow, static recoil, and vital capacity. Am Rev Respir Dis. 1980 Feb;121(2):339-42. doi: 10.1164/arrd.1980.121.2.339.

  PMID: 7362140 BACKGROUND

• Williams M, Garrard A, Cafarella P, Petkov J, Frith P. Quality of recalled dyspnoea is different from exercise-induced dyspnoea: an experimental study. Aust J Physiother. 2009;55(3):177-83. doi: 10.1016/s0004-9514(09)70078-9.

  PMID: 19681739 BACKGROUND

• Walentynowicz M, Bogaerts K, Van Diest I, Raes F, Van den Bergh O. Was it so bad? The role of retrospective memory in symptom reporting. Health Psychol. 2015 Dec;34(12):1166-74. doi: 10.1037/hea0000222. Epub 2015 May 25.

  PMID: 26010720 BACKGROUND

• Miravitlles M, Ferrer J, Baro E, Lleonart M, Galera J. Differences between physician and patient in the perception of symptoms and their severity in COPD. Respir Med. 2013 Dec;107(12):1977-85. doi: 10.1016/j.rmed.2013.06.019. Epub 2013 Jul 24.

  PMID: 23890959 BACKGROUND

• Meek PM, Lareau SC, Anderson D. Memory for symptoms in COPD patients: how accurate are their reports? Eur Respir J. 2001 Sep;18(3):474-81. doi: 10.1183/09031936.01.00083501.

  PMID: 11589344 BACKGROUND

• Elmberg V, Ekstrom M. Effect of the trajectory of exertional breathlessness on symptom recall and anticipation: A randomized controlled trial. PLoS One. 2020 Sep 11;15(9):e0238937. doi: 10.1371/journal.pone.0238937. eCollection 2020.

  PMID: 32915891 DERIVED

• Sandberg J, Lansing R, Anderberg P, Currow D, Sundh J, Ahmadi Z, Palmqvist S, Ekstrom M. Relating Experienced To Recalled breathlessness Observational (RETRO) study: a prospective study using a mobile phone application. BMJ Open Respir Res. 2019 Feb 12;6(1):e000370. doi: 10.1136/bmjresp-2018-000370. eCollection 2019.

  PMID: 30956800 DERIVED

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacob Sandberg, MD

  Blekinge County Council Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 16, 2018
• Study Start: May 11, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

SE (1)