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The Relating Experienced To Recalled Breathlessness Observational Study (RETRO)

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ClinicalTrials.gov Identifier: NCT03468205
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Magnus Ekström, Skane University Hospital

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.


Condition or disease
Breathlessness Dyspnea

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: The Relating Experienced To Recalled Breathlessness Observational Study
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Actual breathlessness. [ Time Frame: Up to one week. Starting from installation of application. ]
    Intensity of breathlessness on a 0-10 Numerical Rating scale. 0 being no breathlessness and 10 being the worst imaginable breathlessness.


Secondary Outcome Measures :
  1. Recalled breathlessness [ Time Frame: Up to one week. Starting from installation of application. ]
    Intensity of breathlessness on a 0-10 numerical scale self. 0 being no breathlessness and 10 being the worst imaginable breathlessness.

  2. Multidimensional dyspnea profile (MDP) [ Time Frame: Up to one week. Starting from installation of application. ]
    Recording all dimensions of breathlessness

  3. Predicted intensity of breathlessness on a 0-10 numerical rating scale [ Time Frame: Up to one week. Starting from installation of application. ]
    Predicting future symptom level. 0 being no breathlessness and 10 being the worst imaginable breathlessness.

  4. Perceived self-efficacy regarding breathlessness [ Time Frame: Up to one week. Starting from installation of application. ]
    Rating on a 0-10 numerical rating scale. 0 being complete control of symptoms and 10 being the no control of symptoms..



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468205


Contacts
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Contact: Magnus Ekström, PhD +46739966612 pmekstrom@gmail.com
Contact: Jacob Sandberg, MD jacob.sandberg@gmail.com

Locations
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Sweden
Örebro University Hospital Recruiting
Örebro, Sweden, SE-70185
Contact: Josefin Sundh, MD       josefin.sundh@regionorebrolan.se   
Sponsors and Collaborators
Skane University Hospital
Investigators
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Study Director: Jacob Sandberg, MD Blekinge County Council Hospital

Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Magnus Ekström, Associate Professor, Skane University Hospital
ClinicalTrials.gov Identifier: NCT03468205     History of Changes
Other Study ID Numbers: RETRO
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Magnus Ekström, Skane University Hospital:
breathlessness
dyspnea
measurement

Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms