Interdisciplinary Approach for Refractory Dyspnoea

June 30, 2022 updated by: Ligue Pulmonaire Neuchâteloise

Impact of an Interdisciplinary Approach in the Management of Refractory Dyspnoea on Patients' Quality of Life by a Respiratory Care Team Non-specialized in Palliative Care

Dyspnoea is a very common symptom in many diseases, not only cardiorespiratory, but also renal or neurological diseases. It can be defined as " difficult, laboured and uncomfortable breathing […]. It is a subjective symptom. As pain, it involves both the patient's perception of the sensation and his reaction to it ". It can occur during even moderate effort and sometimes also at rest and tends to increase as the disease causing it progresses. Dyspnoea has therefore a significant on the various aspects of the patient's daily life and those around him or her (travel, leisure, daily activities, etc.) leading to a decrease in quality of life and possibly to anxiety and/or depressive symptoms. Among a vulnerable, elderly population that benefits from home care, it affects more than 46 % of patients in north-west of Switzerland.

Despite the handicap generated by daily dyspnoea, this complaint is often difficult to recognize by health professionals or family and friends, due in particular to a feeling of helplessness in the care provided. In addition, the treatment of the disease responsible for dyspnoea by the doctor does not always provide relief.

In this context, it is essential that people with dyspnoea, families and friends are supported in their experiences and acquire techniques and alternatives that help them better manage dyspnoea on a daily basis.

The first objective is to evaluate the feasibility of a dyspnoea support program led by a respiratory care team non-specialized in palliative care and its effect on quality of life and control of dyspnoea symptoms by patients .

A second objective is to measure patient's satisfaction about the program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The dyspnoea support program will include 4 steps:

Step 1: Initial interview Before the initial interview, the responsible physician will review or examine the medical records via the request sheet sent by the referring physician or pneumologist containing the patient's diagnoses, history and medications. These files will then be sent to the team coordinator.

The team coordinator will meet the patient to obtain complete informations about his or her experiences with dyspnoea. Validated written questionnaires in French will be completed to complete the evaluation:

  • Edmonton Symptom Assessment scale (ESAS):
  • London Chest Activity of Daily Living (LCADL):
  • Hospital Anxiety and Depression scale (HADS):
  • Chronic Respiratory disease questionnaire (CRQ):

Blood oxygen saturation (Sp02) without O2 will be measured for each patient. If deemed necessary by the responsible physician (Dr. Clark) to complete the evaluation, a spirometry and an Incremental Shuttle Walk Test (ISWT) test will be performed by a physiotherapist.

Step 2: Specialized appointment:

The coordinator will review the patient to present the measures and strategies that will be proposed according to his/her needs and with reference to the evaluation carried out. An anti-dyspnoea checklist providing advice, useful information and exercises to better manage dyspnoea in daily living will be provided, as well as a self-observation logbook to optimize self-energy and fatigue management.

Step 3: Services:

The measures proposed by the coordinator and accepted by the patient will be implemented, for example: work on positions, ventilatory education, use of a fan, pulmonary rehabilitation, stress management, mindfulness meditation, psychosocial services, possible support from the mobile palliative care team, etc. As the measures proposed depend on the evaluation carried out, this is an individualised program. Different measures can be combined in various ways and successions to meet the needs of the patient.

Step 4: Assessment of progress:

Once the program is completed, evolution of dyspnoea perception following the program will be evaluated. CRQ and HADS questionnaires will be completed and patient's satisfaction will be evaluated (look "statistical consideration").

After the program, a follow-up is planned: patients will be seen again at 3 and 6 months after the program. It will then be a matter of completing the CRQ and HADS questionnaires and monitoring the patients' progress.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Neuchâtel
      • Peseux, Neuchâtel, Switzerland, 2034
        • Ligue pulmonaire neuchâteloise

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • refractory breathlessness on exertion or rest (Medical Research Council (MRC) dyspnea scale score ≥2), despite optimum treatment of the underlying disease, as deemed by the responsible physician;
  • advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure, interstitial lung disease or motor neuron disease;
  • willing to engage with proposed therapy (physiotherapy);
  • able to provide informed consent in French.

Exclusion Criteria:

  • Breathlessness of unknown cause;
  • A primary diagnosis of chronic hyperventilation syndrome;
  • Completely house (or hospital or nursing home) bound

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Etude longitudinale
Work on positions, ventilatory education, use of a fan, pulmonary rehabilitation, stress management, mindfulness meditation, psychosocial services, support from the mobile palliative care team
Other: paramedical and non-pharmacological services
Paramedical and non-pharmacological services (work on positions, ventilatory education, use of a fan, pulmonary rehabilitation, stress management, mindfulness meditation, psychosocial services, possible support from the mobile palliative care team)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change measured by the Chronic Respiratory Questionnaire (CRQ) between the initial interview (T0) and the progress report in patients with refractory dyspnea
Time Frame: an average of four month
Minimally important difference is reflected by a change in score of 0.5 on a 7 point scale
an average of four month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure patient satisfaction with the program in the progress report : visual analogic scale
Time Frame: an average of four month
Satisfaction assessment using a visual analogic scale (0-10)
an average of four month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ligue Pulmonaire Neuchâteloise

Investigators

  • Principal Investigator: Jean-Marc Fellrath, Prof, Hôpital neuchâtelois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 10, 2019

First Posted (Actual)

July 11, 2019

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPNE_02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There are no plans to share the data collected with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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