Association of Psycho-social Traits for the Benefit of a First Respiratory Rehabilitation Course - Exploratory Study. (RESPIRSO)

May 17, 2021 updated by: University Hospital, Tours

Respiratory Rehabilitation (RR) is based on a comprehensive multidisciplinary program of personalized and tailored care for patients with chronic respiratory diseases.

The effectiveness of RR in improving quality of life and exercise capacity has long been demonstrated in patients with chronic obstructive pulmonary disease (COPD). More recently, its interest has been highlighted in other chronic respiratory pathologies: asthma, interstitial pathologies, cancer, restrictive pathologies or pulmonary arterial hypertension. Although the efficacy of RR has been well demonstrated on the scale of a patient population, the benefits derived on an individual scale remain unpredictable and variable from one individual to another, without knowing the major determinants of this benefit.

Empirically, RR professionals suspect an association between some psychosocial characteristics and the importance of the benefit derived by patients from RR programmes. Individual personality traits and their relationship to health status, integration into a group, interaction with other group members, and the existence of anxiety or depressive symptoms may be determinants of RR benefit. These psychosocial determinants could also play a central role in the patients' adherence to the long-term rehabilitation process.

The hypothesis being tested is that there is an association between personality traits, anxiety, depressive symptoms, social support, and the benefit of an initial course of RR and the subsequent continuation of maintenance practices.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Respiratory Rehabilitation (RR) is based on a comprehensive multidisciplinary program of personalized and tailored care for patients with chronic respiratory diseases. Carried out in small groups of patients, it offers effort re-training combined with therapeutic education and psychological and social care. It aims at the long-term change of life habits.

The effectiveness of RR in improving quality of life and exercise capacity has long been demonstrated in patients with chronic obstructive pulmonary disease (COPD). More recently, its interest has been highlighted in other chronic respiratory pathologies: asthma, interstitial pathologies, cancer, restrictive pathologies or pulmonary arterial hypertension. Although the efficacy of RR has been well demonstrated on the scale of a patient population, the benefits derived on an individual scale remain unpredictable and variable from one individual to another, without knowing the major determinants of this benefit.

Empirically, RR professionals suspect an association between some psychosocial characteristics and the importance of the benefit derived by patients from RR programmes. Individual personality traits and their relationship to health status, integration into a group, interaction with other group members, and the existence of anxiety or depressive symptoms may be determinants of RR benefit. These psychosocial determinants could also play a central role in the patients' adherence to the long-term rehabilitation process.

The hypothesis being tested is that there is an association between personality traits, anxiety, depressive symptoms, social support, and the benefit of an initial course of RR and the subsequent continuation of maintenance practices.

Main objective n°1: to describe the distribution of 17 psychosocial traits of interest in patients who had a major benefit from the initial RR stage (defined by a decrease ≥7 points of Saint George's Respiratory Questionnaire (SGRQ) compared to patients who did not have a major benefit (defined by a decrease <7 points of the SGRQ).

The 17 traits describe the following:

  1. Personality traits
  2. Existence of anxiety or depressive symptoms
  3. Self-assessment of health status and the degree of control that the subject feels he or she has over the disease.
  4. Felt social support
  5. Interpersonal dimensions
  6. General satisfaction of the subject

Secondary Objective 1 :

Describe the distribution of the 17 psychosocial traits of interest in patients who have implemented maintenance practices for at least one year after the 1st RR course (defined by paramedical care or participation in activities offered by a patient association or declaration of the maintenance of supervised physical activity), compared to patients who have not pursued such an activity or for whom this data is not available.

Secondary objective n°2: Describe the correlations between 17 psychosocial traits of interest and the variation of the following variables between the initial and final assessment of the first RR stage: SGRQ, VQ11 quality of life score, Modified Medical Research Council (mMRC) dyspnea scale, 6-minute walking distance.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

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

  • France
      • Tours, France, 37000
        • Espace du Souffle

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients having a chronic respiratory pathology and having carried out a respiratory rehabilitation program in the 5 years prior to inclusion at the Espace du Souffle in Tours (France).

Description

Inclusion Criteria:

  • Age ≥ 18 years old.
  • Completion of at least one respiratory rehabilitation course at the Espace du Souffle (Tours France) within the 5 years prior to inclusion.
  • Participation Agreement (no opposition confirmed with the return of the questionnaire)

Exclusion Criteria:

  • Protected adults (guardianship or trusteeship)
  • Patient having expressed a refusal of contact for scientific purposes at the Espace du Souffle (Tours France)

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Respiratory rehabilitation course
Patients who has completed at least one respiratory rehabilitation course at the Espace du Souffle (Tours France) within the 5 years prior to inclusion
Other: Brief 15-question questionnaire
Questionnaire is mailed retrospectively to the respiratory rehabilitation program and aimed at targeting 17 psycho-social traits. Response time is estimated at 10 minutes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Distribution of 17 psychosocial traits of interest in patients who had a major benefit from the initial Respiratory Rehabilitation program
Time Frame: At the inclusion

Patients who had a major benefit from the initial Respiratory Rehabilitation program is defined by a decrease ≥7 points of the SGRQ

The 17 psycho-social traits are assessed using a short 15-item questionnaire mailed retrospectively to the Respiratory Rehabilitation Program.
At the inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Distribution of the 17 psychosocial traits of interest in patients who have implemented maintenance practices for at least one year after the 1st Respiratory Rehabilitation program
Time Frame: At the inclusion

Maintenance practices being defined by paramedical care or participation in activities offered by a patient association or declaration of continued supervised physical activity), compared to patients who have not pursued such an activity or for whom this data is not available.

The 17 psycho-social traits are assessed using a short 15-item questionnaire mailed retrospectively to the Respiratory Rehabilitation Program.
At the inclusion
Assess correlations between between 17 psychosocial traits of interest and the variation of the SGRQ between the initial and final assessment of the first Respiratory Rehabilitation program
Time Frame: At the inclusion
The 17 psycho-social traits are assessed using a short 15-item questionnaire mailed retrospectively to the Respiratory Rehabilitation Program.
At the inclusion
Assess correlations between between 17 psychosocial traits of interest and the variation of the VQ11 quality of life score between the initial and final assessment of the first Respiratory Rehabilitation program
Time Frame: initial and final assessment of the first Respiratory Rehabilitation program
The 17 psycho-social traits are assessed using a short 15-item questionnaire mailed retrospectively to the Respiratory Rehabilitation Program.
initial and final assessment of the first Respiratory Rehabilitation program
Assess correlations between between 17 psychosocial traits of interest and the variation of the mMRC dyspnea scale between the initial and final assessment of the first Respiratory Rehabilitation program
Time Frame: At the inclusion
The 17 psycho-social traits are assessed using a short 15-item questionnaire mailed retrospectively to the Respiratory Rehabilitation Program.
At the inclusion
Assess correlations between between 17 psychosocial traits of interest and the variation of the 6-minute walking distance between the initial and final assessment of the first Respiratory Rehabilitation program
Time Frame: At the inclusion
The 17 psycho-social traits are assessed using a short 15-item questionnaire mailed retrospectively to the Respiratory Rehabilitation Program.
At the inclusion

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Tours

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Laurent PLANTIER, MD-PhD, University Hospital, Tours

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RIPH3-RNI19/RESPIRSO
  • 2019-A02774-53 (Other Identifier: IdRCB)

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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