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

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: Completed
• Conditions: Pulmonary Rehabilitation; Respiratory Rehabilitation
• Intervention / Treatment: Other: Brief 15-question questionnaire

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: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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	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

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	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	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	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	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	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

• Sponsor: University Hospital, Tours
• Investigators: Study Director: Laurent PLANTIER, MD-PhD, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2020
• Primary Completion (Actual): February 24, 2021
• Study Completion (Actual): February 24, 2021

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Social support; Personality traits
• Other Study ID 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