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

NCT04279002 | Completed

• 2 other identifiers: RIPH3-RNI19/RESPIRSO2019-A02774-53
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Rehabilitation; Pulmonary Rehabilitation

Keywords

Personality traits; Anxiety; Depression; Social support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  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

  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

  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

  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

  At the inclusion

Study Arms (1)

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

Interventions

Brief 15-question questionnaire OTHER

Questionnaire is mailed retrospectively to the respiratory rehabilitation program and aimed at targeting 17 psycho-social traits. Response time is estimated at 10 minutes

Respiratory rehabilitation course

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

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).

You may qualify if:

• Age ≥ 18 years old.
• Participation Agreement (no opposition confirmed with the return of the questionnaire)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Espace du Souffle

Tours, 37000, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Laurent PLANTIER, MD-PhD

  University Hospital, Tours

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 20, 2020
• Study Start: May 16, 2020
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

FR (1)