Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT04279002
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2020-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association of Psycho-social Traits for the Benefit of a First Respiratory Rehabilitation Course - Exploratory Study.
Sponsor:
University Hospital, Tours
Organization:
Study Overview
Official Title:
Association of Psycho-social Traits for the Benefit of a First Respiratory Rehabilitation Course - Exploratory Study.
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESPIRSO
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-A02774-53 | OTHER | IdRCB | View |