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临床试验/NCT04279002
NCT04279002已完成不适用

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

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2020年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
1
主要终点
Distribution of 17 psychosocial traits of interest in patients who had a major benefit from the initial Respiratory Rehabilitation program

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

Distribution of 17 psychosocial traits of interest in patients who had a major benefit from the initial Respiratory Rehabilitation program

时间窗: 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.

次要结局

  • 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 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)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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