Clinical trial NCT05325086: Effect on Quality of Life of Adapted Information in Pulmonary Rehabilitation in Chronic Respiratory Disease Patients
Official title: Effect on Quality of Life of Information Aimed at Reducing the Impact of a Personality Trait (Openness to Experiences) Identified as a Risk of Non-response to Pulmonary Rehabilitation in Patients With Chronic Respiratory Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Respiratory Disease
Keywords: Pulmonary rehabilitation
Personality traits
Adapted information
Lead sponsor: Korian
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the clinical study is to study the effect of health-related quality of Life of information aimed at reducing the impact of a personality trait (openness to experiences) identified as a risk of non-response to pulmonary rehabilitation in patients with chronic respiratory diseases. This study will determine if a specific information focusing on characteristics of openness to experiences personality trait will lead to better benefits than a general information.

Detailed description: According to the Five Factor Model, personality is made of five dimensions present in varying degrees in individuals and influencing their behavior and life experiences. Several studies showed that some personality traits, according to their level, may positively or negatively influence the quality of life. They can also have an impact on the benefits obtained at the end of one treatment. In the particular context of pulmonary rehabilitation (PR) which is one of the most efficient treatment in respiratory diseases, it has been showed that with a classical support, higher scores for openness to experiences represent a risk factor for non-response in PR on quality of life (i.e. no improvement). Several authors showed that adapted interventions (ex: simple information booklets), based on personality traits, can enhance the effectiveness of the intervention.

Considering that in chronic respiratory diseases, openness to experiences when it is more marked represents a risk of not improving the quality of life following a PR program, the idea of offering information in line with the characteristics of these people (i.e., search for novelties, autonomy, broad and varied interests, etc.) seems relevant and feasible.

The investigators hypothesize that the patients receiving an adapted information aimed at reducing the impact of a personality trait (openness to experiences) will better improve their quality of life in comparison with the patients receiving a neutra information.

The main objective is to assess the impact of life of an adapted information during pulmonary rehabilitation on quality in patients with chronic respiratory diseases.

Eligibility criteria: Inclusion Criteria:

Admitted for a 4-week inpatient pulmonary rehabilitation program Chronic respiratory disease diagnosis 18 and 80 years old Reading and writing skills Oral consent

Exclusion Criteria:

Inability to participate to exercise training Inability to answer a questionnaire Severe or unstable heart disease, orthopedic, neurologic or psychiatric comorbidities Recent exacerbation (\<4 weeks) Pregnant and breastfeeding women Protected adults, pregnant women Participation in another study, with the exception of observational studies

Primary outcomes:
measure: Differential of health-related quality of life from baseline to PR end-stay
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
Secondary outcomes:
measure: Differential of dyspnea from from baseline to PR end-stay
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
measure: Differential of exercise tolerance from from baseline to PR end-stay
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
measure: Differential of self-efficacy from from baseline to PR end-stay
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
measure: Differential of disease-related thinking from from baseline to PR end-stay
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
measure: Differential of disease-related fears from from baseline to PR end-stay
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
Other outcomes:
Locations:
city: Hauteville-Lompnes
country: France
facility: Clinique du Souffle le Pontet
city: Riom-ès-Montagnes
country: France
facility: Clinique du Souffle Les Clarines
Study officials:
affiliation: Korian
name: Benjamin EICHENAUER
role: PRINCIPAL_INVESTIGATOR
affiliation: Korian
name: Nelly HERAUD
role: STUDY_DIRECTOR
affiliation: Université de Lyon
name: Brice CANADA
role: STUDY_DIRECTOR
References: