Effect on Quality of Life of Adapted Information in Pulmonary Rehabilitation in Chronic Respiratory Disease Patients

NCT ID: NCT05325086

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-05
• Study Completion Date: 2023-07-25

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.

Conditions

Chronic Respiratory Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Adapted information arm

In parallel with an inpatient PR program, 4 visits will be carried out: V0 : Inclusion / V1 : Randomization / V2 : Follow-up / V3: End-stay.

At V1:

• Adapted information to the characteristics of a greater openness to experiences will be delivered to patient.
• The following questionnaires will be filled : Big Five Inventory BFI-FR, St. George's Respiratory SGRQ, Dyspnea-12, Self-efficacy for managing chronic disease SEMCD-6, Brief Illness Perception B-IPQ, COPD Anxiety Revised CAF-R, Patient Health PHQ-9, Montreal Cognitive Assessment Mini-MoCA

At V2:

*Semi-structured individual interviews will be performed. Questions will relate to the information distributed during V1 (adapted information), allowing to assess the understanding and the appropriation of it.

At V3:

• The following questionnaires will be filled: SGRQ,Dyspnea-12,SEMCD-6,B-IPQ,CAF-R
• In addition, some questions will be asked to verify the adherence to information and the potential contamination bias

Group Type: EXPERIMENTAL

Adapted information arm

Intervention Type: OTHER

A adapted booklet will be delivered to patients at the start of the stay. This booklet contains adapted information about the pulmonary rehabilitation targetting the characteristics of the openness to experiences personality traits

Neutral information arm

In parallel with an inpatient PR program, 4 visits will be carried out: V0 : Inclusion / V1 : Randomization / V2 : Follow-up / V3: End-stay.

At V1:

• Neutral information will be delivered to patient.
• The following questionnaires will be filled : Big Five Inventory BFI-FR, St. George's Respiratory SGRQ, Dyspnea-12, Self-efficacy for managing chronic disease SEMCD-6, Brief Illness Perception B-IPQ, COPD Anxiety Revised CAF-R, Patient Health PHQ-9, Montreal Cognitive Assessment Mini-MoCA

At V2:

*Semi-structured individual interviews will be performed. Questions will relate to the information distributed during V1 (neutral information), allowing to assess the understanding and the appropriation of it.

At V3:

• The following questionnaires will be filled: SGRQ,Dyspnea-12,SEMCD-6,B-IPQ,CAF-R
• In addition, some questions will be asked to verify the adherence to information and the potential contamination bias

Group Type: SHAM_COMPARATOR

Neutral information arm

Intervention Type: OTHER

A neutral booklet will be delivered to patients at the start of the stay. This booklet contains neutral information about the pulmonary rehabilitation

Interventions

Adapted information arm

A adapted booklet will be delivered to patients at the start of the stay. This booklet contains adapted information about the pulmonary rehabilitation targetting the characteristics of the openness to experiences personality traits

Intervention Type: OTHER

Neutral information arm

A neutral booklet will be delivered to patients at the start of the stay. This booklet contains neutral information about the pulmonary rehabilitation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korian

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin EICHENAUER

Role: PRINCIPAL_INVESTIGATOR

Korian

Nelly HERAUD

Role: STUDY_DIRECTOR

Korian

Brice CANADA

Role: STUDY_DIRECTOR

Université de Lyon

Locations

Clinique du Souffle le Pontet

Hauteville-Lompnes, , France

Clinique du Souffle Les Clarines

Riom-ès-Montagnes, , France

Countries

France

Other Identifiers

MONTREHAL-1

Identifier Type: -

Identifier Source: org_study_id