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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Respiratory Disease
• Intervention / Treatment: Other: Adapted information arm; Other: Neutral information arm

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hauteville-Lompnes, France, 01110
    • Clinique du Souffle le Pontet
  • Riom-ès-Montagnes, France
    • Clinique du Souffle Les Clarines

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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
Sham Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differential of health-related quality of life from baseline to PR end-stay	Assessing differential of health-related quality of life score on St. George's Respiratory Questionnaire (SGRQ) (Jones et al., 1991) from baseline to PR end-stay within and between groups The SGRQ contains 50 questions and evaluates 3 dimensions : symptoms component, activities that cause or are limited by breathlessness and impact component	Changes from baseline (T0) to at the end of the 4-weeks PR (T1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differential of dyspnea from from baseline to PR end-stay	Assessing differential of dyspnea score on DYSPNEA-12 questionnaire (Yorke et al 2010) within and between groups. The Dyspnea-12 contains 12items and evaluate the physical and affective dimensions of dyspnea.	Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
Differential of exercise tolerance from from baseline to PR end-stay	Assessing differential of exercise tolerance on the 6-minute walking test within and between groups.	Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
Differential of self-efficacy from from baseline to PR end-stay	Assessing differential of self-efficacy score on Self-efficacy for managing chronic disease SEMCD-6 questionnaire (Ritter & Lorig, 2014) within and between groups. This questionnaire contains 6 items.	Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
Differential of disease-related thinking from from baseline to PR end-stay	Assessing differential of disease-related thinking score on Brief Illness Perception Questionnaire B-IPQ (Broadbent et al., 2006) within and between groups. This questionnaire contains 8 items.	Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
Differential of disease-related fears from from baseline to PR end-stay	Assessing differential of disease-related fears score on COPD Anxiety Questionnaire Revised CAF-R (Keil et al., 2014) within and between groups. This questionnaire contains 20 items.	Changes from baseline (T0) to at the end of the 4-weeks PR (T1)

Collaborators and Investigators

• Sponsor: Korian
• Investigators: Principal Investigator: Benjamin EICHENAUER, Korian; Study Director: Nelly HERAUD, Korian; Study Director: Brice CANADA, Université de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pulmonary rehabilitation; Personality traits; Adapted information
• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: MONTREHAL-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No