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

July 25, 2023 updated by: Korian

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Differential of health-related quality of life from baseline to PR end-stay
Time Frame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1)

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differential of dyspnea from from baseline to PR end-stay
Time Frame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1)

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
Time Frame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
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
Time Frame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
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
Time Frame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1)

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
Time Frame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1)

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korian

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Benjamin EICHENAUER, Korian
  • Study Director: Nelly HERAUD, Korian
  • Study Director: Brice CANADA, Université de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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