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

Primary Purpose

Chronic Respiratory Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adapted information arm
Neutral information arm
Sponsored by
Korian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Respiratory Disease focused on measuring Pulmonary rehabilitation, Personality traits, Adapted information

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique du Souffle le Pontet
  • Clinique du Souffle Les Clarines

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Adapted information arm

Neutral information arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
April 5, 2022
Last Updated
July 25, 2023
Sponsor
Korian
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1. Study Identification

Unique Protocol Identification Number
NCT05325086
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Disease
Keywords
Pulmonary rehabilitation, Personality traits, Adapted information

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adapted information arm
Arm Type
Experimental
Arm Description
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
Arm Title
Neutral information arm
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Adapted information arm
Intervention Description
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
Intervention Name(s)
Neutral information arm
Intervention Description
A neutral booklet will be delivered to patients at the start of the stay. This booklet contains neutral information about the pulmonary rehabilitation
Primary Outcome Measure Information:
Title
Differential of health-related quality of life from baseline to PR end-stay
Description
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
Time Frame
Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
Secondary Outcome Measure Information:
Title
Differential of dyspnea from from baseline to PR end-stay
Description
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.
Time Frame
Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
Title
Differential of exercise tolerance from from baseline to PR end-stay
Description
Assessing differential of exercise tolerance on the 6-minute walking test within and between groups.
Time Frame
Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
Title
Differential of self-efficacy from from baseline to PR end-stay
Description
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.
Time Frame
Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
Title
Differential of disease-related thinking from from baseline to PR end-stay
Description
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.
Time Frame
Changes from baseline (T0) to at the end of the 4-weeks PR (T1)
Title
Differential of disease-related fears from from baseline to PR end-stay
Description
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.
Time Frame
Changes from baseline (T0) to at the end of the 4-weeks PR (T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin EICHENAUER
Organizational Affiliation
Korian
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nelly HERAUD
Organizational Affiliation
Korian
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Brice CANADA
Organizational Affiliation
Université de Lyon
Official's Role
Study Director
Facility Information:
Facility Name
Clinique du Souffle le Pontet
City
Hauteville-Lompnes
ZIP/Postal Code
01110
Country
France
Facility Name
Clinique du Souffle Les Clarines
City
Riom-ès-Montagnes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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