Chronic Respiratory DiseaseNCT05325086

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

A study testing Adapted information arm and Neutral information arm in people with Chronic Respiratory Disease, run by Korian at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Chronic Respiratory Disease
What is being tested?: Adapted information arm and Neutral information arm
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 136 participants
Where: 2 sitesFrance
Study dates: 5 Apr 2022to 25 Jul 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

France2 sites

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

Other trials in France

About this study

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

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.

Read the 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
Being tested: Adapted information arm, Neutral information arm
Keywords: Pulmonary rehabilitation, Personality traits, Adapted information

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05325086
Study group	Role	What they receive
Adapted information arm	Experimental	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 Receives: Other: Adapted information arm
Neutral information arm	Sham comparator	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 Receives: Other: Neutral information arm

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Apr 202225 Jul 2023

First posted13 Apr 2022
Study start5 Apr 2022
Primary completion25 Jul 2023
Study completion25 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Respiratory DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05325086
Sponsor's protocol ID: MONTREHAL-1
Status last verified: Jul 2023
First submitted: 5 Apr 2022
Last updated: 27 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05325086
Acronym / sponsor ID: MONTREHAL-1
Conditions: Chronic Respiratory Disease
Keywords: Pulmonary rehabilitation, Personality traits, Adapted information
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: KorianUniversity, hospital or other
Study start: 5 Apr 2022 (actual)
Primary completion: 25 Jul 2023 (actual)
Study completion: 25 Jul 2023 (actual)
First posted: 13 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Adapted information arm	Experimental	Other: Adapted information armIn 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
Neutral information arm	Sham comparator	Other: Neutral information armIn 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

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Adapted information armA 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	Other	Adapted information arm
Neutral information armA neutral booklet will be delivered to patients at the start of the stay. This booklet contains neutral information about the pulmonary rehabilitation	Other	Neutral information arm

Primary outcome

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

5 secondary outcomes

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)
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)
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)
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)
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Individual participant dataSharing planned: No

Related trials for Chronic Respiratory Disease

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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Benjamin EICHENAUER principal investigator

Korian

Nelly HERAUD study director

Korian

Brice CANADA study director

Université de Lyon

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Adapted information arm and Neutral information arm in people with Chronic Respiratory Disease, run by Korian at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05325086.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.