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

NCT05325086 | Completed

• 1 other identifier: MONTREHAL-1
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Respiratory Disease

Keywords

Pulmonary rehabilitation; Personality traits; Adapted information

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Differential of dyspnea from from baseline to PR end-stay

  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

  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

  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

  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

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

Study Arms (2)

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

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

Other: Neutral information arm

Interventions

Adapted information arm 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

Adapted information arm

Neutral information arm OTHER

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

Neutral information arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korian: lead

Study Sites (2)

Clinique du Souffle le Pontet

Hauteville-Lompnes, 01110, France

Location

Clinique du Souffle Les Clarines

Riom-ès-Montagnes, France

Location

Study Officials

• Benjamin EICHENAUER

  Korian

  PRINCIPAL INVESTIGATOR

• Nelly HERAUD

  Korian

  STUDY DIRECTOR

• Brice CANADA

  Université de Lyon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 13, 2022
• Study Start: April 5, 2022
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)