Clinical trial NCT06832709: Fitness and Well-being of Caregivers in the Hauts-de-France Region
Official title: Etat Des Lieux De La Santé Physique, Sociale Et Psychologique Des Aidants Dans Le Cadre Des Maladies Respiratoires Chroniques
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: caregivers
fitness
mental health
chronic respiratory disease
Lead sponsor: Lille University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment (2 groups)
Primary purpose: PREVENTION

Brief summary: The ageing of the population is accompanied by an increase in the frequency of chronic illnesses, leading to a rise in the number of caregivers. These caregivers do not have the time to look after their own health, and they are very often in a deteriorated mental state with no knowledge of their level of fitness. A deterioration in their fitness can be a source of the development of diseases induced by a sedentary lifestyle. On the other hand, patients with chronic respiratory disease can benefit from respiratory rehabilitation (RR), which includes outpatient or home-based physical activity. The literature has demonstrated an improvement in the mental state of caregivers following a RR carried out by their loved ones without taking an interest in their fitness. The aim of the study will be to establish 1. a representation of the level of fitness and mental state of caregivers; 2. to assess the presence/absence of benefits on fitness and mental state of caregivers depending on the form of RR: home versus outpatient where the caregiver is not integrated in this last form.

Detailed description: The literature reports more anxiety and depressive symptoms , a greater psychological and social burden and a poorer quality of life in caregivers than in their non-caregivers peers. Knowing the fitness of caregivers, by means of an assessment of their abilities, would make it possible to define their profile, which should reflect an altered fitness linked to a state of ill-being. The results of these assessments would make it possible to establish a prevention policy, and following a rehabilitation programme for their patients, their health should improve. For caregivers who agree to take part in the study, their physical, mental and social health will be assessed. The total duration of the visit, including all the assessments, is estimated at 1h30. We expect the fitness and mental and social state of all the caregivers to deteriorate in line with the indicators available in the literature for people of the same age who are not carers. Following care of the patients, we expect an improvement in fitness and mental state of the carers.

Eligibility criteria: Inclusion Criteria:

* Be of legal age;
* Have a sick relative taking part in a RR program, either as an outpatient at the Clinique de la Mitterie or at home with FormAction Santé;
* Have the cognitive ability to understand the instructions for carrying out the physical tests and the questions for answering the questionnaires;
* Be able to read;
* Have no disability preventing them from carrying out the physical tests;
* Have given their written consent to take part in the research;
* Be willing to comply with all the research procedures and duration.

Exclusion Criteria:

* Refusal to sign consent;
* Operation less than one month old;
* Presence of psychological or psychiatric disorders;
* Impossibility of receiving informed information;
* Impossibility of participating in the entire study;
* Contraindication to physical activity.

Primary outcomes:
measure: functional capacity
timeFrame: 8 weeks
Secondary outcomes:
measure: assessments of fitness
timeFrame: 8 weeks
measure: Short battery physical fitness test
timeFrame: 8 weeks
measure: Assessment of the state of health felt by the two parts of the EuroQol Group questionnaire (1990),
timeFrame: 8 weeks
measure: Physical and mental fatigue questionnaire (Michielsen et al. 2003)
timeFrame: 8 weeks
measure: Charlson Comorbidity Score
timeFrame: 8 weeks
measure: Visual analog scales to measure shortness of breath and fatigue felt in the legs
timeFrame: 8 weeks
measure: Questionnaire on the Perceived Social Burden of Caregivers (Zarit et al., 1986)
timeFrame: 8 weeks
measure: Anxiety and Depression Symptoms Questionnaire (Zigmond et al. 1983)
timeFrame: 8 weeks
measure: EPICES social insecurity questionnaire (Sass et al. 2006)
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Lille University
name: Claudine Fabre, PhD
role: STUDY_DIRECTOR
References:
citation: Houben CHM, Spruit MA, Luyten H, Pennings HJ, van den Boogaart VEM, Creemers JPHM, Wesseling G, Wouters EFM, Janssen DJA. Cluster-randomised trial of a nurse-led advance care planning session in patients with COPD and their loved ones. Thorax. 2019 Apr;74(4):328-336. doi: 10.1136/thoraxjnl-2018-211943. Epub 2019 Jan 19.
citation: Seamark DA, Blake SD, Seamark CJ, Halpin DM. Living with severe chronic obstructive pulmonary disease (COPD): perceptions of patients and their carers. An interpretative phenomenological analysis. Palliat Med. 2004 Oct;18(7):619-25. doi: 10.1191/0269216304pm928oa.
citation: Grosbois JM, Gephine S, Kyheng M, Le Rouzic O, Chenivesse C. Improving the wellbeing of caregivers of patients with COPD using a home-based pulmonary rehabilitation programme. ERJ Open Res. 2022 Dec 12;8(4):00255-2022. doi: 10.1183/23120541.00255-2022. eCollection 2022 Oct.