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

Overview

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.

Interventions

• Other a program of rehabilitation
  physical activities, health education, psychosocial and motivational support

Primary outcome measures

• functional capacity [Time frame: 8 weeks]

Secondary outcome measures (9)

• assessments of fitness [Time frame: 8 weeks]
• Short battery physical fitness test [Time frame: 8 weeks]
• Assessment of the state of health felt by the two parts of the EuroQol Group questionnaire (1990), [Time frame: 8 weeks]
• Physical and mental fatigue questionnaire (Michielsen et al. 2003) [Time frame: 8 weeks]
• Charlson Comorbidity Score [Time frame: 8 weeks]
• Visual analog scales to measure shortness of breath and fatigue felt in the legs [Time frame: 8 weeks]
• Questionnaire on the Perceived Social Burden of Caregivers (Zarit et al., 1986) [Time frame: 8 weeks]
• Anxiety and Depression Symptoms Questionnaire (Zigmond et al. 1983) [Time frame: 8 weeks]
• EPICES social insecurity questionnaire (Sass et al. 2006) [Time frame: 8 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 30661022
• 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. PMID 15540670
• 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. PMID 36655219
• Robic M, Grosbois JM, Racodon M, Le Rouzic O, Ramon P, Masson N, Fabre C, Gephine S. PRHOCARER study: protocol for a multicentre, convergent, mixed-methods trial assessing the effectiveness of pulmonary rehabilitation programmes and the needs of informal carers of people with chronic respiratory diseases. BMJ Open Respir Res. 2026 Mar 4;13(1):e003599. doi: 10.1136/bmjresp-2025-003599. PMID 41781169

Identifiers

NCT: NCT06832709 · D2024-6

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗