Fitness and Well-being of Caregivers in the Hauts-de-France Region (PRHCARER)

February 25, 2025 updated by: Lille University

Etat Des Lieux De La Santé Physique, Sociale Et Psychologique Des Aidants Dans Le Cadre Des Maladies Respiratoires Chroniques

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: program of rehabilitation at home
group of caregivers which their loved ones followed a program of rehabilitataion at home
Other: a program of rehabilitation
physical activities, health education, psychosocial and motivational support
Active Comparator: a program of rehabilitation in a specialized center
group of caregivers which their loved ones followed a program of rehabilitation in a specialized center
Other: a program of rehabilitation
physical activities, health education, psychosocial and motivational support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional capacity
Time Frame: 8 weeks
achieve the highest number of steps on a stepper in 6 minutes
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessments of fitness
Time Frame: 8 weeks
handgrip
8 weeks
Short battery physical fitness test
Time Frame: 8 weeks

SPPB (Short Physical Performance Battery) is the sum of the scores following 3 criteria: the balance test, the walking speed test and the chair rise test. This test makes it possible to evaluate an individual's physical performance.

Score: 0 to 12 with best performance at 12.
8 weeks
Assessment of the state of health felt by the two parts of the EuroQol Group questionnaire (1990),
Time Frame: 8 weeks

Test of: 5 questions offering a score between 1 and 5. Final score: 5 the best result, 15 the worst result.

Helps to indicate how good or bad a state of health is, with a graduated scale (like that of a thermometer) on which 100 is the best state of health you can imagine and 0 is the worst state of health you can imagine. you can imagine.

This scale is numbered from 0 to 100:

  • 100 is the healthiest imaginable.
  • 0 is the worst health imaginable.
8 weeks
Physical and mental fatigue questionnaire (Michielsen et al. 2003)
Time Frame: 8 weeks
10 questions regarding the usual state. With 5 answer options ranging from "never (1)" to "always (5)" The total score is between 10 and 50. (10 = less fatigue, 50 = significant fatigue)
8 weeks
Charlson Comorbidity Score
Time Frame: 8 weeks
Evaluates the level of comorbidity by considering the severity level of 19 predefined comorbidity disorders The investigator counts the number of points without indicating the items. Score 0 to 39 pts. 0 being the least and 39 being the serious
8 weeks
Visual analog scales to measure shortness of breath and fatigue felt in the legs
Time Frame: 8 weeks
Two score scales ranging from 0 to 10 assessing the intensity of fatigue, shortness of breath and fatigue in the legs. 0 being the least serious and 10 being the highest fatigue.
8 weeks
Questionnaire on the Perceived Social Burden of Caregivers (Zarit et al., 1986)
Time Frame: 8 weeks

22 questions on the different feelings of caregivers regarding their personal situations in the context of patient care.

Answers ranging from never (0) to almost always (4) Total score ranging from 0 to 88 pts 0 being the most serious month and 88 being the most serious.
8 weeks
Anxiety and Depression Symptoms Questionnaire (Zigmond et al. 1983)
Time Frame: 8 weeks

To detect anxious and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D):

Total score in 2 categories (A = anxiety and D = depression) 0 = least serious score 21 = worst score
8 weeks
EPICES social insecurity questionnaire (Sass et al. 2006)
Time Frame: 8 weeks
questions on the means, assistance, leisure and housing of the caregiver. The score is continuous, it varies from 0 (absence of precariousness) to 100 (maximum of precariousness). The threshold of 30 is considered the precariousness threshold according to EPICES.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille University

Investigators

  • Study Director: Claudine Fabre, PhD, Lille University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2025

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

November 30, 2029

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D2024-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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