Evaluation of a Connected Interface to Improve the Quality of Life and the Disability of Patient With Rheumatic Diseases

NCT05417477 | Unknown

• 1 other identifier: RECHMPL21_0412
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Musculoskeletal pathologies constitute a major public health problem. Rheumatologists, whether they practice in private or hospital settings, play a major role in the management of responsible for these ailments. Due to the increase in life expectancy, an increase in the number of consultations can be expected. It is therefore imperative that the latter be more efficient, without losing quality. Communication between doctor and patient is bound to evolve due to the multiplicity of IT tools available and those that are emerging, which are increasingly essential, including many smartphone applications. Each targeting a specific pathology (rheumatoid arthritis, ankylosing spondylitis, osteoporosis osteoarthritis, they will allow the patient to self-assess, thus becoming an actor in his own care. A "facilitated" exchange between caregivers and patients would be relevant and would provide added value for all. This is the reason why there is a real need for an application listing precise information on the patient, in a sufficiently succinct way to optimize their transmission to the physiotherapist.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatic and musculoskeletal diseases; e-health; care pathway

Outcome Measures

Primary Outcomes (1)

• Change of the quality of life of patients between baseline and 6 months

  Evaluate the impact of the computer interface on the patient's quality of life by comparing the evolution of the global SF-12 score between baseline and 6 months (longitudinal follow-up). The Survey Form-12 (SF-12) is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 is a shortened version of SF-36. The SF-12 have eight domains : 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems 3. Limitations in usual role activities because of physical health problems 4. Bodily pain 5. General mental health (psychological distress and well-being) 6. Limitations in usual role activities because of emotional problems 7. Vitality (energy and fatigue) 8. General health perceptions

  between baseline and 6 months

Secondary Outcomes (6)

• Percentage of satisfied patients

  between inclusion and 6 months

• Percentage of patients adhering to the interface

  between baseline and 6 months

• Percentage of adherent patients whose disease activity is positively impacted

  between baseline and 6 months

• Percentage of adherent patients whose quality of life is positively impacted

  between baseline and 6 months

• Percentage of adherent patients who are satisfied with the intervention

  between baseline and 6 months

Study Arms (1)

chronic inflammatory rheumatism or osteoarthritis

EXPERIMENTAL

The experimental intervention consists in providing the patient with access to a specific version of the application ''MedicApp'' for the duration of the study. The intervention will be limited for each patient to the entry of their data on the application at regular intervals during the study. The interface on the rheumatologist side will contain the demographic characteristics of the patient, his history, the treatments and the pathology requiring the use of physiotherapy Then, at regular intervals, the scores of the questionnaires addressed to the patient will be available on his interface. The interface, on the physiotherapist side, will contain the summary of the patient's clinical history, his treatments and the reason for the physiotherapy sessions. Then, at regular intervals, the physiotherapist will indicate the patient's locomotor assessment, the type of intervention performed and the final summary.

Device: use of an e-health application

Interventions

use of an e-health application DEVICE

Use of the e-health application throughout the duration of the study combined with the usual management of the disease and 20 physiotherapy sessions.

chronic inflammatory rheumatism or osteoarthritis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 70 years
• Presence of a chronic inflammatory rheumatism (rheumatoid arthritis, axial and/or peripheral spondyloarthritis) or osteoarthritis disease requiring the initiation of at least 20 sessions of physical therapy
• Diagnostic confirmation left to the discretion of the investigating physician
• Accessibility of an internet network (compatible with smartphone and/or computer)
• Information and consent of the patient

You may not qualify if:

• Pregnant or breastfeeding women
• Patient refusing or unable to give consent: patient under guardianship or curator, mentally retarded, dementia, language barrier
• Patient not affiliated to a social security scheme
• Patient under legal protection

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Yves-Marie PERS, MCU-PhD

CONTACT

04.67.33.72.31; ym-pers@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective exploratory pilot study. We plan to recruit 40 patients with Chronic Inflammatory Rheumatism (CIR) and 40 patients with Osteoarthritis (OA) by several investigating teams, for a total of 80 patients.

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 14, 2022
• Study Start: October 1, 2023
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

FR (1)