Enhancing Quality of Life in MS Patients Through Tailored Therapeutic Education

NCT ID: NCT06450600

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-05

Study Completion Date

2025-06-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Within the framework of improving the quality of life for patients with Multiple Sclerosis (MS), this prospective and descriptive study aims to evaluate the effectiveness of a therapeutic education program. The program, designed specifically for MS patients, includes individual sessions to identify needs, fears, and questions, followed by targeted educational workshops. These workshops address understanding the disease, managing bladder and sphincter issues, fatigue management, and psychological well-being, relying on a multidisciplinary team including physiotherapists, neurologists, psychologists, urologists, occupational therapists, nurses, and nutritionists. The primary goal is to assess the impact of this program on the quality of life of patients, measured by the MSQOL-54 questionnaire, with secondary measures such as the Urinary Handicap Scale (M.H.U). Fifty patients will be recruited from the Department of Physical Medicine and Rehabilitation at Rabat University Hospital, Morocco, with follow-ups planned at 3 and 6 months. This program aims to provide patients with the knowledge and skills necessary for better management of their condition, thereby promoting active participation in treatment and a significant improvement in their quality of life.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, descriptive, and analytical study without a control group, aiming to measure the impact of a specialized therapeutic education program on the quality of life in individuals diagnosed with multiple sclerosis.

The educational program includes individual sessions to assess patient needs, followed by workshops facilitated by a multidisciplinary team. These workshops are designed to provide comprehensive support and education on various aspects of living with multiple sclerosis.

Understanding the Disease: This workshop will provide participants with a detailed understanding of multiple sclerosis, including its etiology, pathophysiology, and common symptoms. Participants will learn about the importance of early diagnosis, disease progression, and treatment options available.

Managing Bladder and Sphincter Issues: Bladder and sphincter dysfunction are common symptoms of multiple sclerosis that significantly impact quality of life. This workshop will focus on strategies for managing urinary symptoms, including bladder retraining, pelvic floor exercises, and the use of assistive devices. Participants will also receive guidance on managing bowel dysfunction and preventing complications such as urinary tract infections.

Fatigue Management: Fatigue is a pervasive and debilitating symptom of multiple sclerosis. This workshop will explore the causes of fatigue in MS and provide practical strategies for conserving energy and managing daily activities. Participants will learn about pacing techniques, energy-saving devices, and the importance of restorative sleep.

Psychological Well-being: Living with multiple sclerosis can have a significant impact on mental health and emotional well-being. This workshop will address coping strategies for managing stress, anxiety, and depression associated with the disease. Participants will learn relaxation techniques, mindfulness exercises, and how to access support services and community resources.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis (MS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study is an observational, descriptive, and analytical research without a control group, aimed at assessing the impact of a specialized therapeutic education program on the quality of life of patients with multiple sclerosis. Participants will receive individual sessions to assess their needs, followed by targeted educational workshops on various aspects of disease management. The effectiveness of the program will be primarily measured using the Multiple Sclerosis Quality of Life-54 (MSQOL-54) questionnaire, with secondary outcomes assessed by the Urinary Handicap Measure (M.H.U) scale.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Therapeutic Education Program for Multiple Sclerosis Patients

Participants in this arm will receive a comprehensive therapeutic education program designed specifically for individuals diagnosed with multiple sclerosis. The program includes individual assessments to identify patient needs and concerns, followed by targeted educational workshops. These workshops cover a wide range of topics, including disease understanding, bladder and sphincter management, fatigue management, and psychological well-being. The intervention is delivered by a multidisciplinary team, including physiotherapists, neurologists, psychologists, urologists, occupational therapists, nurses, and nutritionists, aiming to improve participants' quality of life by enhancing their disease management skills and overall well-being.

Group Type EXPERIMENTAL

Multiple Sclerosis Therapeutic Education Program

Intervention Type BEHAVIORAL

The "MS Self-Management Education Workshop" is designed as an integral part of our therapeutic education program targeting individuals diagnosed with multiple sclerosis (MS). This intervention focuses on empowering participants with knowledge and skills necessary for effective self-management of their condition. The workshop includes interactive sessions that cover a range of topics critical for MS patients, such as:

Understanding the nature and progression of MS, highlighting the importance of early symptom recognition and management strategies.

Techniques for managing common MS symptoms, including fatigue, mobility issues, and cognitive challenges, with practical advice on daily living adaptations.

Guidance on medication management, including the use of disease-modifying therapies and managing side effects.

Strategies for emotional well-being, including coping mechanisms for dealing with the psychological impact of MS, stress management, and fostering resilience.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multiple Sclerosis Therapeutic Education Program

The "MS Self-Management Education Workshop" is designed as an integral part of our therapeutic education program targeting individuals diagnosed with multiple sclerosis (MS). This intervention focuses on empowering participants with knowledge and skills necessary for effective self-management of their condition. The workshop includes interactive sessions that cover a range of topics critical for MS patients, such as:

Understanding the nature and progression of MS, highlighting the importance of early symptom recognition and management strategies.

Techniques for managing common MS symptoms, including fatigue, mobility issues, and cognitive challenges, with practical advice on daily living adaptations.

Guidance on medication management, including the use of disease-modifying therapies and managing side effects.

Strategies for emotional well-being, including coping mechanisms for dealing with the psychological impact of MS, stress management, and fostering resilience.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MS Self-Management Education Workshop

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged 18 years and older Patients diagnosed with confirmed multiple sclerosis by a neurologist

Exclusion Criteria

* Cognitive disorders Refusal to participate Significant visual impairments
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Akhrif Iman

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Akhrif Iman

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Iman AKHRIF, Secondary education

Role: CONTACT

0696512426 ext. 10000

SARA SKALLI, Secondary education

Role: CONTACT

0661504251 ext. 10000

References

Explore related publications, articles, or registry entries linked to this study.

Lotfi R, El Kardoudi A, Chigr F. Multiple sclerosis in Morocco: Epidemiological, clinical, and therapeutic profile. Mult Scler Relat Disord. 2024 Jan;81:105347. doi: 10.1016/j.msard.2023.105347. Epub 2023 Dec 2.

Reference Type BACKGROUND
PMID: 38061315 (View on PubMed)

Ouadghiri S, El Alaoui Toussi K, Brick C, Ait Benhaddou EH, Benseffaj N, Benomar A, El Yahyaoui M, Essakalli M. Genetic factors and multiple sclerosis in the Moroccan population: a role for HLA class II. Pathol Biol (Paris). 2013 Dec;61(6):259-63. doi: 10.1016/j.patbio.2013.05.002. Epub 2013 Jul 9.

Reference Type BACKGROUND
PMID: 23849771 (View on PubMed)

Dobson R, Giovannoni G. Multiple sclerosis - a review. Eur J Neurol. 2019 Jan;26(1):27-40. doi: 10.1111/ene.13819. Epub 2018 Nov 18.

Reference Type BACKGROUND
PMID: 30300457 (View on PubMed)

McGinley MP, Goldschmidt CH, Rae-Grant AD. Diagnosis and Treatment of Multiple Sclerosis: A Review. JAMA. 2021 Feb 23;325(8):765-779. doi: 10.1001/jama.2020.26858.

Reference Type BACKGROUND
PMID: 33620411 (View on PubMed)

El Alaoui Taoussi K, Ait Ben Haddou E, Benomar A, Abouqal R, Yahyaoui M. [Quality of life and multiple sclerosis: Arabic language translation and transcultural adaptation of "MSQOL-54"]. Rev Neurol (Paris). 2012 May;168(5):444-9. doi: 10.1016/j.neurol.2011.10.011. Epub 2012 May 2. French.

Reference Type BACKGROUND
PMID: 22560010 (View on PubMed)

Palacios S, Ramirez M, Lilue M, Vega B. Evaluation of Femaxeen(R) for control of urinary incontinence in women: A randomized, double-blind, placebo-controlled study. Maturitas. 2020 Mar;133:1-6. doi: 10.1016/j.maturitas.2019.12.008. Epub 2019 Dec 16.

Reference Type BACKGROUND
PMID: 32005419 (View on PubMed)

Demaille-Wlodyka S, Donze C, Givron P, Gallien P; ETP Sofmer Group. Self care programs and multiple sclerosis: physical therapeutics treatment - literature review. Ann Phys Rehabil Med. 2011 Mar;54(2):109-28. doi: 10.1016/j.rehab.2011.01.003. Epub 2011 Feb 18. English, French.

Reference Type BACKGROUND
PMID: 21388907 (View on PubMed)

Perneger TV, Sudre P, Muntner P, Uldry C, Courteheuse C, Naef AF, Jacquemet S, Nicod L, Rochat T, Assal JP. Effect of patient education on self-management skills and health status in patients with asthma: a randomized trial. Am J Med. 2002 Jul;113(1):7-14. doi: 10.1016/s0002-9343(02)01136-1.

Reference Type BACKGROUND
PMID: 12106617 (View on PubMed)

Stuifbergen AK. Health-promoting behaviors and quality of life among individuals with multiple sclerosis. Sch Inq Nurs Pract. 1995 Spring;9(1):31-50; discussion 51-5.

Reference Type BACKGROUND
PMID: 7777743 (View on PubMed)

Acquadro C, Lafortune L, Mear I. Quality of life in multiple sclerosis: translation in French Canadian of the MSQoL-54. Health Qual Life Outcomes. 2003 Nov 24;1:70. doi: 10.1186/1477-7525-1-70.

Reference Type BACKGROUND
PMID: 14636427 (View on PubMed)

Giordano A, Testa S, Bassi M, Cilia S, Bertolotto A, Quartuccio ME, Pietrolongo E, Falautano M, Grobberio M, Niccolai C, Allegri B, Viterbo RG, Confalonieri P, Giovannetti AM, Cocco E, Grasso MG, Lugaresi A, Ferriani E, Nocentini U, Zaffaroni M, De Livera A, Jelinek G, Solari A, Rosato R. Viability of a MSQOL-54 general health-related quality of life score using bifactor model. Health Qual Life Outcomes. 2021 Sep 25;19(1):224. doi: 10.1186/s12955-021-01857-y.

Reference Type BACKGROUND
PMID: 34563229 (View on PubMed)

Stern B, Hojs Fabjan T, Rener-Sitar K, Zaletel-Kragelj L. Validation of The Slovenian Version of Multiple Sclerosis Quality of Life (MSQOL-54) Instrument. Zdr Varst. 2017 Oct 9;56(4):260-267. doi: 10.1515/sjph-2017-0035. eCollection 2017 Oct.

Reference Type BACKGROUND
PMID: 29062401 (View on PubMed)

Rotstein D, Montalban X. Reaching an evidence-based prognosis for personalized treatment of multiple sclerosis. Nat Rev Neurol. 2019 May;15(5):287-300. doi: 10.1038/s41582-019-0170-8.

Reference Type BACKGROUND
PMID: 30940920 (View on PubMed)

Kaya T, Goksel Karatepe A, Atici Ozturk P, Gunaydin R. Impact of peer-led group education on the quality of life in patients with ankylosing spondylitis. Int J Rheum Dis. 2016 Feb;19(2):184-91. doi: 10.1111/1756-185X.12256. Epub 2013 Dec 14.

Reference Type BACKGROUND
PMID: 24330320 (View on PubMed)

Song Y, Xie X, Chen Y, Wang Y, Yang H, Nie A, Chen H. The effects of WeChat-based educational intervention in patients with ankylosing spondylitis: a randomized controlled trail. Arthritis Res Ther. 2021 Mar 4;23(1):72. doi: 10.1186/s13075-021-02453-7.

Reference Type BACKGROUND
PMID: 33663558 (View on PubMed)

Borba AKOT, Arruda IKG, Marques APO, Leal MCC, Diniz ADS. Knowledge and attitude about diabetes self-care of older adults in primary health care. Cien Saude Colet. 2019 Jan;24(1):125-136. doi: 10.1590/1413-81232018241.35052016. English, Portuguese.

Reference Type BACKGROUND
PMID: 30698247 (View on PubMed)

Nassar CM, Montero A, Magee MF. Inpatient Diabetes Education in the Real World: an Overview of Guidelines and Delivery Models. Curr Diab Rep. 2019 Sep 12;19(10):103. doi: 10.1007/s11892-019-1222-6.

Reference Type BACKGROUND
PMID: 31515653 (View on PubMed)

Guarnaccia S, Quecchia C, Festa A, Magoni M, Moneda M, Gretter V, Scarcella C, Pluda A, Gasparotti C, Frassine M, Vitale L, D'Agata E, Limina RM, Donato F. Evaluation of a diagnostic therapeutic educational pathway for asthma management in youth. Pediatr Allergy Immunol. 2018 Mar;29(2):180-185. doi: 10.1111/pai.12839. Epub 2017 Dec 19.

Reference Type BACKGROUND
PMID: 29168239 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.inserm.fr/dossier/sclerose-en-plaques-sep/

NATIONAL INSTITUTE OF HEALTH AND MEDICAL RESEARCH (INSERM). Sclérose en plaques (SEP) : Une recherche active pour améliorer la prise en charge des patients

https://dumas.ccsd.cnrs.fr/dumas-01799522/document

PETER, Mireille and DE BRUYCKER, Christelle. L'éducation thérapeutique du patient dans la SEP: Place au patient. In: Le Courrier de la SEP, May 2015, No. 143. CHRU de Lille.

https://dumas.ccsd.cnrs.fr/dumas-01212307/document

BERTIN, Juliette and GENTY, Margot. Place de l'éducation thérapeutique dans la prise en charge de la sclérose en plaques. \[online\]. Paris Academy, University Paris VI Pierre and Marie Curie, academic year 2014-2015.

https://www.neurologyletters.com/article_170305_9fb537f166dd3c37f265a9c50996bc2a.pdf

PATHAK, Lokesh. Personalized Treatment for Multiple Sclerosis: The Role of Precision Medicine. Neurology Letters, 2023, vol. 2, no 1, p. 30-34.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

u7f528ek

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.