Enhancing Quality of Life in MS Patients Through Tailored Therapeutic Education

Multiple Sclerosis (MS) Clinical Trial

— MS  

Official title:

Enhancing Quality of Life in Multiple Sclerosis: a Study Protocol to Evaluate the Impact of a Therapeutic Education Program

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450600
• Other study ID #: u7f528ek
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 5, 2024
• Est. completion date: June 5, 2025

Study information

• Verified date: April 2024
• Source: Ibn Sina Hospital
• Contact: Iman AKHRIF, Secondary education
• Phone: 0696512426
• Email: imanakhrif6[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 5, 2025
• Est. primary completion date: April 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Sclerosis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akhrif Iman

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA. 2021 Jun 1;325(21):2211. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Arthritis Res Ther. 2021 May 25;23(1):149. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiple Sclerosis Quality of Life-54 (MSQOL-54)	The MSQOL-54 is a multidimensional questionnaire specifically designed to assess the health-related quality of life of patients with multiple sclerosis. It comprises 54 items, each rated from 0 to 100, grouped into 12 dimensions with two independent questions. These dimensions include physical activity, limitations due to physical health, limitations due to emotional state, pain, emotional well-being, energy, perceived health, social function, cognitive function, distress, sexual function, and general well-being.	The MSQOL-54 will be administered at the time of inclusion, 3 months after the initiation of the therapeutic education program, and again at 6 months after the initiation of the program.
Secondary	Measure of Urinary Handicap scale (M.H.U)	The Measure of Urinary Handicap scale (M.H.U) is an assessment tool designed to measure the impact of urinary symptoms on individuals' quality of life. It typically consists of several questions that explore the frequency, severity, and psychosocial impact of urinary symptoms on a person's daily life. The responses to these questions allow for the generation of a score that reflects the degree of handicap or discomfort experienced by the patient due to their urinary symptoms.	The M.H.U will be administered at the time of inclusion, 3 months after the initiation of the therapeutic education program, and again at 6 months after the initiation of the program.

External Links

•   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.
•   NATIONAL INSTITUTE OF HEALTH AND MEDICAL RESEARCH (INSERM). Sclérose en plaques (SEP) : Une recherche active pour améliorer la prise en charge des patients
•   PATHAK, Lokesh. Personalized Treatment for Multiple Sclerosis: The Role of Precision Medicine. Neurology Letters, 2023, vol. 2, no 1, p. 30-34.
•   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.