Enhancing Quality of Life in MS Patients Through Tailored Therapeutic Education

NCT06450600 | Not Yet Recruiting DMC

• 1 other identifier: u7f528ek
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Sclerosis (MS)

Keywords

Multiple Sclerosis; therapeutic education program; bladder dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measure of Urinary Handicap scale (M.H.U)

  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.

Study Arms (1)

Therapeutic Education Program for Multiple Sclerosis Patients

EXPERIMENTAL

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.

Behavioral: Multiple Sclerosis Therapeutic Education Program

Interventions

Multiple Sclerosis Therapeutic Education Program 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.

Also known as: MS Self-Management Education Workshop

Therapeutic Education Program for Multiple Sclerosis Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitive disorders Refusal to participate Significant visual impairments

Sponsors & Collaborators

• Akhrif Iman: lead

Related Publications (18)

• 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.

  PMID: 38061315 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 33620411 BACKGROUND

• 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.

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• 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.

  PMID: 12106617 BACKGROUND

• 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.

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• 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.

  PMID: 14636427 BACKGROUND

• 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.

  PMID: 34563229 BACKGROUND

• 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.

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Related Links

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

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Iman AKHRIF, Secondary education

CONTACT

0696512426; imanakhrif6@gmail.com

SARA SKALLI, Secondary education

CONTACT

0661504251; dr.skalli.sara@gmail.com

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: June 10, 2024
• Study Start: October 5, 2024
• Primary Completion: April 5, 2025
• Study Completion: June 5, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Day 0 (Baseline Assessment): Month 3 (3-Month Follow-up) Month 6 (6-Month Follow-up):
• Access Criteria: Inclusion: Age 18+, confirmed MS diagnosis, ability to provide consent, and available for program and assessments. Exclusion: Cognitive impairment, refusal, significant visual impairment.