Multiple Sclerosis (MS)MSNCT06450600
Enhancing Quality of Life in MS Patients Through Tailored Therapeutic Education
A study testing Multiple Sclerosis Therapeutic Education Program in people with Multiple Sclerosis (MS), run by Akhrif Iman.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- Multiple Sclerosis Therapeutic Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2024to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 18 years and older Patients diagnosed with confirmed multiple sclerosis by a neurologist
Who cannot join
- Cognitive disorders Refusal to participate Significant visual impairments
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Enhancing Quality of Life in Multiple Sclerosis: a Study Protocol to Evaluate the Impact of a Therapeutic Education Program
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.
Read the detailed 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.
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- Multiple Sclerosis Therapeutic Education Program
- Keywords
- Multiple Sclerosis, therapeutic education program, bladder dysfunction
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Sclerosis Therapeutic Education ProgramBehavioural
Also called MS Self-Management Education Workshop
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multiple Sclerosis Therapeutic Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start5 Oct 2024 (estimated)
- Primary completion5 Apr 2025 (estimated)
- Study completion5 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akhrif Iman
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Akhrif Iman, Ibn Sina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450600
- Sponsor's protocol ID
- u7f528ek
- Acronym
- MS
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Objective: Develop and evaluate a structured educational program for MS patients to enhance quality of life. Design: Prospective study assessing program impact without a control group. Recruitment: From Rabat University Hospital's PRM and Neurology sessions. Intervention: Individual needs assessment followed by multidisciplinary-led educational workshops. Assessment: Patients evaluated at baseline, 3 and 6 months using MSQOL-54 and M.H.U scale. Outcome Measures: Primary: MSQOL-54 for quality of life. Secondary: M.H.U scale for urinary symptoms. Sample Size: Fifty patients recruited, considering 10% follow-up loss rate. Follow-up: Patients can withdraw at any time. Statistical Analysis: Collaboration with Epidemiology and Clinical Research Laboratory.
Publications
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.
PubMed 38061315Ouadghiri 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.
PubMed 23849771Dobson 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.
PubMed 30300457McGinley 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.
PubMed 33620411El 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.
PubMed 22560010Palacios 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.
PubMed 32005419Demaille-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.
PubMed 21388907Perneger 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.
PubMed 12106617Stuifbergen 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.
PubMed 7777743Acquadro 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.
PubMed 14636427Giordano 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.
PubMed 34563229Stern 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.
PubMed 29062401Rotstein 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.
PubMed 30940920Kaya 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.
PubMed 24330320Song 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.
PubMed 33663558
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Quality of Life in Multiple Sclerosis: a Study Protocol to Evaluate the Impact of a Therapeutic Education Program
- ClinicalTrials.gov ID
- NCT06450600
- Acronym / sponsor ID
- MS / u7f528ek
- Conditions
- Multiple Sclerosis (MS)
- Keywords
- Multiple Sclerosis, therapeutic education program, bladder dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Akhrif ImanOther government
- Study start
- 5 Oct 2024 (estimated)
- Primary completion
- 5 Apr 2025 (estimated)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Education Program for Multiple Sclerosis Patients | Experimental | Behavioral: Multiple Sclerosis Therapeutic Education ProgramParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years and older Patients diagnosed with confirmed multiple sclerosis by a neurologist
Key exclusion criteria (1 listed)
- Cognitive disorders Refusal to participate Significant visual impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Sclerosis Therapeutic Education ProgramAlso: MS Self-Management Education WorkshopThe "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. | Behavioural | Therapeutic Education Program for Multiple Sclerosis Patients |
Primary outcome
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Time frame: 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.
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.
1 secondary outcome
Measure of Urinary Handicap scale (M.H.U)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Background: PubMed 38061315Lotfi 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.
- Background: PubMed 23849771Ouadghiri 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.
- Background: PubMed 30300457Dobson 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.
- Background: PubMed 33620411McGinley 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.
- Background: PubMed 22560010El 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.
- Background: PubMed 32005419Palacios 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.
- Background: PubMed 21388907Demaille-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.
- Background: PubMed 12106617Perneger 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.
- Background: PubMed 7777743Stuifbergen 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.
- Background: PubMed 14636427Acquadro 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.
- Background: PubMed 34563229Giordano 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.
- Background: PubMed 29062401Stern 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.
- NATIONAL INSTITUTE OF HEALTH AND MEDICAL RESEARCH (INSERM). Sclérose en plaques (SEP) : Une recherche active pour améliorer la prise en charge des patientsLink provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- PATHAK, Lokesh. Personalized Treatment for Multiple Sclerosis: The Role of Precision Medicine. Neurology Letters, 2023, vol. 2, no 1, p. 30-34.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study Objective: Develop and evaluate a structured educational program for MS patients to enhance quality of life. Design: Prospective study assessing program impact without a control group. Recruitment: From Rabat University Hospital's PRM and Neurology sessions. Intervention: Individual needs assessment followed by multidisciplinary-led educational workshops. Assessment: Patients evaluated at baseline, 3 and 6 months using MSQOL-54 and M.H.U scale. Outcome Measures: Primary: MSQOL-54 for quality of life. Secondary: M.H.U scale for urinary symptoms. Sample Size: Fifty patients recruited, considering 10% follow-up loss rate. Follow-up: Patients can withdraw at any time. Statistical Analysis: Collaboration with Epidemiology and Clinical Research Laboratory.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple Sclerosis Therapeutic Education Program in people with Multiple Sclerosis (MS), run by Akhrif Iman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iman AKHRIF, Secondary education (0696512426 ext. 10000, imanakhrif6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Sclerosis Quality of Life-54 (MSQOL-54) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06450600, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.