Enhancing Quality of Life in MS Patients Through Tailored Therapeutic Education (MS)

June 7, 2024 updated by: Akhrif Iman

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

Other Names:
  • MS Self-Management Education Workshop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akhrif Iman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 5, 2024

Primary Completion (Estimated)

April 5, 2025

Study Completion (Estimated)

June 5, 2025

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • u7f528ek

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Day 0 (Baseline Assessment):

Month 3 (3-Month Follow-up)

Month 6 (6-Month Follow-up):

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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