- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06769763
mHealth Effect on Multiple Sclerosis Patients' Quality of Life and Self-care Practices
Arabic Mobile Application for Multiple Sclerosis (MS) Patients and Its Effect on Their Quality of Life and Self-care Practices
The goal of this clinical trial is to learn if an Arabic mobile application for multiple sclerosis patients will improve self-care practice and the quality of life of patients or not. The main question it aims to answer is:
Does the Arabic mobile application for MS patients will improve their self-care and quality of life?
Participants will:
Use the developed application or usual care without using the application for 3 months Be followed up during the 12 week period and asked to follow the instructions in the application
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt
- Faculty of medicine, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed clinically with multiple sclerosis.
- From 18 to 50 years old (adult).
- With smartphones.
- Willing to participate in the study and use the mobile application.
Exclusion Criteria:
- Patients who are bedridden or in a wheelchair
- Illiterate patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: App users
This arm is the interventional group who will use the application for 3 months
|
This is an Arabic application for MS patients that provides them with information about self-care like nutrition, exercise, mental health, and self-management, in addition to other features like symptom tracking and medication reminders.
|
|
No Intervention: Control arm
This arm will not use the application during the period of follow-up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of mHealth on the self-care practices of multiple sclerosis patients
Time Frame: From enrollment to the end of follow-up at 12 weeks
|
The effect of mHealth on the self-care practices of multiple sclerosis patients will be assessed using the self-care for chronic disease inventory questionnaire.
The score ranges from 0 to 100, the higher the score the better the self-care practices.
|
From enrollment to the end of follow-up at 12 weeks
|
|
The effect of mHealth on the quality of life of multiple sclerosis patients
Time Frame: From enrollment to the end of follow-up at 12 weeks
|
The effect of mHealth on the quality of life (QoL) of multiple sclerosis patients will be assessed using the multiple sclerosis international quality of life (Musiqol) questionnaire.
The score will be transformed into a range from 0 to 100; the higher the score, the better the QoL practices.
|
From enrollment to the end of follow-up at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The usability of the developed application
Time Frame: After 12 weeks of enrollment
|
The usability of the developed application will be assessed using the app usability questionnaire.
The patients will choose a number between 1 to 7 (Likert scale), as 1 strongly disagree, 2 disagree, 3 somewhat disagree 4 neutral, 5 somewhat agree, 6 agree, and 7 strongly agree.
Then the total average of all scored items for each participant will be calculated; the higher the average, the better the app's usability
|
After 12 weeks of enrollment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nargis Albert Labib, Professor of public Health and Community Medicine, Faculty of Medicine, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD-204-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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