Back to resultsEffectiveness of a Digital Health Application for Multiple Sclerosis (Levidex)
Primary Purpose
Multiple Sclerosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
levidex
Control
treatment as usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 Impaired health-related quality of life (total score of the Hamburg Quality of Life Questionnaire for Multiple Sclerosis [HALEMS] ≥ 2) Specialist treatment in the last three months before study inclusion Diagnosis of MS (relevant ICD-10-GM diagnoses G35.x), confirmed by a medical document or equivalent certificate Sufficient cognitive and motor skills to use an online program Consent to participate Sufficient knowledge of the German language Access to the Internet Exclusion Criteria: Presence of severe impairment of independence or abilities (degree of care ["Pflegegrad", § 15 SGB XI] ≥ 3)
Sites / Locations
- GAIA AG
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Participants allocated to the intervention group will receive access to levidex in addition to treatment as usual (TAU). levidex is a digital health application designed for individuals with Multiple Sclerosis (MS), accessible through a web browser. The application comprises 16 modules, with the majority focusing on treatment methods derived from cognitive behavioral therapy (CBT) and health behavior change. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 365 days.
Participants allocated to the control group will receive an overview of relevant brochures from the Deutsche Multiple Sklerose Gesellschaft (German Multiple Sclerosis Society) on the topic of lifestyle in Multiple Sclerosis (MS) in addition to treatment as usual (TAU). After 6 months, they will be offered access to levidex.
Outcomes
Primary Outcome Measures
Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)
The HALEMS measures MS-specific quality of life. It covers the following domains: fatigue, thinking, mobility lower limb, mobility upper limb, communication and mood. The total score is calculated as the average of the scores in the six domains and ranges from 1 to 5. Higher scores represent lower quality of life.
Secondary Outcome Measures
Patient Health Questionnaire (PHQ-9)
The PHQ-9 measures depressive symptoms. Each of the 9 items is answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (almost every day). The total score ranges from 0 to 27. Higher scores represent higher depressive symptoms.
Work and Social Assessment Scale (WSAS)
The WSAS measures an individual's perception of work and social functioning. It consists of 5 items that are answered on a 9-point Likert scale ranging from 0 (not at all impaired) to 8 (very severely impaired). The total score has a range of 0-40, with higher scores representing higher disability.
Global index score of the Multiple Sclerosis International Quality of Life (MuSiQoL)
The MuSiQoL measures MS-specific quality of life. It comprises 31 items covering 9 domains (activities of daily living, psychological well-being, symptoms, relationships with friends, relationships with family, relationships with the healthcare system, sentimental and sexual life, coping, and rejection). Each item is scored on a 6-point Likert scale. The score on each dimension is obtained by computing the mean of the item scores for that dimension. All dimension scores are linearly transformed to a 0-100 scale. The global index score is computed as the mean of the dimension scores. Higher scores represent higher quality of life.
Generalized Anxiety Disorder Scale-7 (GAD-7)
The GAD-7 is a 7-item self-report anxiety questionnaire. Items are rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score can range from 0 to 21, higher scores representing higher anxiety.
Frenchay Activities Index (FAI)
The FAI assesses participation in social and lifestyle activities with 15 items that are scored on a 4-point Likert scale ranging from 1 to 4. It covers three subdomains (domestic chores, outdoor, work/leisure activities). The total score ranges from 15 to 60. Higher scores represent more activity.
Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)
The HALEMS measures MS-specific quality of life. It covers the following domains: fatigue, thinking, mobility lower limb, mobility upper limb, communication and mood. The total score is calculated as the average of the scores in the six domains and ranges from 1 to 5. Higher scores represent lower quality of life.
Full Information
NCT ID
NCT06090305
First Posted
October 13, 2023
Last Updated
October 19, 2023
Sponsor
Gaia AG
Collaborators
University Hospital Schleswig-Holstein, Universität Duisburg-Essen
1. Study Identification
Unique Protocol Identification Number
NCT06090305
Brief Title
Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex)
Official Title
Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex): Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 25, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gaia AG
Collaborators
University Hospital Schleswig-Holstein, Universität Duisburg-Essen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The trial aims to evaluate the effectiveness of a novel digital health application (levidex), which was designed to increase quality of life in persons with multiple sclerosis (MS). Therefore, 470 people with MS will be recruited and randomized to two groups: (1) an intervention group that will receive access to levidex in addition to treatment as usual (TAU) (n = 235) and (2) a control group receiving an overview of relevant brochures from the Deutsche Multiple Sklerose Gesellschaft (German Multiple Sclerosis Society) on the topic of lifestyle in MS in addition to TAU (n = 235).The primary outcome measure is the total score on the Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS), collected 6 months post-randomization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
470 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants allocated to the intervention group will receive access to levidex in addition to treatment as usual (TAU). levidex is a digital health application designed for individuals with Multiple Sclerosis (MS), accessible through a web browser. The application comprises 16 modules, with the majority focusing on treatment methods derived from cognitive behavioral therapy (CBT) and health behavior change. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 365 days.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants allocated to the control group will receive an overview of relevant brochures from the Deutsche Multiple Sklerose Gesellschaft (German Multiple Sclerosis Society) on the topic of lifestyle in Multiple Sclerosis (MS) in addition to treatment as usual (TAU). After 6 months, they will be offered access to levidex.
Intervention Type
Behavioral
Intervention Name(s)
levidex
Intervention Description
Participants will receive access to the digital health application levidex in addition to treatment as usual (TAU).
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Participants will receive access to an overview of relevant brochures from the Deutsche Multiple Sklerose Gesellschaft (German Multiple Sclerosis Society) on the topic of lifestyle in MS in addition to treatment as usual (TAU).
Intervention Type
Other
Intervention Name(s)
treatment as usual (TAU)
Intervention Description
treatment as usual (TAU)
Primary Outcome Measure Information:
Title
Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)
Description
The HALEMS measures MS-specific quality of life. It covers the following domains: fatigue, thinking, mobility lower limb, mobility upper limb, communication and mood. The total score is calculated as the average of the scores in the six domains and ranges from 1 to 5. Higher scores represent lower quality of life.
Time Frame
6 months after randomization
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
The PHQ-9 measures depressive symptoms. Each of the 9 items is answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (almost every day). The total score ranges from 0 to 27. Higher scores represent higher depressive symptoms.
Time Frame
3 and 6 months after randomization
Title
Work and Social Assessment Scale (WSAS)
Description
The WSAS measures an individual's perception of work and social functioning. It consists of 5 items that are answered on a 9-point Likert scale ranging from 0 (not at all impaired) to 8 (very severely impaired). The total score has a range of 0-40, with higher scores representing higher disability.
Time Frame
3 and 6 months after randomization
Title
Global index score of the Multiple Sclerosis International Quality of Life (MuSiQoL)
Description
The MuSiQoL measures MS-specific quality of life. It comprises 31 items covering 9 domains (activities of daily living, psychological well-being, symptoms, relationships with friends, relationships with family, relationships with the healthcare system, sentimental and sexual life, coping, and rejection). Each item is scored on a 6-point Likert scale. The score on each dimension is obtained by computing the mean of the item scores for that dimension. All dimension scores are linearly transformed to a 0-100 scale. The global index score is computed as the mean of the dimension scores. Higher scores represent higher quality of life.
Time Frame
3 and 6 months after randomization
Title
Generalized Anxiety Disorder Scale-7 (GAD-7)
Description
The GAD-7 is a 7-item self-report anxiety questionnaire. Items are rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score can range from 0 to 21, higher scores representing higher anxiety.
Time Frame
3 and 6 months after randomization
Title
Frenchay Activities Index (FAI)
Description
The FAI assesses participation in social and lifestyle activities with 15 items that are scored on a 4-point Likert scale ranging from 1 to 4. It covers three subdomains (domestic chores, outdoor, work/leisure activities). The total score ranges from 15 to 60. Higher scores represent more activity.
Time Frame
3 and 6 months after randomization
Title
Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)
Description
The HALEMS measures MS-specific quality of life. It covers the following domains: fatigue, thinking, mobility lower limb, mobility upper limb, communication and mood. The total score is calculated as the average of the scores in the six domains and ranges from 1 to 5. Higher scores represent lower quality of life.
Time Frame
3 months after randomization
Other Pre-specified Outcome Measures:
Title
HALEMS Subscales (cognition; fatigue; mobility lower limb; mobility upper limb; communication; and mood)
Description
The HALEMS measures MS-specific quality of life. It covers the following domains: fatigue, thinking, mobility lower limb, mobility upper limb, communication and mood. each domain score ranges from 1 to 5. Higher scores represent lower quality of life.
Time Frame
3 and 6 months after randomization
Title
Intake of disease-modifying drugs overall (last 3 months)
Time Frame
3 and 6 months after randomization
Title
Intake of DMDs classified according to efficacy (category 1-3, according to current German clinical guideline) (last 3 months)
Time Frame
3 and 6 months after randomization
Title
Number of days on sick leave/sick pay (last 3 months)
Time Frame
3 and 6 months after randomization
Title
Number of days in inpatient treatment (last 3 months)
Time Frame
3 and 6 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18
Impaired health-related quality of life (total score of the Hamburg Quality of Life Questionnaire for Multiple Sclerosis [HALEMS] ≥ 2)
Specialist treatment in the last three months before study inclusion
Diagnosis of MS (relevant ICD-10-GM diagnoses G35.x), confirmed by a medical document or equivalent certificate
Sufficient cognitive and motor skills to use an online program
Consent to participate
Sufficient knowledge of the German language
Access to the Internet
Exclusion Criteria:
Presence of severe impairment of independence or abilities (degree of care ["Pflegegrad", § 15 SGB XI] ≥ 3)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gitta A. Jacob, PhD
Phone
+4940349930374
Email
gitta.jacob@gaia-group.com
First Name & Middle Initial & Last Name or Official Title & Degree
Linda T. Betz, PhD
Email
linda.betz@gaia-group.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamila Jauch-Chara, MD
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
GAIA AG
City
Hamburg
ZIP/Postal Code
22085
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gitta A. Jacob, PhD
Email
gitta.jacob@gaia-group.com
First Name & Middle Initial & Last Name & Degree
Linda T. Betz, PhD
Email
linda.betz@gaia-group.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex)
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