Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex)

Multiple Sclerosis Clinical Trial

— LAMONT  

Official title:

Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex): Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090305
• Other study ID #: levidex RCT 2023
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2024
• Source: Gaia AG
• Contact: Gitta A. Jacob, PhD
• Phone: +4940349930374
• Email: gitta.jacob[@]gaia-group.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• levidex
Participants will receive access to the digital health application levidex in addition to treatment as usual (TAU).
• Control
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).

Other:
• treatment as usual (TAU)
treatment as usual (TAU)

Locations

Country	Name	City	State
Germany	GAIA AG	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Gaia AG	Universität Duisburg-Essen, University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HALEMS Subscales (cognition; fatigue; mobility lower limb; mobility upper limb; communication; and mood)	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.	3 and 6 months after randomization
Other	Intake of disease-modifying drugs overall (last 3 months)		3 and 6 months after randomization
Other	Intake of DMDs classified according to efficacy (category 1-3, according to current German clinical guideline) (last 3 months)		3 and 6 months after randomization
Other	Number of days on sick leave/sick pay (last 3 months)		3 and 6 months after randomization
Other	Number of days in inpatient treatment (last 3 months)		3 and 6 months after randomization
Primary	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.	6 months after randomization
Secondary	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.	3 and 6 months after randomization
Secondary	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.	3 and 6 months after randomization
Secondary	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.	3 and 6 months after randomization
Secondary	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.	3 and 6 months after randomization
Secondary	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.	3 and 6 months after randomization
Secondary	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.	3 months after randomization