Digital Lifemodel App Levidex Fails to Meet Major Finish Level for Early MS in POWER@MS1 Trial

Nicole Krause, PhD

(Credit: University Medical Center Hamburg–Eppendorf)

Newly printed findings from the randomized managed POWER@MS1 trial (NCT03968172) assessing Levidex confirmed that the cognitive behavioral therapy-based, personalised digital utility didn’t differ from a nonpersonalized psychoeducational utility “dexilev” in its results on inflammatory illness exercise in newly recognized sufferers with a number of sclerosis (MS). Overall, use of this personalised life-style app failed to satisfy its mixed major finish level of T2 lesions and new relapses.¹

Among 234 sufferers with MS within the examine, researchers reported no distinction between the intervention group (IG; n = 115) and management group (CG; n = 119) within the time to the primary relapse and/or new T2 lesion (ITT evaluation, HR, 0.91; 95% CI, 0.66-1.27; P = .596). Over the follow-up interval, authors famous a median of two.3 (SD, 4.4) new T2 lesions within the IG vs 2.2 (SD, 4.4) new T2 lesions within the CG. Additionally, there have been no between-group variations amongst untreated sufferers with MS (HR, 1.08; 95% CI, 0.64-1.82; P = .78) and extremely adherent individuals (HR, 1.25 95% CI, 0.82-1.92; P = .298).

“This pragmatic RCT did not meet its ambitious primary end point. Additional personal support might induce more pronounced behavior change and possibly have a greater impact on MS disease activity, but such potential advantages remain to be demonstrated, and they must be weighed against the higher costs and limited scalability of person-delivered treatments, compared to fully automated digital interventions,” lead creator Nicole Krause, PhD, public well being scientist in Department of Neurology at University Medical Center Hamburg–Eppendorf, and colleagues wrote.¹ “Nevertheless, the study shows that close clinical and MRI follow-up in the first years after diagnosis and extensive lifestyle information is appreciated and adhered to by people recently diagnosed with MS.”

The trial enrolled individuals between July 2019 to April 2022 from 20 examine facilities in Germany and adopted up till April 2023. Neurologists decided bodily impairment of the individuals utilizing the Expanded Disability Status Scale (EDSS).² Researchers analyzed that mixed major endpoint, new T2 lesion and/or relapse, utilizing Cox proportional hazards regression. Key secondary finish factors of the trial included self-reported high quality of life (QoL), measured by Hamburg Quality of Life in MS Scale (HAQUAMS)³, and well being habits, measured by the Hospital Anxiety and Depression Scale (HADS).

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Out of the entire variety of randomized sufferers with MS from the examine, 90% accomplished follow-up surveys (n = 211). Even although the core examine interval was 12 months, researchers invited early recruited individuals to stay within the examine. The examine excluded 1 participant from major consequence analyses due to lacking MRI knowledge following randomization.

All advised, individuals within the IG with entry to levidex perceived this system as extra convincing (OR, 2.80; 95% CI, 1.64-4.76; P <.001), had a better expectation relating to a optimistic impact on their situation (OR, 2.72; 95% CI, 1.57-4.71, P <.001) and have been extra prone to suggest this system to a buddy with comparable issues (OR, 4.70; 95% CI, 2.46-8.97; P <.001) in contrast with CG individuals at 4 weeks. At 3-months put up randomization, authors famous that danger information was increased within the CG (HR, −0.52; 95% CI, −0.93 to −0.10; P = .015); nevertheless, the distinction of 4.2 versus 4.7 factors out of 10 was marginal. In addition, food regimen high quality was reported increased within the IG 3 months put up randomization in contrast with these within the CG (HR, 0.43; 95% CI, 0.14-0.72; P = .004).

In subgroup analyses, individuals with decrease QoL (HAQUAMS rating at the very least 2; HR, 1.02; 95% CI, 0.54- 1.92; P = .96), increased bodily impairment (EDSS at the very least 2; HR, 0.9; 95% CI, 0.47-1.72; P = .75) and average to extreme signs of tension (HADS-A, rating 8–17; HR, 0.97; 95%-CI, 0.54-1.73; P = .91) or melancholy (HADS-D, rating 8–16; HR, 0.25; 95% CI, 0.06-1.05; P = .06) displayed no impact on the first finish level. Combining all cut-offs, authors detected no impact on the first finish level (HR, 1.06; 95% CI, 0.68-1.64; P = .81). In phrases of security, no adversarial occasions or harms, past psychological affect, have been anticipated and reported throughout examine conduct.

REFERENCES
1. Krause N, Derad C, von Glasenapp B, et al. Digital life-style administration utility (levidex) for empowerment and well being behaviour change in early a number of sclerosis – Results of the randomised managed POWER@MS1 trial. Mult Scler. Published on-line August 12, 2025. doi:10.1177/13524585251356410
2. Kurtzke JF. Rating neurologic impairment in a number of sclerosis: an expanded incapacity standing scale (EDSS). Neurology. 1983;33(11):1444-1452. doi:10.1212/wnl.33.11.1444
3. Gold SM, Heesen C, Schulz H, et al. Disease particular high quality of life devices in a number of sclerosis: validation of the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS). Mult Scler. 2001;7(2):119-130. doi:10.1177/135245850100700208
4. Zigmond AS, Snaith RP. The hospital anxiousness and melancholy scale. Acta Psychiatr Scand. 1983;67(6):361-370. doi:10.1111/j.1600-0447.1983.tb09716.x