Dataset Information

Reliability and acceptance of dreaMS, a software application for people with multiple sclerosis: a feasibility study.

ABSTRACT:

Background

There is an unmet need for reliable and sensitive measures for better monitoring people with multiple sclerosis (PwMS) to detect disease progression early and adapt therapeutic measures accordingly.

Objective

To assess reliability of extracted features and meaningfulness of 11 tests applied through a smartphone application ("dreaMS").

Methods

PwMS (age 18-70 and EDSS ≤ 6.5) and matched healthy volunteers (HV) were asked to perform tests installed on their smartphone once or twice weekly for 5 weeks. Primary outcomes were test-retest reliability of test features (target: intraclass correlation [ICC] ≥ 0.6 or median coefficient of variation [mCV] < 0.2) and reported meaningfulness of the tests by PwMS. Meaningfulness was self-assessed for each test on a 5-point Likert scale (target: mean score of > 3) and by a structured interview.

Clinicaltrials

gov Identifier: NCT04413032.

Results

We included 31 PwMS (21 [68%] female, mean age 43.4 ± 12.0 years, median EDSS 3.0 [range 1.0-6.0]) and 31 age- and sex-matched healthy volunteers. Out of 133 features extracted from 11 tests, 89 met the preset reliability criteria. All 11 tests were perceived as highly meaningful to PwMS.

Conclusion

The dreaMS app reliably assessed features reflecting key functional domains meaningful to PwMS. More studies with longer follow-up are needed to prove validity of these measures as digital biomarkers in PwMS.

SUBMITTER: Woelfle T

PROVIDER: S-EPMC9427170 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Reliability and acceptance of dreaMS, a software application for people with multiple sclerosis: a feasibility study.

Woelfle Tim T Pless Silvan S Reyes Oscar O Wiencierz Andrea A Feinstein Anthony A Calabrese Pasquale P Gugleta Konstantin K Kappos Ludwig L Lorscheider Johannes J Naegelin Yvonne Y

Journal of neurology 20220830 1

<h4>Background</h4>There is an unmet need for reliable and sensitive measures for better monitoring people with multiple sclerosis (PwMS) to detect disease progression early and adapt therapeutic measures accordingly.<h4>Objective</h4>To assess reliability of extracted features and meaningfulness of 11 tests applied through a smartphone application ("dreaMS").<h4>Methods</h4>PwMS (age 18-70 and EDSS ≤ 6.5) and matched healthy volunteers (HV) were asked to perform tests installed on their smartph ...[more]

PMID: 36042020

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Project description:BackgroundMotor imagery (MI) is increasingly used in neurorehabilitation to facilitate motor performance. Our previous study results demonstrated significantly improved walking after rhythmic-cued MI in people with multiple sclerosis (pwMS). The present feasibility study was aimed to obtain preliminary information of changes in walking, fatigue, quality of life (QoL) and MI ability following cued and non-cued MI in pwMS. The study further investigated the feasibility of a larger study and examined the reliability of a two-dimensional gait analysis system.MethodsAt the MS-Clinic, Department of Neurology, Medical University of Innsbruck, Austria, 15 adult pwMS (1.5-4.5 on the Expanded Disability Status Scale, 13 females) were randomised to one of three groups: 24 sessions of 17 min of MI with music and verbal cueing (MVMI), with music alone (MMI), or non-cued (MI). Descriptive statistics were reported for all outcomes. Primary outcomes were walking speed (Timed 25-Foot Walk) and walking distance (6-Minute Walk Test). Secondary outcomes were recruitment rate, retention, adherence, acceptability, adverse events, MI ability (Kinaesthetic and Visual Imagery Questionnaire, Time-Dependent MI test), fatigue (Modified Fatigue Impact Scale) and QoL (Multiple Sclerosis Impact Scale-29). The reliability of a gait analysis system used to assess gait synchronisation with music beat was tested.ResultsParticipants showed adequate MI abilities. Post-intervention, improvements in walking speed, walking distance, fatigue, QoL and MI ability were observed in all groups. Success of the feasibility criteria was demonstrated by recruitment and retention rates of 8.6% (95% confidence interval, CI 5.2, 13.8%) and 100% (95% CI 76.4, 100%), which exceeded the target rates of 5.7% and 80%. Additionally, the 83% (95% CI 0.42, 0.99) adherence rate surpassed the 67% target rate. Intra-rater reliability analysis of the gait measurement instruments demonstrated excellent Intra-Class Correlation coefficients for step length of 0.978 (95% CI 0.973, 0.982) and step time of 0.880 (95% CI 0.855, 0.902).ConclusionResults from our study suggest that cued and non-cued MI are valuable interventions in pwMS who were able to imagine movements. A larger study appears feasible, however, substantial improvements to the methods are required such as stratified randomisation using a computer-generated sequence and blinding of the assessors.Trial registrationISRCTN ISRCTN92351899. Registered 10 December 2015.

Project description:BACKGROUND:Mobile health (mHealth) apps might have the potential to promote self-management of people with multiple sclerosis (MS) in everyday life. However, the uptake of MS apps remains poor, and little is known about the facilitators and barriers for their efficient utilization, such as technology acceptance. OBJECTIVE:The aim of this study was to examine the acceptance of mHealth apps for disease management in the sense of behavioral intentions to use and explore determinants of utilization among people with MS based on the Unified Theory of Acceptance and Use of Technology (UTAUT). METHODS:Participants for this Web-based cross-sectional study were recruited throughout Germany with the support of regional MS associations and self-help groups. To identify determinants of intention to use MS apps, a measure based on the UTAUT was adapted with 4 key determinants (performance expectancy, effort expectancy, social influence, and facilitating conditions) and extended by Intolerance of Uncertainty (IU) and electronic health literacy. Potential influencing effects of both MS and computer self-efficacy (C-SE) as mediators and fatigue as a moderator were analyzed using Hayes's PROCESS macro (SPSS version 3.0) for IBM SPSS version 24.0. RESULTS:A total of 98 participants (mean age 47.03 years, SD 10.17; 66/98, 67% female) with moderate fatigue levels completed the survey. Although most participants (91/98, 92%) were daily smartphone users, almost two-thirds (62/98, 63%) reported no experience with MS apps. Overall, the acceptance was moderate on average (mean 3.11, SD 1.31, minimum=1 and maximum=5), with lower scores among persons with no experience (P=.04) and higher scores among current users (P<.001). In multiple regression analysis (R2=63% variance explained), performance expectancy (beta=.41) and social influence (beta=.33) were identified as significant predictors of acceptance (all P<.001). C-SE was confirmed as a partial mediator in the relationship between IU and acceptance (indirect effect: B=-.095, 95% CI -0.227 to -0.01). Furthermore, a moderated mediation by C-SE was shown in the relationship between IU and behavioral intentions to use MS apps for low (95% CI -0.42 to -0.01) and moderate levels (95% CI -0.27 to -0.01) of fatigue. CONCLUSIONS:Overall, this exploratory pilot study indicates for the first time that positive expectations about the helpfulness for self-management purposes and social support might be important factors to be considered for improving the acceptance of MS apps among smartphone users with MS. However, given some inconsistent findings, especially regarding the role of effort expectancy and IU and self-efficacy, the conceptual model needs replication with a larger sample of people with MS, varying more in fatigue levels, and a longitudinal assessment of the actual usage of MS apps predicted by acceptance in the sense of behavioral intentions to use.

Project description:Physical activity and exercise are effective approaches in prevention and therapy of multiple diseases. Although the specific characteristics of lengthening contractions have the potential to be beneficial in many clinical conditions, eccentric training is not commonly used in clinical populations with metabolic, orthopaedic, or neurologic conditions. The purpose of this pilot study is to investigate the feasibility, functional benefits, and systemic responses of an eccentric exercise program focused on the trunk and lower extremities in people with low back pain (LBP) and multiple sclerosis (MS). A six-week eccentric training program with three weekly sessions is performed by people with LBP and MS. The program consists of ten exercises addressing strength of the trunk and lower extremities. The study follows a four-group design (N = 12 per group) in two study centers (Israel and Germany): three groups perform the eccentric training program: A) control group (healthy, asymptomatic); B) people with LBP; C) people with MS; group D (people with MS) receives standard care physiotherapy. Baseline measurements are conducted before first training, post-measurement takes place after the last session both comprise blood sampling, self-reported questionnaires, mobility, balance, and strength testing. The feasibility of the eccentric training program will be evaluated using quantitative and qualitative measures related to the study process, compliance and adherence, safety, and overall program assessment. For preliminary assessment of potential intervention effects, surrogate parameters related to mobility, postural control, muscle strength and systemic effects are assessed. The presented study will add knowledge regarding safety, feasibility, and initial effects of eccentric training in people with orthopaedic and neurological conditions. The simple exercises, that are easily modifiable in complexity and intensity, are likely beneficial to other populations. Thus, multiple applications and implementation pathways for the herein presented training program are conceivable. Trial registration: DRKS00020483 (DRKS, German Clinical Trials Register; 24th January 2020 -retrospectively registered; https://www.drks.de/DRKS00020483).

Project description:IntroductionSelf-administered in-home digital therapeutics could expand access to cognitive rehabilitation for individuals with multiple sclerosis (MS), over half of whom experience cognitive impairment (CI). However, feasibility in an MS population must be clarified. This study was conducted to assess the feasibility of deploying a videogame-like digital treatment for CI in MS, including initial efficacy and barriers to adherence.MethodsIn this pilot study, 21 participants with MS completed an in-clinic baseline neurological evaluation. Cognitive tests included paper-and-pencil Brief International Cognitive Assessment for Multiple Sclerosis [BICAMS-which included the Symbol Digit Modalities Test (SDMT)] and other unsupervised tablet-based tests (including Match: an unsupervised test of executive functions and processing speed, developed at UCSF; and the Cogstate MS Battery). Participants then completed an in-home, tablet-based, videogame-like investigational digital treatment (Project: EVO™) for 25 min daily, 5 days weekly, for 4 weeks. This was followed by a repeat in-clinic evaluation.ResultsOf the 21 participants (mean [standard deviation, SD] age 53.8 [11.6] years, median Expanded Disability Status Scale (EDSS) 2.5 [SD 2.0, IQR [2-3.5]]) enrolled to use the digital therapeutic at home (mean [SD] SDMT z score: - 0.21 [1.16]), 18 completed the study, during which they completed an average of 19.7 days (median [SD]: 20.5 [8.4]). Overall, 78% of these 18 participants completed 75% of prescribed days (i.e., at least 15), and 50% completed all 20 days or more. Over the 4-week period, scores of processing speed improved significantly (based on one-sided t test), including SDMT (p = 0.003) and Match (p = 0.006). The Cogstate DET test (psychomotor function) also increased (p = 0.006). Mean increase in SDMT was 3.6 points. Male sex, not being employed, and higher baseline anxiety all were significantly associated with greater improvement in SDMT over the 4-week period. Interestingly, lower baseline cognitive scores were associated with greater number of sessions completed (e.g., SDMT: p = 0.003, R2 = 0.44). Adjusting for employment, a proxy for time available, did not significantly improve the model fit.DiscussionDeploying an in-home digital tool to improve processing speed in MS is feasible, and shows preliminary efficacy. A larger, randomized controlled clinical trial is ongoing.

Project description:BackgroundMultiple sclerosis (MS) is a stressful condition. Mental health comorbidity is common. Stress can increase the risk of depression, reduce quality of life (QOL), and possibly exacerbate disease activity in MS. Mindfulness-Based Stress Reduction (MBSR) may help, but has been little studied in MS, particularly among more disabled individuals.MethodsThe objective of this study was to test the feasibility and likely effectiveness of a standard MBSR course for people with MS. Participant eligibility included: age > 18, any type of MS, an Expanded Disability Status Scale (EDSS) </= 7.0. Participants received either MBSR or wait-list control. Outcome measures were collected at baseline, post-intervention, and three-months later. Primary outcomes were perceived stress and QOL. Secondary outcomes were common MS symptoms, mindfulness, and self-compassion.ResultsFifty participants were recruited and randomised (25 per group). Trial retention and outcome measure completion rates were 90% at post-intervention, and 88% at 3 months. Sixty percent of participants completed the course. Immediately post-MBSR, perceived stress improved with a large effect size (ES 0.93; p < 0.01), compared to very small beneficial effects on QOL (ES 0.17; p = 0.48). Depression (ES 1.35; p < 0.05), positive affect (ES 0.87; p = 0.13), anxiety (ES 0.85; p = 0.05), and self-compassion (ES 0.80; p < 0.01) also improved with large effect sizes. At three-months post-MBSR (study endpoint) improvements in perceived stress were diminished to a small effect size (ES 0.26; p = 0.39), were negligible for QOL (ES 0.08; p = 0.71), but were large for mindfulness (ES 1.13; p < 0.001), positive affect (ES 0.90; p = 0.54), self-compassion (ES 0.83; p < 0.05), anxiety (ES 0.82; p = 0.15), and prospective memory (ES 0.81; p < 0.05).ConclusionsRecruitment, retention, and data collection demonstrate that a RCT of MBSR is feasible for people with MS. Trends towards improved outcomes suggest that a larger definitive RCT may be warranted. However, optimisation changes may be required to render more stable the beneficial treatment effects on stress and depression.Trial registrationClinicalTrials.gov Identifier NCT02136485 ; trial registered 1st May 2014.

Dataset Information

Reliability and acceptance of dreaMS, a software application for people with multiple sclerosis: a feasibility study.

Background

Objective

Methods

Clinicaltrials

Results

Conclusion

Publications

Reliability and acceptance of dreaMS, a software application for people with multiple sclerosis: a feasibility study.

Similar Datasets

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