Dataset Information

The Feasibility of a Web-Based Educational Lifestyle Program for People With Multiple Sclerosis: A Randomized Controlled Trial.

ABSTRACT:

Background

Modifiable lifestyle factors are important to aid people with multiple sclerosis in the self-management of their disease. Current self-management programs are limited by their face-to-face mode of delivery but there is immense potential with the internet to deliver these programs effectively.

Objective

The aims of this study are to assess the feasibility of a digitalized educational lifestyle self-management program for people with MS.

Methods

In this randomized controlled trial, people with MS were randomly allocated to participate in a 6-week tailored web-based educational lifestyle program or 6-week generic standard-care educational course, and were blinded to their allocation. Participants were recruited through multiple sclerosis (MS) Societies in four countries: Australia, New Zealand, Canada, and the United States. The primary outcome was to assess acceptability of the program defined as percentage completion of all modules at 6-weeks post-course commencement. Secondary outcomes included evaluating participant responses to the follow-up survey across three domains: accessibility, learnability, and desirability.

Results

Thirty-five participants from Australia, Canada, New Zealand, and the US completed the baseline survey and were randomized. Four participants were deemed ineligible due to incomplete baseline data; therefore, nine out of 15 and eight out of 16 participants completed 100% of the course in the intervention and standard-care arm courses, respectively.

Conclusions

This study found that this web-based educational lifestyle program is a feasible means of delivering educational content to people with MS via the internet according to our a priori targets of >40% of participants in the intervention arm, and >25% in the control arm to completing 100% of the course. It is therefore appropriate to evaluate this intervention further in a large, randomized controlled trial.

Trial registration

This study was prospectively registered with the Australian New Zealand Clinical Trials Registry (ID: ACTRN12621000245897).

SUBMITTER: Bevens W

PROVIDER: S-EPMC9092338 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The Feasibility of a Web-Based Educational Lifestyle Program for People With Multiple Sclerosis: A Randomized Controlled Trial.

Bevens William W Weiland Tracey J TJ Gray Kathleen K Neate Sandra L SL Nag Nupur N Simpson-Yap Steve S Reece Jeanette J Yu Maggie M Jelinek George A GA

Frontiers in public health 20220427

<h4>Background</h4>Modifiable lifestyle factors are important to aid people with multiple sclerosis in the self-management of their disease. Current self-management programs are limited by their face-to-face mode of delivery but there is immense potential with the internet to deliver these programs effectively.<h4>Objective</h4>The aims of this study are to assess the feasibility of a digitalized educational lifestyle self-management program for people with MS.<h4>Methods</h4>In this randomized ...[more]

PMID: 35570898

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Project description:BackgroundDigital health interventions increase access to multiple sclerosis (MS)-related knowledge for people living with MS; however, our understanding of factors associated with engagement in web-based learning is limited.ObjectiveThis study aims to examine associations between participant sociodemographic, health, and lifestyle-related characteristics and the commencement and completion of the Multiple Sclerosis Online Course (MSOC) in a randomized controlled trial (RCT).MethodsAn intervention course was developed based on the Overcoming MS Program-an evidence-based lifestyle modification program for MS, and a standard care course was developed based on international MS website information. An RCT was conducted to compare the effectiveness of the intervention course versus the standard care course in improving health outcomes in people living with MS. Participant data were collected from a baseline survey. Associations between baseline participant characteristics and MSOC commencement and completion, respectively, were assessed using multivariate log-binomial regression.ResultsOverall, 1893 participants enrolled in the RCT, and 45.27% (n=857) completed the baseline survey: 23.5% (n=444) in the intervention course and 21.8% (n=413) in the standard care course. Of these 857 participants, 631 (73.6%) commenced the standard care course or intervention course, and 49.1% (218/444) and 54.2% (224/413) completed the intervention course and standard care course, respectively. University education, partnered relationship status, and higher mental and physical quality of life were associated with 19%, 12%, 20%, and 22% higher rates of course commencement, respectively. Clinically significant fatigue was associated with a 10% reduction in the likelihood of commencement. Strongest associations with intervention course completion included middle and older adulthood, male sex, fatigue, and preexisting adherence to a diet program, with 96%, 27%, 24%, and 19% higher rates of completion observed, respectively, whereas higher self-efficacy was associated with up to 35% lower intervention course completion. Associations with standard care course completion included practicing meditation (20% higher completion), whereas employment was associated with 22% lower completion.ConclusionsSociodemographic and clinical factors, as well as lifestyle-related factors, were important factors in MSOC commencement and completion. These data may help guide the design and enhancement of digital health interventions tailored for people living with MS.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12621001605886; https://tinyurl.com/2vyve9p9.International registered report identifier (irrid)RR2-10.1186/s12883-023-03298-0.

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.

Project description:BackgroundWeb-based computer-tailored interventions for multiple health behaviors can improve the strength of behavior habits in people who want to reduce their cardiovascular risk. Nonetheless, few randomized controlled trials have tested this assumption to date.ObjectiveThe study aim was to test an 8-week Web-based computer-tailored intervention designed to improve habit strength for physical activity and fruit and vegetable consumption among people who want to reduce their cardiovascular risk. In a randomized controlled design, self-reported changes in perceived habit strength, self-efficacy, and planning across different domains of physical activity as well as fruit and vegetable consumption were evaluated.MethodsThis study was a randomized controlled trial involving an intervention group (n=403) and a waiting control group (n=387). Web-based data collection was performed in Germany and the Netherlands during 2013-2015. The intervention content was based on the Health Action Process Approach and involved personalized feedback on lifestyle behaviors, which indicated whether participants complied with behavioral guidelines for physical activity and fruit and vegetable consumption. There were three Web-based assessments: baseline (T0, N=790), a posttest 8 weeks after the baseline (T1, n=206), and a follow-up 3 months after the baseline (T2, n=121). Data analysis was conducted by analyzing variances and structural equation analysis.ResultsSignificant group by time interactions revealed superior treatment effects for the intervention group, with substantially higher increases in self-reported habit strength for physical activity (F1,199=7.71, P=.006, Cohen's d=0.37) and fruit and vegetable consumption (F1,199=7.71, P=.006, Cohen's d=0.30) at posttest T1 for the intervention group. Mediation analyses yielded behavior-specific sequential mediator effects for T1 planning and T1 self-efficacy between the intervention and habit strength at follow-up T2 (fruit and vegetable consumption: beta=0.12, 95% CI 0.09-0.16, P<.001; physical activity: beta=0.04, 95% CI 0.02-0.06, P<.001).ConclusionsOur findings indicate the general effectiveness and practicality of Web-based computer-tailored interventions in terms of increasing self-reported habit strength for physical activity and fruit and vegetable consumption. Self-efficacy and planning may play major roles in the mechanisms that facilitate the habit strength of these behaviors; therefore, they should be actively promoted in Web-based interventions. Although the results need to take into account the high dropout rates and medium effect sizes, a large number of people were reached and changes in habit strength were achieved after 3 months.Trial registrationClinicaltrials.gov NCT01909349; https://clinicaltrials.gov/ct2/show/NCT01909349 (Archived by WebCite at http://www.webcitation.org/6g5F0qoft) and Nederlands Trial Register NTR3706 http://www.trialregister.nl/ trialreg/admin/rctview.asp?TC=3706 (Archived by WebCite at http://www.webcitation.org/6g5F5HMLX).

Project description:BackgroundMultiple Sclerosis (MS) is a chronic inflammatory neurodegenerative disease with diverse symptomatology, significantly impacting patients' quality of life (QoL). While pharmacological therapies focus primarily on reducing inflammation and relapse rates, non-pharmacological interventions, including digital health applications, have shown promise in improving QoL among persons with MS (PwMS). Pilot studies had shown the feasibility and acceptability of levidex, a digital health application based on cognitive behavioral therapy (CBT) principles, a broad set of behavior change techniques, and relevant lifestyle-change advice. This randomized controlled trial aimed to examine the effects of levidex on MS-related QoL over 6 months.MethodsParticipants who were diagnosed with MS for at least one year were recruited via the internet in Germany, using a secure survey software platform, and were randomly assigned to the intervention group (IG), in which they received standard care + levidex, or an active control group (CG), in which they received standard care and were offered web-adapted material on the topic of lifestyle change from the German Multiple Sclerosis Society (DMSG). The primary outcome was MS-related QoL after 6 months, measured by the Hamburg Quality of Life Questionnaire in MS (HAQUAMS); secondary outcomes included QoL subscales, sick days, and health behavior, among others. Analyses of Covariance (ANCOVA) were used to examine intervention effects at 6 months. Participants were recruited between November 2020 and February 2022.ResultsA total of 421 adult participants (mean age: 47.5, 78.1% women) were included and randomized (IG, n = 195, CG, n = 226). After 6 months, the IG exhibited significantly higher MS-related QoL, compared to the CG (total score HAQUAMS, adjusted group mean difference = -0.14, 95% CI: [-0.22, -0.06], p = 0.001; Cohen's d = 0.23), with significant effects also observed on the cognitive and mood subscales. At 6 months, IG participants also reported significantly fewer sick days (median = 2 days in IG vs. 6 days in CG; W = 3939, p = 0.012) and significantly higher levels of daily activities, as measured by the Frenchay Activity Index, adjusted group mean difference = 1.37, 95% CI = [0.33, 2.40], p = 0.010; Cohen's d = 0.16. Safety analyses showed no adverse events and good satisfaction.ConclusionsCompared to the control group, levidex facilitated clinically relevant improvements in MS-related QoL, reduced sick days, and enhanced activity in PwMS over 6 months. These findings suggest that levidex can serve as an effective non-pharmacological adjunctive treatment element to standard care and could help improve QoL among PwMS.Trial registrationRegistered on 22.09.2020 at the German Clinical Trials Register DRKS00023023.

Dataset Information

The Feasibility of a Web-Based Educational Lifestyle Program for People With Multiple Sclerosis: A Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

Publications

The Feasibility of a Web-Based Educational Lifestyle Program for People With Multiple Sclerosis: A Randomized Controlled Trial.

Similar Datasets

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