Potentials and barriers of using digital tools for collecting daily measurements in multiple sclerosis research

Objective Digital tools offer new ways of collecting outcome data in intervention research. Little is known about the potentials and barriers of using such tools for outcome measurement in multiple sclerosis trials. This study aimed to examine reporting adherence and barriers experienced by people with multiple sclerosis in an intervention study using three different digital tools for outcome measurement. Methods This was a mixed-methods study conducted in the context of a randomized controlled trial. Data collected during the randomized controlled trial were analysed to assess reporting adherence. Twenty-three semi-structured, in-depth interviews were conducted to investigate randomized controlled trial participants’ experiences. Results Reporting adherence was high for all three measurement tools, but lower in the control group. Four main barriers were defined: (1) the self-monitoring aspect and repeated tests imbedded in the digital tools affected participants’ behavior during the randomized controlled trial. (2) Self-monitoring caused some participants to worry more about their health. (3) Passively collected data did not always correspond with participants’ own experiences, which caused them to question the validity of the collected data. (4) Daily reporting using different digital tools placed a significant burden on participants. Conclusion The study indicates a high reporting adherence using digital tools among people with multiple sclerosis. However, future studies should carefully consider the overall burden imposed on participants when taking this approach. Measures should be taken to avoid the potential unintended effects of the self-monitoring and gamification aspects of using digital tools. These measures could include passive monitoring, reducing the frequency of reporting and blinding participants to their own data.

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Effectiveness of a Dyadic Buddy App for Smoking Cessation: Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/27162 ◽

2021 ◽

Vol 23 (9) ◽

pp. e27162

Author(s):

Philipp Schwaninger ◽

Corina Berli ◽

Urte Scholz ◽

Janina Lüscher

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Controlled Trial ◽

Intervention Group ◽

The Self ◽

Daily Smoking ◽

Control Group ◽

Smoking Abstinence ◽

Self Monitoring ◽

Randomized Controlled

Background Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (buddy) in daily life. Objective The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. Methods A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. Results A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. Conclusions Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. Trial Registration ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7723-z

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Effectiveness of a Dyadic Buddy App for Smoking Cessation: Randomized Controlled Trial (Preprint)

10.2196/preprints.27162 ◽

2021 ◽

Author(s):

Philipp Schwaninger ◽

Corina Berli ◽

Urte Scholz ◽

Janina Lüscher

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Controlled Trial ◽

Intervention Group ◽

The Self ◽

Daily Smoking ◽

Control Group ◽

Smoking Abstinence ◽

Self Monitoring ◽

Randomized Controlled

BACKGROUND Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (<i>buddy</i>) in daily life. OBJECTIVE The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. METHODS A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. RESULTS A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. CONCLUSIONS Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. CLINICALTRIAL ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-019-7723-z

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Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

10.21203/rs.3.rs-16509/v4 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

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Efficacy of Guizhi Fuling Wan for primary dysmenorrhea: protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05834-0 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Yun Du ◽

Yatong Li ◽

Xianyun Fu ◽

Chenjie Li ◽

Lou Yanan

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Blood Stasis ◽

The Self ◽

Blood Stasis Syndrome ◽

Control Group ◽

Primary Dysmenorrhea ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Self Rating

Abstract Background Primary dysmenorrhea (PD) is one of the main gynecological complaints in women of child-bearing age, but limited effective treatments are available. Guizhi Fuling Wan (GFW), one of the most widely known traditional Chinese medicine (TCM) formulations, has been commonly used in clinical practice to treat gynecological disorders in China. In recent years, a growing number of studies have shown that GFW is beneficial for patients with PD. However, the quality of evidence is limited, and there are few studies on specific TCM syndromes of GFW for PD. Therefore, we plan to conduct a randomized controlled trial to explore the efficacy and safety of GFW for PD patients with heat-burning blood-stasis syndrome. Methods and analysis The clinical study is a randomized, double-blinded, placebo-controlled trial. Eligible patients will be randomly assigned to the GFW group (treated with GFW) and the control group (treated with a matching placebo) in a 1:1 ratio for three menstrual cycles with a 3-month follow-up. The primary outcome will be the mean change of pain intensity measured by the visual analog scale (VAS). The secondary outcomes will include the Cox Menstrual Symptom Scale (CMSS), the Self-rating Depression Scale (SDS), the Self-rating Anxiety Scale (SAS), and the TCM syndrome scale. Adverse events will also be reported. Discussion This randomized trial will be the first rigorous study designed to assess the efficacy and safety of GFW in treating PD with heat-burning blood-stasis syndrome. The finding of this study will provide an objective clinical basis for the use of GFW for PD in the future. Trial registration Chinese Clinical Trial Registry ChiCTR2000034118. Registered on 24 June 2020

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Free From Falls education and exercise program for reducing falls in people with multiple sclerosis: A randomized controlled trial

Multiple Sclerosis Journal ◽

10.1177/13524585211046898 ◽

2021 ◽

pp. 135245852110468

Author(s):

Michelle H Cameron ◽

Andrea Hildebrand ◽

Cinda L Hugos ◽

Grace I Judd ◽

Garnett McMillan ◽

...

Keyword(s):

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Exercise Program ◽

Control Group ◽

Post Intervention ◽

Randomized Controlled ◽

Credible Intervals ◽

Falls In Older Adults ◽

The Impact

Background: People with multiple sclerosis (PwMS) fall frequently. Community-delivered exercise and education reduce falls in older adults, but their efficacy in multiple sclerosis (MS) is unknown. Objectives: To evaluate the impact of the Free From Falls (FFF) group education and exercise program on falls in PwMS. Methods: This was a prospective, assessor-blinded, two-arm parallel randomized controlled trial. Ninety-six participants were randomized to FFF (eight weekly 2 hour sessions) or the control condition (a fall prevention brochure and informing their neurologist of their fall history). Participants counted falls prospectively from enrollment through 6 months following intervention. Effects on fall frequency were evaluated by the Bayesian analysis. Results: The modeled mean fall frequency pre-intervention was 1.2 falls/month in the FFF group (95% credible intervals (CIs) = 0.8–2.0) and 1.4 falls/month in the control group (95% CI = 0.9–2.1). Fall frequency decreased by 0.6 falls/month in both groups over time (nadir 4–6 months post-intervention: FFF 0.6 falls/month (95% CI = 0.4–0.9); control 0.8 falls/month (95% CI = 0.5–1.1)). Conclusion: In-person group exercise and education are not superior to written education and neurologist-initiated interventions for preventing falls in PwMS.

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Effects of momentary self-monitoring on empowerment in a randomized controlled trial in patients with depression

European Psychiatry ◽

10.1016/j.eurpsy.2015.09.004 ◽

2015 ◽

Vol 30 (8) ◽

pp. 900-906 ◽

Cited By ~ 16

Author(s):

C.J.P. Simons ◽

J.A. Hartmann ◽

I. Kramer ◽

C. Menne-Lothmann ◽

P. Höhn ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Group Treatment ◽

Antidepressant Treatment ◽

Controlled Trial ◽

Self Report ◽

Control Group ◽

Self Monitoring ◽

Randomized Controlled ◽

Experimental Group ◽

Reliable Increase

AbstractBackgroundInterventions based on the experience sampling method (ESM) are ideally suited to provide insight into personal, contextualized affective patterns in the flow of daily life. Recently, we showed that an ESM-intervention focusing on positive affect was associated with a decrease in symptoms in patients with depression. The aim of the present study was to examine whether ESM-intervention increased patient empowerment.MethodsDepressed out-patients (n = 102) receiving psychopharmacological treatment who had participated in a randomized controlled trial with three arms: (i) an experimental group receiving six weeks of ESM self-monitoring combined with weekly feedback sessions, (ii) a pseudo-experimental group participating in six weeks of ESM self-monitoring without feedback, and (iii) a control group (treatment as usual only). Patients were recruited in the Netherlands between January 2010 and February 2012. Self-report empowerment scores were obtained pre- and post-intervention.ResultsThere was an effect of group × assessment period, indicating that the experimental (B = 7.26, P = 0.061, d = 0.44, statistically imprecise) and pseudo-experimental group (B = 11.19, P = 0.003, d = 0.76) increased more in reported empowerment compared to the control group. In the pseudo-experimental group, 29% of the participants showed a statistically reliable increase in empowerment score and 0% reliable decrease compared to 17% reliable increase and 21% reliable decrease in the control group. The experimental group showed 19% reliable increase and 4% reliable decrease.ConclusionsThese findings tentatively suggest that self-monitoring to complement standard antidepressant treatment may increase patients’ feelings of empowerment. Further research is necessary to investigate long-term empowering effects of self-monitoring in combination with person-tailored feedback.

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Short group psychoeducation followed by daily electronic self-monitoring in the long-term treatment of bipolar disorders: a multicenter, rater-blind, randomized controlled trial

International Journal of Bipolar Disorders ◽

10.1186/s40345-019-0158-8 ◽

2019 ◽

Vol 7 (1) ◽

Author(s):

Johannes Petzold ◽

René Mayer-Pelinski ◽

Maximilian Pilhatsch ◽

Susan Luthe ◽

Thomas Barth ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Bipolar Disorders ◽

Control Group ◽

Self Monitoring ◽

Randomized Controlled ◽

Long Term Treatment ◽

Group Psychoeducation ◽

Computer Based ◽

Group Sessions

Abstract Background Despite various pharmacological and psychological treatment interventions, bipolar disorders rank among the leading causes of global disease burden. Group psychoeducation has been demonstrated an effective add-on to pharmacotherapy, but it may be difficult to implement in practice depending on the clinical setting and available human resources. Methods Multicenter, rater-blind, randomized controlled trial to investigate the efficacy of a new intervention program consisting of an initial 6-week psychoeducation protocol plus a subsequent structured daily computer-based self-charting program (ChronoRecord) over 54 weeks in remitted patients with bipolar disorders. The control condition included non-structured group sessions followed by daily computer-based self-reports (unstructured like a diary). Both groups received treatment-as-usual. Results Over 2 years, 41 mood episodes occurred in the experimental group (n = 39) compared to 27 in the control group (n = 34), without reaching statistical significance. Time to recurrence did not significantly differ between the experimental and control group (25% relapsed after 112 and 273 days, respectively). There were no significant group-by-time interactions in mood symptoms, quality of life, self-efficacy expectations or perceived involvement in care. Conclusions Six weekly psychoeducational group sessions followed by daily self-monitoring via ChronoRecord for 54 weeks may not be superior to non-structured group meetings followed by unstructured self-reporting. Other psychotherapeutic interventions may be needed to optimize the treatment of patients with bipolar disorders, especially for those at later disease stages. Trial registration Retrospectively registered at German Clinical Trials Register on May 24, 2019; DRKS00017319

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Effect of Prism Adaptation Therapy on the Activities of Daily Living and Awareness for Spatial Neglect: A Secondary Analysis of the Randomized, Controlled Trial

Brain Sciences ◽

10.3390/brainsci11030347 ◽

2021 ◽

Vol 11 (3) ◽

pp. 347

Author(s):

Katsuhiro Mizuno ◽

Kengo Tsujimoto ◽

Tetsuya Tsuji

Keyword(s):

Randomized Controlled Trial ◽

Daily Living ◽

Controlled Trial ◽

The Self ◽

Spatial Neglect ◽

Control Group ◽

Self Awareness ◽

Self Assessment ◽

Randomized Controlled ◽

Prism Group

Background: Rehabilitation for unilateral spatial neglect (USN) using prism adaptation (PA) is one of the most widely used methods, and the effectiveness of PA is well-evidenced. Although the effect of PA generalized various neglect symptoms, the effectiveness for some aspects of neglect is not fully proven. The Catherine Bergego Scale (CBS) was developed to identify problems with the activities of daily living (ADL) caused by USN. The CBS is composed of 10 observation assessments and a self-assessment questionnaire. To assess the self-awareness of USN, the anosognosia score is calculated as the difference between the observational scores and the self-assessment scores. To investigate how PA affects ADL and self-awareness in subacute USN patients during rehabilitation, we analyzed each item of the CBS and self-awareness from a randomized, controlled trial (RCT) that we previously conducted (Mizuno et al., 2011). Methods: A double-masked randomized, controlled trial was conducted to evaluate the effects of a 2-week PA therapy on USN in 8 hospitals in Japan. We compared each item of the CBS, anosognosia score, and absolute value of the anosognosia score between the prism group and the control group. Results: Two of ten items (gaze orientation and exploration of personal belongings) were significantly improved in the prism group compared with those in the control group. The absolute value of the anosognosia score was significantly improved by PA. Conclusions: Improvement of oculomotor exploration by PA may generalize the behavioral level in a daily living environment. This study suggested that PA could accelerate the self-awareness of neglect during subacute rehabilitation.

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An evaluation of the efficacy of two add-on ecological momentary intervention modules for depression in a pragmatic randomized controlled trial (ZELF-i)

10.31234/osf.io/8jfgc ◽

2020 ◽

Author(s):

Jojanneke A. Bastiaansen ◽

Daan Alexander Ornée ◽

Maaike Meurs ◽

Albertine Oldehinkel

Keyword(s):

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Social Functioning ◽

Controlled Trial ◽

Control Group ◽

Depression Treatment ◽

Self Monitoring ◽

Pragmatic Randomized Controlled Trial ◽

Randomized Controlled ◽

Ecological Momentary

Background Depression treatment might be enhanced by Ecological Momentary Interventions (EMI) based on self-monitoring and person-specific feedback. This study is the first to examine the efficacy of two different EMI modules for depression in routine clinical practice. MethodsOutpatients starting depression treatment at secondary mental health services (N = 161; MIDS-DEPRESSION = 35.9, SD = 10.7; MAGE = 32.8, SD = 12.1; 46% male) participated in a pragmatic randomized controlled trial with three arms. Two experimental groups engaged in 28 days of systematic self-monitoring (5 times per day), and received weekly feedback on either positive affect and activities (Do-module) or negative affect and thinking patterns (Think-module). The control group received no additional intervention. Participants completed questionnaires on depressive symptoms (primary outcome), social functioning, and empowerment before and after the intervention period, and at four measurements during a 6-month follow-up period. ResultsOf the 90 (out of 110) participants who completed the intervention, 86% would recommend it. However, the experimental groups did not show significantly more or faster changes over time than the control group in terms of depressive symptoms, social functioning and empowerment. Furthermore, trajectories of the two EMI modules were very similar. ConclusionsWe did not find statistical evidence that this type of EMI augments the efficacy of regular depression treatment, regardless of module content. We cannot rule out that EMIs have a positive impact on other domains or provide a more efficient way of delivering care. Nonetheless, EMI’s promise of effectiveness has not materialized yet.

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Effects of virtual reality associated with serious games for upper limb rehabilitation in patients with multiple sclerosis. A randomized controlled trial

10.21203/rs.3.rs-16509/v3 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance.Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment.Results: In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance. Trial registration: This randomized controlled trial has been registered at ClinicalTrials.gov Identifier: NCT04171908, Nov 2019.

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