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Feasibility of a smartphone app to enhance physical activity in progressive MS: a pilot randomized controlled pilot trial over three months.

ABSTRACT: Background:People with chronic progressive multiple sclerosis (CPMS) have limited options in medical treatment. Enhancing physical activity (PA) might promote neuroregeneration in multiple sclerosis (MS) and positively influence disability, thus providing an alternative to medical treatment. Previous studies indicate that evidence-based patient information (EBPI) is essential for inducing behavioral change, e.g. enhancing PA. Objective:To investigate feasibility of a smartphone app providing EBPI about the benefit of PA and a simple activity feedback to enhance PA in people with CPMS in a pilot randomized controlled trial over 3 months. Methods:Thirty-eight people with CPMS (mean age 51 years, median Expanded Disability Status Scale 4.0) were 1:1 randomized into either a control group (n = 20) or an intervention group (n = 18). The intervention group received access to a multimedia EBPI app including activity feedback, texts, figures and videos. In the control group, participants received a leaflet with unspecific information about exercising in general. The EPBI itself was designed based on a systematic review. At baseline and after 3 months, all participants underwent clinical performance tests, filled in questionnaires and received an activity monitor (Actigraph®) for 7 days. The primary endpoint was the rate of responders defined as participants with a 20% increase of physical acitivity (time of moderate or vigiorous PA-MVPA) or 20% increase of the number of steps, both assessed with the activity monitor. As secondary endpoints, we compared accelerometry, performance and questionnaires adjusted for baseline measurments between the groups (ANCOVA). Moreover, we used questionnaires to compare knowledge about exercise (activity requiring physical effort, carried out to improve or improve health and fitness) in MS, usability of the app in general and motivation towards a more active lifestyle after 3 months in both groups. Results:The groups showed significant differences in disease duration and PA according to the Godin-Leisure Time Exercise Questionnaire at baseline. After 3 months, we detected no difference in the rate of responders, which was an overall 22%. However, MVPA significantly increased in both groups (p < 0.001) and the intervention group tended to have a higher motivation towards a more active lifestyle (Cohens D = 0.7, p = 0.09) as measured by the questionnaire. Reponses also showed, that participants appreciated the app but claimed a lack of interactivity as a short-coming. Conclusion:Just providing information in a multimedia smartphone app did not enhance physical activitiy more than a simple leaflet in this small pilot trial in CPMS. However, the group of app users tended to have a higher motivation towards a more active lifestyle. Overall, the concept of a smartphone app to support an active lifestyle in MS is highly appreciated by participants.

SUBMITTER: Nasseri NN

PROVIDER: S-EPMC7319035 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Feasibility of a smartphone app to enhance physical activity in progressive MS: a pilot randomized controlled pilot trial over three months.

Nasseri Navina N NN Ghezelbash Eghbal E Zhai Yuyang Y Patra Stefan S Riemann-Lorenz Karin K Heesen Christoph C Rahn Anne C AC Stellmann Jan-Patrick JP

PeerJ 20200623

<h4>Background</h4>People with chronic progressive multiple sclerosis (CPMS) have limited options in medical treatment. Enhancing physical activity (PA) might promote neuroregeneration in multiple sclerosis (MS) and positively influence disability, thus providing an alternative to medical treatment. Previous studies indicate that evidence-based patient information (EBPI) is essential for inducing behavioral change, e.g. enhancing PA.<h4>Objective</h4>To investigate feasibility of a smartphone ap ...[more]

PMID: 32612882

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Project description:BackgroundAlcohol use disorder (AUD) is a significant public health concern worldwide. Alcohol consumption is a leading cause of death in the United States and has a significant negative impact on individuals and society. Relapse following treatment is common, and adjunct intervention approaches to improve alcohol outcomes during early recovery continue to be critical. Interventions focused on increasing physical activity (PA) may improve AUD treatment outcomes. Given the ubiquity of smartphones and activity trackers, integrating this technology into a mobile app may be a feasible, acceptable, and scalable approach for increasing PA in individuals with AUD.ObjectiveThis study aims to test the Fit&Sober app developed for patients with AUD. The goals of the app were to facilitate self-monitoring of PA engagement and daily mood and alcohol cravings, increase awareness of immediate benefits of PA on mood and cravings, encourage setting and adjusting PA goals, provide resources and increase knowledge for increasing PA, and serve as a resource for alcohol relapse prevention strategies.MethodsTo preliminarily test the Fit&Sober app, we conducted an open pilot trial of patients with AUD in early recovery (N=22; 13/22, 59% women; mean age 43.6, SD 11.6 years). At the time of hospital admission, participants drank 72% of the days in the last 3 months, averaging 9 drinks per drinking day. The extent to which the Fit&Sober app was feasible and acceptable among patients with AUD during early recovery was examined. Changes in alcohol consumption, PA, anxiety, depression, alcohol craving, and quality of life were also examined after 12 weeks of app use.ResultsParticipants reported high levels of satisfaction with the Fit&Sober app. App metadata suggested that participants were still using the app approximately 2.5 days per week by the end of the intervention. Pre-post analyses revealed small-to-moderate effects on increase in PA, from a mean of 5784 (SD 2511) steps per day at baseline to 7236 (SD 3130) steps per day at 12 weeks (Cohen d=0.35). Moderate-to-large effects were observed for increases in percentage of abstinent days (Cohen d=2.17) and quality of life (Cohen d=0.58) as well as decreases in anxiety (Cohen d=-0.71) and depression symptoms (Cohen d=-0.58).ConclusionsThe Fit&Sober app is an acceptable and feasible approach for increasing PA in patients with AUD during early recovery. A future randomized controlled trial is necessary to determine the efficacy of the Fit&Sober app for long-term maintenance of PA, ancillary mental health, and alcohol outcomes. If the efficacy of the Fit&Sober app could be established, patients with AUD would have a valuable adjunct to traditional alcohol treatment that can be delivered in any setting and at any time, thereby improving the overall health and well-being of this population.Trial registrationClinicalTrials.gov NCT02958280; https://www.clinicaltrials.gov/ct2/show/NCT02958280.

Project description:BackgroundSeveral mobile apps that monitor symptoms of rheumatoid arthritis (RA) exist, but a recent systematic review indicated that high-quality apps are lacking. When patients self-monitor their own disease with patient-reported outcomes (PROs) and self-initiate care at the right moment, it may be possible to reduce the frequency of their clinic visits, which would reduce health care burden and costs. We developed an app, that is, the MijnReuma Reade app, for this purpose and performed 2 pilot tests with weekly self-monitoring.ObjectiveThe primary objective of this study was to design, develop, and evaluate the usability, satisfaction, and usage of the MijnReuma Reade app-an app that allows patients with RA to monitor their own disease. The secondary objective was to review the patients' perspectives on app usage and its intended purpose.MethodsThis app was designed in collaboration with patients with RA, rheumatologists, and information technology experts. Two 1-month pilot studies were performed, after which satisfaction (0-10 scale), usability (system usability scale, 0-100), and usage (proportion of completed questionnaires) of this app were assessed. After the second pilot study, semistructured interviews were performed to determine patients' perspectives and the promoters and barriers of app usage.ResultsIn the first and second pilot study, 42 and 27 patients were included, respectively. Overall, the patients were satisfied (medians, 8 and 7) and found the app usable (mean system usability scores, 76 and 71) in pilot studies 1 and 2, respectively. App usage declined over time in both the pilot studies; 61% (17/28) and 37% (10/27) of the patients who disclosed their usage statistics completed the final weekly questionnaire in pilot study 1 and pilot study 2, respectively. Approximately 81% (25/31) of the patients indicated they would like to skip hospital visits if the self-monitored disease activity is low. In the semistructured interviews, technical problems, internal resistance (respondent fatigue, the app reminded them of their disease), and a lack of symptoms were identified as barriers for usage. Patients reported that "experiencing more grip on their disease" and "improved communication with their physician" were promoters for usage. Patients reported that pain positively mediated usage, that is, more pain promoted and less pain discouraged app usage.ConclusionsThis study illustrates the feasibility of the MijnReuma Reade app that enables self-monitoring of the disease activity in patients with RA with the overarching aim to allocate clinical consultations according to need. Satisfaction with the app and usability of the app were found to be high; however, app usage declined over time. Patients acknowledged the potential of the app to self-monitor their own disease and would like to be able to skip clinic visits if the monitored disease activity is low. To evaluate this strategy, a randomized controlled trial is underway.

Project description:BackgroundYoung people often struggle to self-manage type 1 diabetes during the transition from childhood to adulthood. Mobile health (mHealth) apps may have the potential to support self-management, but evidence is limited and randomized controlled trials are needed.ObjectiveWe assessed whether the mHealth app "Young with Diabetes" improved young people's self-management measured by glycated hemoglobin (HbA1c) and three self-reported psychometric scales.MethodsYoung people (14-22 years) with inadequate glycemic control and their parents were enrolled in a randomized controlled trial and assigned either to Young with Diabetes and usual care (Young with Diabetes group) or to usual care alone (control). Young with Diabetes use was monitored; functions included a chat room, contact the health care provider, reminders, tips, information about the diabetes department and type 1 diabetes topics, carbohydrate counting, and a parents' section. Outcomes included HbA1c and three self-reported psychometric scales: Perceived Competence in Diabetes Scale; Health Care Climate Questionnaire; and Problem Areas In Diabetes care survey. Data were collected at baseline and at 2, 7, and 12 months.ResultsA total of 151 young people were randomized (Young with Diabetes group=76, control=75) and 49 parents agreed to participate. At 12 months, HbA1c was significantly higher (4.1 mmol/mol; 0.4 %) in the Young with Diabetes group, compared to the control group (P=.04); this finding did not occur when comparing app users (Young with Diabetes use ≥5 days) with nonusers. Young people used Young with Diabetes on a mean of 10.5 days. They spent the most time chatting about alcohol and searching for information about sex. Most young people and half of the parents reported that Young with Diabetes helped them. More than 80% would recommend Young with Diabetes to peers.ConclusionsYoung with Diabetes did not improve HbA1c, but it may be a useful complement to self-management. Qualitative evaluation is needed to explore benefits and shortcomings of Young with Diabetes. Health care providers should address young peoples' knowledge about sensitive topics, provide them with peer support, and be aware of parents' need for information about how to support.Trial registrationClinicalTrials.gov NCT02632383; https://clinicaltrials.gov/ct2/show/NCT02632383 (Archived by WebCite at http://www.webcitation.org/6zCK2u7xM).

Project description:Seventy percent of patients with irritable bowel syndrome (IBS) identify certain foods as triggers for their symptom flare-ups. To help identify potential trigger foods, practitioners often rely on patient food and gastrointestinal (GI) symptom journaling. The aim of the study was to evaluate the feasibility and usability of a novel food and symptom journal app, specifically designed for patients with IBS. Secondary aims were to explore the effect of using the app on GI symptoms and to describe associations between diet and GI symptoms suggested by individual patient data.The feasibility and usability of the novel app was studied in 11 IBS patients (8 women), aged 21-65 years. Participants were asked to log GI symptoms (abdominal pain, bloating, diarrhea, constipation) using a 100-point color-graded sliding scale (green=none, red=severe) four times a day and to log every meal/snack they ate (at least three times a day) over a 2-week period. The app's feasibility as a data collection tool was evaluated by daily completion, compliance, data hoarding, and fatigability rates. Usability was evaluated with the System Usability Scale (SUS). To explore potential impact of using the app on bowel distress, we compared before and after intervention IBS-Symptom Severity Scale (IBS-SSS) scores. Meal entries were analyzed for nutrients using the Nutrition Data System for Research. Regression analyses were conducted for each participant journal to explore relationships between meal nutrients and subsequent GI symptoms.Daily average completion rates of the minimum requested entries for meal and GI symptoms were 112±47% and 78±44%, respectively. Average 24-h compliance rates were 90±19% and 94±12%, respectively. The SUS score was above average (mean 83, range 65-97.5; n=10). Most participants did not have a clinically significant decrease in IBS-SSS. At least one strong association (P?0.05) between GI symptoms and a meal nutrient was found in 73% of participants. The mean number of associations was 2 (range 0-7; n=11). Patterns of associations differed between individual participants.Our app appeared to be a feasible and usable tool for IBS patients. Our findings are in line with anecdotes that most IBS patients have food triggers and that these vary by individual. Future studies can explore whether individualized dietary changes guided by an app can result in IBS symptom improvement.

Project description:BackgroundAlthough many smoking cessation smartphone apps exist, few have been independently evaluated, particularly in older populations. In 2017, of the 112 commercially available smoking cessation apps in Australia, only 6 were deemed to be of high quality, in that they partially adhered to Australian guidelines. Mobile health (mHealth) apps have the potential to modify smoking behavior at a relatively low cost; however, their acceptability in older smokers remains unknown. Rigorous scientific evaluation of apps is thus urgently needed to assist smokers and clinicians alike.ObjectiveWe conducted a pilot randomized controlled trial to evaluate the feasibility of a large-scale trial to assess the use and acceptability of a high-quality smoking cessation app in older smokers.MethodsAdult inpatient and outpatient smokers with computer and smartphone access were recruited face to face and via telephone interviews from Metropolitan Hospitals in Brisbane, Australia. Participants were randomized 1:1 to the intervention (requested to download the "My QuitBuddy" smoking cessation app on their smartphone) or the control group (provided access to a tailored smoking cessation support webpage [Quit HQ]). The My QuitBuddy app is freely available from app stores and provides personalized evidenced-based smoking cessation support. Quit HQ offers regular email support over 12 weeks. No training or instructions on the use of these e-resources were given to participants. Outcomes at 3 months included recruitment and retention rates, use and acceptability of e-resource (User Version of the Mobile App Rating Scale [uMARS]), changes in quitting motivation (10-point scale), and self-reported smoking abstinence.ResultsWe randomized 64 of 231 potentially eligible individuals (27.7%). The mean age of participants was 62 (SD 8). Nicotine dependence was moderate (mean Heaviness of Smoking Index [HSI] 2.8 [SD 1.2]). At 3 months the retention rate was (58/64, 91%). A total of 15 of 31 participants in the intervention arm (48%) used the app at least once, compared with 10 of 33 (30%) in the control arm. uMARS scores for e-resource use and acceptability were statistically similar (P=.29). Motivation to quit was significantly higher in the intervention arm compared with the control arm (median 6 [IQR 4-8] versus 4 [IQR 4-5], respectively, P=.02). According to the intention-to-treat analysis, smoking abstinence was nonsignificantly higher in the intervention group (4/31 [13%], 95% CI 4%-30%, versus 2/33 [6%], 95% CI 1%-20%; P=.42). The estimated number needed to treat was 14.ConclusionsInternet and mHealth smoking cessation resources appear acceptable to a minority of older smokers. Smokers who engaged with the allocated e-resources rated them equally, and there were trends toward greater uptake, increased motivation, and higher abstinence rates in the app group; however, only the change in motivation reached statistical significance (median score 6 versus 4, respectively, P=.02). This results of this pilot study suggest that apps may improve quit outcomes in older adults who are willing to use them. Further research into user-app interactions should be undertaken to facilitate improvements in app design and consumer engagement. These favorable trends should be explored in larger trials with sufficient statistical power.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12619000159156; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376849&isReview=true.

Project description:BackgroundAscites is a common, painful, and serious complication of cirrhosis. Body weight is a reliable proxy for ascites volume; therefore, daily weight monitoring is recommended to optimize ascites management.ObjectiveThis study aims to evaluate the feasibility of a smartphone app in facilitating outpatient ascites management.MethodsIn this feasibility study, patients with cirrhotic ascites requiring active management were identified in both inpatient and outpatient settings. Patients were provided with a Bluetooth-connected scale, which transmitted weight data to a smartphone app and then via the internet to an electronic medical record (EMR). Weights were monitored every weekday. In the event of a weight change of ≥5 lbs in 1 week, patients were called and administered a short symptom questionnaire, and providers received an email alert. The primary outcomes of this study were the percentage of enrolled days during which weight data were successfully transmitted to an EMR and the percentage of weight alerts that prompted responses by the provider.ResultsIn this study, 25 patients were enrolled: 12 (48%) were male, and the mean age was 58 (SD 13; range 35-81) years. A total of 18 (72%) inpatients were enrolled. Weight data were successfully transmitted to an EMR during 71.2% (697/979) of the study enrollment days, with technology issues reported on 16.5% (162/979) of the days. Of a total of 79 weight change alerts fired, 41 (52%) were triggered by weight loss and 38 (48%) were by weight gain. Providers responded in some fashion to 66 (84%) of the weight alerts and intervened in response to 45 (57%) of the alerts, for example, by contacting the patient, scheduling clinic or paracentesis appointments, modifying the diuretic dose, or requesting a laboratory workup. Providers responded equally to weight increase and decrease alerts (P=.87). The staff called patients a mean of 3.7 (SD 3.5) times per patient, and the number of phone calls correlated with technology issues (r=0.60; P=.002). A total of 60% (15/25) of the patients chose to extend their participation beyond 30 days. A total of 17 patient readmissions occurred during the study period, with only 4 (24%) related to ascites.ConclusionsWe demonstrated the feasibility of a smartphone app to facilitate the management of ascites and reported excellent rates of patient and provider engagement. This innovation could enable early therapeutic intervention, thereby decreasing the burden of morbidity and mortality among patients with cirrhosis.

Project description:BACKGROUND:Persistent smoking after a cancer diagnosis predicts worse treatment outcomes and mortality, but access to effective smoking cessation interventions is limited. Smartphone apps can address this problem by providing a highly accessible, low-cost smoking cessation intervention designed for patients with a recent cancer diagnosis. OBJECTIVE:This study aimed to summarize our development process and report the trial design, feasibility, participant acceptability, preliminary effectiveness, and impact on processes of change (eg, cancer stigma) of the first-known smoking cessation smartphone app targeted for cancer patients. METHODS:We used an agile, user-centered design framework to develop a fully automated smartphone app called Quit2Heal that provided skills training and stories from cancer survivors focusing on coping with internalized shame, cancer stigma, depression, and anxiety as core triggers of smoking. Quit2Heal was compared with the National Cancer Institute's QuitGuide, a widely used stop smoking app for the general population, in a pilot double-blinded randomized trial with a 2-month follow-up period. Participants were 59 adult smokers diagnosed with cancer within the past 12 months and recruited through 2 cancer center care networks and social media over a 12-month period. The most common types of cancer diagnosed were lung (21/59, 36%) and breast (10/59, 17%) cancers. The 2-month follow-up survey retention rate was 92% (54/59) and did not differ by study arm (P=.15). RESULTS:Compared with QuitGuide participants, Quit2Heal participants were more satisfied with their assigned app (90% [19/21] for Quit2Heal vs 65% [17/26] for QuitGuide; P=.047) and were more likely to report that the app assigned to them was made for someone like them (86% [18/21] for Quit2Heal vs 62% [16/26] for QuitGuide; P=.04). Quit2Heal participants opened their app a greater number of times during the 2-month trial period, although this difference was not statistically significant (mean 10.0, SD 14.40 for Quit2Heal vs mean 6.1, SD 5.3 for QuitGuide; P=.33). Self-reported 30-day point prevalence quit rates at the 2-month follow-up were 20% (5/25) for Quit2Heal versus 7% (2/29) for QuitGuide (odds ratio 5.16, 95% CI 0.71-37.29; P=.10). Quit2Heal participants also showed greater improvement in internalized shame, cancer stigma, depression, and anxiety, although these were not statistically significant (all P>.05). CONCLUSIONS:In a pilot randomized trial with a high short-term retention rate, Quit2Heal showed promising acceptability and effectiveness for helping cancer patients stop smoking. Testing in a full-scale randomized controlled trial with a longer follow-up period and a larger sample size is required to test the effectiveness, mediators, and moderators of this promising digital cessation intervention. TRIAL REGISTRATION:ClinicalTrials.gov NCT03600038; https://clinicaltrials.gov/ct2/show/NCT03600038.

Project description:BackgroundThe sequential multiple assignment randomized trial (SMART) design allows for changes in the intervention during the trial period. Despite its potential and feasibility for defining the best sequence of interventions, so far, it has not been utilized in a smartphone/gamified intervention for physical activity.ObjectiveWe aimed to investigate the feasibility of the SMART design for assessing the effects of a smartphone app intervention to improve physical activity in adults. We also aimed to describe the participants' perception regarding the protocol and the use of the app for physical activity qualitatively.MethodsWe conducted a feasibility 24-week/two-stage SMART in which 18 insufficiently active participants (<10,000 steps/day) were first randomized to group 1 (smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol). Participants were motivated to increase their step count by at least 2000 steps/day each week. Based on the 12-week intermediate outcome, responders continued the intervention and nonresponders were rerandomized to subsequent treatment, including a new group 3 (smartphone app + tailored messages + gamification) in which they were instructed to form groups to use several game elements available in the chosen app (Pacer). We considered responders as those with any positive slope in the linear relationship between weeks and steps per day at the end of the first stage of the intervention. We compared the accelerometer-based steps per day before and after the intervention, as well as the slopes of the app-based steps per day between the first and second stages of the intervention.ResultsTwelve participants, including five controls, finished the intervention. We identified two responders in group 1. We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group. However, the rerandomization of five nonresponders led to a change in the slope of the steps per day (median -198 steps/day [IQR -279 to -103] to 20 steps/day [IQR -204 to 145]; P=.08). Finally, in three participants from group 2, we observed an increase in the number of steps per day up to the sixth week, followed by an inflection to baseline values or even lower (ie, a quadratic relationship). The qualitative analysis showed that participants' reports could be classified into the following: (1) difficulty in managing the app and technology or problems with the device, (2) suitable response to the app, and (3) difficulties to achieve the goals.ConclusionsThe SMART design was feasible and changed the behavior of steps per day after rerandomization. Rerandomization should be implemented earlier to take advantage of tailored messages. Additionally, difficulties with technology and realistic and individualized goals should be considered in interventions for physical activity using smartphones.Trial registrationBrazilian Registry of Clinical Trials RBR-8xtc9c; http://www.ensaiosclinicos.gov.br/rg/RBR-8xtc9c/.

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Feasibility of a smartphone app to enhance physical activity in progressive MS: a pilot randomized controlled pilot trial over three months.

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Feasibility of a smartphone app to enhance physical activity in progressive MS: a pilot randomized controlled pilot trial over three months.

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