Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women.
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SUBMITTER: Jaffar A
PROVIDER: S-EPMC8125738 | biostudies-literature | 2021 Apr
REPOSITORIES: biostudies-literature
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Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women.
Jaffar Aida A Mohd Sidik Sherina S Foo Chai Nien CN Muhammad Noor Azimah NA Abdul Manaf Rosliza R Fadhilah Ismail Siti Irma SI Suhaili Nazhatussima N
International journal of environmental research and public health 20210430 9
<h4>Background</h4>The delivery of pelvic floor muscle training (PFMT) through mHealth apps has been shown to produce promising results in improving pelvic floor muscle strength and urinary incontinence (UI). However, there is limited evidence on mHealth apps designed for pregnant women who are at high risk of developing UI. This pilot study aims to evaluate the feasibility of conducting an effectiveness trial for a newly developed PFMT app among pregnant women in Malaysia.<h4>Methods</h4>This i ...[more]
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Project description:IntroductionPelvic floor muscle training (PFMT) strongly recommended to incontinent pregnant women. The Kegel Exercise Pregnancy Training-app trial is a multicentre cluster-randomised study aims to assess the effectiveness and its cost-effectiveness of the mobile app guidance in PFMT among incontinent pregnant women.Methods and analysis370 pregnant women (aged 18 years old and above) will be recruited with International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form. Ten clusters (primary care clinics) will be randomly assigned to either PFMT or usual care in a 1:1 ratio by an independent researcher (sealed envelope). The primary outcome will be urinary incontinence, and the secondary outcomes (quality of life; PFMT adherence, psychological status and mobile apps' usability) will be assessed at four measurement time points (t0: baseline) and postintervention (t1: 4 weeks, t2: 8 weeks and t3: 8 weeks postnatal). T-test analysis will determine any significant differences at the baseline between the control and intervention groups. The mixed-model analysis will determine the effectiveness of the intervention at the population-average level for both the primary and secondary outcomes. For the cost-effectiveness analysis, expenditures during the study and 6 months after the intervention will be compared between the groups using the multiway sensitivity analysis. The recruitment planned will be in December 2020, and the planned end of the study will be in August 2021.Ethics and disseminationThis study protocol was approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia (JKEUPM-2019-368) and Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia, NMRR-19-412-47116 (IIR) with the ANZCTR registration. This study will obtain informed written consent from all the study participants. The results which conform with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials will be published for dissemination in peer-reviewed journals and conference proceedings.Trial registration numberACTRN12619000379112.
| S-EPMC7805359 | biostudies-literature
Project description:BackgroundWhile structured compassion training programs have shown promise for increasing compassion among medical trainees, a major challenge is applying the concepts and practices taught during the program into the complex, dynamic, time-pressured, and often hectic hospital workplace.ObjectiveThe purpose of this pilot study was to examine the feasibility, acceptability, and preliminary effects of Compassion Coach, a mobile health (mHealth) smartphone app designed to bolster a 6-week mindfulness and self-compassion training program for medical trainees.MethodsIn Compassion Coach, notifications to remind, encourage, and measure the perceived impact of informal mindfulness and compassion practices taught during the program were delivered at 7 AM, 12 PM, and 7 PM, respectively, 3 times per week over the course of the training program. The app also contained a library of guided audio formal mindfulness and compassion practices to allow quick and easy access. In this pilot study, we collected data from 29 medical students and residents who downloaded Compassion Coach and completed surveys assessing perceived effectiveness and acceptability. Engagement with the Compassion Coach app was passively tracked through notification response rate and library resource access over time.ResultsThe average response rate to notifications was 58% (SD 29%; range 12%-98%), with a significant decline over time (P=.009; odds ratio 0.98, 95% CI 0.96-0.99). Across all participants and occasions, the majority agreed the informal practices prompted by Compassion Coach helped them feel grounded and centered (110/150, 73%), improved compassion (29/41, 71%), reduced burnout (106/191, 56%), and improved their mood (133/191, 70%). In total, 16 (55%) of the 29 participants accessed guided audio recordings on average 3 (SD 3.4) times throughout the program. At the posttreatment time point, most participants (13/18, 72%) indicated that Compassion Coach helped them engage in compassion practices in daily life, and half (9/18, 50%) indicated that Compassion Coach helped improve interactions with patients.ConclusionsOverall, preliminary results of Compassion Coach are encouraging and suggest the integration of a smartphone app with an ongoing mindfulness and self-compassion training program may bolster the effects of the program on medical trainees. However, there was variability in engagement with Compassion Coach and perceived helpfulness. Additional research is indicated to optimize this novel mHealth approach and conduct a study powered to formally evaluate effects.
| S-EPMC11632279 | biostudies-literature
Project description:BackgroundSwallowing difficulties (ie, dysphagia) are common among older adults, with a 13% to 54% prevalence. Adequate interventions to improve the swallowing function of older adults would reduce morbidity and enhance health-related quality of life outcomes. Mobile health (mHealth) apps may help alleviate dysphagia symptoms by providing programs that maximize the intensity and frequency of training without requiring high costs or regular clinic visits.ObjectiveThe aim of this pilot study was to assess the usability of swallowing training apps by quantitatively and qualitatively evaluating older adults' self-reported data, taking into consideration their educational levels and exposure to mobile technology. We conducted surveys and brief interviews while the participants used a swallowing intervention app we developed. We subsequently identified and resolved individual-specific usability issues to improve future implementation of the app protocol for older persons with swallowing difficulties.MethodsA total of 11 participants (10 women, 91%; mean age 75.7 years, SD 3.93) from two district-run senior welfare centers took part in this study. The participants were divided into a high-potential group and a low-potential group based on their total number of years of education and smart device usage. To investigate the usability of the app twice (ie, in the second week of the intervention and the postintervention stage), we used mixed methods consisting of both quantitative approaches, namely the System Usability Scale (SUS) and modified Computer Self-Efficacy Scale (mCSES) surveys, and qualitative approaches (ie, interviews).ResultsThe quantitative results of the SUS and mCSES surveys revealed that the high-potential group was more inclined to adopt and learn new technology than the low-potential group. Specifically, within the high-potential group, a Wilcoxon signed-rank test indicated that the postintervention mCSES scores (median 65.50) were significantly higher than those in the second week of intervention (median 54.00; z=-2.023, P=.04). Additionally, the usability scores in the low-potential group were within the "marginal acceptability" range even after completion of an 8-week intervention program. Qualitative analyses via semi-structured interviews yielded promising outcomes regarding app acceptability, training program utilization, emotional responses, and learning experience.ConclusionsTo the best of the authors' knowledge, this usability and feasibility study is the first report of a swallowing training app designed to improve the swallowing function of older adults. Future research should consider several issues, such as user characteristics, pretraining education, and the intensity and innate characteristics of the intervention program.
| S-EPMC7418014 | biostudies-literature
Project description:BackgroundMost smokers are ambivalent about quitting-they want to quit someday, but not now. Interventions are needed that can engage ambivalent smokers, build their motivation for quitting, and support future quit attempts. Mobile health (mHealth) apps offer a cost-effective platform for such interventions, but research is needed to inform their optimal design and assess their acceptability, feasibility, and potential effectiveness.ObjectiveThis study aims to assess the feasibility, acceptability, and potential impact of a novel mHealth app for smokers who want to quit smoking someday but are ambivalent about quitting in the near term.MethodsWe enrolled adults across the United States who smoked more than 10 cigarettes a day and were ambivalent about quitting (n=60). Participants were randomly assigned to 1 of 2 versions of the GEMS app: standard care (SC) versus enhanced care (EC). Both had a similar design and identical evidence-based, best-practice smoking cessation advice and resources, including the ability to earn free nicotine patches. EC also included a series of exercises called experiments designed to help ambivalent smokers clarify their goals, strengthen their motivation, and learn important behavioral skills for changing smoking behavior without making a commitment to quit. Outcomes were analyzed using automated app data and self-reported surveys at 1 and 3 months post enrollment.ResultsParticipants who installed the app (57/60, 95%) were largely female, White, socioeconomically disadvantaged, and highly nicotine dependent. As expected, key outcomes trended in favor of the EC group. Compared to SC users, EC participants had greater engagement (mean sessions 19.9 for EC vs 7.3 for SC). An intentional quit attempt was reported by 39.3% (11/28) of EC users and 37.9% (11/29) of SC users. Seven-day point prevalence smoking abstinence at the 3-month follow-up was reported by 14.7% (4/28) of EC users and 6.9% (2/29) of SC users. Among participants who earned a free trial of nicotine replacement therapy based on their app usage, 36.4% (8/22) of EC participants and 11.1% (2/18) of SC participants requested the treatment. A total of 17.9% (5/28) of EC and 3.4% (1/29) of SC participants used an in-app feature to access a free tobacco quitline. Other metrics were also promising. EC participants completed an average of 6.9 (SD 3.1) out of 9 experiments. Median helpfulness ratings for completed experiments ranged from 3 to 4 on a 5-point scale. Finally, satisfaction with both app versions was very good (mean 4.1 on a 5-point Likert scale) and 95.3% (41/43) of all respondents would recommend their app version to others.ConclusionsAmbivalent smokers were receptive to the app-based intervention, but the EC version, which combined best-practice cessation advice with self-paced, experiential exercises, was associated with greater use and evidence of behavior change. Further development and evaluation of the EC program is warranted.Trial registrationClinicalTrials.gov NCT04560868; https://clinicaltrials.gov/ct2/show/NCT04560868.
| S-EPMC10365568 | biostudies-literature
Project description:BackgroundSubstance use disorder is one of the severe public health problems worldwide. Inequitable resources, discrimination, and physical distances limit patients' access to medical help. Automated conversational agents have the potential to provide in-home and remote therapy. However, automatic dialogue agents mostly use text and other methods to interact, which affects the interaction experience, treatment immersion, and clinical efficacy.ObjectiveThe aim of this paper is to describe the design and development of Echo-APP, a tablet-based app with the function of a virtual digital psychotherapist, and to conduct a pilot study to explore the feasibility and preliminary efficacy results of Echo-APP for patients with methamphetamine use disorder.MethodsEcho-APP is an assessment and rehabilitation program developed for substance use disorder (SUD) by a team of clinicians, psychotherapists, and computer experts. The program is available for Android tablets. In terms of assessment, the focus is on the core characteristics of SUD, such as mood, impulsivity, treatment motivation, and craving level. In terms of treatment, Echo-APP provides 10 treatment units, involving awareness of addiction, motivation enhancement, emotion regulation, meditation, etc. A total of 47 patients with methamphetamine dependence were eventually enrolled in the pilot study to receive a single session of the Echo-APP-based motivational enhancement treatment. The outcomes were assessed before and after the patients' treatment, including treatment motivation, craving levels, self-perception on the importance of drug abstinence, and their confidence in stopping the drug use.ResultsIn the pilot study, scores on the Stages of Change Readiness and Treatment Eagerness Scale and the questionnaire on motivation for abstaining from drugs significantly increased after the Echo-APP-based treatment (P<.001, Cohen d=-0.60), while craving was reduced (P=.01, Cohen d=0.38). Patients' baseline Generalized Anxiety Disorder-7 assessment score (β=3.57; P<.001; 95% CI 0.80, 2.89) and Barratt Impulsiveness Scale (BIS)-motor impulsiveness score (β=-2.10; P=.04; 95% CI -0.94, -0.02) were predictive of changes in the patients' treatment motivation during treatment. Moreover, patients' baseline Generalized Anxiety Disorder-7 assessment score (β=-1.607; P=.03; 95% CI -3.08, -0.14), BIS-attentional impulsivity score (β=-2.43; P=.004; 95% CI -4.03, -0.83), and BIS-nonplanning impulsivity score (β=2.54; P=.002; 95% CI 0.98, 4.10) were predictive of changes in craving scores during treatment.ConclusionsEcho-APP is a practical, accepted, and promising virtual digital psychotherapist program for patients with methamphetamine dependence. The preliminary findings lay a good foundation for further optimization of the program and the promotion of large-scale randomized controlled clinical studies for SUD.
| S-EPMC9929731 | biostudies-literature
Project description:ObjectiveThe aim of this study was to explore the feasibility of conducting a randomized controlled trial of dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke and to explore the magnitude and direction of change on arm outcomes.DesignThis is a single-blind, two-arm parallel group, feasibility randomized controlled trial.SettingIn-patient rehabilitation.SubjectsThe study participants were stroke survivors with arm hemiparesis two to four weeks after stroke receiving in-patient rehabilitation.InterventionsParticipants were randomized 2:1 to wear Lycra® gauntlets for eight hours daily for eight weeks, plus usual rehabilitation (n = 27), or to usual rehabilitation only (n = 16).Main measuresRecruitment, retention, fidelity, adverse events and completeness of data collection were examined at 8 and 16 weeks; arm function (activity limitation; Action Research Arm Test, Motor Activity Log) and impairment (Nine-hole Peg Test, Motricity Index, Modified Tardieu Scale). Structured interviews explored acceptability.ResultsOf the target of 51, 43 (84%) participants were recruited. Retention at 8 weeks was 32 (79%) and 24 (56%) at 16 weeks. In total, 11 (52%) intervention group participants and 6 (50%) control group participants (odds ratio = 1.3, 95% confidence interval = 0.2 to 7.8) had improved Action Research Arm Test level by 8 weeks; at 16 weeks, this was 8 (61%) intervention and 6 (75.0%) control participants (odds ratio = 1.1, 95% confidence interval = 0.1 to 13.1). Change on other measures favoured control participants. Acceptability was influenced by 26 adverse reactions.ConclusionRecruitment and retention were low, and adverse reactions were problematic. There were no indications of clinically relevant effects, but the small sample means definitive conclusions cannot be made. A definitive trial is not warranted without orthoses adaptation.
| S-EPMC6613174 | biostudies-literature
Project description:Sarcoidosis-associated fatigue (SAF) is a common clinical problem with limited treatment options. This study was undertaken to determine the feasibility of performing a definitive trial to determine the clinical efficacy methylphenidate in SAF. This was a parallel-arm, double-blind, placebo-controlled randomised controlled feasibility trial enrolling sarcoidosis patients reporting significant fatigue. Patients with a Fatigue Assessment Scale score of more than 21 were randomised to receive up to either 10 mg two times per day methylphenidate or identical placebo capsules two times per day, in a dose escalation fashion, for up to 24 weeks. Outcomes included number of participants eligible and willing to participate, withdrawal rates, adherence rates and ability to maintain blinding. Of 385 patients screened, 56 (14.5%) were eligible and 23 (41% of eligible patients) were randomised. No withdrawals occurred. One participant in the methylphenidate arm discontinued study medications due to chest pain. The side effect profile was not different between the groups. Median medication adherence rates were 98% and 99% in the methylphenidate and placebo arms, respectively. A greater proportion of participants receiving methylphenidate predicted their allocated treatment while blinded compared with those receiving placebo (93.3% vs 57.1%). The investigator could not predict the treatment allocation. Both groups showed clinically meaningful improvements in fatigue from baseline, although no between-group difference was seen. The data support the feasibility of performing a double-blind parallel trial powered to determine the clinical efficacy of methylphenidate for SAF, however, a multicentre study will be required. NCT02643732.
| S-EPMC8144057 | biostudies-literature
Project description:BackgroundType 1 diabetes (T1D) affects more than 165,000 individuals younger than 20 years in the United States of America. The transition from parent management to parent-child team management, with the child taking on increased levels of self-care, can be stressful and is associated with a deterioration in self-management behaviors. Therefore, a mobile app intervention, MyT1DHero, was designed to facilitate diabetes-specific positive parent-adolescent communication and improve diabetes-related outcomes. The MyT1DHero intervention links an adolescent with T1D and their parent through 2 separate app interfaces and is designed to promote positive communication regarding T1D management.ObjectiveThe aim of this pilot study was to determine (1) the initial efficacy of the MyT1DHero intervention in improving diabetes outcomes in adolescents, specifically the hemoglobin A1c (HbA1c) levels, diabetes care adherence, and quality of life, and (2) the adolescents' overall satisfaction with this intervention.MethodsThis pilot study included 30 adolescent-parent pairs who used the MyT1DHero app in a 12-week single-arm clinical trial. Participants were recruited from the local pediatric endocrinology subspecialty clinic via snowball sampling. HbA1c levels, diabetes care adherence, quality of life, family conflict, and satisfaction levels were measured and analyzed using paired sample two-sided t tests and linear regression analyses.ResultsThe final analysis included 25 families. The mean age of the adolescents was 12.28 (SD 1.62) years. Half of the participants (13/25) reported a diabetes diagnosis of less than 5 years. After 12 weeks of the intervention, diabetes care adherence significantly improved (before the study: mean 3.87 [SD 0.59]; after the study: mean 4.19 [SD 0.65]; t21=-2.52, P=.02, d=0.52) as did quality of life (before the study: mean 4.02 [SD 0.84]; after the study: mean 4.27 [SD 0.73]; t24=2.48, P=.01, d=0.32). HbA1c levels (before the study: mean 8.94 [SD 1.46]; after the study: mean 8.87 [SD 1.29]; t24=0.67, P=.51, d=0.04) and family conflict (before the study: mean 2.45 [SD 0.55]; after the study: mean 2.61 [SD 0.45]; t23=0.55, P=.14, d=0.32) changed in the hypothesized direction, but the change was not significant. However, higher use of the mobile app was associated with more improvement in HbA1c levels (F1,20=9.74, P<.005; R2=0.33). Overall, the adolescents were satisfied with the app intervention.ConclusionsIn a 12-week pilot study of the mobile app intervention designed to facilitate parent-adolescent communication for improving diabetes outcomes, significant benefits were demonstrated in self-care adherence and quality of life. A randomized controlled trial with a longer intervention is needed to replicate these findings and to determine the stability of the intervention effects.Trial registrationClinicalTrials.gov NCT03436628; https://clinicaltrials.gov/ct2/show/NCT03436628.
| S-EPMC8479605 | biostudies-literature
Project description:Pre-eclampsia is one of the leading causes of maternal death and morbidity in low-resource countries due to delays in case identification and a shortage of health workers trained to manage the disorder. Pre-eclampsia Integrated Estimate of RiSk (PIERS) on the Move (PotM) is a low cost, easy-to-use, mobile health (mHealth) platform that has been created to aid health workers in making decisions around the management of hypertensive pregnant women. PotM combines two previously successful innovations into a mHealth app: the miniPIERS risk assessment model and the Phone Oximeter.The aim of this study was to assess the usability of PotM (with mid-level health workers) for iteratively refining the system.Development of the PotM user interface involved usability testing with target end-users in South Africa. Users were asked to complete clinical scenario tasks, speaking aloud to give feedback on the interface and then complete a questionnaire. The tool was then evaluated in a pilot clinical evaluation in Tygerberg Hospital, Cape Town.After ethical approval and informed consent, 37 nurses and midwives evaluated the tool. During Study 1, major issues in the functionality of the touch-screen keyboard and date scroll wheels were identified (total errors n=212); during Study 2 major improvements in navigation of the app were suggested (total errors n=144). Overall, users felt the app was usable using the Computer Systems Usability Questionnaire; median (range) values for Study 1 = 2 (1-6) and Study 2 = 1 (1-7). To demonstrate feasibility, PotM was used by one research nurse for the pilot clinical study. In total, more than 500 evaluations were performed on more than 200 patients. The median (interquartile range) time to complete an evaluation was 4 min 55 sec (3 min 25 sec to 6 min 56 sec).By including target end-users in the design and evaluation of PotM, we have developed an app that can be easily integrated into health care settings in low- and middle-income countries. Usability problems were often related to mobile phone features (eg, scroll wheels, touch screen use). Larger scale evaluation of the clinical impact of this tool is underway.
| S-EPMC4417132 | biostudies-other
Project description:BackgroundFrailty is a geriatric syndrome characterized by chronic inflammation and metabolic insufficiency that creates vulnerability to poor outcomes with aging. We hypothesize that interventions which target common underlying mechanism of aging could ameliorate frailty. Ketone bodies are metabolites produced during fasting or on a ketogenic diet that have pleiotropic effects on inflammatory and metabolic aging pathways in laboratory animal models. Ketone esters (KEs) are compounds that induce ketosis without dietary changes, but KEs have not been studied in an older adult population. Our long-term goal is to examine if KEs modulate aging biology mechanisms and clinical outcomes relevant to frailty in older adults.ObjectivesThe primary objective of this randomized, placebo-controlled, double-blinded, parallel-group, pilot trial is to determine tolerability of 12-weeks of KE ingestion in a broad population of older adults (≥ 65 years). Secondary outcomes include safety and acute blood ketone kinetics. Exploratory outcomes include physical function, cognitive function, quality of life, aging biomarkers and inflammatory measures.MethodsCommunity-dwelling adults who are independent in activities of daily living, with no unstable acute medical conditions (n = 30) will be recruited. The study intervention is a KE or a taste, appearance, and calorie matched placebo beverage. Initially, acute 4-hour ketone kinetics after 12.5g or 25g of KE consumption will be assessed. After collection of baseline safety, functional, and biological measurements, subjects will randomly be allocated to consume KE 25g or placebo once daily for 12-weeks. Questionnaires will assess tolerability daily for 2-weeks, and then via phone interview at bi-monthly intervals. Safety assessments will be repeated at week 4. All measures will be repeated at week 12.ConclusionThis study will evaluate feasibility, tolerability, and safety of KE consumption in older adults and provide exploratory data across a range of aging-related endpoints. This data will inform design of larger trials to rigorously test KE effects on aging mechanisms and clinical outcomes relevant to frailty.
| S-EPMC11410252 | biostudies-literature