Dataset Information

International ResearchKit App for Women with Menstrual Pain: Development, Access, and Engagement.

ABSTRACT: BACKGROUND:Primary dysmenorrhea is a common condition in women of reproductive age. A previous app-based study undertaken by our group demonstrated that a smartphone app supporting self-acupressure introduced by a health care professional can reduce menstrual pain. OBJECTIVE:This study aims to evaluate whether a specific smartphone app is effective in reducing menstrual pain in 18- to 34-year-old women with primary dysmenorrhea in a self-care setting. One group of women has access to the full-featured study app and will be compared with 2 control groups who have access to fewer app features. Here, we report the trial design, app development, user access, and engagement. METHODS:On the basis of the practical implications of the previous app-based study, we revised and reengineered the study app and included the ResearchKit (Apple Inc) framework. Behavior change techniques (BCTs) were implemented in the app and validated by expert ratings. User access was estimated by assessing recruitment progress over time. User evolution and baseline survey respondent rate were assessed to evaluate user engagement. RESULTS:The development of the study app for a 3-armed randomized controlled trial required a multidisciplinary team. The app is accessible for the target population free of charge via the Apple App Store. In Germany, within 9 months, the app was downloaded 1458 times and 328 study participants were recruited using it without external advertising. A total of 98.27% (5157/5248) of the app-based baseline questions were answered. The correct classification of BCTs used in the app required psychological expertise. CONCLUSIONS:Conducting an innovative app study requires multidisciplinary effort. Easy access and engagement with such an app can be achieved by recruitment via the App Store. Future research is needed to investigate the determinants of user engagement, optimal BCT application, and potential clinical and self-care scenarios for app use. TRIAL REGISTRATION:ClinicalTrials.gov NCT03432611; https://clinicaltrials.gov/ct2/show/NCT03432611 (Archived by WebCite at http://www.webcitation.org/75LLAcnCQ).

SUBMITTER: Wang J

PROVIDER: S-EPMC7055820 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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International ResearchKit App for Women with Menstrual Pain: Development, Access, and Engagement.

Wang Jiani J Rogge Alizé A AA Armour Mike M Smith Caroline A CA D'Adamo Christopher R CR Pischke Claudia R CR Yen Hung-Rong HR Wu Mei-Yao MY Moré Ari Ojeda Ocampo AOO Witt Claudia M CM Pach Daniel D

JMIR mHealth and uHealth 20200211 2

<h4>Background</h4>Primary dysmenorrhea is a common condition in women of reproductive age. A previous app-based study undertaken by our group demonstrated that a smartphone app supporting self-acupressure introduced by a health care professional can reduce menstrual pain.<h4>Objective</h4>This study aims to evaluate whether a specific smartphone app is effective in reducing menstrual pain in 18- to 34-year-old women with primary dysmenorrhea in a self-care setting. One group of women has access ...[more]

PMID: 32058976

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Project description:BackgroundThe lack of noninvasive methods to study dysmenorrhea has resulted in poor understanding of the mechanisms underlying pain, insufficient diagnostic tests, and limited treatment options. To address this knowledge gap, we have developed a magnetic resonance imaging-based strategy for continuously monitoring the uterus in relationship to participants' spontaneous pain perception.ObjectiveThe study objective was to evaluate whether magnetic resonance imaging can detect real-time changes in myometrial activity during cramping episodes in women with dysmenorrhea, with a handheld squeeze bulb for pain reporting.Study designSixteen women with dysmenorrhea and 10 healthy control women both on and off their menses were evaluated with magnetic resonance imaging while not taking analgesic medication. Continuous magnetic resonance imaging was acquired using half-Fourier acquisition single-shot turbo spin echo sequence along with simultaneous reporting of pain severity with a squeeze bulb. Pearson's coefficient was used to compare results between reviewers. Proportional differences between women with dysmenorrhea and controls on/off menses were evaluated with a Fisher exact test. The temporal relationships between signal changes were evaluated with Monte Carlo simulations.ResultsSpontaneous progressive decreases in myometrial signal intensity were more frequently observed in women on their menses than in the absence of pain in the same women off their menses or participants without dysmenorrhea (P < .01). Women without reductions in myometrial signal intensity on their menses either had a history of endometriosis or were not in pain. Observations of myometrial events were consistently reported between 2 raters blinded to menstrual pain or day status (r = 0.97, P < .001). Episodes of cramping occurred either immediately before or 32-70 seconds after myometrial signal change onset (P < .05).ConclusionTransient decreases in myometrial uterine T2-weighted signal intensity can be reliably measured in women with menstrual pain. The directionality of signal change and temporal relationship to pain onset suggest that cramping pain may be caused by a combination of uterine pressure and hemodynamic dysfunction.

Project description:BackgroundChildhood obesity is an ongoing problem in developed countries that needs targeted prevention in the youngest age groups. Children in socioeconomically disadvantaged families are most at risk. Mobile health (mHealth) interventions offer a potential route to target these families because of its relatively low cost and high reach. The Growing healthy program was developed to provide evidence-based information on infant feeding from birth to 9 months via app or website. Understanding user engagement with these media is vital to developing successful interventions. Engagement is a complex, multifactorial concept that needs to move beyond simple metrics.ObjectiveThe aim of our study was to describe the development of an engagement index (EI) to monitor participant interaction with the Growing healthy app. The index included a number of subindices and cut-points to categorize engagement.MethodsThe Growing program was a feasibility study in which 300 mother-infant dyads were provided with an app which included 3 push notifications that was sent each week. Growing healthy participants completed surveys at 3 time points: baseline (T1) (infant age ≤3 months), infant aged 6 months (T2), and infant aged 9 months (T3). In addition, app usage data were captured from the app. The EI was adapted from the Web Analytics Demystified visitor EI. Our EI included 5 subindices: (1) click depth, (2) loyalty, (3) interaction, (4) recency, and (5) feedback. The overall EI summarized the subindices from date of registration through to 39 weeks (9 months) from the infant's date of birth. Basic descriptive data analysis was performed on the metrics and components of the EI as well as the final EI score. Group comparisons used t tests, analysis of variance (ANOVA), Mann-Whitney, Kruskal-Wallis, and Spearman correlation tests as appropriate. Consideration of independent variables associated with the EI score were modeled using linear regression models.ResultsThe overall EI mean score was 30.0% (SD 11.5%) with a range of 1.8% - 57.6%. The cut-points used for high engagement were scores greater than 37.1% and for poor engagement were scores less than 21.1%. Significant explanatory variables of the EI score included: parity (P=.005), system type including "app only" users or "both" app and email users (P<.001), recruitment method (P=.02), and baby age at recruitment (P=.005).ConclusionsThe EI provided a comprehensive understanding of participant behavior with the app over the 9-month period of the Growing healthy program. The use of the EI in this study demonstrates that rich and useful data can be collected and used to inform assessments of the strengths and weaknesses of the app and in turn inform future interventions.

Project description:BackgroundUsing smartphones to enroll, obtain consent, and gather self-reported data from patients has the potential to enhance our understanding of disease burden and quantify physiological impact in the real world. It may also be possible to harness integral smartphone sensors to facilitate remote collection of clinically relevant data.ObjectiveWe conducted the Patient Rheumatoid Arthritis Data From the Real World (PARADE) observational study using a customized ResearchKit app with a bring-your-own-device approach. Our objective was to assess the feasibility of using an entirely digital approach (social media and smartphone app) to conduct a real-world observational study of patients with rheumatoid arthritis.MethodsWe conducted this observational study using a customized ResearchKit app with a bring-your-own-device approach. To recruit patients, the PARADE app, designed to guide patients through a series of tasks, was publicized via social media platforms and made available for patients in the United States to download from the Apple App Store. We collected patient-reported data, such as medical history, rheumatoid arthritis-related medications (past and present), and a range of patient-reported outcome measures. We included in the assessment a joint-pain map and a novel objective assessment of wrist range of movement, measured by the smartphone-embedded gyroscope and accelerometer.ResultsWithin 1 month of recruitment via social media campaigns, 399 participants self-enrolled, self-consented, and provided complete demographic data. Joint pain was the most frequently reported rheumatoid arthritis symptom to bother study participants (344/393, 87.5%). Severe patient-reported wrist pain appeared to be inversely linked with the range of wrist movement measured objectively by the app. At study entry, 292 of 399 participants (73.2%) indicated a preference for participating in a mobile app-based study. The number of participants in the study declined to 45 of 399 (11.3%) at week 12.ConclusionsDespite the declining number of participants over time, the combination of social media and smartphone app with sensor integration was a feasible and cost-effective approach for the collection of patient-reported data in rheumatoid arthritis. Integral sensors within smartphones can be harnessed to provide novel end points, and the novel wrist range of movement test warrants further clinical validation.

Project description:Pain is one of the most prevalent health-related concerns and is among the top 3 most common reasons for seeking medical help. Scientific publications of data collected from pain tracking and monitoring apps are important to help consumers and healthcare professionals select the right app for their use.The main objectives of this paper were to (1) discover user engagement patterns of the pain management app, Manage My Pain, using data mining methods; and (2) identify the association between several attributes characterizing individual users and their levels of engagement.User engagement was defined by 2 key features of the app: longevity (number of days between the first and last pain record) and number of records. Users were divided into 5 user engagement clusters employing the k-means clustering algorithm. Each cluster was characterized by 6 attributes: gender, age, number of pain conditions, number of medications, pain severity, and opioid use. Z tests and chi-square tests were used for analyzing categorical attributes. Effects of gender and cluster on numerical attributes were analyzed using 2-way analysis of variances (ANOVAs) followed up by pairwise comparisons using Tukey honest significant difference (HSD).The clustering process produced 5 clusters representing different levels of user engagement. The proportion of males and females was significantly different in 4 of the 5 clusters (all P ≤.03). The proportion of males was higher than females in users with relatively high longevity. Mean ages of users in 2 clusters with high longevity were higher than users from other 3 clusters (all P <.001). Overall, males were significantly older than females (P <.001). Across clusters, females reported more pain conditions than males (all P <.001). Users from highly engaged clusters reported taking more medication than less engaged users (all P <.001). Females reported taking a greater number of medications than males (P =.04). In 4 of 5 clusters, the percentage of males taking an opioid was significantly greater (all P ≤.05) than that of females. The proportion of males with mild pain was significantly higher than that of females in 3 clusters (all P ≤.008).Although most users of the app reported being female, male users were more likely to be highly engaged in the app. Users in the most engaged clusters self-reported a higher number of pain conditions, a higher number of current medications, and a higher incidence of opioid usage. The high engagement by males in these clusters does not appear to be driven by pain severity which may, in part, be the case for females. Use of a mobile pain app may be relatively more attractive to highly-engaged males than highly-engaged females, and to those with relatively more complex chronic pain problems.

Project description:Menstrual hygiene management (MHM) practices vary worldwide and depend on the individual's socioeconomic status, personal preferences, local traditions and beliefs, and access to water and sanitation resources. MHM practices can be particularly unhygienic and inconvenient for girls and women in poorer settings. Little is known about whether unhygienic MHM practices increase a woman's exposure to urogenital infections, such as bacterial vaginosis (BV) and urinary tract infection (UTI). This study aimed to determine the association of MHM practices with urogenital infections, controlling for environmental drivers. A hospital-based case-control study was conducted on 486 women at Odisha, India. Cases and controls were recruited using a syndromic approach. Vaginal swabs were collected from all the participants and tested for BV status using Amsel's criteria. Urine samples were cultured to assess UTI status. Socioeconomic status, clinical symptoms and reproductive history, and MHM and water and sanitation practices were obtained by standardised questionnaire. A total of 486 women were recruited to the study, 228 symptomatic cases and 258 asymptomatic controls. Women who used reusable absorbent pads were more likely to have symptoms of urogenital infection (AdjOR=2.3, 95%CI1.5-3.4) or to be diagnosed with at least one urogenital infection (BV or UTI) (AdjOR=2.8, 95%CI1.7-4.5), than women using disposable pads. Increased wealth and space for personal hygiene in the household were protective for BV (AdjOR=0.5, 95%CI0.3-0.9 and AdjOR=0.6, 95%CI0.3-0.9 respectively). Lower education of the participants was the only factor associated with UTI after adjusting for all the confounders (AdjOR=3.1, 95%CI1.2-7.9). Interventions that ensure women have access to private facilities with water for MHM and that educate women about safer, low-cost MHM materials could reduce urogenital disease among women. Further studies of the effects of specific practices for managing hygienically reusable pads and studies to explore other pathogenic reproductive tract infections are needed.

Project description:BACKGROUND:There is increasing information characterizing menstrual cycle length in women, but less information is available on the potential differences across lifestyle variables. OBJECTIVE:This study aimed to describe differences in menstrual cycle length, variability, and menstrual phase across women of different ages and BMI among a global cohort of Flo app users. We have also reported on demographic and lifestyle characteristics across median cycle lengths. METHODS:The analysis was run based on the aggregated anonymized dataset from a menstrual cycle tracker and ovulation calendar that covers all phases of the reproductive cycle. Self-reported information is documented, including demographics, menstrual flow and cycle length, ovulation information, and reproductive health and diseases. Data from women aged ?18 years and who had logged at least three cycles (ie, 2 completed cycles and 1 current cycle) in the Flo app were included (1,579,819 women). RESULTS:Of the 1.5 million users, approximately half (638,683/1,579,819, 40.42%) were aged between 18 and 24 years. Just over half of those reporting BMIs were in the normal range (18.5-24.9 kg/m2; 202,420/356,598, 56.76%) and one-third were overweight or obese (>25 kg/m2; 120,983/356,598, 33.93%). A total of 16.32% (257,889/1,579,819) of women had a 28-day median cycle length. There was a higher percentage of women aged ?40 years who had a 27-day median cycle length than those aged between 18 and 24 years (22,294/120,612, 18.48% vs 60,870/637,601, 9.55%), but a lower percentage with a 29-day median cycle length (10,572/120,612, 8.77% vs 79,626/637,601, 12.49%). There were a higher number of cycles with short luteal phases in younger women, whereas women aged ?40 years had a higher number of cycles with longer luteal phases. Median menstrual cycle length and the length of the follicular and luteal phases were not remarkably different with increasing BMI, except for the heaviest women at a BMI of ?50 kg/m2. CONCLUSIONS:On a global scale, we have provided extensive evidence on the characteristics of women and their menstrual cycle length and patterns across different age and BMI groups. This information is necessary to support updates of current clinical guidelines around menstrual cycle length and patterns for clinical use in fertility programs.

Project description:BackgroundChronic pain imposes a large burden on individuals and society. A patient-centric digital chronic pain management app called Manage My Pain (MMP) can be used to enhance communication between providers and patients and promote self-management.ObjectiveThe purpose of this study was to evaluate the real-world engagement of patients in urban and rural settings in Ontario, Canada with the MMP app alongside their standard of care and assess the impact of its usage on clinical outcomes of pain and related mental health.MethodsA total of 246 participants with chronic pain at a rural and 2 urban pain clinics were recruited into this prospective, open-label, exploratory study that compared the use of MMP, a digital health app for pain that incorporates validated questionnaires and provides patients with summarized reports of their progress in combination with standard care (app group), against data entered on paper-based questionnaires (nonapp group). Participants completed validated questionnaires on anxiety, depression, pain catastrophizing, satisfaction, and daily opioid consumption up to 4.5 months after the initial visit (short-term follow-up) and between 4.5 and 7 months after the initial visit (long-term follow-up). Engagement and clinical outcomes were compared between participants in the two groups.ResultsA total of 73.6% (181/246) of the participants agreed to use the app, with 63.4% (111/175) of them using it for at least one month. Individuals who used the app rated lower anxiety (reduction in Generalized Anxiety Disorder 7-item questionnaire score by 2.10 points, 95% CI -3.96 to -0.24) at short-term follow-up and had a greater reduction in pain catastrophizing (reduction in Pain Catastrophizing Scale score by 5.23 points, 95% CI -9.55 to -0.91) at long-term follow-up relative to patients with pain who did not engage with the MMP app.ConclusionsThe use of MMP by patients with chronic pain is associated with engagement and improvements in self-reported anxiety and pain catastrophizing. Further research is required to understand factors that impact continued engagement and clinical outcomes in patients with chronic pain.Trial registrationClinicalTrials.gov NCT04762329; https://clinicaltrials.gov/ct2/show/NCT04762329.

Dataset Information

International ResearchKit App for Women with Menstrual Pain: Development, Access, and Engagement.

Publications

International ResearchKit App for Women with Menstrual Pain: Development, Access, and Engagement.

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