Dataset Information

The Healthy Pregnancy Research Program: transforming pregnancy research through a ResearchKit app.

ABSTRACT: Although maternal morbidity and mortality in the US is among the worst of developed countries, pregnant women have been under-represented in research studies, resulting in deficiencies in evidence-based guidance for treatment. There are over two billion smartphone users worldwide, enabling researchers to easily and cheaply conduct extremely large-scale research studies through smartphone apps, especially among pregnant women in whom app use is exceptionally high, predominantly as an information conduit. We developed the first pregnancy research app that is embedded within an existing, popular pregnancy app for self-management and education of expectant mothers. Through the large-scale and simplified collection of survey and sensor generated data via the app, we aim to improve our understanding of factors that promote a healthy pregnancy for both the mother and developing fetus. From the launch of this cohort study on 16 March 2017 through 17 December 2017, we have enrolled 2058 pregnant women from all 50 states. Our study population is diverse geographically and demographically, and fairly representative of US population averages. We have collected 14,045 individual surveys and 107,102 total daily measurements of sleep, activity, blood pressure, and heart rate during this time. On average, women stayed engaged in the study for 59 days and 45 percent who reached their due date filled out the final outcome survey. During the first 9 months, we demonstrated the potential for a smartphone-based research platform to capture an ever-expanding array of longitudinal, objective, and subjective participant-generated data from a continuously growing and diverse population of pregnant women.

SUBMITTER: Radin JM

PROVIDER: S-EPMC6550256 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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The Healthy Pregnancy Research Program: transforming pregnancy research through a ResearchKit app.

Radin Jennifer M JM Steinhubl Steven R SR Su Andrew I AI Bhargava Hansa H Greenberg Benjamin B Bot Brian M BM Doerr Megan M Topol Eric J EJ

NPJ digital medicine 20180905

Although maternal morbidity and mortality in the US is among the worst of developed countries, pregnant women have been under-represented in research studies, resulting in deficiencies in evidence-based guidance for treatment. There are over two billion smartphone users worldwide, enabling researchers to easily and cheaply conduct extremely large-scale research studies through smartphone apps, especially among pregnant women in whom app use is exceptionally high, predominantly as an information ...[more]

PMID: 31304325

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Project description: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).

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:BackgroundPreventing progression from prediabetes to diabetes-or slowing the progression of diabetes-is an urgent task worldwide. Previous studies have shown that mobile health (mHealth) may powerfully support self-management for patients with type 2 diabetes. Certainly, mHealth improves health care efficiency and gives patients convenient access to self-management of their own health. Many health care apps are available right now, and their use in clinical studies with large-scale real-life data is expected. However, the usage patterns of those apps-especially in the absence of intervention by medical professionals-remain unknown.ObjectiveWe developed GlucoNote, an app that uses Apple's ResearchKit to support self-management for patients with type 2 diabetes and prediabetes; the app does not require prescription or intervention by medical professionals. We evaluated its usage patterns via a remotely conducted study.MethodsiPhone users across Japan who have type 2 diabetes or prediabetes were free to download GlucoNote and to participate in the study after they provided consent electronically on the app. The 522 users who enrolled in the study within 1 year of its release were analyzed. We analyzed the retention rates of 357 participants who recorded at least 1 of 4 items-body weight, blood sugar, blood pressure, or dietary information. Characteristics of participants who used GlucoNote longer than 4 weeks (robust users) were compared with those of participants who did not (nonrobust users). The changes among robust users were evaluated.ResultsThe median observation and retention durations were 382 days (interquartile range [IQR] 275-423) and 8 days (IQR 1-63), respectively. The retention rates for 2 days and for 4, 8, and 12 weeks were 0.627 (95% CI 0.575-0.675), 0.353 (0.304-0.403), 0.272 (0.227-0.319), and 0.220 (0.179-0.265), respectively. Men were more likely to be robust users than women (P=.02). At week 0, robust users were more likely than nonrobust users to have a higher daily energy intake (median 1595 [IQR 1198-1788] kcal vs 1451 [IQR 769-1657] kcal; P=.04) and have higher daily step counts (median 6108 [IQR 3797-9227] vs 5171 [IQR 2885-7258]; P=.001). Among robust users, body weight decreased from weeks 0 to 4 (mean 71.3 [SD 14.1] kg to 70.8 [SD 13.9] kg; P=.002) by mean 0.6% (SD 1.6).ConclusionsGlucoNote offered a valuable opportunity to evaluate usage patterns of apps. Future challenges include improving low retention rates and evaluating their effects.

Project description:BackgroundThe patient-centered medical home (PCMH) model, an important component of healthcare transformation in the United States, is an approach to primary care delivery with the goal of improving population health and the patient care experience while reducing costs. PCMH research most often focuses on system level indicators including healthcare use and cost; descriptions of patient and provider experience with PCMH are relatively sparse and commonly limited in scope. This study, part of a mixed-methods evaluation of a multi-year New York State initiative to refine and expand the PCMH model, describes patient and provider experience with New York State PCMH and its key components.MethodsThe qualitative component of the evaluation included focus groups with patients of PCMH practices in 5 New York State counties (n = 9 groups and 67 participants) and interviews with providers and practice administrators at New York State PCMH practices (n = 9 interviews with 10 participants). Through these focus groups and interviews, we elicited first-person descriptions of experiences with, as well as perspectives on, key components of the New York State PCMH model, including accessibility, expanded use of electronic health records, integration of behavioral health care, and care coordination.ResultsThere was evident progress and some satisfaction with the PCMH model, particularly regarding integrated behavioral health and, to some extent, expanded use of electronic health records. There was less evident progress with respect to improved access and reasonable wait times, which caused patients to continue to use urgent care or the emergency department as substitutes for primary care.ConclusionsIt is critical to understand the strengths and limitations of the PCMH model, so as to continue to improve upon and promote it. Strengths of the model were evident to participants in this study; however, challenges were also described. It is important to note that these challenges are difficult to separate from wider healthcare system issues, including inadequate incentives for value-based care, and carry implications for PCMH and other models of healthcare delivery.

Project description:ABSTRACT A healthy diet during pregnancy has been associated with beneficial child and maternal health outcomes but is challenging to achieve. Recent technological advances offer new opportunities to support pregnant women in their food choices—for instance, via apps. This is already reflected by a wide availability of pregnancy-related apps, but health care professionals feel unsure about their potential. Therefore, the Dutch Google Play Store and Apple App Store were reviewed to identify existing apps on diet and pregnancy. App quality was assessed using the 1) Mobile App Rating Scale (MARS; i.e., assessing functionality, aesthetics, engagement, information quality), 2) Dutch dietary guidelines for pregnant women, and 3) App Behavior Change Scale (ABACUS). Fifty-seven unique apps were identified with an average star rating of 4.2 ± 0.6 and MARS quality score of 3.2 ± 0.3, indicating a moderate quality. Most apps scored best in terms of functionality and aesthetics (4.0 ± 0.4 and 3.3 ± 0.6), but lowest in terms of engagement (2.5 ± 0.6). Regarding nutrition information provision, most apps were incomplete or deviated from the Dutch guidelines. Folic acid supplementation (91%), hygiene (81%), caffeine (79%), and alcohol (77%) were the most commonly addressed nutrition aspects, whereas licorice (11%), iodine (19%), and soy (18%) were only addressed in a few apps. Moreover, a median of 2 out of 21 ABACUS behavior change items were identified per app, which were predominantly related to the category “knowledge and information.” Thus, despite the abundance of apps supporting a healthy diet during pregnancy in the Dutch app stores, there is an urgent need for apps with complete and scientifically sound dietary information that is supported by effective behavior change techniques. Evaluation of 57 diet-related pregnancy apps from Dutch app stores indicated that apps had moderate quality, contained basic dietary information with limited details, and implementation of behavior change techniques was limited.

Project description:BackgroundExcessive gestational weight gain (GWG) during pregnancy is a major public health concern associated with negative health outcomes for both mother and child. Scalable interventions are needed, and digital interventions have the potential to reach many women and promote healthy GWG. Most previous studies of digital interventions have been small pilot studies or have not included women from all BMI categories. We therefore examined the effectiveness of a smartphone app in a large sample (n=305) covering all BMI categories.ObjectiveTo investigate the effectiveness of a 6-month intervention (the HealthyMoms app) on GWG, body fatness, dietary habits, moderate-to-vigorous physical activity (MVPA), glycemia, and insulin resistance in comparison to standard maternity care.MethodsA 2-arm parallel randomized controlled trial was conducted. Women in early pregnancy at maternity clinics in Östergötland, Sweden, were recruited. Eligible women who provided written informed consent completed baseline measures, before being randomized in a 1:1 ratio to either an intervention (n=152) or control group (n=153). The control group received standard maternity care while the intervention group received the HealthyMoms smartphone app for 6 months (which includes multiple features, eg, information; push notifications; self-monitoring; and feedback features for GWG, diet, and physical activity) in addition to standard care. Outcome measures were assessed at Linköping University Hospital at baseline (mean 13.9 [SD 0.7] gestational weeks) and follow-up (mean 36.4 [SD 0.4] gestational weeks). The primary outcome was GWG and secondary outcomes were body fatness (Bod Pod), dietary habits (Swedish Healthy Eating Index) using the web-based 3-day dietary record Riksmaten FLEX, MVPA using the ActiGraph wGT3x-BT accelerometer, glycemia, and insulin resistance.ResultsOverall, we found no statistically significant effect on GWG (P=.62); however, the data indicate that the effect of the intervention differed by pre-pregnancy BMI, as women with overweight and obesity before pregnancy gained less weight in the intervention group as compared with the control group in the imputed analyses (-1.33 kg; 95% CI -2.92 to 0.26; P=.10) and completers-only analyses (-1.67 kg; 95% CI -3.26 to -0.09; P=.031]). Bayesian analyses showed that there was a 99% probability of any intervention effect on GWG among women with overweight and obesity, and an 81% probability that this effect was over 1 kg. The intervention group had higher scores for the Swedish Healthy Eating Index at follow-up than the control group (0.27; 95% CI 0.05-0.50; P=.017). We observed no statistically significant differences in body fatness, MVPA, glycemia, and insulin resistance between the intervention and control group at follow up (P≥.21).ConclusionsAlthough we found no overall effect on GWG, our results demonstrate the potential of a smartphone app (HealthyMoms) to promote healthy dietary behaviors as well as to decrease weight gain during pregnancy in women with overweight and obesity.Trial registrationClinicalTrials.gov NCT03298555; https://clinicaltrials.gov/ct2/show/NCT03298555.International registered report identifier (irrid)RR2-10.2196/13011.

Dataset Information

The Healthy Pregnancy Research Program: transforming pregnancy research through a ResearchKit app.

Publications

The Healthy Pregnancy Research Program: transforming pregnancy research through a ResearchKit app.

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