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Enhancing Diabetes Self-Management Through Collection and Visualization of Data From Multiple Mobile Health Technologies: Protocol for a Development and Feasibility Trial.

ABSTRACT: BACKGROUND:Self-management is integral for control of type 2 diabetes mellitus (T2DM). Patient self-management is improved when they receive real-time information on their health status and behaviors and ongoing facilitation from health professionals. However, timely information for these behaviors is notably absent in the health care system. Providing real-time data could help improve patient understanding of the dynamics of their illness and assist clinicians in developing targeted approaches to improve health outcomes and in delivering personalized care when and where it is most needed. Mobile technologies (eg, wearables, apps, and connected scales) have the potential to make these patient-provider interactions a reality. What strategies might best help patients overcome self-management challenges using self-generated diabetes-related data? How might clinicians effectively guide patient self-management with the advantage of real-time data? OBJECTIVE:This study aims to describe the protocol for an ongoing study (June 2016-May 2019) that examines trajectories of symptoms, health behaviors, and associated challenges among individuals with T2DM utilizing multiple mobile technologies, including a wireless body scale, wireless glucometer, and a wrist-worn accelerometer over a 6-month period. METHODS:We are conducting an explanatory sequential mixed methods study of 60 patients with T2DM recruited from a primary care clinic. Patients were asked to track relevant clinical data for 6 months using a wireless body scale, wireless glucometer, a wrist-worn accelerometer, and a medication adherence text message (short message service, SMS) survey. Data generated from the devices were then analyzed and visualized. A subset of patients is currently being interviewed to discuss their challenges and successes in diabetes self-management, and they are being shown visualizations of their own data. Following the data collection period, we will conduct interviews with study clinicians to explore ways in which they might collaborate with patients. RESULTS:This study has received regulatory approval. Patient enrollment ongoing with a sample size of 60 patients is complete, and up to 20 clinicians will be enrolled. At the patient level, data collection is complete, but data analysis is pending. At the clinician level, data collection is currently ongoing. CONCLUSIONS:This study seeks to expand the use of mobile technologies to generate real-time data to enhance self-management strategies. It also seeks to obtain both patient and provider perspectives on using real-time data to develop algorithms for software that will facilitate real-time self-management strategies. We expect that the findings of this study will offer important insight into how to support patients and providers using real-time data to manage a complex chronic illness. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/13517.

SUBMITTER: Shaw RJ

PROVIDER: S-EPMC6746071 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Enhancing Diabetes Self-Management Through Collection and Visualization of Data From Multiple Mobile Health Technologies: Protocol for a Development and Feasibility Trial.

Shaw Ryan J RJ Barnes Angel A Steinberg Dori D Vaughn Jacqueline J Diane Anna A Levine Erica E Vorderstrasse Allison A Crowley Matthew J MJ Wood Eleanor E Hatch Daniel D Lewinski Allison A Jiang Meilin M Stevenson Janee J Yang Qing Q

JMIR research protocols 20190603 6

<h4>Background</h4>Self-management is integral for control of type 2 diabetes mellitus (T2DM). Patient self-management is improved when they receive real-time information on their health status and behaviors and ongoing facilitation from health professionals. However, timely information for these behaviors is notably absent in the health care system. Providing real-time data could help improve patient understanding of the dynamics of their illness and assist clinicians in developing targeted app ...[more]

PMID: 31162127

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Project description:BackgroundPast mobile health (mHealth) efforts to empower type 2 diabetes (T2D) self-management include portals, text messaging, collection of biometric data, electronic coaching, email, and collection of lifestyle information.ObjectiveThe primary objective was to enhance patient activation and self-management of T2D using the US Department of Defense's Mobile Health Care Environment (MHCE) in a patient-centered medical home setting.MethodsA multisite study, including a user-centered design and a controlled trial, was conducted within the US Military Health System. Phase I assessed preferences regarding the enhancement of the enabling technology. Phase II was a single-blinded 12-month feasibility study that randomly assigned 240 patients to either the intervention (n=123, received mHealth technology and behavioral messages tailored to Patient Activation Measure [PAM] level at baseline) or the control group (n=117, received equipment but not messaging. The primary outcome measure was PAM scores. Secondary outcome measures included Summary of Diabetes Self-Care Activities (SDSCA) scores and cardiometabolic outcomes. We used generalized estimating equations to estimate changes in outcomes.ResultsThe final sample consisted of 229 patients. Participants were 61.6% (141/229) male, had a mean age of 62.9 years, mean glycated hemoglobin (HbA1c) of 7.5%, mean BMI of 32.7, and a mean duration of T2D diagnosis of 9.8 years. At month 12, the control group showed significantly greater improvements compared with the intervention group in PAM scores (control mean 7.49, intervention mean 1.77; P=.007), HbA1c (control mean -0.53, intervention mean -0.11; P=.006), and low-density lipoprotein cholesterol (control mean -7.14, intervention mean 4.38; P=.01). Both groups showed significant improvement in SDSCA, BMI, waist size, and diastolic blood pressure; between-group differences were not statistically significant. Except for patients with the highest level of activation (PAM level 4), intervention group patients exhibited significant improvements in PAM scores. For patients with the lowest level of activation (PAM level 1), the intervention group showed significantly greater improvement compared with the control group in HbA1c (control mean -0.09, intervention mean -0.52; P=.04), BMI (control mean 0.58, intervention mean -1.22; P=.01), and high-density lipoprotein cholesterol levels (control mean -4.86, intervention mean 3.56; P<.001). Significant improvements were seen in AM scores, SDSCA, and waist size for both groups and in diastolic and systolic blood pressure for the control group; the between-group differences were not statistically significant. The percentage of participants who were engaged with MHCE for ≥50% of days period was 60.7% (68/112; months 0-3), 57.4% (62/108; months 3-6), 49.5% (51/103; months 6-9), and 43% (42/98; months 9-12).ConclusionsOur study produced mixed results with improvement in PAM scores and outcomes in both the intervention and control groups. Structural design issues may have hampered the influence of tailored behavioral messaging within the intervention group.Trial registrationClinicalTrials.gov NCT02949037; https://clinicaltrials.gov/ct2/show/NCT02949037.International registered report identifier (irrid)RR2-10.2196/resprot.6993.

Project description:BACKGROUND:Mobile interventions hold promise as an intervention modality to engage children in improving diabetes self-management education, attitudes, and behaviors. OBJECTIVE:This pilot study aimed to explore the usability, acceptability, and feasibility of delivering a mobile diabetes educational tool to parent-child pairs in a clinical setting. METHODS:This mixed methods pilot study comprised two concurrent phases with differing study participants. Phase 1 used user testing interviews to collect qualitative data on the usability and acceptability of the tool. Phase 2 used a single-arm pre- and poststudy design to quantitatively evaluate the feasibility and preliminary efficacy of the intervention. Study participants (English-speaking families with youth aged 5-14 years with insulin-dependent diabetes) were recruited from an urban hospital in Massachusetts, United States. In phase 1, parent-child pairs were invited to complete the intervention together and participate in 90-min user testing interviews assessing the tool's usability and acceptability. Interview transcripts were analyzed using a directed content analysis approach. In phase 2, parent-child pairs were invited to complete the intervention together in the clinical setting. Measures included parental and child knowledge, attitudes, and behaviors related to diabetes management (self-report surveys) and child hemoglobin A1c levels (medical record extractions); data were collected at baseline and 1-month follow-up. Pre- and postoutcomes were compared using paired t tests and the Fisher exact test. RESULTS:A total of 11 parent-child pairs (N=22) participated in phase 1 of the study, and 10 parent-child pairs (N=20) participated in phase 2 of the study. Participants viewed the mobile educational tool as acceptable (high engagement and satisfaction with the layout, activities, and videos) and identified the areas of improvement for tool usability (duration, directions, and animation). CONCLUSIONS:The findings from this pilot study suggest that the mobile educational tool is an informative, engaging, and feasible way to deliver diabetes self-management education to parents and children in an urban hospital setting. Data will inform future iterations of this mobile diabetes educational intervention to improve usability and test intervention efficacy.

Project description:AimThis study will test the feasibility and effectiveness of mobile technology intervention on the patients' self-management of oral anticancer medication. Secondary objectives include acceptability, the usefulness of text messages, and satisfaction by participants and nurses.MethodsThis prospective two-arm study will recruit patients (N = 220) with metastatic breast cancer and initiating treatment with palbociclib (Ibrance ®). Allowing for attrition, patients will be randomized into the control (N = 100) or intervention (N = 100) group. Unidirectional text message reminders will be sent during the treatment cycle through a secure web application using the patient's smartphone. Self-reported survey responses will be collected at three time points; at consent, end of treatment cycles, and the follow-up clinic visit and include a demographic questionnaire, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Post study questionnaire and the R-15 Patient Satisfaction Questionnaire. Nurses providing care for study patients will complete the Adaptation of Stamps Nurse Workload questionnaire. Data will be analysed an intent-to-treat analysis comparing the two arms. Study approval was obtained in December 2019 and funded in January 2020.DiscussionSmartphones are globally available and have text messaging capability which is increasingly being used as an intervention in healthcare studies. This study will test a low-cost, nurse-led intervention that enhances the patient's experience with oral anti-cancer medications, improves access to care, reduces costs, and improves the satisfaction of nurses caring for oncology patients.ImpactDespite the ease of administering oral anti-cancer medications, oncology patients maynot take them as prescribed and consequently, these factors affect patient outcomes and disease control. Given the importance of taking oral anti-cancer medications and the difficulties patients experience in achieving it, the effective use of mobile technology interventions can actively engage patients in their care and improve medication self-management of anticancer treatment regimens.

Project description:BACKGROUND:Patients with diabetes lack information on which commercially available applications (apps) improve diabetes-related outcomes. We conducted a rapid evidence review to examine features, clinical efficacy, and usability of apps for self-management of type 1 and type 2 diabetes in adults. METHODS:Ovid/Medline and the Cochrane Database of Systematic Reviews were searched for systematic reviews and technology assessments. Reference lists of relevant systematic reviews were examined for primary studies. Additional searches for primary studies were conducted online, through Ovid/Medline, Embase, CINAHL, and ClinicalTrials.gov . Studies were evaluated for eligibility based on predetermined criteria, data were extracted, study quality was assessed using a risk of bias tool, information on app features was collected, and app usability was assessed. Results are summarized qualitatively. RESULTS:Fifteen articles evaluating 11 apps were identified: six apps for type 1 and five apps for type 2 diabetes. Common features of apps included setting reminders and tracking blood glucose and hemoglobin A1c (HbA1c), medication use, physical activity, and weight. Compared with controls, use of eight apps, when paired with support from a healthcare provider or study staff, improved at least one outcome, most often HbA1c. Patients did not experience improvements in quality of life, blood pressure, or weight, regardless of app used or type of diabetes. Study quality was variable. Of the eight apps available for usability testing, two were scored "acceptable," three were "marginal," and three were "not acceptable." DISCUSSION:Limited evidence suggests that use of some commercially available apps, when combined with additional support from a healthcare provider or study staff, may improve some short-term diabetes-related outcomes. The impact of these apps on longer-term outcomes is unclear. More rigorous and longer-term studies of apps are needed. REGISTRATION:This review was funded by the Agency for Healthcare Research and Quality (AHRQ). The protocol is available at: http://www.effectivehealthcare.ahrq.gov/topics/diabetes-mobile-devices/research-protocol .

Project description:BACKGROUND:Patients with type 2 diabetes mellitus (T2DM) struggle with the management of their condition due to difficulty relating lifestyle behaviors with glycemic control. While self-monitoring of blood glucose (SMBG) has proven to be effective for those treated with insulin, it has been shown to be less beneficial for those only treated with oral medications or lifestyle modification. We hypothesized that the effective self-management of non-insulin treated T2DM requires a behavioral intervention that empowers patients with the ability to self-monitor, understand the impact of lifestyle behaviors on glycemic control, and adjust their self-care based on contextualized SMBG data. OBJECTIVE:The primary objective of this randomized controlled trial (RCT) is to determine the impact of bant2, an evidence-based, patient-centered, behavioral mobile app intervention, on the self-management of T2DM. Our second postulation is that automated feedback delivered through the mobile app will be as effective, less resource intensive, and more scalable than interventions involving additional health care provider feedback. METHODS:This study is a 12-month, prospective, multicenter RCT in which 150 participants will be randomly assigned to one of two groups: the control group will receive current standard of care, and the intervention group will receive the mobile phone app system in addition to standard of care. The primary outcome measure is change in glycated hemoglobin A1c from baseline to 12 months. RESULTS:The first patient was enrolled on July 28, 2015, and we anticipate completing this study by September, 2018. CONCLUSIONS:This RCT is one of the first to evaluate an evidence-based mobile app that focuses on facilitating lifestyle behavior change driven by contextualized and structured SMBG. The results of this trial will provide insights regarding the usage of mobile tools and consumer-grade devices for diabetes self-care, the economic model of using incentives to motivate behavior change, and the consumption of test strips when following a rigorously structured approach for SMBG. TRIAL REGISTRATION:ClinicalTrials.gov NCT02370719; https://clinicaltrials.gov/ct2/show/NCT02370719 (Archived at http://www.webcitation.org/6jpyjfVRs).

Dataset Information

Enhancing Diabetes Self-Management Through Collection and Visualization of Data From Multiple Mobile Health Technologies: Protocol for a Development and Feasibility Trial.

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Enhancing Diabetes Self-Management Through Collection and Visualization of Data From Multiple Mobile Health Technologies: Protocol for a Development and Feasibility Trial.

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