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A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial.

ABSTRACT: While optimal blood glucose control is known to reduce the long-term complications associated with type 1 diabetes mellitus, adolescents often struggle to achieve their blood glucose targets. However, their strong propensity toward technology presents a unique opportunity for the delivery of novel self-management interventions. To support type 1 diabetes self-management in this population, we developed the diabetes self-management app bant, which included wireless blood glucose reading transfer, out-of-range blood glucose trend alerts, coaching around out-of-range trend causes and fixes, and a point-based incentive system.The primary objective was to evaluate bant 's effect on hemoglobin A1c (HbA1c) through a randomized controlled trial (RCT). Secondary measures (eg, self-monitoring of blood glucose [SMBG]) were also collected to assess bant 's impact on the self-management behaviors of adolescents with type 1 diabetes.We enrolled 92 adolescents into a 12-month RCT, with 46 receiving usual care and 46 receiving usual care plus bant. Clinical outcome data were collected at quarterly research visits via validated tools, electronic chart review, glucometer downloads, and semistructured interviews. App satisfaction was assessed at 6 and 12 months, and at trial end, users ranked bant components based on perceived usefulness. Mobile analytics captured frequency of blood glucose uploads, which were used to categorize participants into high, moderate, low, or very low engagement levels.Linear mixed models showed no changes in primary and secondary clinical outcomes. However, exploratory regression analysis demonstrated a statistically significant association between increased SMBG and improved HbA1c in the intervention group. For a subgroup of bant users taking SMBG ?5 daily, there was a significant improvement in HbA1c of 0.58% (P=.02), while the parallel subgroup in the control arm experienced no significant change in HbA1c (decrease of 0.06%, P=.84). Although app usage did diminish over the trial, on average, 35% (16/46 participants) were classified as moderately or highly engaged (uploaded SMBG ?3 days a week) over the 12 months.Although primary analysis of clinical outcomes did not demonstrate differences between the bant and control groups, exploratory analysis suggested that bant may positively impact the use of SMBG data and glycemic control among youth. The next generation of bant will aim to remove barriers to use, such as deploying the app directly to personal devices instead of secondary research phones, and to explore the utility of integrating bant into routine clinical care to facilitate more frequent feedback. Future evaluations of mHealth apps should consider more robust research tools (eg, ResearchKit) and alternative RCT study designs to enable more rapid and iterative evaluations, better suited to the nature of rapidly evolving consumer technology.ClinicalTrials.gov NCT01899274; https://clinicaltrials.gov/ct2/show/NCT01899274 (Archived by WebCite at http://www.webcitation.org/6qWrqF1yw).

SUBMITTER: Goyal S

PROVIDER: S-EPMC5495971 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial.

Goyal Shivani S Goyal Shivani S Nunn Caitlin A CA Rotondi Michael M Couperthwaite Amy B AB Reiser Sally S Simone Angelo A Katzman Debra K DK Cafazzo Joseph A JA Palmert Mark R MR

JMIR mHealth and uHealth 20170619 6

<h4>Background</h4>While optimal blood glucose control is known to reduce the long-term complications associated with type 1 diabetes mellitus, adolescents often struggle to achieve their blood glucose targets. However, their strong propensity toward technology presents a unique opportunity for the delivery of novel self-management interventions. To support type 1 diabetes self-management in this population, we developed the diabetes self-management app bant, which included wireless blood glucos ...[more]

PMID: 28630037

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Project description:BackgroundAs the increasing prevalence of type 2 diabetes mellitus has put pressure on health systems to appropriately manage these patients, there have been a growing number of mobile apps designed to improve the self-management of diabetes. One such app, BlueStar, has been shown to significantly reduce hemoglobin A1c (HbA1c) levels in small studies and is the first app in the United States to receive Food and Drug Administration approval as a mobile prescription therapy. However, the impact of the app across real-world population among different clinical sites and health systems remains unclear.ObjectiveThe primary objective of this study was to conduct a pragmatic randomized controlled trial of the BlueStar mobile app to determine if app usage leads to improved HbA1c levels among diverse participants in real-life clinical contexts. We hypothesized that this mobile app would improve self-management and HbA1c levels compared with controls.MethodsThe study consisted of a multicenter pragmatic randomized controlled trial. Overall, 110 participants randomized to the immediate treatment group (ITG) received the intervention for 6 months, and 113 participants randomized to the wait-list control (WLC) group received usual care for the first 3 months and then received the intervention for 3 months. The primary outcome was glucose control measured by HbA1c levels at 3 months. Secondary outcomes assessed intervention impact on patient self-management, experience of care, and self-reported health utilization using validated scales, including the Problem Areas in Diabetes, the Summary of Diabetes Self-Care Activities, and the EuroQol-5D. Intervention usage data were collected directly from the app.ResultsThe results of an analysis of covariance controlling for baseline HbA1c levels did not show evidence of intervention impact on HbA1c levels at 3 months (mean difference [ITG-WLC] -0.42, 95% CI -1.05 to 0.21; P=.19). Similarly, there was no intervention effect on secondary outcomes measuring diabetes self-efficacy, quality of life, and health care utilization behaviors. An exploratory analysis of 57 ITG participants investigating the impact of app usage on HbA1c levels showed that each additional day of app use corresponded with a 0.016-point decrease in participants' 3-month HbA1c levels (95% CI -0.03 to -0.003). App usage varied significantly by site, as participants from 1 site logged in to the app a median of 36 days over 14 weeks (interquartile range [IQR] 10.5-124); those at another site used the app significantly less (median 9; IQR 6-51).ConclusionsThe results showed no difference between intervention and control arms for the primary clinical outcome of glycemic control measured by HbA1c levels. Although there was low usage of the app among participants, results indicate contextual factors, particularly site, had a significant impact on overall usage. Future research into the patient and site-specific factors that increase app utilization are needed.Trial registrationClinicaltrials.gov NCT02813343; https://clinicaltrials.gov/ct2/show/NCT02813343 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02813343).

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).

Project description:BackgroundHealth literacy is a critically important skill that helps people become active participants in their health care. Multiple studies in the United States and across the world have documented the association of health literacy with multiple health outcomes. In particular, the elderly and many members of minority groups have been shown to have low levels of health literacy; the same groups are disproportionately affected by chronic illnesses. These twin burdens affect the people most in need of the skills and knowledge required for coping with chronic illnesses. Chronic disease self-management (CDSM) is a logical target for a general health literacy intervention. In an approach that spans across specific diseases, CDSM targets problems and skills needed to cope with issues such as fatigue, pain, stress, depression, sleep disturbance, and treatment adherence. In a previous study, we showed that a computer-delivered tailored information intervention targeting health literacy could improve treatment and adherence and be cost effective, but it is not clear that this same strategy will be effective in persons with low health literacy and multiple chronic conditions.ObjectiveThe purpose of this study is to develop a computer-delivered mobile intervention that will provide individuals with chronic conditions the necessary information to cope with their conditions.MethodsIn this project, we will complete a qualitative study on the status and needs of individuals with more than one chronic condition. Results of this study will be used to develop a mobile tailored information app that will address self-management challenges in the areas of pain, sleep, fatigue, depression, anger, stress, memory problems, and treatment adherence. The impact of the intervention on patient quality of life, patient-provider relationships, health literacy, and patient activation will be assessed. We will also explore the extent to which health literacy mediates important outcomes, such as health-related quality of life and health service utilization.ResultsWe are currently completing the preliminary qualitative and usability studies that will inform the content and design of the intervention. We anticipate that the intervention will be complete in 2017, and the clinical trial of its efficacy will also commence in 2017.ConclusionsResults will provide evidence on the usefulness of a mobile tailored information app for improving health literacy, patient activation, health-related quality of life, and self-reported health in patients with multiple chronic conditions.Trial registrationClinicaltrials.gov NCT02922439; https://clinicaltrials.gov/ct2/show/NCT02922439 (Archived by WebCite at http://www.webcitation.org/6pTiqDAyN).

Project description:BackgroundDelivering self-management support to people with type 2 diabetes mellitus is essential to reduce the health system burden and to empower people with the skills, knowledge, and confidence needed to take an active role in managing their own health.ObjectiveThis study aims to evaluate the adoption, use, and effectiveness of the My Diabetes Coach (MDC) program, an app-based interactive embodied conversational agent, Laura, designed to support diabetes self-management in the home setting over 12 months.MethodsThis randomized controlled trial evaluated both the implementation and effectiveness of the MDC program. Adults with type 2 diabetes in Australia were recruited and randomized to the intervention arm (MDC) or the control arm (usual care). Program use was tracked over 12 months. Coprimary outcomes included changes in glycated hemoglobin (HbA1c) and health-related quality of life (HRQoL). Data were assessed at baseline and at 6 and 12 months, and analyzed using linear mixed-effects regression models.ResultsA total of 187 adults with type 2 diabetes (mean 57 years, SD 10 years; 41.7% women) were recruited and randomly allocated to the intervention (n=93) and control (n=94) arms. MDC program users (92/93 participants) completed 1942 chats with Laura, averaging 243 min (SD 212) per person over 12 months. Compared with baseline, the mean estimated HbA1c decreased in both arms at 12 months (intervention: 0.33% and control: 0.20%), but the net differences between the two arms in change of HbA1c (-0.04%, 95% CI -0.45 to 0.36; P=.83) was not statistically significant. At 12 months, HRQoL utility scores improved in the intervention arm, compared with the control arm (between-arm difference: 0.04, 95% CI 0.00 to 0.07; P=.04).ConclusionsThe MDC program was successfully adopted and used by individuals with type 2 diabetes and significantly improved the users' HRQoL. These findings suggest the potential for wider implementation of technology-enabled conversation-based programs for supporting diabetes self-management. Future studies should focus on strategies to maintain program usage and HbA1c improvement.Trial registrationAustralia New Zealand Clinical Trials Registry (ACTRN) 12614001229662; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614001229662.

Project description:BackgroundMany women experience urgency (UUI) and mixed (MUI) urinary incontinence but commonly hesitate to seek care. Treatment access and self-management for these conditions can be supported through eHealth approaches.ObjectiveThis study aimed to investigate the efficacy of the mobile app Tät II for self-management of UUI and MUI in women.MethodsThis randomized controlled trial included women ≥18 years old with UUI or MUI and ≥2 leakages per week. Those with red-flag symptoms were excluded. Participants were recruited via analog and digital advertisements and screened for initial selection through a web-based questionnaire. Data were collected using another questionnaire and a 2-day bladder diary. A telephone interview confirmed the symptom diagnosis. Participants were randomized (1:1) to receive access to a treatment app (including pelvic floor muscle training, bladder training, psychoeducation, lifestyle advice, tailored advice, exercise log, reinforcement messages, and reminders) or an information app (control group), with no external treatment guidance provided. The primary outcome was incontinence symptoms at the 15-week follow-up, measured using the International Consultation on Incontinence Questionnaire (ICIQ)-Urinary Incontinence Short Form (ICIQ-UI SF). Urgency symptoms were assessed using the ICIQ-Overactive Bladder Module (ICIQ-OAB) and quality of life using the ICIQ-Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). Incontinence episode frequency (IEF) was calculated per bladder diary entries. Improvement was measured using the Patient's Global Impression of Improvement. All outcomes were self-reported. Cure was defined as no leakages per the bladder diary. Intention-to-treat analysis was performed.ResultsBetween April 2017 and March 2018, 123 women (mean age 58.3, SD 9.6 years) were randomized to the treatment (n=60, 2 lost to follow-up) or information (n=63) group. Of these, 35 (28%) women had UUI, and 88 (72%) had MUI. Mean ICIQ-UI SF score at follow-up was lower in the treatment group than in the information group (estimated difference -3.1, 95% CI -4.8 to -1.3). The estimated between-group difference was -1.8 (95% CI -2.8 to -0.99) for mean ICIQ-OAB score and -6.3 (95% CI -10.5 to -2.1) for the mean ICIQ-LUTSqol score at follow-up. IEF reduction from baseline to follow-up was greater in the treatment group (-10.5, IQR -17.5 to -3.5) than in the information group (P<.001). Improvement was reported by 87% (52/60) of treatment group participants and by 30% (19/63) of information group participants. The cure rate was 32% in the treatment group, and 6% in the information group (odds ratio 5.4, 95% CI 1.9-15.6; P=.002). About 67% (40/60) of the treatment group participants used the app more than thrice a week.ConclusionsThe treatment app was effective for improving urgency and mixed incontinence in women. When self-management is appropriate, this app may be a good alternative to pharmacological treatment or other conservative management, thus increasing access to care.Trial registrationClinicalTrials.gov NCT03097549; https://clinicaltrials.gov/ct2/show/NCT03097549.

Project description:Nonspecific low back pain (NLBP) is the diagnosis for individuals with back pain that has no underlying medical cause (eg, tumor, infection, fracture, herniated disc, spinal stenosis). The American College of Physicians (ACP) and American Pain Society (APS) recommend multidisciplinary treatments for NLBP that lasts more than 4 weeks. This approach, however, is impractical for many physicians to implement, and relatively few providers offer NLBP treatment that meets the joint ACP-APS guidelines.This study evaluated the efficacy of a mobile-Web intervention called "FitBack" to help users implement self-tailored strategies to manage and prevent NLBP occurrences.A total of 597 adults were recruited, screened, consented, and assessed online at baseline, at 2 months (T2), and at 4 months (T3). After baseline assessments, participants were randomized into three groups: FitBack intervention, alternative care group that received 8 emails urging participants to link to six Internet resources for NLBP, and control group. The FitBack group also received weekly email reminder prompts for 8 weeks plus emails to do assessments. The control group was only contacted to do assessments.Users of the FitBack program showed greater improvement compared to the control group in every comparison of the critical physical, behavioral, and worksite outcome measures at 4-month follow-up. In addition, users of the FitBack program performed better than the alternative care group on current back pain, behavioral, and worksite outcomes at 4-month follow-up. For example, subjects in the control group were 1.7 times more likely to report current back pain than subjects in the FitBack group; subjects in the alternative care group were 1.6 times more likely to report current back pain at 4-month follow-up. Further, the users of the FitBack program showed greater improvement compared to both the control and alternative care groups at 4-month follow-up on patient activation, constructs of the Theory of Planned Behavior, and attitudes toward pain.This research demonstrated that a theoretically based stand-alone mobile-Web intervention that tailors content to users' preferences and interests can be an effective tool in self-management of low back pain. When viewed from the RE-AIM perspective (ie, reach, efficacy/effectiveness, adoption, implementation fidelity, and maintenance), this study supports the notion that there is considerable value in this type of intervention as a potentially cost-effective tool that can reach large numbers of people. The results are promising considering that the FitBack intervention was neither supported by professional caregivers nor integrated within a health promotion campaign, which might have provided additional support for participants. Still, more research is needed on how self-guided mobile-Web interventions will be used over time and to understand factors associated with continuing user engagement.Clinicaltrials.gov NCT01950091; http://clinicaltrials.gov/ct2/show/NCT01950091 (Archived by WebCite at http://www.webcitation.org/6TwZucX77).

Project description:BackgroundA system that combines technology and web-based coaching can help treat chronic conditions such as diabetes. However, the effectiveness of apps in mobile health (mHealth) interventions is inconclusive and unclear due to heterogeneous interventions and varying follow-up durations. In addition, randomized controlled trial data are limited, and long-term follow-up is lacking, especially for apps integrated into electronic medical records.ObjectiveWe aimed to assess the effect of an electronic medical record-integrated mobile app for personalized diabetes self-care, focusing on the self-monitoring of blood glucose and lifestyle modifications, on glycemic control in patients with type 2 diabetes mellitus.MethodsIn a 26-week, 3-arm, randomized, controlled, open-label, parallel group trial, patients with type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) level of ≥7.5% were recruited. The mHealth intervention consisted of self-monitoring of blood glucose with the automatic transfer of glucose, diet, and physical activity counseling data (iCareD system). Participants were randomly assigned to the following three groups: usual care (UC), mobile diabetes self-care (MC), and MC with personalized, bidirectional feedback from physicians (MPC). The primary outcome was the change in HbA1c levels at 26 weeks. In addition, diabetes-related self-efficacy, self-care activities, and satisfaction with the iCareD system were assessed after the intervention.ResultsA total of 269 participants were enrolled, and 234 patients (86.9%) remained in the study at 26 weeks. At 12 weeks after the intervention, the mean decline in HbA1c levels was significantly different among the 3 groups (UC vs MC vs MPC: -0.49% vs -0.86% vs -1.04%; P=.02). The HbA1c level decreased in all groups; however, it did not differ among groups after 26 weeks. In a subgroup analysis, HbA1c levels showed a statistically significant decrease after the intervention in the MPC group compared with the change in the UC or MC group, especially in patients aged <65 years (P=.02), patients with a diabetes duration of ≥10 years (P=.02), patients with a BMI of ≥25.0 kg/m2 (P=.004), patients with a C-peptide level of ≥0.6 ng/mL (P=.008), and patients who did not undergo treatment with insulin (P=.004) at 12 weeks. A total of 87.2% (137/157) of the participants were satisfied with the iCareD system.ConclusionsThe mHealth intervention for diabetes self-care showed short-term efficacy in glycemic control, and the effect decreased over time. The participants were comfortable with using the iCareD system and exhibited high adherence.Trial registrationClinical Research Information Service, Republic of Korea KCT0004128; https://tinyurl.com/bdd6pa9m.

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).

Dataset Information

A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial.

Publications

A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial.

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