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A Mobile App for Chronic Disease Self-Management: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Health 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. OBJECTIVE:The 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. METHODS:In 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. RESULTS:We 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. CONCLUSIONS:Results 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 REGISTRATION:Clinicaltrials.gov NCT02922439; https://clinicaltrials.gov/ct2/show/NCT02922439 (Archived by WebCite at http://www.webcitation.org/6pTiqDAyN).

SUBMITTER: Ownby RL

PROVIDER: S-EPMC5399224 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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A Mobile App for Chronic Disease Self-Management: Protocol for a Randomized Controlled Trial.

Ownby Raymond L RL Acevedo Amarilis A Waldrop-Valverde Drenna D Caballero Joshua J Simonson Michael M Davenport Rosemary R Kondwani Kofi K Jacobs Robin J RJ

JMIR research protocols 20170405 4

<h4>Background</h4>Health 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 ...[more]

PMID: 28381395

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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:BackgroundChronic kidney disease (CKD) is a global health burden. Self-management plays a key role in improving modifiable risk factors.ObjectiveThe aim of this study was to evaluate the effectiveness of wearable devices, a health management platform, and social media at improving the self-management of CKD, with the goal of establishing a new self-management intervention model.MethodsIn a 90-day prospective experimental study, a total of 60 people with CKD at stages 1-4 were enrolled in the intervention group (n=30) and control group (n=30). All participants were provided with wearable devices that collected exercise-related data. All participants maintained dietary diaries using a smartphone app. All dietary and exercise information was then uploaded to a health management platform. Suggestions about diet and exercise were provided to the intervention group only, and a social media group was created to inspire the participants in the intervention group. Participants' self-efficacy and self-management questionnaire scores, Kidney Disease Quality of Life scores, body composition, and laboratory examinations before and after the intervention were compared between the intervention and control groups.ResultsA total of 49 participants completed the study (25 in the intervention group and 24 in the control group); 74% of the participants were men and the mean age was 51.22 years. There were no differences in measured baseline characteristics between the groups except for educational background. After the intervention, the intervention group showed significantly higher scores for self-efficacy (mean 171.28, SD 22.92 vs mean 142.21, SD 26.36; P<.001) and self-management (mean 54.16, SD 6.71 vs mean 47.58, SD 6.42; P=.001). Kidney Disease Quality of Life scores were also higher in the intervention group (mean 293.16, SD 34.21 vs mean 276.37, SD 32.21; P=.02). The number of steps per day increased in the intervention group (9768.56 in week 1 and 11,389.12 in week 12). The estimated glomerular filtration rate (eGFR) of the intervention group was higher than that of the control group (mean 72.47, SD 24.28 vs mean 59.69, SD 22.25 mL/min/1.73m2; P=.03) and the decline in eGFR was significantly slower in the intervention group (-0.56 vs -4.58 mL/min/1.73m2). There were no differences in body composition between groups postintervention.ConclusionsThe use of wearable devices, a health management platform, and social media support not only strengthened self-efficacy and self-management but also improved quality of life and a slower eGFR decline in people with CKD at stages 1-4. These results outline a new self-management model to promote healthy lifestyle behaviors for patients with CKD.Trial registrationClinicalTrials.gov NCT04617431; https://www.clinicaltrials.gov/ct2/show/NCT04617431.

Project description:BackgroundTherapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA)-related symptoms. This study aims to investigate the differences in self-management between a smartphone app (CareHand), using hand exercises and educational advices, compared with a standard approach, on hand overall function, pain intensity, stiffness, and grip and pinch strength in patients with hand RA.MethodsThe project is a prospective, longitudinal, superiority, randomized controlled trial. Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment). Control intervention involves a paper sheet with exercises and recommendations, and the experimental group includes the use of a smartphone app, which provides individualized exercise programs, self-management, and educational strategies to promote adherence to treatment. Both intervention protocols will last for 3 months. The principal investigator will conduct an educational session at baseline for all participants. Primary outcome comprises the overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer). Outcome measures will be collected at baseline, and at 1 month and 3-month follow-up.DiscussionThis study will evaluate the effectiveness of a tele-rehabilitation tool, which uses exercise and self-management strategies, compared to a conventional approach, in patients with hand RA. The smartphone app will allow to monitor the patient's status and to enhance patient-therapist communication. Some limitations may be related to the short follow-up duration and the lack of evaluation of psychosocial factors. Overall, this new way of promoting long-term effects in patients with a chronic rheumatic disease could be feasible and easy to implement in daily life clinical practice and current musculoskeletal care.Trial registrationClinicalTrials.gov NCT04263974 . Registered on 7 March 2020. Date of last update 15 April 2020. Ethics committee code: PI_RH_2018.

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:BackgroundWhile 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.ObjectiveThe 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.MethodsWe 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.ResultsLinear 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.ConclusionAlthough 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.Trial registrationClinicalTrials.gov NCT01899274; https://clinicaltrials.gov/ct2/show/NCT01899274 (Archived by WebCite at http://www.webcitation.org/6qWrqF1yw).

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:BackgroundThe adherence to secondary prevention treatment in patients with coronary heart disease (CHD) is low. Digital therapeutics (DTx) refers to an emerging branch of medicine that delivers medical interventions directly to patients using evidence-based, clinically evaluated, technology-based software algorithms or apps to facilitate disease management, which may be an efficient tool to optimize adherence.ObjectiveThis paper aims to investigate the effect of mobile app-based self-management DTx on long-term use of secondary prevention medications in patients with CHD in China.MethodsThis pilot study was a parallel-designed, open-labeled, single-center, randomized controlled trial. Hospitalized patients with CHD admitted to Peking University First Hospital between April 2016 and June 2017 were randomized before discharge on a 1:1 ratio. The intervention group received regular follow-up combined with DTx, which is a self-management mobile app already installed on an Android 5 (Mi Pad 1, Xiaomi Corporation) tablet. Structured data from the hospital informatics system were integrated automatically, and medication, lifestyle intervention plan, follow-up protocol, and patient education materials were also provided according to the diagnosis. Participants could use DTx for self-management at home. The control group was under conventional hospital-based follow-up care. Patients were followed up for 1 year, and the primary end point was the percentage of all guideline-recommended medications at 12 months. The secondary end points included the percentage adhered to standard secondary prevention medications at 6 months, the control rate of lipid profile, and blood pressure at 6 months and 1 year.ResultsAmong 300 randomized patients with CHD, 290 (96.7%) were included in the final analysis, including 49.3% (143/290) and 50.7% (147/290) of patients from the intervention and control groups, respectively. Baseline characteristics were similar between the 2 groups. There was a statistically significant improvement in the percentage of all guideline-recommended medications at 12 months in the intervention group compared with the control group (relative risk [RR] 1.34, 95% CI 1.12-1.61; P=.001), and there was no interaction with baseline characteristics. The intervention group had a significantly higher proportion of patients achieving blood pressure under control (systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg) and low-density lipoprotein cholesterol <1.8 mmol/L (RR 1.45, 95% CI 1.22-1.72; P<.001 and RR 1.40, 95% CI 1.11-1.75; P=.004, respectively) at 12 months. Furthermore, on logistic regression, the intervention group had a lower risk of withdrawing from guideline-recommended medications (odds ratio 0.46, 95% CI 0.27-0.78; P=.004).ConclusionsAmong patients with CHD, using a mobile app-based self-management DTx in addition to traditional care resulted in a significant improvement in guideline-recommended medication adherence at 12 months. The results of the trial will be applicable to primary care centers, especially in rural areas with less medical resources.Trial registrationClinicalTrials.gov NCT03565978; https://clinicaltrials.gov/ct2/show/NCT03565978.

Dataset Information

A Mobile App for Chronic Disease Self-Management: Protocol for a Randomized Controlled Trial.

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A Mobile App for Chronic Disease Self-Management: Protocol for a Randomized Controlled Trial.

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