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Incorporating Behavioral Trigger Messages Into a Mobile Health App for Chronic Disease Management: Randomized Clinical Feasibility Trial in Diabetes.

ABSTRACT: BACKGROUND:Although there is a rise in the use of mobile health (mHealth) tools to support chronic disease management, evidence derived from theory-driven design is lacking. OBJECTIVE:The objective of this study was to determine the impact of an mHealth app that incorporated theory-driven trigger messages. These messages took different forms following the Fogg behavior model (FBM) and targeted self-efficacy, knowledge, and self-care. We assess the feasibility of our app in modifying these behaviors in a pilot study involving individuals with diabetes. METHODS:The pilot randomized unblinded study comprised two cohorts recruited as employees from within a health care system. In total, 20 patients with type 2 diabetes were recruited for the study and a within-subjects design was utilized. Each participant interacted with an app called capABILITY. capABILITY and its affiliated trigger (text) messages integrate components from social cognitive theory (SCT), FBM, and persuasive technology into the interactive health communications framework. In this within-subjects design, participants interacted with the capABILITY app and received (or did not receive) text messages in alternative blocks. The capABILITY app alone was the control condition along with trigger messages including spark and facilitator messages. A repeated-measures analysis of variance (ANOVA) was used to compare adherence with behavioral measures and engagement with the mobile app across conditions. A paired sample t test was utilized on each health outcome to determine changes related to capABILITY intervention, as well as participants' classified usage of capABILITY. RESULTS:Pre- and postintervention results indicated statistical significance on 3 of the 7 health survey measures (general diet: P=.03; exercise: P=.005; and blood glucose: P=.02). When only analyzing the high and midusers (n=14) of capABILITY, we found a statistically significant difference in both self-efficacy (P=.008) and exercise (P=.01). Although the ANOVA did not reveal any statistically significant differences across groups, there is a trend among spark conditions to respond more quickly (ie, shorter log-in lag) following the receipt of the message. CONCLUSIONS:Our theory-driven mHealth app appears to be a feasible means of improving self-efficacy and health-related behaviors. Although our sample size is too small to draw conclusions about the differential impact of specific forms of trigger messages, our findings suggest that spark triggers may have the ability to cue engagement in mobile tools. This was demonstrated with the increased use of capABILITY at the beginning and conclusion of the study depending on spark timing. Our results suggest that theory-driven personalization of mobile tools is a viable form of intervention. TRIAL REGISTRATION:ClinicalTrials.gov NCT04132089; http://clinicaltrials.gov/ct2/show/NCT004122089.

SUBMITTER: Sittig S

PROVIDER: S-EPMC7105932 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Incorporating Behavioral Trigger Messages Into a Mobile Health App for Chronic Disease Management: Randomized Clinical Feasibility Trial in Diabetes.

Sittig Scott S Wang Jing J Iyengar Sriram S Myneni Sahiti S Franklin Amy A

JMIR mHealth and uHealth 20200316 3

<h4>Background</h4>Although there is a rise in the use of mobile health (mHealth) tools to support chronic disease management, evidence derived from theory-driven design is lacking.<h4>Objective</h4>The objective of this study was to determine the impact of an mHealth app that incorporated theory-driven trigger messages. These messages took different forms following the Fogg behavior model (FBM) and targeted self-efficacy, knowledge, and self-care. We assess the feasibility of our app in modifyi ...[more]

PMID: 32175908

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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:BackgroundLife Goals is an evidence-based self-management intervention that assists individuals with bipolar disorder (BD) by aligning BD symptom coping strategies with their personal goals. The intervention can be availed via in-person and telephonic sessions, and it has been recently developed as an individualized, customizable mobile app.ObjectiveWe examined the feasibility, usability, and acceptability of the Life Goals self-management app among individuals diagnosed with BD who used the app for up to 6 months.MethodsA total of 28 individuals with BD used the Life Goals app on their personal smartphone for 6 months. They completed key clinical outcome measurements of functioning, disability, and psychiatric symptoms at baseline, 3 months, and 6 months, in addition to a poststudy survey about usability and satisfaction.ResultsParticipants used the app for a median of 25 times (IQR 13-65.75), and for a longer time during the first 3 months of the study. The modules on depression and anxiety were the most frequently used, accounting for 35% and 22% of total usage, respectively. Overall, the study participants found the app useful (15/25, 60%) and easy to use (18/25, 72%), and they reported that the screen displayed the material adequately (22/25, 88%). However, less than half of the participants found the app helpful in managing their health (10/25, 40%) or in making progress on their wellness goals (9/25, 36%). Clinical outcomes showed a trend for improvements in mental and physical health and mania-related well-being.ConclusionsThe Life Goals app showed feasibility of use among individuals with BD. Higher user engagement was observed in the initial 3 months with users interested more frequently in the mood modules than other wellness modules. Participants reported acceptability with the ease of app use and satisfaction with the app user interface, but the app showed low success in encouraging self-management within this small sample. The Life Goals app is a mobile health technology that can provide individuals with serious mental illness with more flexible access to evidence-based treatments.

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:BACKGROUND:Improving the quality of patient care through the use of mobile devices is one of the hot topics in the health care field. In unwanted situations like an accident, ambulances and rescuers often require a certain amount of time to arrive at the scene. Providing immediate cardiopulmonary resuscitation (CPR) to patients might improve survival. OBJECTIVE:The primary objective of this study was to evaluate the feasibility of an emergency and mutual-aid app model in Taiwan and to provide a reference for government policy. METHODS:A structured questionnaire was developed as a research tool. All questionnaires were designed according to the technology acceptance model, and a Likert scale was used to measure the degree of agreement or disagreement. Moreover, in-depth interviews were conducted with six experts from medical, legal, and mobile app departments. Each expert was interviewed once to discuss feasible countermeasures and suggestions. Statistical Package for the Social Sciences (SPSS version 19; IBM Corp, Armonk, New York) was used to perform all statistical analyses, including descriptive statistics, independent sample t-tests, variance analysis, and Pearson correlation analysis. RESULTS:We conducted this study between October 20, 2017, and November 10, 2017, at the Taipei Medical University Hospital. Questionnaires were distributed to medical personnel, visiting guests, family members, and volunteers. A total of 113 valid questionnaires were finally obtained after the exclusion of incomplete questionnaires. Cronbach ? values for self-efficacy (perceived ease of use), use attitude (perceived usefulness), and use willingness and frequency were above .85, meeting the criterion of greater than .70. We observed that the reliability of each subquestion was acceptable and the values for use attitude (perceive usefulness) and use willingness and frequency were more than .90. CONCLUSIONS:The findings suggest that perceived ease of use and perceived usefulness of the app model affect use willingness. However, perceived usefulness had an intermediary influence on use willingness. Experts in law, medical, and technology fields consider that an emergency and mutual-aid model can be implemented in Taiwan. Along with the development of an emergency and mutual-aid app model, we recommend an increase in the number of automated external defibrillators per region and promotion of correct knowledge about CPR in order to decrease morbidity and mortality.

Project description:BackgroundMiddle-aged adults (40-65 years) report higher stress levels than most other age groups. There is a need to determine the feasibility of using a meditation app to reduce stress and improve stress-related outcomes in middle-aged adults with a focus on men, as previous meditation app-based studies have reported a low proportion of or even no male participants.ObjectiveThis study aims to (1) determine the feasibility (ie, acceptability and demand with a focus on men) of a consumer-based meditation app (Calm), to reduce stress among middle-aged adults reporting elevated stress levels, and (2) explore the preliminary effects of Calm on perceived stress, psychological outcomes (anxiety, depressive symptoms, mindfulness, and general coping), health behaviors (physical activity and eating habits), and COVID-19 perceptions.MethodsThis feasibility randomized controlled trial evaluated an app-based meditation intervention in middle-aged adults (N=83) with elevated stress levels (ie, Perceived Stress Scale score ≥15) and limited or no previous experience with meditation. Participants were randomized to the intervention group (Calm app) or a control (educational podcasts; POD) group. Participants completed self-report assessments at baseline and postintervention (week 4). Feasibility was measured as acceptability and demand using Bowen framework. Feasibility and COVID-19 perceptions data were examined using descriptive statistics, and preliminary effects were evaluated using repeated measures analysis of variance.ResultsParticipants were satisfied with Calm (27/28, 96%) and found it appropriate or useful (26/28, 93%). Most reported they would likely continue using the Calm app (18/28, 64%). More Calm users reported satisfaction, appropriateness or usefulness, and intent to continue app use than POD users. Calm users (n=33) completed a mean of 20 (SD 31.1) minutes of meditation on the days they meditated and 103 (SD 109.1) minutes of meditation per week. The average adherence rate to the prescribed meditation was 71% among Calm app users, compared to 62% among POD users. Recruitment rate of men was 35% (29/83). Of those randomized to Calm, 55% (15/29) were men, and retention among them was higher (14/15, 93%) than that among women (12/20, 60%). No significant within or between group differences were observed.ConclusionsA 4-week, app-based mindfulness meditation intervention (Calm) may be feasible for middle-aged adults and a useful stress-management tool. Calm users expressed satisfaction with the app and felt it was appropriate and useful. Significant improvements in perceived stress and psychological outcomes or stress-related health behaviors were not observed. Even though men spent less time in meditation than women did and completed fewer weekly sessions, they were more likely to adhere to the prescription. Further research is needed for improving stress and stress-related outcomes among middle-aged adults with emphasis on the effects of mindfulness meditation apps for men.Trial registrationClinicalTrials.gov NCT04272138; https://clinicaltrials.gov/ct2/show/NCT04272138.

Project description:ObjectiveTo examine the feasibility and usability of EnergyPoints™, an innovative mobile health app that teaches and guides people with cancer to implement daily acupressure to self-manage their fatigue and sleep disturbances.Methods and interventionThe study used an integrated agile, human-centered approach. Adults (age 18 years and over) with cancer experiencing at least moderate fatigue, and living in the Greater New York City community, were recruited from social media, patient advocacy groups, and referrals. Twenty participants (in 3 sprints of 3, 5, and 12) were video-recorded thinking aloud while using the app for the first time. They then used the app at home to self-administer acupressure (twice daily for 1 week) while continuously wearing a fitness tracker. Each participant completed an exit interview and modified Computer System Usability Questionnaire post-participation.ResultsParticipants were ages 40 to 76 years and 65% female; 65% were non-Hispanic white. Mean pass rates per ritual exceeded 80%. Users completed (totally or partially) greater than 90% of stimulating acupressure and 70% of relaxing acupressure rituals. Sprint 3 SPs totally completed at least 1 ritual 87% of the time. The majority agreed or strongly agreed the app was easy to use (90%), easy to learn (85%), easy to understand (75%), and effective in helping perform self-acupressure (85%). In an analysis of ease of completing 5 key tasks, all successfully completed the tasks; 3 users required some assistance. Of 654 usability statements, those coded as personal experience/context (197), content related to acupressure learning (105), and content related to the onboarding/profile (71) were most frequent. The design team integrated recommendations into the app before the next sprint.ConclusionsFindings supported feasibility and usability, as well as acceptability, and led to significant alterations and improvements. EnergyPoints™ offers an opportunity to mainstream acupressure and help cancer survivors self-manage their symptoms.

Project description:BACKGROUND:Diabetes is a significant public health issue. Saudi Arabia has the highest prevalence of type 2 diabetes mellitus (T2DM) in the Arab world. Currently, it affects 31.6% of the general population, and the prevalence of T2DM is predicted to rise to 45.36% by 2030. Mobile health (mHealth) offers improved and cost-effective care to people with T2DM. However, the efficiency of engagement strategies and features of this technology need to be reviewed and standardized according to stakeholder and expert perspectives. OBJECTIVE:The main objective of this study was to identify the most agreed-upon features for T2DM self-management mobile apps; the secondary objective was to identify the most agreed-upon strategies that prompt users to use these apps. METHODS:In this study, a 4-round modified Delphi method was applied by experts in the domain of diabetes care. RESULTS:In total, 11 experts with a mean age of 47.09 years (SD 11.70) consented to participate in the study. Overall, 36 app features were generated. The group of experts displayed weak agreement in their ranking of intervention components (Kendall W=0.275; P<.001). The top 5 features included insulin dose adjustment according to carbohydrate counting and blood glucose readings (5.36), alerting a caregiver of abnormal or critical readings (6.09), nutrition education (12.45), contacts for guidance if required (12.64), and offering patient-specific education tailored to the user's goals, needs, and blood glucose readings (12.90). In total, 21 engagement strategies were generated. Overall, the experts showed a moderate degree of consensus in their strategy rankings (Kendall W=0.454; P<.001). The top 5 engagement strategies included a user-friendly design (educational and age-appropriate design; 2.82), a free app (3.73), allowing the user to communicate or send information/data to a health care provider (HCP; 5.36), HCPs prescribing the mobile app in the clinic and asking about patients' app use compliance during clinical visits (6.91), and flexibility and customization (7.91). CONCLUSIONS:This is the first study in the region consisting of a local panel of experts from the diabetes field gathering together. We used an iterative process to combine the experts' opinions into a group consensus. The results of this study could thus be useful for health app developers and HCPs and inform future decision making on the topic.

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:BackgroundChronic low back pain is challenging to manage due to multidisciplinary considerations. It has substantial socioeconomic impacts and cannot be simply treated with pharmacotherapy, nonsurgical intervention, or spine surgery. Medical consensus recommends optimizing conservative self-management therapies (eg, home exercise, wellness strategies, yoga, etc) as first-line treatment options for chronic low back pain. However, access to these modalities is often limited and secondary to cost, convenience, and ease of use. Mobile health apps have emerged as a cost-effective and accessible option for chronic low back pain self-management. Established in-person pain programs can provide the structure for an optimal mobile app adaptation. PainNavigator (PainNavigator, Inc) is an example of a mobile app that is based on an Ascension-Illinois group-based pain program-Pain Rehabilitation Outpatient-Camp.ObjectiveThis was a prospective pilot clinical trial that evaluated the PainNavigator platform's utility in low back pain management to inform future trial development.MethodsA total of 75 participants who used PainNavigator were studied. Pain, Enjoyment, and General Activity (PEG-3) scale scores and scores from a brief anxiety and depression scale based on the Patient Health Questionnaire-4 (PHQ-4) were obtained at baseline and following program completion. The PEG-3 total score was used, in addition to individual items-Average Pain, Pain Effect on Enjoyment, and Pain Effect on Activity. The PHQ-4 total score was also used, in addition to other individual items, including Felt Depressed, Loss of Interest, Felt Anxious, and Difficult to Control Worry. Paired sample t tests (2-tailed) compared mean differences in scores from before and after participants received the intervention.ResultsThe analysis found that PEG-3 (n=27) and PHQ-4 (n=27) total scores were significantly lower upon the completion of PainNavigator (P<.001 and P=.001, respectively). The findings showed a 36% reduction in PEG-3 total scores, a 40% reduction in pain intensity, and a 40% reduction in PHQ-4 total scores. Scores for individual PEG-3 scale and PHQ-4 items also significantly decreased. All PEG-3 measures had large effect sizes. The PHQ-4 total score and Difficult to Control Worry item had large effect sizes, while the other three measures had medium effect sizes.ConclusionsThese findings show that PainNavigator has clinical significance in managing chronic low back pain and can be easily utilized to improve patient care. All PEG-3 scale and PHQ-4 measures significantly improved following the use of the platform, supporting the multidimensional, biopsychosocial approach to low back pain management. Differences in effect sizes may inform quality improvement investigations, such as optimizing features that impact measures with only medium effect sizes. This feasibility study demonstrates an effective protocol, and it will inform future, more extensive randomized controlled trials.

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Incorporating Behavioral Trigger Messages Into a Mobile Health App for Chronic Disease Management: Randomized Clinical Feasibility Trial in Diabetes.

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Incorporating Behavioral Trigger Messages Into a Mobile Health App for Chronic Disease Management: Randomized Clinical Feasibility Trial in Diabetes.

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