Pilot and feasibility of the SMART IBD mobile app to improve self-management in pediatric inflammatory bowel disease.

OBJECTIVES: Access to evidence-based self-management support in pediatric inflammatory bowel disease (IBD) is a significant challenge. Digital therapeutic solutions can increase access and provide data to patients and providers that would otherwise not be available. We have iteratively developed a mobile application, Self-Management Assistance with Recommended Treatment (SMART) IBD, that allows patients to access self-management support and record symptoms and medication adherence. METHODS: We conducted a pilot and feasibility study for this digital therapeutic tool in which patients used SMART IBD for 30 days. RESULTS: Results indicated that patients rated the app quality as good and accessed the app adequately overall, with some pages being used often. Medication adherence increased over the course of the study and was associated with sleep duration, mood, and stool consistency and blood content. CONCLUSIONS: Overall, this study demonstrated adequate feasibility for the SMART IBD app and initial findings suggest that additional research is needed to explore the potential impact of this tool in clinical care.

Feasibility pilot trial of a tailored medication adherence-promotion intervention for adolescents and young adults with cancer: Study design and protocol.

BACKGROUND: Medication non-adherence is common among adolescents and young adults (AYAs) with cancer and associated with poor health outcomes. AYAs with cancer endorse multiple barriers to adherence that differ across individuals, suggesting that tailoring intervention content to an AYA's specific barriers may have the potential to improve adherence. The purpose of this manuscript is to report on ORBIT-guided Phase I design efforts to create the first tailored adherence-promotion intervention for AYAs with cancer and the study protocol for the ongoing Phase II pilot feasibility trial. METHODS: Phase I design included qualitative interviews (n = 15 AYAs) to understand patient preferences for adherence-promotion care, development and refinement of a best-worst scaling exercise barriers tool (n = 5 AYAs), and development of intervention modules and a tailoring algorithm. In the ongoing Phase II pilot feasibility trial, AYAs (ages 15-24 years) with cancer currently taking oral chemotherapy or prophylactic medication will be recruited from three children's hospitals. Feasibility, acceptability, and usability will be assessed and these outcomes along with data on medication adherence will be used to inform the next phases of intervention development and testing. CONCLUSIONS: If promising, this program of research ultimately has the potential to equip clinicians with additional strategies for supporting adherence among AYAs with cancer. NCT05706610.

Children with uncontrolled asthma from economically disadvantaged neighborhoods: Needs assessment and the development of a school-based telehealth and electronic inhaler monitoring system.

BACKGROUND: Children from economically disadvantaged communities often encounter healthcare access barriers, increasing risk for poorly controlled asthma and subsequent healthcare utilization. This highlights the need to identify novel intervention strategies for these families. OBJECTIVE: To better understand the needs and treatment preferences for asthma management in children from economically disadvantaged communities and to develop a novel asthma management intervention based on an initial needs assessment and stakeholder feedback. METHODS: Semistructured interviews and focus groups were conducted with 19 children (10-17 years old) with uncontrolled asthma and their caregivers, 14 school nurses, 8 primary care physicians, and three school resource coordinators from economically disadvantaged communities. Interviews and focus groups were audio-taped and transcribed verbatim and then analyzed thematically to inform intervention development. Using stakeholder input, an intervention was developed for children with uncontrolled asthma and presented to participants for feedback to fully develop a novel intervention. RESULTS: The needs assessment resulted in five themes: (1) barriers to quality asthma care, (2) poor communication across care providers, (3) problems identifying and managing symptoms and triggers among families, (4) difficulties with adherence, and (5) stigma. A proposed video-based telehealth intervention was proposed to stakeholders who provided favorable and informative feedback for the final development of the intervention for children with uncontrolled asthma. CONCLUSIONS: Stakeholder input and feedback provided information critical to the development of a multicomponent (medical and behavioral) intervention in a school setting that uses technology to facilitate care, collaboration, and communication among key stakeholders to improve asthma management for children from economically disadvantaged neighborhoods.

The microbiome in adolescents with irritable bowel syndrome and changes with percutaneous electrical nerve field stimulation.

BACKGROUND: Irritable bowel syndrome (IBS), a disorder of the gut-brain axis, is affected by the microbiome. Microbial studies in pediatric IBS, especially for centrally mediated treatments, are lacking. We compared the microbiome between pediatric IBS patients and healthy controls (HC), in relation to symptom severity, and with percutaneous electrical nerve field stimulation (PENFS), a non-invasive treatment targeting central pain pathways. METHODS: We collected a stool sample, questionnaires and a 1-2 week stool and pain diary from 11 to 18 years patients with IBS. A patient subset completed 4 weeks of PENFS and repeated data collection immediately after and/or 3 months after treatment. Stool samples were collected from HC. Samples underwent metagenomic sequencing to evaluate diversity, composition, and abundance of species and MetaCyc pathways. KEY RESULTS: We included 27 cases (15.4 ± 2.5 year) and 34 HC (14.2 ± 2.9 year). Twelve species including Firmicutes spp., and carbohydrate degradation/long-chain fatty acid (LCFA) synthesis pathways, were increased in IBS but not statistically significantly associated with symptom severity. Seventeen participants (female) who completed PENFS showed improvements in pain (p = 0.012), disability (p = 0.007), and catastrophizing (p = 0.003). Carbohydrate degradation and LCFA synthesis pathways decreased post-treatment and at follow-up (FDR p-value <0.1). CONCLUSIONS AND INFERENCES: Firmicutes, including Clostridiaceae spp., and LCFA synthesis pathways were increased in IBS patients suggesting pain-potentiating effects. PENFS led to marked improvements in abdominal pain, functioning, and catastrophizing, while Clostridial species and LCFA microbial pathways decreased with treatment, suggesting these as potential targets for IBS centrally mediated treatments.

Use of Behavior Change Techniques and Quality of Commercially Available Inflammatory Bowel Disease Apps.

BACKGROUND: Inclusion of evidence-based behavior change techniques (e.g., self-monitoring) in mobile health apps has the potential to promote adherence to inflammatory bowel disease treatment. While inflammatory bowel disease management apps exist, the extent to which they incorporate behavior change techniques remains unknown. AIMS: The present study systematically evaluated the content and quality of free, commercially available inflammatory bowel disease management apps. METHODS: Apps were identified using a systematic search of the Apple App and Google Play stores. Apps were evaluated using Abraham and Michie's taxonomy of 26 behavior change techniques. A literature search was conducted to identify behavior change techniques specific and relevant for people with inflammatory bowel disease. App quality was assessed using the Mobile App Rating Scale with scores ranging from 1 (Inadequate) to 5 (Excellent). RESULTS: A total of 51 inflammatory bowel disease management apps were evaluated. Apps included 0-16 behavior change techniques (Mean = 4.55) and 0-10 inflammatory bowel disease management behavior change techniques (Mean = 3.43). App quality ranged from 2.03 to 4.62 (Mean = 3.39) out of 5.00. Two apps, My IBD Care: Crohn's & Colitis and MyGiHealth GI Symptom Tracker, included the highest number of overall and inflammatory bowel disease management behavior change techniques along with high-quality scores. Bezzy IBD was the only app with a high number of overall and inflammatory bowel disease management behavior change techniques with a primary focus on social support/change. CONCLUSION: Most inflammatory bowel disease management apps reviewed included evidence-based inflammatory bowel disease management behavior change techniques.

Examining the Unified Theory of Behavior Change Constructs Among Adolescents Taking Attention-Deficit/Hyperactivity Disorder Medicine: A Longitudinal Study.

OBJECTIVE: To quantitatively validate the preintention factors, behavioral intentions, and implementation factors and examine the relationships theorized by the Unified Theory of Behavior Change (UTBC) model among adolescents with attention-deficit/hyperactivity disorder (ADHD). METHODS: We conducted longitudinal analyses of data from 40 adolescents with ADHD, aged 11 to 15 years old, and their parents, including self-report of UTBC constructs using standardized measures. We collected pharmacy dispensing records for adolescents for the 4 months that followed. We used bivariate correlations to examine relationships between medication continuity, behavioral intentions, preintention factors, and the implementation factors. We conducted paired sample t-tests to compare adolescent and parent responses on UTBC items. RESULTS: Adolescents (mean [standard deviation {SD}] age = 13.3 [1.2] years, 75% male, 77.5% non-Hispanic Black, 90% publicly insured) reported a mean total ADHD symptom score = 29.8/54 (SD = 10.94) and mean total impairment score = 18.7/52 (SD = 10.90) and had a mean percentage of days covered with medicine over 4 months = 0.21 (range = 0-0.97). Adolescent intention to take ADHD medicine every school day was significantly related to adolescents' subsequent medication continuity (r = 0.37, P < .05). Adolescent self-concept/image and confidence taking ADHD medicine were the most important factors related to the intention to take ADHD medicine every school day. Adolescents reported less belief and intention to take ADHD medicine and more barriers to taking ADHD medicine compared to their parents. CONCLUSION: The UTBC model shed light on factors related to subsequent medication use, providing a plausible mechanism for additional research to intervene to promote future medication continuity.

Digital Therapeutic Self-Management Intervention in Adolescents With Inflammatory Bowel Disease.

The objective of this study was to design, code, and test the feasibility, acceptability, and preliminary efficacy of a digital therapeutic self-management tool for pediatric inflammatory bowel disease (IBD). The Self-Management Assistance for Recommended Treatment (SMART) portal development involved an iterative co-design process with a series of focus group/interview sessions with key stakeholders. Subsequently, a pilot, single-arm, open-label trial was conducted with 22 patients; medication adherence was the primary outcome. Usage data for the SMART portal were good, with patients demonstrating better engagement than parents. Results from the trial demonstrated improvement in medication adherence ( M = 24%-31%; t = 7.94, P < 0.05) and self-management barriers as well as trends in health-related quality of life and symptoms. The SMART portal is a feasible digital therapeutic self-management tool for pediatric IBD that demonstrated preliminary efficacy in this pilot trial. Large, controlled trials are needed to definitively determine the clinical efficacy of this tool.

Technology-Assisted Stepped-Care to Promote Adherence in Adolescents with Asthma: A Pilot Study.

To examine the feasibility, acceptability, and preliminary efficacy of a technology-assisted stepped-care behavioral intervention to improve adherence in adolescents with asthma. Thirty adolescents (Mage = 14.66, 53% male) with moderate to severe-persistent asthma completed daily adherence monitoring and medication reminders via a mobile app (Step 1). Participants with < 68% adherence during Step 1 received a telehealth behavioral intervention (Step 2). Twenty-six of 30 participants (87%) completed Step 1. Step 2 was indicated for 18 participants and was completed by 17. Participants favorably rated their experience in the study. Improvements in adherence (40-58%, p = .048) and decreases in asthma composite severity scores (CASI 6.08-5.08, p = .023) were observed for the full sample. Technology-assisted stepped-care is feasible and acceptable. Participants demonstrated improved adherence and asthma composite severity scores once they received the appropriate step of the intervention. Future studies should include a control group, a longer time-frame and an intermediate intervention step.

Digital headache self-management interventions for patients with a primary headache disorder: A systematic review of randomized controlled trials.

OBJECTIVE: This article systematically reviews the empirical literature examining the efficacy of digital headache management interventions for patients with a primary headache disorder. BACKGROUND: Digital headache management interventions provide opportunities to improve access to behavioral headache interventions to underserved groups. METHODS: A systematic search of PubMed, Scopus, and EBSCO (PsycInfo, Education Research Complete, ERIC, Health Source: Nursing/Academic Edition, Psychology and Behavioral Sciences Collection) and reference review was conducted. Included studies had to recruit a sample with a primary headache diagnosis, be a randomized controlled trial including a digital component, assess a headache outcome (i.e., frequency, duration, severity, intensity, disability) or quality of life, and be published in English. Two authors independently extracted data for included studies. The methodological quality of studies was assessed using the revised Cochrane risk-of-bias tool. RESULTS: Thirteen studies with unique interventions met inclusion criteria. More than half of the studies were pilots; however, nearly 70% (9/13) demonstrated significant between-group or within-group improvements on one or more headache-related outcomes. All interventions included some form of relaxation training and the majority were delivered via interactive website. While fewer than half the studies report participant race and/or ethnicity, of those that do, 83% (5/6) reported a predominately White/Caucasian sample. CONCLUSIONS: Efficacy testing of digital headache interventions is in its infancy with the majority of these studies relying on pilot studies with small samples comprised of homogenous patient populations. Interactive websites were the most common digital medium to deliver digital headache management interventions and have demonstrated promising results. Further testing using large-scale randomized controlled trials and exploration of other digital tools is warranted. Future studies with more diverse samples are needed to inform health equity of digital headache interventions.

A systematic evaluation of primary headache management apps leveraging behavior change techniques.

BACKGROUND: Mobile health apps have the potential to promote adherence to headache management through the use of evidence-based behavior change techniques (e.g., self-monitoring). While many headache management apps exist, the extent to which these apps include behavior change techniques remains unknown. Thus, the present study systematically evaluated the content and quality of commercially available headache management apps. METHODS: Headache apps were identified using a systematic search in the Apple App and Google Play stores. A total of 55 apps were evaluated using the taxonomy of behavior change techniques and app quality using the Mobile App Rating Scale. RESULTS: Headache management apps included 0-14 behavior change techniques (Mean [M] = 5.89) and 0-8 headache management behavior change techniques (M = 4.29). App quality ranged from 2.84-4.67 (M = 3.73) out of 5.00. Three apps, Migraine Trainer, Easeday: Headache & Migraine, and PainScale, included the highest number of overall and headache management behavior change techniques along with good quality scores. CONCLUSIONS: While randomized controlled trials are necessary to determine the efficacy of individual headache apps, most existing apps include evidence-based headache management behavior change techniques. Headache apps often focus on either self-monitoring or stress management via relaxation training, suggesting that patients' needs should be used to inform app selection.

Decision making about anti-TNF therapy: A pilot trial of a shared decision-making intervention.

OBJECTIVE: We conducted a pre-post pilot trial to determine the feasibility and acceptability of a multi-component intervention (pre-clinic letter, shared decision making cards and follow-up phone call) designed to facilitate SDM in pediatric inflammatory bowel disease (IBD). METHODS: We recruited physicians (n = 11) caring for IBD patients and families (n = 36) expected to discuss anti-tumor necrosis treatment. We measured feasibility and acceptability of the intervention, observed SDM, perceived SDM, decision conflict, and regret. Medical records were used to assess clinical outcomes, time to decision and adherence. We compared all outcomes between the usual care and intervention study arms. RESULTS: Two out of three intervention components were feasible. Visit length increased significantly in the intervention arm. Parents and patients rated the intervention as acceptable, as did most physicians. The intervention was associated with a higher-level of observed SDM. There was no difference perceived SDM, decision conflict, regret or quality of life outcomes between arms. Physician global assessment improved over time in the intervention arm. CONCLUSIONS: This pilot trial provides important guidance for developing a larger scale trial of a modified intervention. PRACTICE IMPLICATIONS: Overall, our intervention shows promise in supporting SDM and engaging both parents and patients in pediatric IBD decisions.

Establishing Clinical Cut-points on the Pediatric PROMIS-Pain Interference Scale in Youth With Abdominal Pain.

OBJECTIVE: Abdominal pain is a common presenting complaint in youth seeking medical care and can be debilitating. Therefore, it is important to understand the impact of pain on functioning using a clinically sensitive approach. The National Institutes of Health has established a common core of psychometrically precise measures through the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative. The Pediatric PROMIS-Pain Interference (PPPI) scale was developed to measure pain-related interference, drawing from existing legacy measures. However, its clinical validity has not been thoroughly established in clinical populations. The current study sought to develop clinical cut-points and investigate the validity of the PPPI in a large sample (N=5281) of youth presenting to gastroenterological care with abdominal pain symptoms. MATERIALS AND METHODS: Convergent validity of the PPPI was investigated. Quartile and tertile groupings of the PPPI were calculated and compared with cut-points derived from healthy populations and mixed convenience samples on clinical outcomes via multivariate analyses of variance. RESULTS: There was good evidence of convergent validity. The tertile solution was superior in classifying different levels of pain-related outcomes as compared with other cut-points. The tertile solution suggested the following PPPI groupings: minimal (≤51), moderate (52 to 59), and severe (≥60). DISCUSSION: Results suggest the PPPI is a valid measure with clinically meaningful cut-points to assess pain-related interference in youth with abdominal pain.

Systematic evaluation of commercially available pain management apps examining behavior change techniques.

ABSTRACT: Mobile health (mHealth) apps have the potential to enhance pain management through the use of daily diaries, medication and appointment reminders, education, and facilitating communication between patients and providers. Although many pain management apps exist, the extent to which these apps use evidence-based behavior change techniques (BCTs) remains largely unknown, making it nearly impossible for providers to recommend apps with evidence-based strategies. This study systematically evaluated commercially available pain management apps for evidence-based BCTs and app quality. Pain management apps were identified using the search terms "pain" and "pain management" in the App and Google Play stores. Reviewed apps were specific to pain management, in English, for patients, and free. A total of 28 apps were coded using the taxonomy of BCTs. App quality was assessed using the Mobile App Rating Scale. Apps included 2 to 15 BCTs (M = 7.36) and 1 to 8 (M = 4.21) pain management-specific BCTs. Prompt intention formation, instruction, behavioral-health link, consequences, feedback, and self-monitoring were the most common BCTs used in the reviewed apps. App quality from the Mobile App Rating Scale ranged from 2.27 to 4.54 (M = 3.65) out of a possible 5, with higher scores indicating better quality. PainScale followed by Migraine Buddy demonstrated the highest number of overall and pain management BCTs as well as good quality scores. Although existing apps should be assessed through randomized controlled trials and future apps should include capabilities for electronic medical record integration, current pain management apps often use evidence-based pain management BCTs.

The Impact of COVID-19 on Pediatric Adherence and Self-Management.

The COVID-19 pandemic has presented unique circumstances that have the potential to both positively and negatively affect pediatric adherence and self-management in youth with chronic medical conditions. The following paper discusses how these circumstances (e.g., stay-at-home orders, school closures, changes in pediatric healthcare delivery) impact disease management at the individual, family, community, and healthcare system levels. We also discuss how barriers to pediatric adherence and self-management exacerbated by the pandemic may disproportionately affect underserved and vulnerable populations, potentially resulting in greater health disparities. Given the potential for widespread challenges to pediatric disease management during the pandemic, ongoing monitoring and promotion of adherence and self-management is critical. Technology offers several opportunities for this via telemedicine, electronic monitoring, and mobile apps. Moreover, pediatric psychologists are uniquely equipped to develop and implement adherence-promotion efforts to support youth and their families in achieving and sustaining optimal disease management as the current public health situation continues to evolve. Research efforts addressing the short- and long-term impact of the pandemic on pediatric adherence and self-management are needed to identify both risk and resilience factors affecting disease management and subsequent health outcomes during this unprecedented time.

A Micro-longitudinal Approach to Measuring Medication Adherence in Pediatric Inflammatory Bowel Diseases.

Measuring medication adherence in pediatric inflammatory bowel diseases (IBD) is challenging because of complexities in personalized treatment regimens and increased use of biologic mono- and combination therapy. Objective measurement of adherence via electronic monitoring is the gold standard; however, it is not useful for daily monitoring when multiple medication formulations (eg, pills, injections, infusions) as well as vitamins/supplements are prescribed. Although validated subjective measures are available, they are not designed for daily use and do not capture day-to-day variation in adherence. In the following article, a new approach to measuring adherence regardless of a patient's specific medication regimen is presented. Utilizing a micro-longitudinal design, 30 days of daily self-reported medication adherence data was collected from youth with IBD via text message. Results reflect mean adherence rates from studies utilizing pill counts and electronic monitoring, suggesting promise for the use of self-reported daily diaries to assess medication adherence in pediatric IBD.

Digital Therapeutic Self-Management Intervention in Adolescents With Migraine: Feasibility and Preliminary Efficacy of "Migraine Manager".

OBJECTIVE: The objective of this study was to design, code, and pilot test the feasibility and preliminary efficacy of a self-management digital therapeutic tool for adolescents with migraine. BACKGROUND: Self-management of migraine in adolescents is complex and has important implications for health outcomes. A comprehensive and accessible approach to self-management is needed for youth with migraine, their parents, and clinicians. METHODS: An iterative co-design process was used to develop and optimize the Migraine Manager's digital therapeutic self-management tool. Subsequently, 40 adolescents, age 11-18 years, were enrolled in an 8-week single-arm open label trial (N = 36 analyzed). The primary outcome was headache days. RESULTS: Usage data for Migraine Manager were similar to other health app usage data and feedback from participants was uniformly positive, indicating acceptable feasibility. Preliminary efficacy was demonstrated by a reduction in headache days from 17.2 ± 8.5 at baseline to 7.9 ± 7.2 at 8 weeks (95% CI, -13.0 to -7.8; P < .001). There was also statistically significant improvement in patient physical functioning quality of life reported by both patients (baseline = 55.7 ± 20.4; 8 weeks = 69.7 ± 21.9, P = .005) and parents (baseline = 58.5 ± 22.8; 8 weeks = 74.3 ± 18.1, P = .002), and in parent-reported ingestion issues subscale of the adherence barriers scale from baseline to 8 weeks (baseline = 6.0 ± 2.6; 8 weeks = 5.2 ± 3.0, P = .020). CONCLUSIONS: A self-management digital therapeutic tool for adolescents with migraine can offer care to patients who might not otherwise receive such services. Migraine Manager demonstrated the feasibility and preliminary efficacy in this pilot trial, highlighting the potential beneficial impact of this tool. Larger controlled trials with long-term follow-up are needed to definitively determine the clinical efficacy of Migraine Manager.

Perceived stigma, illness uncertainty, and depressive symptoms in youth with inflammatory bowel disease: The moderating effect of mindfulness.

Perceived illness stigma is associated with increased depressive symptoms in youth with inflammatory bowel disease (IBD), but the mechanisms by which stigma influences emotional adjustment remain unclear. It is possible that youth with IBD who are more present-focused and better able to come to terms with aspects of their disease that are less controllable (i.e. are mindful) may develop more adaptive strategies when facing illness uncertainty, resulting in more positive emotional adjustment. The present study examined the indirect association between illness stigma, illness uncertainty, depressive symptoms, and the potential moderating effect of mindfulness on this process. One hundred and seven youth (56 female, 51 male; Mage = 14.73) with IBD completed measures of illness stigma (SS-C), illness uncertainty (CUIS), depressive symptoms (CDI-2), and trait mindfulness (MAAS-A). Analyses revealed a significant SS-C → CUIS → CDI-2 indirect path (ß = .686, 95% CI = .1346 to 1.489), which was moderated by MAAS-A (ß = -.445, 95% CI = -.972 to -.083). Results indicate that the SS-C → CUIS → CDI-2 indirect path was significant at low, but not medium or high, levels of MAAS-A. Illness uncertainty appears to be a potential route through which stigma impacts emotional adjustment in youth with IBD, particularly for youth characterized by low mindfulness. Clinical interventions that emphasize mindfulness training along with acknowledgement/acceptance of IBD illness factors may help diminish the negative effects of stigma and illness uncertainty on adjustment in this population.

Systematic Review of Digital Interventions for Pediatric Asthma Management.

BACKGROUND: Pediatric patients with asthma take only approximately half of their prescribed medication. Digital interventions to improve adherence for youth with asthma exist and have the potential to improve accessibility, cost-effectiveness, and customizability. OBJECTIVE: To systematically review published research examining digital interventions to promote adherence to the treatment of pediatric asthma. METHODS: A systematic search of the PubMed, Scopus, CINAHL, PsycINFO, and reference review databases was conducted. Articles were included if adherence was an outcome in a randomized controlled trial of a digital intervention for children with asthma. We compared samples, intervention characteristics, adherence measurement and outcomes, as well as additional health outcomes across studies. RESULTS: Of the 264 articles reviewed, 15 studies met inclusion criteria and were included in the review. Overall, 87% of the digital interventions demonstrated improved adherence and 53% demonstrated improved health outcomes. All the promising interventions included a behavioral component and most were 3 to 6 months in length, delivered through a digital stand-alone medium (eg, automated personalized texts, mobile health apps, and website), and assessed adherence to controller medication. CONCLUSIONS: Overall, digital interventions aimed at improving adherence are promising and also improve health outcomes in addition to medication adherence. Although future studies using evidence-based adherence assessment and multifactorial design should be conducted, the current literature suggests that both digital stand-alone interventions and interventions combining digital technology with support from a health care team member result in improved adherence and asthma outcomes. Recommendations for digital interventions for pediatric patients with asthma with adherence concerns are provided.