Development and Evaluation of a Digital App for Patient Self-Management of Opioid Use Disorder: Usability, Acceptability, and Utility Study.

BACKGROUND: Self-management of opioid use disorder (OUD) is an important component of treatment. Many patients receiving opioid agonist treatment in methadone maintenance treatment settings benefit from counseling treatments to help them improve their recovery skills but have insufficient access to these treatments between clinic appointments. In addition, many addiction medicine clinicians treating patients with OUD in a general medical clinic setting do not have consistent access to counseling referrals for their patients. This can lead to decreases in both treatment retention and overall progress in the patient's recovery from substance misuse. Digital apps may help to bridge this gap by coaching, supporting, and reinforcing behavioral change that is initiated and directed by their psychosocial and medical providers. OBJECTIVE: This study aimed to conduct an acceptability, usability, and utility pilot study of the KIOS app to address these clinical needs. METHODS: We developed a unique, patient-centered computational software system (KIOS; Biomedical Development Corporation) to assist in managing OUD in an outpatient, methadone maintenance clinic setting. KIOS tracks interacting self-reported symptoms (craving, depressed mood, anxiety, irritability, pain, agitation or restlessness, difficulty sleeping, absenteeism, difficulty with usual activities, and conflicts with others) to determine changes in both the trajectory and severity of symptom patterns over time. KIOS then applies a proprietary algorithm to assess the individual's patterns of symptom interaction in accordance with models previously established by OUD experts. After this analysis, KIOS provides specific behavioral advice addressing the individual's changing trajectory of symptoms to help the person self-manage their symptoms. The KIOS software also provides analytics on the self-reported data that can be used by patients, clinicians, and researchers to track outcomes. RESULTS: In a 4-week acceptability, usability (mean System Usability Scale-Modified score 89.5, SD 9.2, maximum of 10.0), and utility (mean KIOS utility questionnaire score 6.32, SD 0.25, maximum of 7.0) pilot study of 15 methadone-maintained participants with OUD, user experience, usability, and software-generated advice received high and positive assessment scores. The KIOS clinical variables closely correlated with craving self-report measures. Therefore, managing these variables with advice generated by the KIOS software could have an impact on craving and ultimately substance use. CONCLUSIONS: KIOS tracks key clinical variables and generates advice specifically relevant to the patient's current and changing clinical state. Patients in this pilot study assigned high positive values to the KIOS user experience, ease of use, and the appropriateness, relevance, and usefulness of the specific behavioral guidance they received to match their evolving experiences. KIOS may therefore be useful to augment in-person treatment of opioid agonist patients and help fill treatment gaps that currently exist in the continuum of care. A National Institute on Drug Abuse-funded randomized controlled trial of KIOS to augment in-person treatment of patients with OUD is currently being conducted.

KIOS: A smartphone app for self-monitoring for patients with bipolar disorder.

OBJECTIVES: This study examined the use of a self-monitoring/self-management smartphone application (app) for patients with bipolar disorder. The app was specifically designed with patient-centered computational software system based on concepts from nonlinear systems (chaos) theory. METHODS: This was a randomized, active comparator study of use of the KIOS app compared to an existing free app that has high utilization rates known as eMoods, over 52 weeks, and performed in three academic centers. Patients were evaluated monthly utilizing the Bipolar Inventory of Symptoms Schedule (BISS). The primary outcome measure was the persistence of using the app over the year of the study. RESULTS: Patients assigned to KIOS persisted in the study longer than those assigned to eMoods; 57 patients (87.70%) in the KIOS group versus 42 (73.69%) in the eMoods group completed the study (p = 0.03). By 52 weeks, significantly more of KIOS group (84.4%) versus eMoods group (54%) entered data into their programs (χ2 = 14.2, df = 1, p = 0.0002). Patient satisfaction for KIOS was greater (F = 5.21, df = 1, 108, p = 0.025) with a standardized effect size (Cohen's d) of 0.41. There was no difference in clinical outcome at the end of the study between the two groups. CONCLUSIONS: This is the first randomized comparison study comparing two apps for the self-monitoring/self-management of bipolar disorder. The study revealed greater patient satisfaction and greater adherence to a patient-centered software program (KIOS) than a monitoring program that does not provide feedback (eMoods).

Development of a Patient-Centered Software System to Facilitate Effective Management of Bipolar Disorder.

Objective: Self-management of bipolar disorder (BD) is an important component of treatment. Methods: We developed a patient-centered computational software system based on concepts from nonlinear systems (chaos) theory with mobile access to assist in managing BD known as KIOS. KIOS tracks interacting symptoms to determine theprecise state of a BD patient. Once the patient's state is identified and the trajectory of the patient established, specific advice is generated to help manage the course of the disease. KIOS also provides analytics that can be used by clinicians and researchers to track outcomes and the course of illness. A 12-week field test was completed. Results: In 20 BD subjects, use of KIOS was associated with improvements in primary symptom categories of BD. Usability and generated advice were rated as a median of 6 out of a maximum of 7. Conclusions: The KIOS focus on change illuminates problems in the same way that humans experience them, implying that the future state will be consequent to changes made to impact the current state. Randomized clinical trial is indicated.

The relationship between vestibular function and topographical memory in older adults.

Research during the past two decades has demonstrated an important role of the vestibular system in topographical orientation and memory and the network of neural structures associated with them. Almost all of the supporting data have come from animal or human clinical studies, however. The purpose of the present study was to investigate the link between vestibular function and topographical memory in normal elderly humans. Twenty-five participants aged 70 to 85 years who scored from mildly impaired to normal on the Montreal Cognitive Assessment (MoCA) received three topographical memory tests: the Camden Topographical Recognition Memory Test (CTMRT), a computerized topographical mental rotation test (TMRT), and a virtual pond maze (VPM). They also received six vestibular or oculomotor tests: optokinetic nystagmus (OKN), visual pursuit (VP), actively generated vestibulo-ocular reflex (VOR), the sensory orientation test (SOT) for posture, and two measures of rotational memory (error in degrees, or RM°, and correct directional recognition, or RM→). The only significant bivariate correlations were among the three vestibular measures primarily assessing horizontal canal function (VOR, RM°, and RM→). A multiple regression analysis showed significant relationships between vestibular and demographic predictors and both the TMRT (R = 0.78) and VPM (R = 0.66) measures. The significant relationship between the vestibular and topographical memory measures supports the theory that vestibular loss may contribute to topographical memory impairment in the elderly.

Inhibition of Candida albicans biofilm formation on denture material.

OBJECTIVE: The aim was to determine the ability of several thin-film polymer formulations, with and without incorporated antifungals, to inhibit Candida albicans biofilm growth on denture material. The inhibition of C. albicans biofilms on maxillary dentures could play a significant role in preventing the development of denture stomatitis. STUDY DESIGN: Low-porosity and high-porosity thin-film polymer formulations were used and one of the following fungicides was added: 1) chlorhexidine diacetate at 1.0%; 2) nystatin at 1.0%; or 3) amphotericin B at 0.1%. These coatings were placed on rectangular (12 x 10 mm) dental resin material samples. A subset of the coated dental materials were brushed to simulate denture cleaning for 1 minute per day for 1 year. Candida albicans biofilms were formed on polymethylmethacrylate (PMMA) specimens placed in 24-well polystyrene plates, and the extent of biofilm formation on coated and noncoated specimens was assessed using a 2,3-bis(2-methoxy-4-nitro-5-sulfo-phenyl)-2H-tetrazolium-5-carboxanilide (XTT) reduction assay. RESULTS: Thin-film polymer PMMA coatings alone, without an antifungal agent, produced a small significant reduction in C. albicans biofilm formation compared with control PMMA. However, incorporation of antifungal medications into the thin-film polymer reduced biofilm formation between 70% and 80% with nystatin, and between 50% and 60% with amphotericin B. Biofilm reduction with chlorhexidine (up to 98%) was significantly greater than all other formulations tested (P < .025). CONCLUSION: This novel thin-film coating with various antifungals effectively inhibits C. albicans biofilm formation and should be evaluated as a potential preventive therapy for denture stomatitis.