Asynchronous Video Directly Observed Therapy to Monitor Short-Course Latent Tuberculosis Infection Treatment: Results of a Randomized Controlled Trial.

Background: Observing medication ingestion through self-recorded videos (video directly observed therapy [VDOT]) has been shown to be a cost-effective alternative to in-person directly observed therapy (DOT) for monitoring adherence to treatment for tuberculosis disease. VDOT could be a useful tool to monitor short-course latent tuberculosis infection (LTBI) treatment. Methods: We conducted a prospective randomized controlled trial comparing VDOT (intervention) and clinic-based DOT (control) among patients newly diagnosed with LTBI who agreed to a once-weekly 3-month treatment regimen of isoniazid and rifapentine. Study outcomes were treatment completion and patient satisfaction. We also assessed costs. Pre- and posttreatment interviews were conducted. Results: Between March 2016 and December 2019, 130 participants were assigned to VDOT (n = 68) or DOT (n = 62). Treatment completion (73.5% vs 69.4%, P = .70) and satisfaction with treatment monitoring (92.1% vs 86.7%, P = .39) were slightly higher in the intervention group than the control group, but neither was statistically significant. VDOT cost less per patient (median, $230; range, $182-$393) vs DOT (median, $312; range, $246-$592) if participants used their own smartphone. Conclusions: While both groups reported high treatment satisfaction, VDOT was not associated with higher LTBI treatment completion. However, VDOT cost less than DOT. Volunteer bias might have reduced the observed effect since patients opposed to any treatment monitoring could have opted for alternative unobserved regimens. Given similar outcomes and lower cost, VDOT may be useful for treatment monitoring when in-person observation is prohibited or unavailable (eg, during a respiratory disease outbreak). The trial was registered at the National Institutes of Health (ClinicalTrials.gov NTC02641106). Clinical Trials Registration: ClinicalTrials.gov NTC02641106; registered 24 October 2016.

Tuberculosis Treatment Monitoring by Video Directly Observed Therapy in 5 Health Districts, California, USA.

We assessed video directly observed therapy (VDOT) for monitoring tuberculosis treatment in 5 health districts in California, USA, to compare adherence between 174 patients using VDOT and 159 patients using in-person directly observed therapy (DOT). Multivariable linear regression analyses identified participant-reported sociodemographics, risk behaviors, and treatment experience associated with adherence. Median participant age was 44 (range 18-87) years; 61% of participants were male. Median fraction of expected doses observed (FEDO) among VDOT participants was higher (93.0% [interquartile range (IQR) 83.4%-97.1%]) than among patients receiving DOT (66.4% [IQR 55.1%-89.3%]). Most participants (96%) would recommend VDOT to others; 90% preferred VDOT over DOT. Lower FEDO was independently associated with US or Mexico birth, shorter VDOT duration, finding VDOT difficult, frequently taking medications while away from home, and having video-recording problems (p<0.05). VDOT cost 32% (range 6%-46%) less than DOT. VDOT was feasible, acceptable, and achieved high adherence at lower cost than DOT.

Using social and mobile tools for weight loss in overweight and obese young adults (Project SMART): a 2 year, parallel-group, randomised, controlled trial.

BACKGROUND: Few weight loss interventions are evaluated for longer than a year, and even fewer employ social and mobile technologies commonly used among young adults. We assessed the efficacy of a 2 year, theory-based, weight loss intervention that was remotely and adaptively delivered via integrated user experiences with Facebook, mobile apps, text messaging, emails, a website, and technology-mediated communication with a health coach (the SMART intervention). METHODS: In this parallel-group, randomised, controlled trial, we enrolled overweight or obese college students (aged 18-35 years) from three universities in San Diego, CA, USA. Participants were randomly assigned (1:1) to receive either the intervention (SMART intervention group) or general information about health and wellness (control group). We used computer-based permuted-block randomisation with block sizes of four, stratified by sex, ethnicity, and college. Participants, study staff, and investigators were masked until the intervention was assigned. The primary outcome was objectively measured weight in kg at 24 months. Differences between groups were evaluated using linear mixed-effects regression within an intention-to-treat framework. Objectively measured weight at 6, 12, and 18 months was included as a secondary outcome. The trial is registered with ClinicalTrials.gov, number NCT01200459. FINDINGS: Between May 18, 2011, and May 17, 2012, 404 individuals were randomly assigned to the intervention (n=202) or control (n=202). Participants' mean (SD) age was 22·7 (3·8) years. 284 (70%) participants were female and 125 (31%) were Hispanic. Mean (SD) body-mass index at baseline was 29·0 (2·8) kg/m(2). At 24 months, weight was assessed in 341 (84%) participants, but all 404 were included in analyses. Weight, adjusted for sex, ethnicity, and college, was not significantly different between the groups at 24 months (-0·79 kg [95% CI -2·02 to 0·43], p=0·204). However, weight was significantly less in the intervention group compared with the control group at 6 months (-1·33 kg [95% CI -2·36 to -0·30], p=0·011) and 12 months (-1·33 kg [-2·30 to -0·35], p=0·008), but not 18 months (-0·67 kg [95% CI -1·69 to 0·35], p=0·200). One serious adverse event in the intervention group (gallstones) could be attributable to rapid and excessive weight loss. INTERPRETATION: Social and mobile technologies did not facilitate sustained reductions in weight among young adults, although these approaches might facilitate limited short-term weight loss. FUNDING: The National Heart, Lung, and Blood Institute of the National Institutes of Health (U01 HL096715).

Clinical trial management of participant recruitment, enrollment, engagement, and retention in the SMART study using a Marketing and Information Technology (MARKIT) model.

Advances in information technology and near ubiquity of the Internet have spawned novel modes of communication and unprecedented insights into human behavior via the digital footprint. Health behavior randomized controlled trials (RCTs), especially technology-based, can leverage these advances to improve the overall clinical trials management process and benefit from improvements at every stage, from recruitment and enrollment to engagement and retention. In this paper, we report the results for recruitment and retention of participants in the SMART study and introduce a new model for clinical trials management that is a result of interdisciplinary team science. The MARKIT model brings together best practices from information technology, marketing, and clinical research into a single framework to maximize efforts for recruitment, enrollment, engagement, and retention of participants into a RCT. These practices may have contributed to the study's on-time recruitment that was within budget, 86% retention at 24 months, and a minimum of 57% engagement with the intervention over the 2-year RCT. Use of technology in combination with marketing practices may enable investigators to reach a larger and more diverse community of participants to take part in technology-based clinical trials, help maximize limited resources, and lead to more cost-effective and efficient clinical trial management of study participants as modes of communication evolve among the target population of participants.

Validity of PALMS GPS scoring of active and passive travel compared with SenseCam.

PURPOSE: The objective of this study is to assess validity of the personal activity location measurement system (PALMS) for deriving time spent walking/running, bicycling, and in vehicle, using SenseCam (Microsoft, Redmond, WA) as the comparison. METHODS: Forty adult cyclists wore a Qstarz BT-Q1000XT GPS data logger (Qstarz International Co., Taipei, Taiwan) and SenseCam (camera worn around the neck capturing multiple images every minute) for a mean time of 4 d. PALMS used distance and speed between global positioning system (GPS) points to classify whether each minute was part of a trip (yes/no), and if so, the trip mode (walking/running, bicycling, or in vehicle). SenseCam images were annotated to create the same classifications (i.e., trip yes/no and mode). Contingency tables (2 × 2) and confusion matrices were calculated at the minute level for PALMS versus SenseCam classifications. Mixed-effects linear regression models estimated agreement (mean differences and intraclass correlation coefficients) between PALMS and SenseCam with regard to minutes/day in each mode. RESULTS: Minute-level sensitivity, specificity, and negative predictive value were ≥88%, and positive predictive value was ≥75% for non-mode-specific trip detection. Seventy-two percent to 80% of outdoor walking/running minutes, 73% of bicycling minutes, and 74%-76% of in-vehicle minutes were correctly classified by PALMS. For minutes per day, PALMS had a mean bias (i.e., amount of over or under estimation) of 2.4-3.1 min (11%-15%) for walking/running, 2.3-2.9 min (7%-9%) for bicycling, and 4.3-5 min (15%-17%) for vehicle time. Intraclass correlation coefficients were ≥0.80 for all modes. CONCLUSIONS: PALMS has validity for processing GPS data to objectively measure time spent walking/running, bicycling, and in vehicle in population studies. Assessing travel patterns is one of many valuable applications of GPS in physical activity research that can improve our understanding of the determinants and health outcomes of active transportation as well as its effect on physical activity.