Browsing by Subject "intervention"

Now showing 1 - 7 of 7
  • Thumbnail Image
    ItemOpen Access
    A Smoking Cessation Mobile App for Persons Living With HIV: Preliminary Efficacy and Feasibility Study.
    (JMIR formative research, 2022-08) Schnall, Rebecca; Liu, Jianfang; Alvarez, Gabriella; Porras, Tiffany; Ganzhorn, Sarah; Boerner, Samantha; Huang, Ming-Chun; Trujillo, Paul; Cioe, Patricia

    Background

    The prevalence of smoking in the United States general population has gradually declined to the lowest rate ever recorded; however, this has not been true for persons with HIV.

    Objective

    We conducted a pilot test to assess the feasibility and efficacy of the Lumme Quit Smoking mobile app and smartwatch combination with sensing capabilities to improve smoking cessation in persons with HIV.

    Methods

    A total of 40 participants were enrolled in the study and randomly assigned 1:1 to the control arm, which received an 8-week supply of nicotine replacement therapy, a 30-minute smoking cessation counseling session, and weekly check-in calls with study staff, or to the intervention arm, which additionally received the Lumme Quit Smoking app and smartwatch.

    Results

    Of the 40 participants enrolled, 37 completed the follow-up study assessments and 16 used the app every day during the 56-day period. During the 6-month recruitment and enrollment period, 122 people were screened for eligibility, with 67.2% (82/122) deemed ineligible. Smoking criteria and incompatible tech were the major reasons for ineligibility. There was no difference in the proportion of 7-day point prevalence abstinence by study arm and no significant decrease in exhaled carbon monoxide for the intervention and control arms separately. However, the average exhaled carbon monoxide decreased over time when analyzing both arms together (P=.02).

    Conclusions

    Results suggest excellent feasibility and acceptability of using a smoking sensor app among this smoking population. The knowledge gained from this research will enable the scientific community, clinicians, and community stakeholders to improve tobacco cessation outcomes for persons with HIV.

    Trial registration

    ClinicalTrials.gov NCT04808609; https://clinicaltrials.gov/ct2/show/NCT04808609.
  • Thumbnail Image
    ItemOpen Access
    Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.
    (Clin Trials, 2015-12) Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P
    BACKGROUND/AIMS: The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. METHODS: Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. RESULTS: The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over 2 years to promote and sustain engagement. The personal coaching intervention, alternatively, was primarily personal coaching with trained coaches based on a proven intervention, enhanced with a mobile application, but where all interactions with the technology were participant-initiated. CONCLUSION: The complexity and length of the technology-based randomized clinical trial created challenges in engagement and technology adaptation, which were generally discovered using novel remote monitoring technology and addressed using the adaptive intervention design. Investigators should plan to develop tools and procedures that explicitly support continuous remote monitoring of interventions to support adaptive intervention design in long-term, technology-based studies, as well as developing the interventions themselves.
  • Thumbnail Image
    ItemOpen Access
    Evaluation of ML-Based Clinical Decision Support Tool to Replace an Existing Tool in an Academic Health System: Lessons Learned.
    (Journal of personalized medicine, 2020-08-27) Woo, Myung; Alhanti, Brooke; Lusk, Sam; Dunston, Felicia; Blackwelder, Stephen; Lytle, Kay S; Goldstein, Benjamin A; Bedoya, Armando
    There is increasing application of machine learning tools to problems in healthcare, with an ultimate goal to improve patient safety and health outcomes. When applied appropriately, machine learning tools can augment clinical care provided to patients. However, even if a model has impressive performance characteristics, prospectively evaluating and effectively implementing models into clinical care remains difficult. The primary objective of this paper is to recount our experiences and challenges in comparing a novel machine learning-based clinical decision support tool to legacy, non-machine learning tools addressing potential safety events in the hospitals and to summarize the obstacles which prevented evaluation of clinical efficacy of tools prior to widespread institutional use. We collected and compared safety events data, specifically patient falls and pressure injuries, between the standard of care approach and machine learning (ML)-based clinical decision support (CDS). Our assessment was limited to performance of the model rather than the workflow due to challenges in directly comparing both approaches. We did note a modest improvement in falls with ML-based CDS; however, it was not possible to determine that overall improvement was due to model characteristics.
  • Thumbnail Image
    ItemOpen Access
    IMPaCT: A Pilot Randomized Trial of an Intervention to Reduce Preterm Birth Among Non-Hispanic Black Patients at High Risk.
    (Health equity, 2022-01) Wheeler, Sarahn M; Massengale, Kelley EC; Fitzgerald, Thelma A; Truong, Tracy; Østbye, Truls; Corneli, Amy; Swamy, Geeta K

    Introduction

    Preterm birth is a major cause of neonatal morbidity and mortality rate. Non-Hispanic black patients disproportionately experience preterm birth and nonadherence to evidence-based preventive measures. Interventions tailored to non-Hispanic black birthing individuals (NHBBIs) that address barriers to preterm birth preventions are urgently needed.

    Methods

    Together with a community-engaged multidisciplinary stakeholder group, we developed an intervention to improve adherence to preterm birth preventions among black pregnant patients with prior preterm birth. The intervention included the following: (1) preterm birth prevention education, (2) an employment navigation toolkit, and (3) encouragement text messages. We piloted the intervention by recruiting self-identified non-Hispanic black patients at or before 20 weeks of gestation with a prior preterm birth and randomizing them to the intervention or an active control. The primary outcomes were feasibility and acceptability. Our secondary outcomes were preliminary efficacy based on birth outcomes, patient experience, and pregnancy-specific anxiety (PSA). Descriptive statistics, analysis of verbatim survey responses, Wilcoxon signed rank, and Fisher's exact were used to describe and compare quantitative and qualitative data.

    Results

    We identified 53 individuals who met the inclusion criteria, 35 were reachable remotely and 30 were enrolled and randomized. More than 80% (n=26) were retained throughout the study, and 100% of participants identified at least one intervention component as helpful. In this small pilot, there were no detectable differences in adherence to preterm birth preventive recommendations. No difference in preterm births, other pregnancy, or patient experience outcomes was detected between the intervention and active control participants.

    Discussion

    The intervention is feasible and acceptable. Larger, appropriately powered studies are needed to assess whether the intervention will decrease PSA and reduce preterm birth. This trial was registered with ClinicalTrials.gov (NCT04933812).
  • Thumbnail Image
    ItemOpen Access
    Improving mental health among people living with HIV: a review of intervention trials in low- and middle-income countries.
    (Glob Ment Health (Camb), 2015-01) Sikkema, Kathleen J; Dennis, Alexis C; Watt, Melissa H; Choi, Karmel W; Yemeke, Tatenda T; Joska, John A
    People living with HIV (PLWH) experience greater psychological distress than the general population. Evidence from high-incomes countries suggests that psychological interventions for PLWH can improve mental health symptoms, quality of life, and HIV care engagement. However, little is known about the effectiveness of mental health interventions for PLWH in low and middle-income countries (LMICs), where the large majority of PLWH reside. This systematized review aims to synthesize findings from mental health intervention trials with PLWH in LMICs to inform the delivery of mental health services in these settings. A systematic search strategy was undertaken to identify peer-reviewed published papers of intervention trials addressing negative psychological states or disorders (e.g., depression, anxiety) among PLWH in LMIC settings. Search results were assessed against pre-established inclusion and exclusion criteria. Data from papers meeting criteria were extracted for synthesis. Twenty-six papers, published between 2000 and 2014, describing 22 unique interventions were identified. Trials were implemented in sub-Saharan Africa (n=13), Asia (n=7), and the Middle East (n=2), and addressed mental health using a variety of approaches, including cognitive-behavioral (n=18), family-level (n=2), and pharmacological (n=2) treatments. Four randomized controlled trials reported significant intervention effects in mental health outcomes, and eleven preliminary studies demonstrated promising findings. Among the limited mental health intervention trials with PLWH in LMICs, few demonstrated efficacy. Mental health interventions for PLWH in LMICs must be further developed and adapted for resource-limited settings to improve effectiveness.
  • Thumbnail Image
    ItemOpen Access
    The Association Between Engagement and Weight Loss Through Personal Coaching and Cell Phone Interventions in Young Adults: Randomized Controlled Trial.
    (JMIR mHealth and uHealth, 2018-10) Lin, Pao-Hwa; Grambow, Steven; Intille, Stephen; Gallis, John A; Lazenka, Tony; Bosworth, Hayden; Voils, Corrine L; Bennett, Gary G; Batch, Bryan; Allen, Jenifer; Corsino, Leonor; Tyson, Crystal; Svetkey, Laura

    Background

    Understanding how engagement in mobile health (mHealth) weight loss interventions relates to weight change may help develop effective intervention strategies.

    Objective

    This study aims to examine the (1) patterns of participant engagement overall and with key intervention components within each intervention arm in the Cell Phone Intervention For You (CITY) trial; (2) associations of engagement with weight change; and (3) participant characteristics related to engagement.

    Methods

    The CITY trial tested two 24-month weight loss interventions. One was delivered with a smartphone app (cell phone) containing 24 components (weight tracking, etc) and included prompting by the app in predetermined frequency and forms. The other was delivered by a coach via monthly calls (personal coaching) supplemented with limited app components (18 overall) and without any prompting by the app. Engagement was assessed by calculating the percentage of days each app component was used and the frequency of use. Engagement was also examined across 4 weight change categories: gained (≥2%), stable (±2%), mild loss (≥2% to <5%), and greater loss (≥5%).

    Results

    Data from 122 cell phone and 120 personal coaching participants were analyzed. Use of the app was the highest during month 1 for both arms; thereafter, use dropped substantially and continuously until the study end. During the first 6 months, the mean percentage of days that any app component was used was higher for the cell phone arm (74.2%, SD 20.1) than for the personal coaching arm (48.9%, SD 22.4). The cell phone arm used the apps an average of 5.3 times/day (SD 3.1), whereas the personal coaching participants used them 1.7 times/day (SD 1.2). Similarly, the former self-weighed more than the latter (57.1% days, SD 23.7 vs 32.9% days, SD 23.3). Furthermore, the percentage of days any app component was used, number of app uses per day, and percentage of days self-weighed all showed significant differences across the 4 weight categories for both arms. Pearson correlation showed a negative association between weight change and the percentage of days any app component was used (cell phone: r=-.213; personal coaching: r=-.319), number of apps use per day (cell phone: r=-.264; personal coaching: r=-.308), and percentage of days self-weighed (cell phone: r=-.297; personal coaching: r=-.354). None of the characteristics examined, including age, gender, race, education, income, energy expenditure, diet quality, and hypertension status, appeared to be related to engagement.

    Conclusions

    Engagement in CITY intervention was associated with weight loss during the first 6 months. Nevertheless, engagement dropped substantially early on for most intervention components. Prompting may be helpful initially. More flexible and less intrusive prompting strategies may be needed during different stages of an intervention to increase or sustain engagement. Future studies should explore the motivations for engagement and nonengagement to determine meaningful levels of engagement required for effective intervention.

    Trial registration

    ClinicalTrials.gov NCT01092364; https://clinicaltrials.gov/ct2/show/NCT01092364 (Archived by WebCite at http://www.webcitation.org/72V8A4e5X).
  • Thumbnail Image
    ItemOpen Access
    Understanding Our Own Biology: The Relevance of Auto-Biological Attributions for Mental Health
    (Clinical Psychology: Science and Practice, 2017-03-01) MacDuffie, KE; Strauman, TJ
    As knowledge of the neurobiological basis of psychopathology has advanced, public perceptions have shifted toward conceptualizing mental disorders as disorders of biology. However, little is known about how patients respond to biological information about their own disorders. We refer to such information as auto-biological—describing our own biological systems as a component of our identity. Drawing on research from attribution theory, we explore the potential for auto-biological information to shape how patients view themselves in relation to their disorders. We propose an attributional framework for presenting auto-biological information in a way that encourages agency, rather than destiny. We argue that this framework has the potential to change expectations and improve outcomes in the treatment of psychiatric disorders.