The future of clinical research communications, today.
Browse completed and active clinical studies to learn more about how research communications are being re-defined with Mosio. Contact us to add your study.
Using a Web-Based Data Collection Platform to Implement an Effective Electronic Patient-Reported Outcome Registry
2019 (Active)
Vincent A. Lizzio, M.D., Caleb M. Gulledge, B.S., Fabien Meta, M.D., Sreten Franovic, B.S., M.S., and Eric C. Makhni, M.D., M.B.A
Modern health care places significant emphasis on patient-centered care. As a result, many orthopaedic providers are incorporating routine patient-reported outcome measure (PROM) collection into their practice. However, routine PROM collection often disrupts clinical workflow and can place a burden on both the patient and the provider. Electronic PROM collection systems, if implemented deliberately to maximize convenience and efficiency, have the potential to mitigate these obstacles. This technique guide presents an overview of designing and implementing a PROM-based clinical registry for the ambulatory orthopaedic clinic using Research Electronic Data Capture (REDCap; Vanderbilt University, Nashville, TN). We outline the basic steps of creating a simple but effective patient registry using this accessible data collection platform.
Telehealth and texting intervention to improve HIV care engagement, mental health and substance use outcomes in youth living with HIV: a pilot feasibility and acceptability study protocol
2018 (Active)
Angie R Wootton, Dominique A Legnitto, Valerie A Gruber, Carol Dawson-Rose, Torsten B Neilands, Mallory O Johnson, Parya Saberi
The Y2TEC study is a single-site randomised pilot study with the primary aim of examining the feasibility and acceptability of a 12-session telehealth and text message–based counselling series for YLWH. The secondary aim is to evaluate the preliminary impact of the intervention on improved engagement in HIV care, enhanced mental health and reduced substance use for YLWH. The University of California, San Francisco (UCSF) Institutional Review Board (IRB) has reviewed and approved this study. The intervention was designed based on the results of our formative mixed-methods and qualitative research on youth-friendly HIV counselling methods. The intervention is delivered to participants in two condition groups (ie, intervention and waitlist control) via remote telehealth sessions delivered over 4 months, with a cross-over design (see table 1). The overall duration of participation is 8 months.
Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers
2018 (Completed)
Chloe E. Atreya, Ai Kubo, Hala T. Borno, Blake Rosenthal, Matthew Campanella, John P. Rettger, Galen Joseph, I. Elaine Allen, Alan P. Venook, Andrea Altschuler, Anand Dhruva
A metastatic cancer diagnosis is associated with high levels of distress in patients and caregivers. Mindfulness interventions can reduce distress and improve quality of life in cancer patients. However, standard mindfulness training relies on in-person instruction, which is often not practical for either patients receiving chemotherapy or their caregivers. In the Being Present single arm pilot study, we designed and tested an 8-week audio-based mindfulness meditation program for patients with metastatic colorectal cancer receiving chemotherapy with or without a participating caregiver. The study accrued 33 of 74 (45%) eligible patients consenting together with 20 family caregivers (53 participants total) within nine months. Forty-one participants were evaluable (77%); 10 of 12 cases of attrition were attributable to hospitalization or death. Median participant age was 51 (range 21–78 years); 38% were men. Baseline levels of distress were similar in patients and caregivers. The top reasons for participation cited in pre-intervention interviews were to increase relaxation/calm, improve mood/emotions, and reduce stress/anxiety. In measures of adherence, 59% of responses to weekly texts asking: “Have you practiced today?” were “Yes” and 59% of interviewees reported practicing >50% of the time. Compared to baseline, post-intervention surveys demonstrated significantly reduced distress (p = 0.01) and anxiety (p = 0.03); as well as increased non-reactivity (p<0.01), and feeling at peace (p<0.01). Post-intervention qualitative interviews, where 71% of participants reported benefit, were consistent with quantitative findings. In the interviews, participants spontaneously described reduced stress/anxiety and increased relaxation/calm. Benefits appeared to be accentuated in patient-caregiver pairs as compared to unpaired patients. Seventy-nine percent of participants reported plans for continued practice after study completion. We conclude that the Being Present audio-based mindfulness meditation program is of interest to, feasible, and acceptable for patients with metastatic colorectal cancer and caregivers, with initial evidence of efficacy. These results will guide plans for a follow-up study.
Randomized Controlled Trial Examining Health Care Access Interventions for Taxi Drivers
2016 (Active)
Memorial Sloan Kettering Cancer Center
Antiretroviral therapy (ART) improves the health of people living with HIV and can reduce infectiousness, preventing HIV transmission. The potential preventive benefits of ART are undermined by beliefs that it is safe to have condomless sex when viral load is below levels of detection (infectiousness beliefs and risk perceptions). In this study we hypothesized that infectiousness beliefs and HIV transmission risk perceptions would prospectively predict people living with HIV engaging in more condomless sex with HIV-negative and unknown HIV status sex partners. Sexually active HIV-positive men (n=538, 76%) and women (n= 166, 24%) completed computerized interviews of sexually transmitted infections (STI) symptoms and diagnoses, unannounced pill counts for medication adherence, medical chart abstracted HIV viral load, and 28 daily cell-phone delivered prospective sexual behavior assessments. Results showed that a total of 313 (44%) participants had engaged in condomless sex with HIV-negative/unknown status sex partners and these individuals demonstrated higher rates of STI symptoms and diagnoses. Two-thirds of participants who had condomless sex with HIV-negative/unknown status partners had not disclosed their HIV status. Multivariable logistic regression models showed that beliefs regarding viral load and HIV infectiousness and perceptions of lower risk for HIV transmission resulting from HIV viral suppression predicted condomless sex with potentially uninfected partners over and above sex behaviors with HIV-positive partners and STI symptoms/diagnoses. Interventions that address HIV status disclosure and aggressively treat STI in sexually active people living with HIV should routinely accompany the use of HIV treatments as prevention.
Pilot Study of Triphala and Rubia Cordifolia on Gut Microbiome and Skin
2018 (Completed)
Raja Sivamani, MD, University of California-Davis, Department of Dermatology
Herbal supplements such as Rubia cordifolia and Triphala [a mix of Emblica officinalis (Amalaki), Terminalia bellerica (Bibhitaki), and Terminalia chebula (Haritaki)] are commonly used for skin based treatments in India. However, the scientific evidence for their specific effects on the skin are scant. Rubia cordifolia is a root that is used in skin care for pigmentation and inflammation.1 Triphala is thought to have antioxidant properties and reduce inflammation in general. Herbs have been shown to modulate the gut microbiome, as previous studies have suggested that triphala may modify the gut microbiome.2
Novel methods to estimate antiretroviral adherence: protocol for a longitudinal study
2018 (Active)
Parya Saberi, Kristin Ming, Dominique Legnitto, Torsten B Neilands, Monica Gandhi, and Mallory O Johnson
There is currently no gold standard for assessing antiretroviral (ARV) adherence, so researchers often resort to the most feasible and cost-effective methods possible (eg, self-report), which may be biased or inaccurate. The goal of our study was to evaluate the feasibility and acceptability of innovative and remote methods to estimate ARV adherence, which can potentially be conducted with less time and financial resources in a wide range of clinic and research settings. Here, we describe the research protocol for studying these novel methods and some lessons learned.
Use of Xtampza ER to overcome difficulties in swallowing opioid pills
2017 (Active)
Ajay Wasan, MD, MSc, Andrea G. Gillman, PhD
Xtampza ER is an oral opioid medication capsule that can be opened to allow the pellets to be added to food or drink. This study will investigate whether Xtampza ER can adequately address common quality of care deficits of opioid medications.
Edtech-HPV: A Community Approach Using Education and Technology to Increase HPV Vaccination (Edtech-HPV)
2017 (Active)
Memorial Sloan Kettering Cancer Center
This study is a two-arm randomized controlled trial, implemented to assess the effectiveness of a community-based educational program with and without a text messaging reminder system, in increasing the rate of HPV vaccination completion among children of Mexican Americans.
Feasibility and Acceptability of Text Messaging to Assess Daily Substance Use and Sexual Behaviors among Urban Emerging Adults
2017 (Complete)
Erin E. Bonar, Rebecca M. Cunningham, R. Lorraine Collins, James A. Cranford, Stephen T. Chermack, Marc A. Zimmerman, Frederic C. Blow, and Maureen A. Walton
Daily process research can help distinguish causal relationships between substance use and sexual risk behaviors in high-risk groups, such as urban emerging adults. We employed text messaging to assess 18–25 year-olds’ daily substance use and sexual risk behaviors over 28 days. We describe the implementation of this method, attitudes regarding the daily surveys, and correlates of survey completion.
Facet joint injections for people with persistent non-specific low back pain (Facet Injection Study): a feasibility study for a randomised controlled trial.
2017 (Complete)
David R Ellard, Martin Underwood, Felix Achana, James HL Antrobus, Shyam Balasubramanian, Sally Brown, Melinda Cairns, James Griffin, Frances Griffiths, Kirstie Haywood, Charles Hutchinson, Ranjit Lall, Stavros Petrou, Nigel Stallard, Colin Tysall, David A Walsh, Harbinder Sandhu
Developing predictive models for return to work using the Military Power, Performance and Prevention (MP3) musculoskeletal injury risk algorithm: a study protocol for an injury risk assessment programme
2016 (Active)
Daniel I Rhon, Deydre S Teyhen, Scott W Shaffer, Stephen L Goffar, Kyle Kiesel, and Phil P Plisky
Musculoskeletal injuries are a primary source of disability in the US Military, and low back pain and lower extremity injuries account for over 44% of limited work days annually. History of prior musculoskeletal injury increases the risk for future injury. This study aims to determine the risk of injury after returning to work from a previous injury. The objective is to identify criteria that can help predict likelihood for future injury or re-injury.
Advice given by community members to pregnant women: a mixed methods study
2016 (Completed)
Bianca A. Verma, Lauren P. Nichols, Melissa A. Plegue, Michelle H. Moniz, Manisha Rai, and Tammy Chang
Smoking and excess weight gain during pregnancy have been shown to have serious health consequences for both mothers and their infants. Advice from friends and family on these topics influences pregnant women’s behaviors. The purpose of our study was to compare the advice that community members give pregnant women about smoking versus the advice they give about pregnancy weight gain.
HIV Disclosure and Transmission Risks to Sex Partners Among HIV-Positive Men
2016 (Completed)
Seth C. Kalichman, PhD, corresponding author Moira O. Kalichman, MSW, Chauncey Cherry, PhD, and Tamar Grebler, BA
Disclosure of HIV-positive status to sex partners is critical to protecting uninfected partners. In addition, people living with HIV often risk criminal prosecution when they do not inform sex partners of their HIV status. The current study examined factors associated with nondisclosure of HIV status by men living with HIV in Atlanta, GA (92% African African, mean age = 43.8), who engage in condomless sex with uninfected sex partners. Sexually active HIV-positive men (N = 538) completed daily electronic sexual behavior assessments over the course of 28 days and completed computerized interviews, drug testing, medication adherence assessments, and HIV viral load retrieved from medical records. Results showed that 166 (30%) men had engaged in condomless vaginal or anal intercourse with an HIV-uninfected or unknown HIV status sex partner to whom they had not disclosed their HIV status. Men who engaged in nondisclosed condomless sex were less adherent to their HIV treatment, more likely to have unsuppressed HIV, demonstrated poorer disclosure self-efficacy, enacted fewer risk reduction communication skills, and held more beliefs that people with HIV are less infectious when treated with antiretroviral therapy. We conclude that undisclosed HIV status is common and related to condomless sex with uninfected partners. Men who engage in nondisclosed condomless sex may also be more infectious given their nonadherence and viral load. Interventions are needed in HIV treatment as prevention contexts that attend to disclosure laws and enhance disclosure self-efficacy, improve risk reduction communication skills, and increase understanding of HIV infectiousness.
Wraparound care for youth injured by violence: study protocol for a pilot randomised control trial
2015 (Completed)
Carolyn Snider, Depeng Jiang, Sarvesh Logsetty, Trevor Strome, and Terry Klassen
Injury by violence is the fourth cause of death and the leading reason for a youth to visit an emergency department (ED) in Canada. In Winnipeg, 20% of youth who visit an ED with an injury due to violence have a second visit for a subsequent violent injury within 1 year. Youth injured by violence are in a reflective and receptive state of mind, rendering the ED setting appropriate for intervention.
Sexual Behaviors and Transmission Risks among People Living with HIV: Beliefs, Perceptions, and Challenges to Using Treatments as Prevention
2015 (Completed)
Seth C. Kalichman, Chauncey Cherry, Moira O. Kalichman, Christopher Washington, Tamar Grebler, Ginger Hoyt, Cindy Merely, and Brandi Welles
Antiretroviral therapy (ART) improves the health of people living with HIV and can reduce infectiousness, preventing HIV transmission. The potential preventive benefits of ART are undermined by beliefs that it is safe to have condomless sex when viral load is below levels of detection (infectiousness beliefs and risk perceptions). In this study we hypothesized that infectiousness beliefs and HIV transmission risk perceptions would prospectively predict people living with HIV engaging in more condomless sex with HIV-negative and unknown HIV status sex partners. Sexually active HIV-positive men (n=538, 76%) and women (n= 166, 24%) completed computerized interviews of sexually transmitted infections (STI) symptoms and diagnoses, unannounced pill counts for medication adherence, medical chart abstracted HIV viral load, and 28 daily cell-phone delivered prospective sexual behavior assessments. Results showed that a total of 313 (44%) participants had engaged in condomless sex with HIV-negative/unknown status sex partners and these individuals demonstrated higher rates of STI symptoms and diagnoses. Two-thirds of participants who had condomless sex with HIV-negative/unknown status partners had not disclosed their HIV status. Multivariable logistic regression models showed that beliefs regarding viral load and HIV infectiousness and perceptions of lower risk for HIV transmission resulting from HIV viral suppression predicted condomless sex with potentially uninfected partners over and above sex behaviors with HIV-positive partners and STI symptoms/diagnoses. Interventions that address HIV status disclosure and aggressively treat STI in sexually active people living with HIV should routinely accompany the use of HIV treatments as prevention.
Text Message Appointment Reminders Increase Patient Engagement in Clinical Trials (Case Study)
2015 (Active)
IQVIA (formerly, Quintiles)
Key Findings:
- The amount of daily SMSs sent is positively correlated with study visit attendance rates.
- 175 average text messages sent per day is statistically associated with a 10.07% average increase in study visit attendance.
- There was a 91.6% reduction in resources utilized to remind study patients of screening visits.
- Increased ability to optimize study screening department planning and resources due to appointment confirmations.
Text Messaging Enhances Clinical Trial Patient Recruitment (Case Study)
2014 (Active)
Johnson County Clin-Trials (JCCT)
Figure 1 confirms that the increase in text messages also increased enrollment rates, and Figure 2 verifies that there was a statistically significant relationship between text messaging and patients enrolled.
