Browsing by Subject "clinical trial"

Now showing 1 - 10 of 15
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    A randomized controlled trial assessing denture adhesive efficacy on denture retention across 13 hours
    (Wiley, 2024-04) Klukowska, Malgorzata; Grender, Julie; Gossweiler, Ana; Biomedical and Applied Sciences, School of Dentistry
    Purpose To compare the effects of two denture adhesive formulations on the bite force required to dislodge a maxillary denture in adult participants during a 13-h test period. Materials and Methods Twenty-two participants with a fair-to-poor fitting maxillary denture opposed by natural dentition or a stable mandibular denture were enrolled in this single-center, randomized, double-blind, two-treatment, 4-period crossover study. Participants were randomly assigned a product usage sequence so that each participant used each product twice during the 4-day test period. The test product was a denture cream adhesive formulated with an optimized calcium/zinc partial salt of polyvinyl methyl ether/maleic acid (Fixodent Ultra technology); the control product was a cream adhesive formulated with a calcium/zinc partial salt of polyvinyl methyl ether/maleic acid (Fixodent Original technology). On each study day, bite force at dislodgement was measured with a gnathodynamometer at baseline, representing the “no adhesive” score. Then, after standardized product application to the participant's existing maxillary denture by site staff, bite force measurements were retaken at 1, 3, 5, 7, 9, 11, and 13 h. The change from baseline and the 13-h area under the bite-force–change-from-baseline curve were analyzed via an analysis of variance. Results Twenty-one participants completed all test periods; one additional participant completed three test periods so 22 participants were included in the analysis. There were 15 females and 7 males with a mean age of 70 years. The mean 13-h area under the bite-force–change-from-baseline curve was 8% greater (p = 0.010) for the test adhesive (114.3 lb) than for the control adhesive (105.9 lb). Both adhesives showed a statistically significant increase in bite force (p < 0.001) at each time point compared to no adhesive. Conclusions The optimized calcium/zinc partial salt of polyvinyl methyl ether/maleic acid test adhesive provided superior maxillary denture retention relative to that of the control adhesive across 13 h. Both adhesives increased bite force at dislodgement compared to no adhesive.
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    Automated Self-management (ASM) vs. ASM-Enhanced Collaborative Care for Chronic Pain and Mood Symptoms: the CAMMPS Randomized Clinical Trial
    (Springer, 2019-06-21) Kroenke, Kurt; Baye, Fitsum; Lourens, Spencer G.; Evans, Erica; Weitlauf, Sharon; McCalley, Stephanie; Porter, Brian; Matthias, Marianne S.; Bair, Matthew J.; Medicine, School of Medicine
    Background Chronic musculoskeletal pain is often accompanied by depression or anxiety wherein co-occurring pain and mood symptoms can be more difficult to treat than either alone. However, few clinical trials have examined interventions that simultaneously target both pain and mood conditions. Objective To determine the comparative effectiveness of automated self-management (ASM) vs. ASM-enhanced collaborative care. Design Randomized clinical trial conducted in six primary care clinics in a VA medical center. Participants Two hundred ninety-four patients with chronic musculoskeletal pain of at least moderate intensity and clinically significant depressive and/or anxiety symptoms. Intervention ASM consisted of automated monitoring and 9 web-based self-management modules. Comprehensive symptom management (CSM) combined ASM with collaborative care management by a nurse-physician team. Both interventions were delivered for 12 months. Main Measures Primary outcome was a composite pain-anxiety-depression (PAD) z-score consisting of the mean of the BPI, PHQ-9, and GAD-7 z-scores: 0.2, 0.5, and 0.8 represent potentially small, moderate, and large clinical differences. Secondary outcomes included global improvement, health-related quality of life, treatment satisfaction, and health services use. Key Results Both CSM and ASM groups had moderate PAD score improvement at 12 months (z = − 0.65 and − 0.52, respectively). Compared to the ASM group, the CSM group had a − 0.23 (95% CI, − 0.38 to − 0.08; overall P = .003) greater decline in composite PAD z-score over 12 months. CSM patients were also more likely to report global improvement and less likely to report worsening at 6 (P = .004) and 12 months (P = .013). Conclusions Two intervention models relying heavily on telecare delivery but differing in resource intensity both produced moderate improvements in pain and mood symptoms. However, the model combining collaborative care led by a nurse-physician team with web-based self-management was superior to self-management alone.
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    Durability of Response to Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma Using UGN-101, a Mitomycin-Containing Reverse Thermal Gel: OLYMPUS Trial Final Report
    (AUA, 2022-04) Matin, Surena F.; Pierorazio, Phillip M.; Kleinmann, Nir; Gore, John L.; Shabsigh, Ahmad; Hu, Brian; Chamie, Karim; Godoy, Guilherme; Hubosky, Scott G.; Rivera, Marcelino; O'Donnell, Michael; Quek, Marcus; Raman, Jay D.; Knoedler, John J.; Scherr, Douglas; Weight, Christopher; Weizer, Alon; Woods, Michael; Kaimakliotis, Hristos; Smith, Angela B.; Linehan, Jennifer; Coleman, Jonathan; Humphreys, Mitchell R.; Pak, Raymond; Lifshitz, David; Verni, Michael; Klein, Ifat; Konorty, Marina; Strauss-Ayali, Dalit; Hakim, Gil; Seltzer, Elyse; Schoenberg, Mark; Lerner, Seth P.; Urology, School of Medicine
    Purpose: Our goal was to evaluate long-term safety and durability of response to UGN-101, a mitomycin-containing reverse thermal gel, as primary chemoablative treatment for low-grade upper tract urothelial carcinoma. Materials and Methods: In this open-label, single-arm, multicenter, phase 3 trial (NCT02793128), patients ≥18 years of age with primary or recurrent biopsy-proven low-grade upper tract urothelial carcinoma received 6 once-weekly instillations of UGN-101 via retrograde catheter to the renal pelvis and calyces. Those with complete response (defined as negative ureteroscopic evaluation, negative cytology and negative for-cause biopsy) 4–6 weeks after the last instillation were eligible for up to 11 monthly maintenance instillations and were followed for ≥12 months with quarterly evaluation of response durability. Durability of complete response was determined by ureteroscopic evaluation; duration of response was estimated by the Kaplan-Meier method. Treatment-emergent adverse events (TEAEs) were monitored. Results: Of 71 patients who initiated treatment, 41 (58%) had complete response to induction therapy and consented to long-term followup; 23/41 patients (56%) remained in complete response after 12 months (95% CI 40, 72), comprising 6/12 (50%) who did not receive any maintenance instillations and 17/29 (59%) who received ≥1 maintenance instillation. Kaplan-Meier analysis of durability was estimated as 82% (95% CI 66, 91) at 12 months. Ureteric stenosis was the most frequently reported TEAE (31/71, 44%); an increasing number of instillations appeared to be associated with increased incidence of urinary TEAEs. Conclusions: Durability of response to UGN-101 with or without maintenance treatment is clinically meaningful, offering a kidney-sparing therapeutic alternative for patients with low-grade disease.
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    Effect of Depression Treatment on Health Behaviors and Cardiovascular Risk Factors Among Primary Care Patients with Depression: Data from the eIMPACT Trial
    (2023-12) Schuiling, Matthew D.; Stewart, Jesse; Hirsh, Adam; Wu, Wei
    Background. Although depression is a risk factor for cardiovascular disease (CVD), few clinical trials in people without CVD have examined the effect of depression treatment on CVD-related outcomes. It’s unknown if successful depression treatment improves indicators of CVD risk, such as CVD-relevant health behaviors, traditional CVD risk factors, and CVD events. Methods. We examined data from eIMPACT trial, a phase II randomized controlled trial conducted from 2015-2020. Depressive symptoms, CVD-relevant health behaviors (self-reported CVD prevention medication adherence, sedentary behavior, and sleep quality) and traditional CVD risk factors (blood pressure and lipid fractions) were assessed. Incident CVD events over four years were identified using a statewide health information exchange. Results. The intervention group exhibited greater improvement in depressive symptoms (p < 0.01) and sleep quality (p < 0.01) than the usual care group, but there was no intervention effect on systolic blood pressure (p = 0.36), low-density lipoprotein cholesterol (p = 0.38), high-density lipoprotein cholesterol (p = 0.79), triglycerides (p = 0.76), CVD prevention medication adherence (p = 0.64), or sedentary behavior (p = 0.57). There was an intervention effect on diastolic blood pressure that favored the usual care group (p = 0.02). CVD-relevant health behaviors did not mediate any intervention effects on traditional CVD risk factors. Twenty-two participants (10%) experienced an incident CVD event. The likelihood of an CVD event did not differ between the intervention group (12.1%) and the usual care group (8.3%; HR = 1.45, 95% CI: 0.62-3.40, p = 0.39). Conclusions. Successful depression treatment alone improves self-reported sleep quality but is not sufficient to lower CVD risk of people with depression. Alternative approaches may be needed reduce CVD risk in depression. Trial Registration: ClinicalTrials.gov Identifier: NCT02458690
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    Effect of Health Information Exchange Plus a Care Transitions Intervention on Post-Hospital Outcomes Among VA Primary Care Patients: a Randomized Clinical Trial
    (Springer, 2022-02-23) Boockvar, Kenneth S.; Koufacos, Nicholas S.; May, Justine; Schwartzkopf, Ashley L.; Guerrero, Vivian M.; Judon, Kimberly M.; Schubert , Cathy C.; Franzosa, Emily; Dixon, Brian E.; Epidemiology, Richard M. Fairbanks School of Public Health
    Background Health information exchange (HIE) notifications when patients experience cross-system acute care encounters offer an opportunity to provide timely transitions interventions to improve care across systems. Objective To compare HIE notification followed by a post-hospital care transitions intervention (CTI) with HIE notification alone. Design Cluster-randomized controlled trial with group assignment by primary care team. Patients Veterans 65 or older who received primary care at 2 VA facilities who consented to HIE and had a non-VA hospital admission or emergency department visit between 2016 and 2019. Interventions For all subjects, real-time HIE notification of the non-VA acute care encounter was sent to the VA primary care provider. Subjects assigned to HIE plus CTI received home visits and telephone calls from a VA social worker for 30 days after arrival home, focused on patient activation, medication and condition knowledge, patient-centered record-keeping, and follow-up. Measures Primary outcome: 90-day hospital admission or readmission. Secondary outcomes: emergency department visits, timely VA primary care team telephone and in-person follow-up, patients’ understanding of their condition(s) and medication(s) using the Care Transitions Measure, and high-risk medication discrepancies. Key Results A total of 347 non-VA acute care encounters were included and assigned: 159 to HIE plus CTI and 188 to HIE alone. Veterans were 76.9 years old on average, 98.5% male, 67.8% White, 17.1% Black, and 15.1% other (including Hispanic). There was no difference in 90-day hospital admission or readmission between the HIE-plus-CTI and HIE-alone groups (25.8% vs. 20.2%, respectively; risk diff 5.6%; 95% CI − 3.3 to 14.5%, p = .25). There was also no difference in secondary outcomes. Conclusions A care transitions intervention did not improve outcomes for veterans after a non-VA acute care encounter, as compared with HIE notification alone. Additional research is warranted to identify transitions services across systems that are implementable and could improve outcomes.
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    Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 Infections in an Open-Label, Phase 2 Trial
    (Elsevier, 2016-11) Gane, Edward J.; Kowdley, Kris V.; Pound, David; Stedman, Catherine A. M.; Davis, Mitchell; Etzkorn, Kyle; Gordon, Stuart C.; Bernstein, David; Everson, Gregory; Rodriguez-Torres, Maribel; Tsai, Naoky; Khalid, Omer; Yang, Jenny C.; Lu, Sophia; Dvory-Sobol, Hadas; Stamm, Luisa M.; Brainard, Diana M.; McHutchison, John G.; Tong, Myron; Chung, Raymond T.; Beavers, Kimberly; Poulos, John E.; Kwo, Paul Y.; Nguyen, Mindie H.; Department of Medicine, IU School of Medicine
    Background & Aims Studies are needed to determine the optimal regimen for patients with chronic hepatitis C virus (HCV) genotype 2, 3, 4, or 6 infections whose prior course of antiviral therapy has failed, and the feasibility of shortening treatment duration. We performed a phase 2 study to determine the efficacy and safety of the combination of the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/4A protease inhibitor GS-9857 in these patients. Methods We performed a multicenter, open-label trial at 32 sites in the United States and 2 sites in New Zealand from March 3, 2015 to April 27, 2015. Our study included 128 treatment-naïve and treatment-experienced patients (1 with HCV genotype 1b; 33 with HCV genotype 2; 74 with HCV genotype 3; 17 with genotype HCV 4; and 3 with HCV genotype 6), with or without compensated cirrhosis. All patients received sofosbuvir-velpatasvir (400 mg/100 mg fixed-dose combination tablet) and GS-9857 (100 mg) once daily for 6–12 weeks. The primary end point was sustained virologic response 12 weeks after treatment (SVR12). Results After 6 weeks of treatment, SVR12s were achieved by 88% of treatment-naïve patients without cirrhosis (29 of 33; 95% confidence interval, 72%–97%). After 8 weeks of treatment, SVR12s were achieved by 93% of treatment-naïve patients with cirrhosis (28 of 30; 95% CI, 78%–99%). After 12 weeks of treatment, SVR12s were achieved by all treatment-experienced patients without cirrhosis (36 of 36; 95% CI, 90%–100%) and 97% of treatment-experienced patients with cirrhosis (28 of 29; 95% CI, 82%–100%). The most common adverse events were headache, diarrhea, fatigue, and nausea. Three patients (1%) discontinued treatment due to adverse events. Conclusions In a phase 2 open-label trial, we found sofosbuvir-velpatasvir plus GS-9857 (8 weeks in treatment-naïve patients or 12 weeks in treatment-experienced patients) to be safe and effective for patients with HCV genotype 2, 3, 4, or 6 infections, with or without compensated cirrhosis.
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    Enrollment of Diverse Populations in the INGENIOUS Pharmacogenetics Clinical Trial
    (Frontiers, 2020-06) Shah-Williams, Ebony; Levy, Kenneth D.; Zang, Yong; Holmes, Ann M.; Stoughton, Christa; Dexter, Paul; Skaar, Todd C.; Medicine, School of Medicine
    Recruitment of diverse populations and subjects living in Medically Underserved Areas and Populations (MUA/P’s) into clinical trials is a considerable challenge. Likewise, representation of African-Americans in pharmacogenetic trials is often inadequate, but critical for identifying genetic variation within and between populations. To identify enrollment patterns and variables that predict enrollment in a diverse underserved population, we analyzed data from the INGENIOUS (Indiana GENomics Implementation and Opportunity for the UnderServed), pharmacogenomics implementation clinical trial conducted at a community hospital for underserved subjects (Safety net hospital), and a statewide healthcare system (Academic hospital). We used a logistic regression model to identify patient variables that predicted successful enrollment after subjects were contacted and evaluated the reasons that clinical trial eligible subjects refused enrollment. In both healthcare systems, African-Americans were less likely to refuse the study than non-Hispanic Whites (Safety net, OR = 0.68, and p < 0.002; Academic hospital, OR = 0.64, and p < 0.001). At the Safety net hospital, other minorities were more likely to refuse the study than non-Hispanic Whites (OR = 1.58, p < 0.04). The odds of refusing the study once contacted increased with patient age (Safety net hospital, OR = 1.02, p < 0.001, Academic hospital, OR = 1.02, and p < 0.001). At the Academic hospital, females were less likely to refuse the study than males (OR = 0.81, p = 0.01) and those not living in MUA/P’s were less likely to refuse the study than those living in MUA/P’s (OR = 0.81, p = 0.007). The most frequent barriers to enrollment included not being interested, being too busy, transportation, and illness. A lack of trust was reported less frequently. In conclusion, African-Americans can be readily recruited to pharmacogenetic clinical trials once contact has been successfully initiated. However, health care initiatives and increased recruitment efforts of subjects living in MUA/Ps are needed. Enrollment could be further enhanced by improving research awareness and knowledge of clinical trials, reducing time needed for participation, and compensating for travel.
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    Equipoise and Skepticism: Past, Present and Future
    (2008-08-22T14:35:30Z) Witt, John R.; Meslin, Eric Mark; Tilley, John J.; Lyons, Timothy D.
    Currently, the predominant view in research ethics maintains that physicians can morally justify offering randomized clinical trial enrollment to their patients only if some form of equipoise is present. Thus, the physician must experience (either individually or communally) a state of reasoned uncertainty concerning the relative merits of two or more competing treatments for a given disease before she may recommend that her patient participate in a clinical trial. Increasingly, however, this position has been subject to critical attention and considerable negative scrutiny. My argument engages this trend by turning to the history of philosophy; here I claim that the use of the term “equipoise” in the medical research context is extremely similar to terms and concepts from the philosophical tradition of skepticism, and as a result of this similarity it is possible to understand the principle of equipoise’s vulnerability to already published criticisms. A comparison of the criticisms of equipoise within the medical research literature to criticisms of philosophical skepticism reveals a potentially grim future for equipoise as a legitimate guiding principle for the ethical conduct of clinical research.
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    Evaluation of a peer coach-led intervention to improve pain symptoms (ECLIPSE): Rationale, study design, methods, and sample characteristics
    (Elsevier, 2019) Matthias, Marianne S.; Daggy, Joanne; Adams, Jasma; Menen, Tetla; McCalley, Stephanie; Kukla, Marina; McGuire, Alan B.; Ofner, Susan; Pierce, Emilee; Kempf, Carol; Heisler, Michele; Bair, Matthew J.; Communication Studies, School of Liberal Arts
    Chronic pain is prevalent, costly, and a leading cause of disability. Pain self-management (i.e., employing self-management strategies including behavioral modifications) is an effective, evidence-based treatment. However, implementation and delivery of a pain self-management model is challenging because of time and resources. Peer supported pain self-management offers a promising approach to implementing pain self-management programs using fewer clinical resources. Evaluation of a Peer Coach-Led Intervention for the Improvement of Pain Symptoms (ECLIPSE) is a randomized controlled trial testing effectiveness of peer coach-delivered pain self-management intervention versus controls receiving a class on pain and pain self-management. ECLIPSE is a Hybrid Type 1 study testing effectiveness while examining implementation factors. ECLIPSE enrolled 215 veterans randomly assigned to the peer coaching (N = 120) or control (N = 95) arm. The peer coaching intervention lasts 6 months, with patient-peer coach pairs instructed to talk twice per month. Coaches attend initial training, are provided a detailed training manual, and attend monthly booster sessions. Outcomes are assessed at baseline, 6 months, and 9 months. The primary outcome is overall pain (intensity and interference), measured by the Brief Pain Inventory (BPI). Secondary outcomes are self-efficacy, social support, pain catastrophizing, patient activation, health-related quality of life, and health care utilization. To maximize implementation potential of pain self-management, innovative delivery methods are needed that do not require additional resources from healthcare teams. A novel and promising approach is a peer-coaching model, in which patients who are successfully managing their pain offer information, ongoing support, and advice to other patients with pain.
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    Feasibility and Effect Sizes of the Revised Daily Engagement of Meaningful Activities Intervention for Persons with Mild Cognitive Impairment and Their Caregivers
    (2016-03) Lu, Yvonne Yueh-Feng; Bakas, Tamilyn; Yang, Ziyi; Weaver, Michael T.; Austrom, Mary Guerriero; Haase, Joan E.; IU School of Nursing
    A nurse-led intervention, Daily Engagement of Meaningful Activities (DEMA), was evaluated for feasibility and effect sizes in a two-group randomized pilot study with 36 patient–caregiver dyads (17 DEMA and 19 attention control). Effect sizes were estimated on 10 outcomes: dyad functional ability awareness congruence; patients' meaningful activity performance and satisfaction, confidence, depressive symptoms, communication satisfaction, physical function, and life satisfaction; and caregivers' depressive symptoms and life changes. High feasibility of DEMA was supported by the following indicators: consent (97.7%), session completion (91.7%), and Time 3 measure completion (97.2%). Compared to the attention control group, the DEMA group had higher dyad congruence in functional ability awareness and life satisfaction 3 months post-intervention and improved physical function at 2 weeks post-intervention. Although DEMA showed high feasibility and benefits on some health-related outcomes, further testing of DEMA in a larger randomized controlled clinical trial is needed.