Browsing by Subject "Randomized trial"
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Item A randomized trial comparing weight loss treatment delivered in large versus small groups(Springer Nature, 2014-09-24) Dutton, Gareth R.; Nackers, Lisa M.; Dubyak, Pamela J.; Rushing, Nicole C.; Huynh, Tuong-Vi T.; Tan, Fei; Anton, Stephen D.; Perri, Michael G.; Mathematical Sciences, School of ScienceBackground: Behavioral interventions for obesity are commonly delivered in groups, although the effect of group size on weight loss has not been empirically evaluated. This behavioral weight loss trial compared the 6- and 12-month weight changes associated with interventions delivered in a large group (LG) or small groups (SG). Methods: Obese adults (N = 66; mean age = 50 years; mean BMI = 36.5 kg/m2; 47% African American; 86% women) recruited from a health maintenance organization were randomly assigned to: (1) LG treatment (30 members/group), or (2) SG treatment (12 members/group). Conditions were comparable in frequency and duration of treatment, which included 24 weekly group sessions (months 1-6) followed by six monthly extended care contacts (months 7-12). A mixed effects model with unstructured covariance matrix was applied to analyze the primary outcome of weight change while accounting for baseline weight and dependence among participants' measurements over time. Results: SG participants lost significantly more weight than LG participants at Month 6 (-6.5 vs. -3.2 kg; p = 0.03) and Month 12 (-7.0 vs. -1.7 kg; p < 0.002). SG participants reported better treatment engagement and self-monitoring adherence at Months 6 and 12, ps < 0.04, with adherence fully mediating the relationship between group size and weight loss. Conclusions: Receiving obesity treatment in smaller groups may promote greater weight loss and weight loss maintenance. This effect may be due to improved adherence facilitated by SG interactions. These novel findings suggest that the perceived efficiency of delivering behavioral weight loss treatment to LGs should be balanced against the potentially better outcomes achieved by a SG approach.Item The Advancing Understanding of Transportation Options (AUTO) study: design and methods of a multi-center study of decision aid for older drivers(BMC, 2021-05-03) Betz, Marian E.; Omeragic, Faris; Meador, Lauren; DiGuiseppi, Carolyn G.; Fowler, Nicole R.; Han, S. Duke; Hill, Linda; Johnson, Rachel L.; Knoepke, Christopher E.; Matlock, Daniel D.; Moran, Ryan; Medicine, School of MedicineBackground: Decision-making about when to stop driving for older adults involves assessment of driving risk, availability of support or resources, and strong emotions about loss of independence. Although the risk of being involved in a fatal crash increases with age, driving cessation can negatively impact an older adult's health and well-being. Decision aids can enhance the decision-making process by increasing knowledge of the risks and benefits of driving cessation and improve decision quality. The impact of decision aids regarding driving cessation for older adults is unknown. Methods: The Advancing Understanding of Transportation Options (AUTO) study is a multi-site, two-armed randomized controlled trial that will test the impact of a decision aid on older adults' decisions about changes in driving behaviors and cessation. AUTO will enroll 300 drivers age ≥ 70 years with a study partner (identified by each driver); the dyads will be randomized into two groups (n = 150/group). The decision aid group will view the web-based decision aid created by Healthwise at baseline and the control group will review information about driving that does not include evidence-based elements on risks and benefits and values clarification about driving decisions. The AUTO trial will compare the effect of the decision aid, versus control, on a) immediate decision quality (measured by the Decisional Conflict Scale; primary outcome); b) longitudinal psychosocial outcomes at 12 and 24 months (secondary outcomes); and c) longitudinal driving behaviors (including reduction or cessation) at 12 and 24 months (secondary outcomes). Planned stratified analyses will examine the effects in subgroups defined by cognitive function, decisional capacity, and readiness to stop driving. Discussion: The AUTO study is the first large-scale randomized trial of a driving decision aid for older adults. Results from this study will directly inform clinical practice about how best to support older adults in decision-making about driving.Item Back Pain Consortium (BACPAC): Protocol and Pilot Study Results for a Randomized Comparative-Effectiveness Trial of Antidepressants, Fear Avoidance Rehabilitation, or the Combination for Chronic Low Back Pain and Comorbid High Negative Affect(Oxford University Press, 2023) Wasan, Ajay D.; Edwards, Robert R.; Kraemer, Kevin L.; Jeong, Jong; Kenney, Megan; Luong, Kevin; Cornelius, Marise C.; Mickles, Caitlin; Dharmaraj, Bhagya; Sharif, Essa; Stoltenberg, Anita; Emerick, Trent; Karp, Jordan F.; Bair, Matt J.; George, Steven Z.; Hooten, William M.; Medicine, School of MedicineObjective: Patients with chronic low back pain (CLBP) and comorbid depression or anxiety disorders are highly prevalent. Negative affect (NA) refers to a combination of negative thoughts, emotions, and behaviors. Patients with CLBP with high NA have greater pain, worse treatment outcomes, and greater prescription opioid misuse. We present the protocol for SYNNAPTIC (SYNergizing Negative Affect & Pain Treatment In Chronic pain). Design: A randomized comparative-effectiveness study of antidepressants, fear-avoidance rehabilitation, or their combination in 300 patients with CLBP with high NA. In the antidepressant- or rehabilitation-only arms, SYNNAPTIC includes an adaptive design of re-randomization after 4 months for nonresponders. Setting: A multisite trial conducted in routine pain clinical treatment settings: pain clinics and physical and occupational therapy treatment centers. Methods: Inclusion criteria include CLBP with elevated depression and anxiety symptoms. Antidepressant and rehabilitation treatments follow validated and effective protocols for musculoskeletal pain in patients with high NA. Power and sample size are based on superior outcomes of combination therapy with these same treatments in a 71-subject 4-arm pilot randomized controlled trial. Conclusions: SYNNAPTIC addresses the lack of evidence-based protocols for the treatment of the vulnerable subgroup of patients with CLBP and high NA. We hypothesize that combination therapy of antidepressants plus fear-avoidance rehabilitation will be more effective than each treatment alone.Item Evaluating the effect of prebiotics on the gut microbiome profile and β cell function in youth with newly diagnosed type 1 diabetes: protocol of a pilot randomized controlled trial(BMC, 2023-08-25) Ismail, Heba M.; Spall, Maria; Evans‑Molina, Carmella; DiMeglio, Linda A.; Pediatrics, School of MedicineIntroduction: Data show that disturbances in the gut microbiota play a role in glucose homeostasis, type 1 diabetes (T1D) risk and progression. The prebiotic high amylose maize starch (HAMS) alters the gut microbiome profile and metabolites favorably with an increase in bacteria producing short chain fatty acids (SCFAs) that have significant anti-inflammatory effects. HAMS also improves glycemia, insulin sensitivity, and secretion in healthy non-diabetic adults. Additionally, a recent study testing an acetylated and butyrylated form of HAMS (HAMS-AB) that further increases SCFA production prevented T1D in a rodent model without adverse safety effects. The overall objective of this human study will be to assess how daily HAMS-AB consumption impacts the gut microbiome profile, SCFA production, β cell heath, function, and glycemia as well as immune responses in newly diagnosed T1D youth. Methods and analysis: We hypothesize that HAMS-AB intake will improve the gut microbiome profile, increase SCFA production, improve β cell health, function and glycemia as well as modulate the immune system. We describe here a pilot, randomized crossover trial of HAMS-AB in 12 newly diagnosed T1D youth, ages 11-17 years old, with residual β cell function. In Aim 1, we will determine the effect of HAMS-AB on the gut microbiome profile and SCFA production; in Aim 2, we will determine the effect of HAMS-AB on β cell health, function and glycemia; and in Aim 3, we will determine the peripheral blood effect of HAMS-AB on frequency, phenotype and function of specific T cell markers. Results will be used to determine the effect-size estimate of using HAMS-AB. We anticipate beneficial effects from a simple, inexpensive, and safe dietary approach. Ethics and dissemination: The Institutional Review Board at Indiana University approved the study protocol. The findings of this trial will be submitted to a peer-reviewed pediatric journal. Abstracts will be submitted to relevant national and international conferences.Item “Is it time to stop driving?”: A Randomized Clinical Trial of an Online Decision Aid for Older Drivers(Wiley, 2022) Betz, Marian E.; Hill, Linda L.; Fowler, Nicole R.; DiGuiseppi, Carolyn; Han, S. Duke; Johnson, Rachel L.; Meador, Lauren; Omeragic, Faris; Peterson, Ryan A.; Matlock, Daniel D.; Medicine, School of MedicineBackground: Many older adults face the difficult decision of when to stop driving. We sought to test whether an online driving decision aid (DDA) would improve decision quality. Methods: This prospective two-arm randomized trial enrolled English-speaking licensed drivers (age ≥70 years) without significant cognitive impairment but with ≥1 diagnosis associated with increased likelihood of driving cessation); all participants received primary care in clinics associated with study sites in three states. The intervention was the online Healthwise® DDA for older adults addressing “Is it time to stop driving?”; control was web-based information for older drivers only. The primary outcome was decision conflict as estimated by the Decisional Conflict Scale (DCS; lower scores indicate higher quality). Secondary outcomes were knowledge and decision self-efficacy about driving decisions. We examined post-randomization differences in primary and secondary outcomes by study arm using generalized linear mixed-effects models with adjustment for site and pre-randomization scores. Results: Among 301 participants (mean age: 77.1 years), 51.2% identified as female and the majority as non-Hispanic (99.0%) and White (95.3%); 98.0% lived in an urban area. Participant characteristics were similar by study arm but differed across sites. Intervention participants had a lower mean DCS score (12.3 DDA vs 15.2 control; adjusted mean ratio [AMR] 0.76, 95%CI 0.61–0.95; p=0.017). Intervention participants had higher mean knowledge scores (88.9 DDA vs 79.9 control; OR 1.13, 95%CI 1.01–1.27, p=0.038); there was no difference between groups in self-efficacy scores. The DDA had high acceptability; 86.9% of those who viewed it said they would recommend it to others in similar situations. Conclusions: The online Healthwise® DDA decreased decision conflict and increased knowledge in this sample of English-speaking, older adults without significant cognitive impairment, although most chose to continue driving. Use of such resources in clinical or community settings may support older adults as they transition from driving to other forms of mobility.Item Pharmacological Management of Delirium in the Intensive Care Unit: A Randomized Pragmatic Clinical Trial(Wiley, 2019-05) Khan, Babar A.; Perkins, Anthony J.; Campbell, Noll L.; Gao, Sujuan; Farber, Mark O.; Wang, Sophia; Khan, Sikandar H.; Zarzaur, Ben L.; Boustani, Malaz A.; Biostatistics, School of Public HealthBACKGROUND/OBJECTIVE: Delirium in the intensive care units (ICUs) is prevalent, with both delirium duration and delirium severity associated with adverse outcomes. We designed a pragmatic trial to test the efficacy of a pharmacological management of delirium (PMD) bundle in improving delirium/coma-free days and reducing delirium severity among ICU patients. DESIGN: A randomized pragmatic clinical trial. SETTING: Medical, surgical, and progressive ICUs of three tertiary care hospitals. PARTICIPANTS: A total of 351 critically ill patients. INTERVENTION: A multicomponent PMD bundle consisting of reducing the exposure to 20 definite anticholinergic medications and benzodiazepines and prescribing low-dose haloperidol. MEASUREMENTS: The primary outcomes were delirium/coma-free days, measured through the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the ICU (CAM-ICU), and delirium severity, measured through Delirium Rating Scale-Revised-98 and the CAM-ICU-7. Secondary outcomes were in-hospital and posthospital discharge 30-day mortality, ICU and hospital lengths of stay, and delirium-related hospital complications. RESULTS: We randomized 351 critically ill delirious patients (mean age = 59.3 years [SD = 16.9 years]; 52% female, 42% African Americans) to receive the PMD bundle or usual care. There were no significant differences in median delirium/coma-free days at day 8 (PMD vs usual care = 4 [interquartile range {IQR} = 2-7] days vs 5 [IQR = 1-7] days; P = .888) or at day 30 (PMD vs usual care = 26 [IQR 19-29] days vs 26 [IQR, 14-29] days; P = .991). There were no significant differences for decrease in delirium severity at day 8, but at hospital discharge, the intervention group showed a greater reduction in delirium severity (mean decrease in CAM-ICU-7 score for PMD vs usual care = 3.2 [SD = 3.3] vs 2.5 [SD = 3.2]; P = .046). No differences were observed between groups for ICU and hospital lengths of stay, mortality, and delirium-related hospital complications. Similar results were observed when analyses were limited to patients 65 years or older and 75 years or older. CONCLUSION AND RELEVANCE: Implementing the PMD bundle in the ICU did not reduce delirium duration or severity among critically ill patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00842608. J Am Geriatr Soc 67:1057-1065, 2019.Item Statistical methods to study heterogeneity of treatment effects(2015-09-25) Taft, Lin H.; Shen, Changyu; Li, Xiaochun; Chen, Peng-Sheng; Wessel, JenniferRandomized studies are designed to estimate the average treatment effect (ATE) of an intervention. Individuals may derive quantitatively, or even qualitatively, different effects from the ATE, which is called the heterogeneity of treatment effect. It is important to detect the existence of heterogeneity in the treatment responses, and identify the different sub-populations. Two corresponding statistical methods will be discussed in this talk: a hypothesis testing procedure and a mixture-model based approach. The hypothesis testing procedure was constructed to test for the existence of a treatment effect in sub-populations. The test is nonparametric, and can be applied to all types of outcome measures. A key innovation of this test is to build stochastic search into the test statistic to detect signals that may not be linearly related to the multiple covariates. Simulations were performed to compare the proposed test with existing methods. Power calculation strategy was also developed for the proposed test at the design stage. The mixture-model based approach was developed to identify and study the sub-populations with different treatment effects from an intervention. A latent binary variable was used to indicate whether or not a subject was in a sub-population with average treatment benefit. The mixture-model combines a logistic formulation of the latent variable with proportional hazards models. The parameters in the mixture-model were estimated by the EM algorithm. The properties of the estimators were then studied by the simulations. Finally, all above methods were applied to a real randomized study in a low ejection fraction population that compared the Implantable Cardioverter Defibrillator (ICD) with conventional medical therapy in reducing total mortality.