Contemporary clinical trials
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Contemp Clin Trials · Sep 2013
Clinical TrialFunctional recovery in lumbar spine surgery: a controlled trial of health behavior change counseling to improve outcomes.
In 2001, the Institute of Medicine issued a challenge to the American health care system to improve the quality of care by focusing on six major areas: safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity. The patient-centered model of care directly addresses important limits of surgical care of the lumbar spine, i.e., the lack of effective methods for increasing patient participation and engagement in post-operative follow-up. Recent evidence indicates that post-surgical outcomes are better among those with higher patient activation. ⋯ From December 2009 through October 2012, 120 participants were recruited and divided into two groups: those receiving (intervention group, 60) and not receiving (control group, 60) the HBCC intervention. The current manuscript provides a detailed description of the theoretical framework and study design of the HBCC and describes the implementation of this health behavior intervention in a university-based spine service. The HBCC provides a model for conducting health behavioral research in a real-world setting.
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Contemp Clin Trials · Sep 2013
Randomized Controlled Trial Multicenter StudyRationale and design of a multicenter randomized clinical trial of extended release gabapentin in provoked vestibulodynia and biological correlates of response.
Few randomized controlled trials (RCTs) have been conducted to establish evidence-based management protocols for provoked vestibulodynia (PVD), a chronic vulvar pain condition affecting approximately 14 million women in the U.S. We describe the rationale and design of an NIH funded multicenter clinical trial utilizing an extended release formulation of gabapentin (G-ER), an intervention that preliminary data suggest may be efficacious for this condition. ⋯ We will conduct the first multicenter RCT to confirm efficacy of an agent that is currently used in clinical practice for treating PVD.
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Contemp Clin Trials · Sep 2013
Randomized Controlled Trial Multicenter StudyA self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease (COPD) and comorbidities: the COPE-III study protocol.
Chronic Obstructive Pulmonary Disease (COPD) frequently coexists with other diseases. Whereas COPD action plans are currently part of usual care, they are less suitable and potentially unsafe for use in the presence of comorbidities. This study evaluates whether an innovative treatment approach directed towards COPD and frequently existing comorbidities can reduce COPD exacerbation days. We hypothesise that this approach, which combines self-initiated action plans and nurse support, will accelerate proper treatment actions and lead to better control of deteriorating symptoms. ⋯ Prudence should be employed before extrapolating the use of COPD specific action plans in patients with comorbidities. This study evaluates the efficacy of tailored action plans for both COPD and common comorbidities.
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Contemp Clin Trials · Sep 2013
Randomized Controlled TrialHealthy Homes/Healthy Kids: a randomized trial of a pediatric primary care-based obesity prevention intervention for at-risk 5-10 year olds.
Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important public health priority. The goal of the Healthy Homes/Healthy Kids (HHHK 5-10) randomized controlled trial is to evaluate the efficacy of a relatively low-cost primary care-based obesity prevention intervention aimed at 5 to 10 year old children who are at risk for obesity. ⋯ The HHHK 5-10 obesity prevention intervention combines brief counseling with a pediatric primary care provider during routine well child visits and follow-up telephone coaching that supports parents in making home environmental changes to support healthful eating, activity patterns, and body weight. The Contact Control condition combines the same provider counseling with telephone coaching focused on safety and injury prevention messages. This manuscript describes the study design and baseline characteristics of participants enrolled in the HHHK 5-10 trial.
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Contemp Clin Trials · Sep 2013
Randomized Controlled TrialEMPOWER: a randomized trial using community health workers to deliver a lifestyle intervention program in African American women with Type 2 diabetes: design, rationale, and baseline characteristics.
African American (AA) women with Type 2 diabetes mellitus (T2DM) in the rural south experience less weight loss and poorer glycemic control in traditional diabetes management programs compared to Caucasians. This paper describes the design, rationale, and baseline characteristics from an innovative community health worker (CHW) delivered intervention program in this population. ⋯ The present sample of AA women from impoverished rural communities exhibited significantly uncontrolled T2DM of long duration with associated obesity and poor lifestyle behaviors. An innovative CHW led lifestyle intervention may lead to more effective strategies for T2DM management in this population.