Viva bien!: Overcoming recruitment challenges in a multiple-risk-factor diabetes trial.
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ABSTRACT:
SUBMITTER: Toobert DJ
PROVIDER: S-EPMC2862983 | biostudies-literature | 2010 Jul-Aug
REPOSITORIES: biostudies-literature
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Viva bien!: Overcoming recruitment challenges in a multiple-risk-factor diabetes trial.
Toobert Deborah J DJ Strycker Lisa A LA Glasgow Russell E RE Osuna Diego D Doty Alyssa Tinley AT Barrera Manuel M Geno Cristy R CR Ritzwoller Debra P DP
American journal of health behavior 20100701 4
<h4>Objectives</h4>To describe recruitment of Latinas in a randomized clinical trial conducted within 2 health care organizations.<h4>Methods</h4>The study relied on project-initiated telephone calls as part of a multifaceted recruitment approach. Chi-square and t tests were conducted to compare participants and nonparticipants on a number of variables.<h4>Results</h4>From 4045 telephone contacts, 280 Latinas agreed to participate. Most were ineligible due to non-Latino ethnicity (89%). Of eligi ...[more]
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Project description:Latinas with type 2 diabetes are in need of culturally sensitive interventions to make recommended longterm lifestyle changes and reduce heart disease risk. To test the longer-term (24-month) effects of a previously successful, culturally adapted, multiple-healthbehavior- change program, ¡Viva Bien!, 280 Latinas were randomly assigned to usual care or ¡Viva Bien!. Treatment included group meetings to promote a culturally adapted Mediterranean diet, physical activity, supportive resources, problem solving, stress-management practices, and smoking cessation. ¡Viva Bien! participants achieved and maintained some lifestyle improvements from baseline through 24 months, including significant improvements for psychosocial outcomes, fat intake, social-environmental support, body mass index, and hemoglobin A1c. Effects tended to diminish over time. The ¡Viva Bien! multiple-behavior program was effective in improving and maintaining some psychosocial, behavioral, and biological outcomes related to heart health across 24 months for Latinas with type 2 diabetes, a high-risk, underserved population (ClinicalTrials.gov number, NCT00233259).
| S-EPMC3196590 | biostudies-literature
Project description:BackgroundCulturally appropriate interventions are needed to assist Latinas in making multiple healthful lifestyle changes.PurposeThe purpose of this study was to test a cultural adaptation of a successful multiple health behavior change program, ¡Viva Bien!MethodsRandom assignment of 280 Latinas with type 2 diabetes to usual care only or to usual care + ¡Viva Bien!, which included group meetings for building skills to promote the Mediterranean diet, physical activity, stress management, supportive resources, and smoking cessation.Results¡Viva Bien! participants compared to usual care significantly improved psychosocial and behavioral outcomes (fat intake, stress management practice, physical activity, and social-environmental support) at 6 months, and some improvements were maintained at 12 months. Biological improvements included hemoglobin A1c and heart disease risk factors.ConclusionsThe ¡Viva Bien! multiple lifestyle behavior program was effective in improving psychosocial, behavioral, and biological/quality of life outcomes related to heart health for Latinas with type 2 diabetes.
| S-EPMC3108326 | biostudies-literature
Project description:PurposeThis paper highlights a descriptive study of the challenges and lessons learned in the recruitment of rural primary care physicians into a randomized clinical trial using an Internet-based approach.MethodsA multidisciplinary/multi-institutional research team used a multilayered recruitment approach, including generalized mailings and personalized strategies such as personal office visits, letters, and faxes to specific contacts. Continuous assessment of recruitment strategies was used throughout study in order to readjust strategies that were not successful.ResultsWe recruited 205 primary care physicians from 11 states. The 205 lead physicians who enrolled in the study were randomized, and the overall recruitment yield was 1.8% (205/11231). In addition, 8 physicians from the same practices participated and 12 nonphysicians participated. The earlier participants logged on to the study Web site, the greater yield of participation. Most of the study participants had logged on within 10 weeks of the study.ConclusionDespite successful recruitment, the 2 major challenges in recruitment in this study included defining a standardized definition of rurality and the high cost of chart abstractions. Because many of the patients of study recruits were African American, the potential implications of this study on the field of health disparities in diabetes are important.
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Project description:PurposePalliative care is increasingly viewed as a necessary component of cancer care, especially for patients with advanced disease. Rigorous clinical trials are thus needed to build the palliative care evidence base, but clinical research-especially participant recruitment-is difficult. Major barriers include (1) patient factors, (2) "gatekeeping," and (3) ethical concerns. Here we discuss an approach to overcoming these barriers, using the Palliative Care Trial (PCT) as a case study.Patients and methodsThe PCT was a 2 × 2 × 2 factorial randomized controlled trial (RCT) of different service delivery models to improve pain control in the palliative setting. It used a recruitment protocol that fused evidence-based strategies with principles of "social marketing," an approach involving the systematic application of marketing techniques. Main components included (1) an inclusive triage algorithm, (2) information booklets targeting particular stakeholders, (3) a specialized recruitment nurse, and (4) standardization of wording across all study communications.ResultsFrom an eligible pool of 607 patients, the PCT enrolled 461 patients over 26 months. Twenty percent of patients referred to the palliative care service were enrolled (76% of those eligible after screening). Several common barriers were minimized; among those who declined participation, family disinterest was uncommon (5%), as was the perception of burden imposed (4%).ConclusionChallenges to clinical trial recruitment in palliative care are significant but not insurmountable. A carefully crafted recruitment and retention protocol can be effective. Our experience with designing and deploying a social-marketing-based protocol shows the benefits of such an approach.
| S-EPMC3825289 | biostudies-literature
Project description:Background: While a scientifically sound study design is the basis for all clinical trials, activities such as patient recruitment present ongoing challenges. The availability of electronic data greatly enhances recruitment efforts, but also may bring new problems. The Journey for Control of Diabetes: the IDEA Study, a randomized clinical study conducted in two distant healthcare settings, utilizes an advanced electronic data system to identify and recruit eligible participants. We believe that communication of difficulties encountered could help researchers who face similar recruitment challenges.Methods: The inclusion criteria included: Type 2 diabetes (DM), an A1C > 7 within 6 months of enrollment, and diabetes educationna?ve within the last year. Preliminary estimates of patient availability were calculated with the following assumptions:Results: Recruitment has been much slower than predicted (50% of subjects recruited at seven months). Recruitment results to date are:The electronic data on the pool of potential subjects is often out of date by the time the subject is screened and randomized. Refreshing the electronic data creates a moving target of potential candidates. A1C data and date of last diabetes education change at a rate faster than the recruitment mailing, screening and randomization process. Therefore, more time, programming, and staffing resources have been needed than originally anticipated to recruit study participants.Conclusions: This analysis of recruitment data demonstrates that initial recruitment capability estimates did not account for the inefficiencies created by outdated data and refreshed electronic encounter data. Daily tracking of all criteria for database accuracy has been a difficult and time-intensive task.
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Project description:BACKGROUND:Fruit and vegetable (F&V) intake can reduce risks for chronic disease, but is much lower than recommended amounts in most Western populations, especially for those with low income levels. Rigorous research is needed on practical, cost-effective interventions that address environmental as well as personal determinants of F&V intake. This paper presents the results of a cluster randomized controlled trial evaluating the efficacy of 'Live Well, Viva Bien' (LWVB), a multicomponent intervention that included discount, mobile fresh F&V markets in conjunction with nutrition education. METHODS:Fifteen subsidized housing sites in Providence County, Rhode Island (8 intervention and 7 control sites) were randomized using a random number generator. Of these, nine housed elderly and/or disabled residents and six housed families. A total of 1597 adult housing site residents (treatment n = 837; control n = 760) were enrolled (73% women, 54% Hispanic, 17% black, Mean age 54 years). A year-long multicomponent intervention including mobile F&V markets plus nutrition education (e.g. campaigns, DVDs, newsletters, recipes, and chef demonstrations) was implemented at intervention sites. Physical activity and stress interventions were implemented at control sites. Follow-up occurred at 6 and 12 months. The main outcome measure was F&V consumption measured by National Cancer Institute's 'Eating at America's Table All Day Screener'. RESULTS:From baseline to 12 months, the intervention group increased total F&V intake by 0.44 cups with the control group decreasing intake by 0.08 cups (p < .02). Results also showed an increased frequency of F&V eating behaviors compared to the control group (p < .01). There was a clear dose response effect of the F&V markets with participants who reported attending all or most of the markets increasing F&V intake by 2.1 cups and 0.86 cups, respectively compared with less than half cup increases for lower levels of market attendance (p < .05). Use of the DVDs, recipes and taste-testings was also associated with greater increases in F&V intake; however, use of other educational components was not. CONCLUSIONS:LWVB is the first cluster, randomized controlled trial to demonstrate the efficacy of year-round F&V markets on improving F&V intake for low-income adults, which provides an evidence-base to bolster the mission of mobile produce markets. Further, the results more broadly support investment in environmental changes to alleviate disparities in F&V consumption and diet-related health inequities. TRIAL REGISTRATION NUMBER:Clinicatrials.gov registration number: NCT02669472.
| S-EPMC6102886 | biostudies-literature
Project description:BACKGROUND:Large-scale studies risk generating inaccurate and missing data due to the complexity of data collection. Technology has the potential to improve data quality by providing operational support to data collectors. However, this potential is under-explored in community-based trials. The Aspirin in reducing events in the elderly (ASPREE) trial developed a data suite that was specifically designed to support data collectors: the ASPREE Web Accessible Relational Database (AWARD). This paper describes AWARD and the impact of system design on data quality. METHODS:AWARD's operational requirements, conceptual design, key challenges and design solutions for data quality are presented. Impact of design features is assessed through comparison of baseline data collected prior to implementation of key functionality (n?=?1000) with data collected post implementation (n?=?18,114). Overall data quality is assessed according to data category. RESULTS:At baseline, implementation of user-driven functionality reduced staff error (from 0.3% to 0.01%), out-of-range data entry (from 0.14% to 0.04%) and protocol deviations (from 0.4% to 0.08%). In the longitudinal data set, which contained more than 39 million data values collected within AWARD, 96.6% of data values were entered within specified query range or found to be accurate upon querying. The remaining data were missing (3.4%). Participant non-attendance at scheduled study activity was the most common cause of missing data. Costs associated with cleaning data in ASPREE were lower than expected compared with reports from other trials. CONCLUSIONS:Clinical trials undertake complex operational activity in order to collect data, but technology rarely provides sufficient support. We find the AWARD suite provides proof of principle that designing technology to support data collectors can mitigate known causes of poor data quality and produce higher-quality data. Health information technology (IT) products that support the conduct of scheduled activity in addition to traditional data entry will enhance community-based clinical trials. A standardised framework for reporting data quality would aid comparisons across clinical trials. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number Register, ISRCTN83772183. Registered on 3 March 2005.
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Project description:Adequate fruit and vegetable (F&V) intake is important for disease prevention. Yet, most Americans, especially low-income and racial/ethnic minorities, do not eat adequate amounts. These disparities are partly attributable to food environments in low-income neighborhoods where residents often have limited access to affordable, healthful food and easy access to inexpensive, unhealthful foods. Increasing access to affordable healthful food in underserved neighborhoods through mobile markets is a promising, year-round strategy for improving dietary behaviors and reducing F&V intake disparities. However, to date, there have been no randomized controlled trials studying their effectiveness. The objective of the 'Live Well, Viva Bien' (LWVB) cluster randomized controlled trial is to evaluate the efficacy of a multicomponent mobile market intervention at increasing F&V intake among residents of subsidized housing complexes.One housing complex served as a pilot site for the intervention group and the remaining 14 demographically-matched sites were randomized into either the intervention or control group. The intervention group received bimonthly, discount, mobile, fresh F&V markets in conjunction with a nutrition education intervention (two F&V campaigns, newsletters, DVDs and cooking demonstrations) for 12 months. The control group received physical activity and stress reduction interventions. Outcome measures include F&V intake (measured by two validated F&V screeners at baseline, six-month and twelve-months) along with potential psychosocial mediating variables. Extensive quantitative and qualitative process evaluation was also conducted throughout the study.Modifying neighborhood food environments in ways that increase access to affordable, healthful food is a promising strategy for improving dietary behaviors among low-income, racial and ethnic minority groups at increased risk for obesity and other food-related chronic diseases. Discount, mobile F&V markets address all the major barriers to eating more F&V (high cost, poor quality, limited access and limited time to shop and cook) and provide a year-round solution to limited access to healthful food in low-income neighborhoods. LWVB is the first randomized controlled trial evaluating the effectiveness of mobile markets at increasing F&V intake. If proven efficacious at increasing F&V consumption, LWVB could be disseminated widely to neighborhoods that have low access to fresh F&V.Clinicatrials.gov registration number: NCT02669472 First Received: January 19, 2016.
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Project description:ObjectiveTo review reasons for suboptimal recruitment for a randomized controlled trial (RCT) of varicocelectomy versus intrauterine insemination (IUI) for treatment of male infertility and to suggest means for improving future study recruitment.DesignSurvey of Reproductive Medicine Network (RMN) participating sites.SettingReproductive Medicine Network.Patient(s)None.Intervention(s)None.Main outcome measure(s)Ascertain reasons for inadequate recruitment and suggest improvements for future varicocelectomy trails.Result(s)This study screened seven and enrolled three couples, with the first couple randomized on June 30, 2010. The study was subsequently stopped on March 30, 2011. The following themes were cited most frequently by sites and therefore determined to be most likely to have played a role in suboptimal recruitment: [1] men must be screened at the beginning of a couple's infertility evaluation, [2] inclusion of infertile women who had failed previous fertility interventions appeared to be associated with the couple's intolerance of a placebo arm, and [3] an apparent bias against the use of unstimulated IUI cycles indicated a prejudicial preference for surgical intervention in the male partner.Conclusion(s)Improved recruitment may be realized through screening infertile men as early as possible while minimizing study-related time commitments. Focused patient education may promote improved equipoise and acceptance of a placebo arm in male infertility studies. Creative approaches to implementing varicocelectomy trials must be considered in addition to having a network of motivated researchers who carry a high volume of possible study participants because very large numbers may need to be screened to complete the clinical trial enrollment.
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Project description:Oncolytic virotherapy (OVT) is a promising approach in which WT or engineered viruses selectively replicate and destroy tumor cells while sparing normal ones. In the last two decades, different oncolytic viruses (OVs) have been modified and tested in a number of preclinical studies, some of which have led to clinical trials in cancer patients. These clinical trials have revealed several critical limitations with regard to viral delivery, spread, resistance, and antiviral immunity. Here, we focus on promising research strategies that have been developed to overcome the aforementioned obstacles. Such strategies include engineering OVs to target a broad spectrum of tumor cells while evading the immune system, developing unique delivery mechanisms, combining other immunotherapeutic agents with OVT, and using clinically translatable mouse tumor models to potentially translate OVT more readily into clinical settings.
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