The use of the electronic medical record (EMR) system in recruitment in clinical trials has the potential for providing a very reliable and cost-effective recruiting methodology which may improve ...participant recruitment in clinical trials. We examined a recruitment approach centered on the use of the EMR, as well as other traditional methods, in the Lifestyle Intervention for Treatment of Diabetes (LIFT Diabetes) trial.
LIFT Diabetes is a randomized controlled trial designed to investigate the effects of two contrasting interventions on cardiovascular disease risk: a community-based intensive lifestyle program aimed at achieving weight loss and a clinic-based enhanced diabetes self-management program. Eligible participants were overweight/obese (body mass index, BMI ≥25 kg/m
) patients with type 2 diabetes who were aged 21 years or older. Recruitment strategies included the use of the EMR system (primary), direct referrals, media advertisements, and community screenings.
A total of 1102 telephone screens were conducted, resulting in randomization of 260 participants (61.5 % from EMR, mean age 56.3 years, 66.2 % women, 48.1 % non-Hispanic blacks) over a 21-month period, with a yield of 23.6 %. Recruitment yields differed by recruitment method, with referrals having the highest yield (27.5 %). A history of cardiovascular disease was the main health reason for exclusion from the study (16.5 %). An additional 8.9 % were excluded for BMI <25 kg/m
(<27 kg/m
for insulin users), 5.4 % could not exercise, 5.2 % had an HbA1c >11 %, and 34.9 % were excluded for other non-medical reasons. Exclusion criteria did not appear to differentially affect enrollment in terms of race or ethnicity.
Future clinical studies should tailor their recruitment strategies based on the participant demographics of interest. Efficient methods such as using the EMR system and referrals should be prioritized over labor-intensive, low-yielding methods such as community screenings and mass mailings.
ClinicalTrials.gov: NCT01806727 . Registered on 5 March 2013.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Abstract
Population health management (PHM) strategies to address diabetes prevention have the potential to engage large numbers of at-risk individuals in a short duration. We examined a PHM approach ...to recruit participants to a diabetes prevention clinical trial in a metropolitan health system. We examined reach and representativeness and assessed differences from active and passive respondents to recruitment outreach, and participants enrolled through two clinical screening protocols. The PHM approach included an electronic health record (EHR) query, physician review of identified patients, letter invitation, and telephone follow-up. Data describe the reach and representativeness of potential participants at multiple stages during the recruitment process. Subgroup analyses examined proportional reach, participant differences based on passive versus active recruitment response, and clinical screening method used to determine diabetes risk status. The PHM approach identified 10,177 potential participants to receive a physician letter invitation, 60% were contacted by telephone, 2,796 (46%) completed telephone screening, 1,961 were eligible from telephone screen, and 599 were enrolled in 15 months. Accrual was unaffected by shifting clinical screening protocols despite the increase in participant burden. Relative to census data, study participants were more likely to be obese, female, older, and Caucasian. Relative to the patient population, enrolled participants were less likely to be Black and were older. Active respondents were more likely to have a higher income than passive responders. PHM strategies have the potential to reach a large number of participants in a relatively short period, though concerted efforts are needed to increase participant diversity.
Large-scale clinical trials and translational studies have demonstrated that weight loss achieved through diet and physical activity reduced the development of diabetes in overweight individuals with ...prediabetes. These interventions also reduced the occurrence of metabolic syndrome and risk factors linked to other chronic conditions including obesity-driven cancers and cardiovascular disease. The Healthy Living Partnerships to Prevent Diabetes (HELP PD) was a clinical trial in which participants were randomized to receive a community-based lifestyle intervention translated from the Diabetes Prevention Program (DPP) or an enhanced usual care condition. The objective of this study is to compare the 12 and 24 month prevalence of metabolic syndrome in the two treatment arms of HELP PD.
The intervention involved a group-based, behavioral weight-loss program led by community health workers monitored by personnel from a local diabetes education program. The enhanced usual care condition included dietary counseling and written materials.
HELP PD included 301 overweight or obese participants (BMI 25–39.9kg/m2) with elevated fasting glucose levels (95–125mg/dl). At 12 and 24 months of follow-up there were significant improvements in individual components of the metabolic syndrome: fasting blood glucose, waist circumference, HDL, triglycerides and blood pressure and the occurrence of the metabolic syndrome in the intervention group compared to the usual care group.
This study demonstrates that a community diabetes prevention program in participants with prediabetes results in metabolic benefits and a reduction in the occurrence of the metabolic syndrome in the intervention group compared to the enhanced usual care group.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
We examined the hypothesis that physical activity will have favorable effects on measures of self-efficacy for a 400-m walk and satisfaction with physical functioning in older adults 70+ years of age ...who have deficits in mobility. We randomized a total of 412 adults aged 70–89 years at elevated risk for mobility disability to either a physical activity or a successful aging educational control intervention for 12 months. Participants in the physical activity intervention had more favorable changes in both outcomes as a result of treatment than those in the successful aging intervention. Gender, age, and scores on a short physical performance battery did not moderate these effects. Physical activity is an effective means of intervening on self-efficacy and satisfaction with physical function in older adults with impaired lower extremity functioning. This is an important finding in light of the importance of these process variables in behavior change and quality of life.
Treatment of breast cancer can significantly diminish functional capacity in patients months and even years after the completion of treatments. Tai chi chuan (TCC) is a moderate form of exercise that ...may be an effective therapy for improving functional capacity among breast cancer survivors. We sought to provide pilot data comparing the efficacy of TCC and psychosocial therapy (PST; physical activity control) for improving functional capacity among breast cancer survivors post treatment. Twenty-one women who had completed treatment of breast cancer were randomized to receive TCC or PST 3 times/wk for 12 weeks. Functional capacity was assessed at baseline and at 12 weeks. The TCC group demonstrated significant improvement in functional capacity (specifically aerobic capacity, muscular strength, and flexibility) whereas the PST group showed significant improvement in flexibility only. These data suggest that TCC may be an efficacious intervention for enhancing functional capacity among breast cancer survivors and may support the need for larger randomized, controlled clinical trials to further elucidate these relationships.
Health-related quality of life (HRQL) and self-esteem are often diminished among women diagnosed and treated for breast cancer. Tai Chi is a moderate form of exercise that may be an effective therapy ...for improving HRQL and self-esteem among these women. We sought to compare the efficacy of Tai Chi Chuan (TCC) and psychosocial support (PST) for improving HRQL and self-esteem among breast cancer survivors.
A group of 21 women diagnosed with breast cancer, who had completed treatment within the last 30 months were randomized to receive 12 weeks of TCC or PST. Participants in both groups met three times a week for 60 minutes. HRQL and self-esteem were assessed at baseline, 6 weeks, and 12 weeks.
The TCC group demonstrated significant improvements in HRQL, while the PST group reported declines in HRQL, with the differences between the two groups approaching significance at week 12. Additionally, the TCC group exhibited improvements in self-esteem, while the PST group reported declines in self-esteem, with the differences between groups reaching statistical significance at week 12. These findings, coupled with a visual inspection of the raw change scores, support the plausibility of a dose-response relationship concerning Tai Chi.
In this pilot investigation, the TCC group exhibited improvements in HRQL and self-esteem from baseline to 6 and 12 weeks, while the support group exhibited declines. Randomized, controlled clinical trials with larger sample sizes are needed.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, ODKLJ, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Summary Background Chronic obstructive pulmonary disease (COPD) patients have lower levels of physical activity compared to age-matched controls, and they limit physical activities requiring normal ...exertion. Our purpose was to compare the effectiveness of a traditional exercise therapy (TET) program with a behavioral lifestyle activity program (LAP) in promoting physical activity. Methods Moderate physical activity (kcal/week) was assessed in 176 COPD patients using the Community Health Activities Model for Seniors questionnaire. Patients were randomized to either a three month TET program that meet thrice weekly or a LAP. The LAP was designed to teach behavioral skills that encouraged the daily accumulation of self-selected physical activities of at least moderate intensity. Interventionist contact was similar (36 h) between the two groups. Patients were assessed at baseline and 3, 6 and 12 months. Results Compared to baseline values, self-reported moderate physical activity increased three months post-randomization with no significant difference ( p = 0.99) found between the TET (2501 ± 197 kcal/week) and the LAP (2498 ± 211 kcal/week). At 6 and 12 months post-randomization, there were no significant differences ( p = 0.37 and 0.69, respectively) in self-reported levels of moderate physical activity between the TET (2210 ± 187 and 2213 ± 218 kcal/week, respectively) and the LAP (2456 ± 198 and 2342 ± 232 kcal/week, respectively). Conclusion Although there was no difference between treatment groups, the TET and the LAP were both effective at in increasing moderate levels of physical activity at 3 months and maintaining moderate physical activity levels 12 months post-randomization. This clinical trial is registered with ClinicalTrials.gov . Its identifier is NCT00328484.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Although research has identified a number of qualities and competencies necessary to be an effective exercise leader, the fitness industry itself is largely unregulated and lacks a unified governing ...body. As such, a plethora of personal trainer certifications exists with varying degrees of validity that fail to ensure qualified trainers and, therefore, protect the consumer. It is argued that the potential consequences of this lack of regulation are poor societal exercise adherence, potential injury to the client, and poor public perception of personal trainers. Additionally, it is not known whether personal trainers are meeting the needs of their clients or what criteria are used in the hiring of personal trainers. Thus, the purpose of this investigation was to examine the current state of personal training in a midsized Southeast city by using focus group methodology. Local personal trainers were recruited for the focus groups (n = 11), and the results from which were transcribed, coded, and analyzed for themes using inductive reasoning by the authors. Qualities and characteristics that identified by participants clustered around 4 main themes. Client selection rationale consisted of qualities that influenced a clientʼs decision to hire a particular trainer (e.g., physique, gender, race). Client loyalty referred to the particular qualities involved in maintaining clients (e.g., motivation skills, empathy, social skills). Credentials referred to formal training (e.g., college education, certifications). Negative characteristics referred to qualities considered unethical or unprofessional (e.g., sexual comments, misuse of power) as well as the consequences of those behaviors (e.g., loss of clients, potential for litigation). These results are discussed regarding the implications concerning college programs, certification organizations, increasing public awareness of expectations of qualified trainers, and a move towards state licensure.
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