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The Enabling Reduction of Low-Grade Inflammation in Seniors (ENRGISE) Pilot Study: Screening Methods and Recruitment Results.

ABSTRACT: BACKGROUND:The Enabling Reduction of Low-grade Inflammation in Seniors (ENRGISE) Pilot Study is a multicenter randomized clinical trial examining the feasibility of testing whether omega-3 fish oil (?-3) and the angiotensin receptor blocker losartan alone or in combination can reduce inflammation and improve walking speed in older adults with mobility impairment. We describe recruitment methods and results. METHODS:Eligible participants were 70 years and older, had elevated interleukin-6 levels (2.5-30 pg/mL) and mobility impairment. RESULTS:Of those who responded to recruitment, 83% responded to mailings. A total of 5,424 telephone screens were completed; of these, 2,011 (37.1%) were eligible for further screening. The most common reasons for ineligibility at the telephone screens were lack of mobility impairment or use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors (n=1.789). Of the 1,305 initial screening visits, 1,087 participants had slow gait speed (<1 m/s). Of these, 701 (64%) had elevated interleukin-6 and were eligible for second screening visits. Of the 582 second screening visits, 335 (57.6%) were eligible to be randomized. A total of 289 participants (96% of goal) were randomized: 180 in the ?-3 stratum (240% of goal); 43 in the losartan (57% of goal), and 66 in the combination (44% of goal). The telephone screen and first screening visit to randomization ratio was 19 to 1 and 4.5 to 1, respectively. The estimated cost of recruitment per randomized participant was $1,782. CONCLUSION:Recruitment for ?-3 exceeded goals, but goals for the losartan and combination strata were not met due to the high proportion of participants taking angiotensin receptor blockers or angiotensin-converting enzyme inhibitors.

SUBMITTER: Cauley JA

PROVIDER: S-EPMC6625594 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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The Enabling Reduction of Low-Grade Inflammation in Seniors (ENRGISE) Pilot Study: Screening Methods and Recruitment Results.

Cauley Jane A JA Manini Todd M TM Lovato Laura L Talton Jennifer J Anton Steven D SD Domanchuk Kathryn K Kennedy Kimberly K Stowe Cynthia L CL Walkup Michael M Fielding Roger A RA Kritchevsky Stephen B SB McDermott Mary M MM Newman Anne B AB Ambrosius Walter T WT Pahor Marco M

The journals of gerontology. Series A, Biological sciences and medical sciences 20190701 8

<h4>Background</h4>The Enabling Reduction of Low-grade Inflammation in Seniors (ENRGISE) Pilot Study is a multicenter randomized clinical trial examining the feasibility of testing whether omega-3 fish oil (ω-3) and the angiotensin receptor blocker losartan alone or in combination can reduce inflammation and improve walking speed in older adults with mobility impairment. We describe recruitment methods and results.<h4>Methods</h4>Eligible participants were 70 years and older, had elevated interl ...[more]

PMID: 30202946

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Project description:BackgroundReducing the number of items in a questionnaire while maintaining relevant information is important as it is associated with advantages such as higher respondent engagement and reduced response error. However, in health care, after the original design, an a posteriori check of the included items in a questionnaire is often overlooked or considered to be of minor importance. When conducted, this is often based on a single selected method. We argue that before finalizing any lifestyle questionnaire, a posteriori validation should always be conducted using multiple approaches to ensure the robustness of the results.ObjectiveThe objectives of this study are to compare the results of two statistical methods for item reduction (variance inflation factor [VIF] and factor analysis [FA]) in a lifestyle questionnaire constructed by combining items from different sources and analyze the different results obtained from the 2 methods and the conclusions that can be made about the original items.MethodsData were collected from 79 participants (heterogeneous in age and sex) with a high risk of metabolic syndrome working in a financial company based in Tokyo. The lifestyle questionnaire was constructed by combining items (asked with daily, weekly, and monthly frequency) from multiple validated questionnaires and other selected questions. Item reduction was conducted using VIF and exploratory FA. Adequacy tests were used to check the data distribution and sampling adequacy.ResultsAmong the daily and weekly questions, both VIF and FA identified redundancies in sleep-related items. Among the monthly questions, both approaches identified redundancies in stress-related items. However, the number of items suggested for reduction often differed: VIF suggested larger reductions than FA for daily questions but fewer reductions for weekly questions. Adequacy tests always confirmed that the structural detection was adequate for the considered items.ConclusionsAs expected, our analyses showed that VIF and FA produced both similar and different findings, suggesting that questionnaire designers should consider using multiple methods for item reduction. Our findings using both methods indicate that many questions, especially those related to sleep, are redundant, indicating that the considered lifestyle questionnaire can be shortened.

Project description:BackgroundAdvancements in screen media devices has transformed the way families engage with screen media. Although these modern devices offer many opportunities, e.g. communication and research online, an in-depth understanding of how these devices affect our health, is lacking. Before a definite randomized controlled trial, the SCREENS pilot study was conducted to assess compliance to and feasibility of two interventions, a measurement protocol, and a survey-based recruitment strategy. Also, the potential of the interventions to impact leisure time spent non-sedentary in children six-to-ten years of age was explored.MethodsFamilies (N = 12) were recruited through a population-based survey sent out in October of 2018 to adults (N = 1,675) in the Municipality of Middelfart, Denmark. Families were randomized to one of two two-week interventions; an Evening Restriction intervention (no screen media use after six pm) and a General Restrict intervention (limit entertainment-based screen media to three hours/week/person). Intervention compliance was assessed objectively by measuring household TV usage, smartphone and tablet activity via an application, and via screen media diaries. During baseline and follow-up, as part of larger protocol, family members wore two triaxial accelerometers for seven consecutive days. The potential of the interventions to impact non-sedentary time was explored based on means and standard errors (SEs).ResultsDespite almost 85% and 75% reductions in leisure screen media use 0% and 50% of families were compliant in the Evening Restrict group and General Restrict group, respectively, based on strict a priori criteria. Participant feedback indicated that the General Restrict intervention generally was feasibly. Compliance to the accelerometry wear protocol was high (median non-wear was <1 hour/week). Moreover, the recruitment strategy was implemented and was feasible. The General restrict intervention might increase children's non-sedentary time (mean (SE): 36.6 (23) min/day, N = 6).ConclusionsThe General Restriction intervention, the accelerometer wear protocol and recruitment strategy, appeared feasible.Trial registrationNCT03788525 at https://clinicaltrials.gov [Retrospectively registered; 27th of December, 2018].

Dataset Information

The Enabling Reduction of Low-Grade Inflammation in Seniors (ENRGISE) Pilot Study: Screening Methods and Recruitment Results.

Publications

The Enabling Reduction of Low-Grade Inflammation in Seniors (ENRGISE) Pilot Study: Screening Methods and Recruitment Results.

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