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Title: The Enabling Reduction of low-grade inflammation in seniors (ENRGISE) pilot study: screening methods and recruitment results

Author
item CAULEY, JANE - University Of Pittsburgh
item MANINI, TODD - University Of Florida
item LOVATO, LAURA - Wake Forest University
item TALTON, JENNIFER - Wake Forest University
item ANTON, STEVEN - University Of Florida
item DOMANCHUK, KATHYRN - Northwestern University
item KENNEDY, KIMBERLY - Wake Forest University
item STOWE, CYNTHIA - Wake Forest University
item WALKUP, MICHAEL - Wake Forest University
item FIELDING, ROGER - Jean Mayer Human Nutrition Research Center On Aging At Tufts University
item KRITCHEVESKY, STEPHEN - Wake Forest University
item MCDERMOTT, MARY - Northwestern University
item NEWMAN, ANNE - University Of Pittsburgh
item AMBROSIUS, WALTER - Wake Forest University
item PAHOR, MARCO - University Of Florida

Submitted to: Journal of Gerontology Medical Science
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 7/4/2018
Publication Date: 9/8/2018
Citation: Cauley, J.A., Manini, T.M., Lovato, L., Talton, J., Anton, S.D., Domanchuk, K., Kennedy, K., Stowe, C.L., Walkup, M., Fielding, R.A., Kritchevesky, S., McDermott, M.M., Newman, A.B., Ambrosius, W.T., Pahor, M. 2018. The Enabling Reduction of low-grade inflammation in seniors (ENRGISE) pilot study: screening methods and recruitment results. Journal of Gerontology Medical Science. https://doi.org/10.1093/gerona/gly204.
DOI: https://doi.org/10.1093/gerona/gly204

Interpretive Summary: The ENabling Reduction of low-Grade Inflammation in SEniors (ENRGISE) Pilot Study was a multicenter randomized clinical trial evaluating whether omega-3 fish oil (omega-3) and the blood pressure lowering drug Losartan alone or in combination can improve walking ability and lower inflammation. This paper describes the recruitment efforts used in this trial. Subjects were eligible if they were over 70 years of age, had elevated inflammation and walked slowly. Most of the participants (83%) learned about the study through recruitment mailings (small informational postcard). We contacted a total of 5,424 potential participants by telephone. About 1/3 (2,011) of those contacted by phone were eligible for further screening. Approximately 1,300 potential participants were screened in person. Approximately 1,000 potential participants walked slowly (walking speed <1m/sec) and about 700 had elevated inflammation. A total of 289 (96% of goal) subjects were randomized. The cost of recruitment per randomized subject was $1,782. Recruitment for the omega-3 group exceeded study goals but recruitment for Losartan and combination arms was not successful due to medical exclusions related to medication use.

Technical Abstract: 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 (omega-3) and the angiotensin receptor blocker (ARB) Losartan (LO) 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, had elevated interleukin (IL)-6 levels (2.5-30 pg/ml) and mobility impairment. RESULTS: Of those who responded to recruitment, 83% responded to mailings. A total of 5424 telephone screens (TS) were completed; of these, 2011(37.1%) were eligible for further screening. The most common reasons for ineligibility at the TS were lack of mobility impairment or use of ARBs or angiotensin-converting-enzyme inhibitors (ACEI). Of the 1305 initial screening visits (SV1), 1087 participants had slow gait speed (<1m/sec). Of these, 701 (64%) had elevated IL-6 and were eligible for second SV (SV2). Of the 582 SV2 visits, 335 (57.6%) were eligible to be randomized. A total of 289 participants (96% of goal) were randomized: 180 in the omega-3 stratum (240% of goal); 43 in the LO (57% of goal) and 66 in the combination (44% of goal). The telephone screen and SV1 to randomization ratio was 19 to 1 and 4.5 to 1, respectively. The estimated cost of recruitment per randomized participant was $1782. CONCLUSION: Recruitment for omega-3 exceeded goals but goals for the LO and combination strata were not met due to the high proportion of participants taking ARBs or ACEIs.