title: Recruiting older people at nutritional risk for clinical trials: what have we learned?
abstract: BACKGROUND
  The difficulty of recruiting older people to clinical trials is well described, but there is limited information about effective ways to screen and recruit older people into trials, and the reasons for their reluctance to enrol. This paper examines recruitment efforts for a community-based health intervention study that targeted older adults.
  
  
  METHODS
  One year randomized control trial. Undernourished men and women, aged ≥ 65 years and living independently in the community were recruited in three Australian states. Participants were allocated to either oral testosterone undecanoate and high calorie oral nutritional supplement or placebo medication and low calorie oral nutritional supplementation. Hospital admissions, functional status, nutritional health, muscle strength, and other variables were assessed.
  
  
  RESULTS
  4023 potential participants were identified and 767 were screened by a variety of methods: hospital note screening, referrals from geriatric health services, advertising and media segments/appearances. 53 participants (7% of total screened) were recruited. The majority of potentially eligible participants declined participation in the trial after reading the information sheet. Media was the more successful method of recruiting, whereas contacting people identified by screening a large number of hospital records was not successful in recruiting any participants.
  
  
  CONCLUSIONS
  Recruitment of frail and older participants is difficult and multiple strategies are required to facilitate participation.
  
  
  BACKGROUND
  Australian Clinical Trial Registry: ACTRN 12610000356066 date registered 4/5/2010.
authors.affiliation: Discipline of Medicine, University of Adelaide, Adelaide, SA, 5000, Australia. cynthia.piantadosi@adelaide.edu.au.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Piantadosi
authors.affiliation: Discipline of Medicine, University of Adelaide, Adelaide, SA, 5000, Australia. ian.chapman@adelaide.edu.au.
authors.forename: Ian M
authors.initials: IM
authors.lastname: Chapman
authors.affiliation: Centre for Education and Research on Ageing, University of Sydney, Concord Hospital, Concord, NSW, 2139, Australia. vasi.naganathan@sydney.edu.au.
authors.forename: Vasi
authors.initials: V
authors.lastname: Naganathan
authors.affiliation: Alfred Health, Caulfield Hospital, 260, Caulfield, VIC, 3162, Australia. Peter.Hunter@cgmc.org.au.
authors.forename: Peter
authors.initials: P
authors.lastname: Hunter
authors.affiliation: John Walsh Centre for Rehabilitation Research, Sydney Medical School, University of Sydney, Sydney, NSW, 2065, Australia. ian.cameron@sydney.edu.au.
authors.forename: Ian D
authors.initials: ID
authors.lastname: Cameron
authors.affiliation: Discipline of Medicine, University of Adelaide, Adelaide, SA, 5000, Australia. renuka.visvanathan@adelaide.edu.au.|Adelaide Geriatrics Training and Research with Aged Care (GTRAC) Centre, School of Medicine, University of Adelaide, Paradise, SA, 5075, Australia. renuka.visvanathan@adelaide.edu.au.|Aged and Extended Care Services, The Queen Elizabeth Hospital, Woodville South, SA, 5011, Australia. renuka.visvanathan@adelaide.edu.au.
authors.forename: Renuka
authors.initials: R
authors.lastname: Visvanathan
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000728:Androgens / Q000008:administration & dosage*; D001315:Australia; D004032:Diet / Q000379:methods; D019587:Dietary Supplements; D005260:Female; D016330:Frail Elderly; D006299:Health Services for the Aged; D006760:Hospitalization; D006801:Humans; D057187:Independent Living; D008297:Male; D044342:Malnutrition / Q000178:diet therapy* / Q000503:physiopathology; D053580:Muscle Strength / Q000187:drug effects; D010358:Patient Participation / Q000523:psychology / Q000706:statistics & numerical data*; D018579:Patient Selection; D013739:Testosterone / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D000728:Androgens; D013739:Testosterone; C010792:testosterone undecanoate