title: TRialing individualized interventions to prevent functional decline in at-risk older adults (TRIIFL): study protocol for a randomized controlled trial nested in a longitudinal observational study.
abstract: BACKGROUND
  Functional decline (FD) is a largely preventable feature of aging, characterized as gradual erosion of functional autonomy. This reduces an older person's capacity for safe, independent community living. The healthcare needs of an unprecedented aging population places pressure on health systems to develop innovative approaches to ensuring older people live healthy and independent lives for as long as possible. TRIIFL aims to demonstrate that: 1. Incipient FD in older people can be identified using a simple telephone-screening process within four weeks of discharge from an emergency department presentation for a minor health event; and 2. Early engagement into a person-centered individualized intervention arrests or reduces the rate of FD over the next 12 months.
  
  
  METHODS
  A randomized controlled trial (RCT) nested within a 13-month longitudinal cohort study. The RCT (conducted over 12 months) tests the effectiveness of a novel, early, home-based, personalized program (compared with no intervention) in arresting or slowing FD. TRIIFL focuses on older adults living independently in the community, who have not yet had a serious health event, yet are potentially on the cusp of FD. Participants in the longitudinal cohort study will be recruited as they present to one large tertiary hospital Emergency Department, providing they are not subsequently admitted to a ward. Sample size calculations indicate that 570 participants need to be recruited into the longitudinal study, with 100 participants randomized into the trial arms. Measures from all subjects will be taken face-to-face at baseline (recruitment), then subsequently by telephone at one, four, seven and thirteen months later. Measures include functional abilities, quality of life, recent falls, mobility dependence, community supports and health service usage. Specific to the nested RCT, the quality of life tool (SF12) applied at one month, will identify individuals with low mental component quality of life scores, who will be invited to enter the RCT.Assessors will be blinded to RCT arm allocation, and subjects in the RCT will be blinded to the intervention being received by other subjects.
  
  
  BACKGROUND
  Australian & New Zealand Clinical Trials Registry: ACTRN12613000234718.
authors: International Centre for Allied Health Evidence, University of South Australia, GPO Box 2471, Adelaide, South Australia, Australia.
authors: Karen
authors: K
authors: Grimmer
authors: Julie
authors: J
authors: Luker
authors: Kate
authors: K
authors: Beaton
authors: Saravana
authors: S
authors: Kumar
authors: Alan
authors: A
authors: Crockett
authors: Kay
authors: K
authors: Price
mesh_terms: D000368:Aged; D006801:Humans; D000367:Age Factors; D000375:Aging / Q000523:psychology; D018479:Early Intervention, Educational; D004636:Emergency Service, Hospital; D015577:Geriatric Assessment; D006299:Health Services for the Aged; D057187:Independent Living; D008137:Longitudinal Studies; D064887:Observational Studies as Topic; D010351:Patient Discharge; D026684:Personal Autonomy; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D012648:Self Care; D013021:South Australia; D013997:Time Factors; D016896:Treatment Outcome
references: Arch Intern Med. 1996 Mar 25;156(6):645-52
references: 8629876
references: Age Ageing. 2009 Jan;38(1):40-6
references: 19141507
references: CMAJ. 2005 Aug 30;173(5):489-95
references: 16129869
references: Br Med Bull. 2005 Jan 31;71:45-59
references: 15684245
references: Int J Qual Health Care. 2001 Apr;13(2):109-16
references: 11430660
references: CMAJ. 1997 Oct 15;157(8):1037-45
references: 9347774
references: COPD. 2012 Dec;9(6):585-95
references: 22946600
references: Med Care. 1992 Jun;30(6):473-83
references: 1593914
references: J Hosp Med. 2008 Nov-Dec;3(6):455-64
references: 19084895
references: Aust Health Rev. 2009 Aug;33(3):423-33
references: 20128758
references: Aust Health Rev. 2013 Jun;37(3):341-7
references: 23701875
references: J Psychiatr Res. 1975 Nov;12(3):189-98
references: 1202204
references: Med Care. 1996 Mar;34(3):220-33
references: 8628042
references: J Am Geriatr Soc. 2002 Jun;50(6):1045-50
references: 12110064
references: J Gen Intern Med. 1993 Dec;8(12):645-52
references: 8120679
references: JAMA. 1963 Sep 21;185:914-9
references: 14044222
references: West J Med. 1997 Oct;167(4):295-8
references: 9348763
references: Gerontologist. 1969 Autumn;9(3):179-86
references: 5349366
references: J Am Geriatr Soc. 1996 Mar;44(3):251-7
references: 8600192
references: Dement Geriatr Cogn Disord. 2008;26(6):528-40
references: 19052453
references: Int J Clin Pract. 2008 Dec;62(12):1900-9
references: 19166437
references: Mech Ageing Dev. 2006 May;127(5):494-6
references: 16487992
references: J Gerontol A Biol Sci Med Sci. 1999 Oct;54(10):M521-6
references: 10568535
references: J Gerontol A Biol Sci Med Sci. 2002 May;57(5):M283-8
references: 11983721
references: J Health Serv Res Policy. 2012 Apr;17(2):68-9
references: 22535900
references: Int J Qual Health Care. 2004 Dec;16(6):465-72
references: 15557356
references: JAMA. 2011 Oct 26;306(16):1782-93
references: 22028354
references: J Am Geriatr Soc. 2004 Apr;52(4):625-34
references: 15066083
references: Aust Fam Physician. 2008 Dec;37(12):1039-42
references: 19142281
references: Disabil Rehabil. 2000 Jan 10-20;22(1-2):80-7
references: 10661760
references: Age Ageing. 2008 Nov;37(6):628-33
references: 18723862
references: Aging Clin Exp Res. 2008 Oct;20(5):419-27
references: 19039283
references: Qual Life Res. 2000;9(9):1005-13
references: 11332222
references: J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56
references: 11253156
references: J Gerontol A Biol Sci Med Sci. 2004 Dec;59(12):1310-7
references: 15699531
references: J Am Geriatr Soc. 2004 Sep;52(9):1417-23
references: 15341540
references: Health Aff (Millwood). 2009 Jul-Aug;28(4):w555-65
references: 19454528
references: J Eval Clin Pract. 2010 Dec;16(6):1295-300
references: 20738478
references: Aust Health Rev. 1999;22(3):95-109
references: 10662237
references: BMC Geriatr. 2008 Sep 30;8:24
references: 18826625
references: Med J Aust. 2004 Jul 19;181(2):70-3
references: 15257639