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

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/DESIGN: 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. TRIALS REGISTRATION: Australian & New Zealand Clinical Trials Registry: ACTRN12613000234718