The LIVE LiFE program
The overarching theoretical framework for the program is Verbrugge and Jette’s Disablement Process, which stresses that both intrinsic (body and mind) and extrinsic (environment) factors can contribute to a process of disablement [
21]. Also, we draw upon the Szanton-Gill resilience model [
22], which suggests that intervening on both individual and environmental factors simultaneously may lead to more lasting program benefits. The program is also built on theories suggesting that lifestyle changes that are built upon the individual’s established daily routines and habits are more likely to lead to sustainable changes [
23‐
25].
Based on what we learned in the open-label phase, the home-based multicomponent fall prevention program included goal clarification, balance and strength training integrated into daily habits, home safety assessment, home hazards removal, vision screening, and medication review (see Table
1). The 12-week program is led by an OT and contains eight home visits and two booster calls from the OT and two visits from a handyman (described in detail below).
Table 1
Dimension, components, and treatment approaches of the LIVE LiFE program
Intrinsic | Personal goals to improve motivation and adherence to the program | The Purpose in Life literature [ 47], incorporated based on results from open-label phase of the current study | The OT asks about personal goals and explicitly directs the program toward the goals (e.g., to walk to church, to spend time with grandchildren) |
Intrinsic | Exercise to improve balance and strength | | Over the course of 8 home visits the OT coaches the participant to incorporate balance and strength activities in daily life activities, for example, tandem walking when walking through the hallway or standing on one leg when working in the kitchen |
Intrinsic | Medication review for medication safety | | Pharmacist reviews scanned list of medications that potentially increase the risk of falls and writes a letter with recommendations to the participant to share with their primary care provider |
Intrinsic | Vision contrast screening to optimize vision | | At-home vision contrast screening provided by the OT using the Mars tool [ 28]. The results and recommendations are written in a letter to the participant to share with the primary care provider or an optometrist |
Extrinsic | Home safety: reduce fall hazards in and around the home | Results on home modification interventions, e.g., the CAPABLE program [ 19] | The OT assesses home safety and provides smaller modifications (e.g., night lights, non-skid strips for the bathtub). Creates a prioritized list of modifications for handyman (e.g., installing grab bars in bathroom, stabilizing shaky banisters, and fixing holes in floors). Handyman installs items up to $500/participant |
The LiFE program is the basis of LIVE LiFE and is the balance and strength component. It is a home-based exercise program developed in Australia for community-living older adults at risk of falling. LiFE is a standardized program effective in reducing falls and recommended by the Centers for Disease Control and Prevention (CDC) [
26]. The content of the LiFE program has been published [
11,
27]. Briefly, eight balance (including static and dynamic) and six strength (hip, knee, and ankle) domains form the basis of these exercises. The older adult chooses movements that improve balance and strength to integrate into daily/household/leisure activities. With help from the OT, participants plan opportunities to practice during the day, which increases adoption and continuation of the exercise program, as it becomes a part of daily life. The activities are tailored to the capacity of the person based on assessments the OT conducts on falls history, functional in-home balance and strength tests, and contextual resources and limitations. The activities are upgraded safely over time. Adherence to the exercise program is recorded daily by the participants and reviewed at each session by the OT.
Expansion of the LiFE program
The home safety component includes an assessment of safety features in the home and ≤ US $500 to address home hazards such as lack of banisters and grab bars, holes in the floor, dim lighting, or slippery floors. After the home safety assessment, the OT suggests possible solutions and provides small adaptations such as nightlights or fluorescent tape applied to slippery steps. For more extensive home hazards, the OT and the participant brainstorm and agree on prioritized modifications and repairs (e.g., installing grab bars in the bathroom or banisters in the stairway). The OT sends a work order to a licensed handyman. When the handyman obtains the order, she or he usually visits the participant twice, first to plan and then to install the adaptations and repairs. This component of the program is provided by Civic Works, an AmeriCorps site in Baltimore, MD.
For the vision screening component, the OT does a contrast sensitivity vision screening with the Mars Letter Contrast Sensitivity Test [
28]. To reflect the usual visual conditions, participants are asked to keep the room lit as usual during the assessment. The Mars results and recommendations are written in a letter and given to the participant to provide to their primary care provider. If the results do not meet the recommended threshold for older adults provided in the Mars manual, participants are referred to an optometrist for an extended vision examination.
For the medication review component, a pharmacologist specializing in older adults reviews a list of the prescribed and over-the-counter drugs collected at the baseline visit and provides simple recommendations in a letter to the participants to share with their primary care provider. The review is based on the updated Beers criteria for potentially inappropriate medication use in older adults [
29]. We specifically target medications known to increase the risk of falls (e.g., medications that target blood pressure or blood sugar, mood stabilizers), the total number of medications, combinations of medications, doses, and frequencies.
Outcomes
For feasibility and acceptability measures, we collect data on refusal to be enrolled after being explained the study, and study retention rates. The OT documents the number (dose) and duration (intensity) of sessions to capture intervention delivery. Documentation on adherence to strength and balance training is provided through an activity log completed daily by the participant and reviewed weekly by the OT. At the end of the program, the OT follows up with the participants as to whether or not they had received the vision and medication referral, whether they have acted on them, and whether the handyman portion of the program has been completed. For acceptability, we collect data on program satisfaction at baseline and at 16 and 32 weeks.
To prepare for an efficacy trial, we explore multiple outcome measures to estimate program impact.
For fall risk and balance, we use the Timed Up and Go (TUG) test [
31] and the 4-Stage Balance Test [
32]. The TUG test measures time in seconds for the participants to get up from a chair, walk 3 m, turn, return to the chair, and sit down. The TUG test has good reliability for trained data collectors [
33] and predicts falls in older adults with lower functioning, such as those with a history of falls [
34]. The 4-Stage Balance test is a test of static balance [
32]. The participant holds for increasingly more challenging balance positions: side-by-side, semi-tandem (the instep of one foot touching the big toe of the other foot), tandem (one foot in front of the other), and balancing on one leg. If an older adult cannot hold the tandem (third position) for 10 s, they are considered at high risk for falls [
35].
Number of falls and near falls are recorded daily by the participants using an investigator-developed monthly falls calendar. A fall is defined as a person unintentionally coming to rest on the ground, floor, or other lower level [
36]. A near fall is defined as a fall that is initiated but arrested by support, for example, from the wall, railing, or another person [
37]. Participants mail the completed calendars at the end of each month using preaddressed, stamped envelopes. A research assistant phones participants who do not return a calendar to ascertain whether they had fallen. When a fall or near fall is marked on the calendar, the research assistant phones and asks follow-up questions on where the fall or near fall took place and whether injuries occurred.
Because fear of falling is central to decreasing falls risk and is considered on the causal pathway, we used multiple measures to learn more about this important concept. Falls efficacy is measured by the 10-item Falls Efficacy Scale (FES), which asks the participant to rate from 0 to 10 their confidence in doing ten activities in or outside the home without falling [
38]. Fear of falling is measured with the Short FES-International (FES-I) scale to assess the participant’s concern about falling when doing seven activities in and around the home. Both the FES and the FES-I are known to mediate fall prevention improvement [
39,
40]. We also ask the participants three single-item questions about their perceptions on fear of falling, including: Are you concerned about falling?, Are you afraid of falling?, and Do you fear falling?
To assess reduction in home hazards, we use the Home Safety Self-Assessment Tool (HSSAT) checklist—a 67-item checklist filled out by the data collector during a home tour with the participant. The house tour includes front and back entrances, hallway, living room, kitchen, bathroom, bedroom, basement/laundry room, stairways, and garage [
41]. The HSSAT is a standardized assessment with sufficient reliability and validity to assess home hazards [
41,
42].
For the medication review component, we assess use of medications as a simple count and listing of the participant’s prescribed and over-the-counter drugs. Participants are also asked whether they have discussed their medications and any associated fall-related concerns with their doctor in the last year (yes/no). The participants are asked whether they have recieved a vision check-up in the last year and whether they use bifocals (yes/no).
We consider possible confounding by assessing difficulties in Activities of Daily Living (ADL) with the Katz ADL Index on eight basic (e.g., eating, bathing) and eight instrumental ADLs (e.g., washing laundry, managing finances) [
43,
44]. The participants report if they had no difficulty and did not need help the prior month (0), had difficulty but did not need help (1), or did need help regardless of difficulty (2). Health-related quality of life is measured by the EuroQol questionnaire (EQ-5D) [
45]. Self-rated health is assessed by asking the participants how they would rate their health in general, from poor (5) to excellent (0). Mobility device use is assessed by asking the participants whether they have used mobility devices indoors and outdoors in the last week and month.
Analysis
Open-label pilot
When the open-label phase participants had completed more than half of the intervention sessions, a study team member interviewed them over the phone. They were asked open-ended questions on the content and delivery of the balance and strength component, home safety component, medication review component, vision screening component, and documentation of the program. The PI interviewed the OT on the same components. The open-label phase revealed that participants did not always feel intrinsically motivated to do the prescribed exercises. Subsequently, drawing upon the health promotion literature on Purpose in Life [
47], we adapted the program to have the OT ask the participant about their own goals, such as spending time with family, cooking dinner, or going to outside activities. Then, based on the participant’s self-identified goals, we adapted the participants´ LIVE LiFE exercise log to prominently display the goal they had chosen for themselves. This allowed the participants to see their exercise activities as connected to or in view of their own goals rather than as something the OT was asking them to do as homework.
Feasibility, acceptability, and responses to primary and secondary outcomes
For feasibility and acceptability of the program, we will examine percentages of people who stay in each arm of the study, and conduct descriptive correlational analyses of the association between the program compliance and demographic and participant health variables. Also, the feasibility of delivering the program will be assessed by exploring the OTs’ documentation of dose and duration. For program compliance analyses, we will distinguish non-compliance with the program from attrition or loss to follow-up, i.e., missing data. We will use the participant satisfaction data to examine the acceptability of the program. To examine whether the program group continues with the exercise component beyond the end of the program, we will use data collected up until 32 weeks to inspect frequency distributions derived from the adherence tracking logs and examine correlations with demographic and other factors to explore predictors of adherence. Also, we will continue to collect fall diaries and examine group differences in falls and near falls up through 32 weeks after the onset of the program.
All analyses of primary and secondary outcomes will follow the intention-to-treat principle: all participants will be counted in their assigned study group once the assignment has been made. We will then perform a sensitivity analysis by excluding the open-label pilot participants (n = 3) from the remaining LIVE LiFE group participants. For the primary aim, the outcome will be improvement in the TUG and the 4-Stage Balance test between baseline and 16 weeks. Effect sizes will be estimated based on Cohen’s D. We will decide on a parametric or non-parametric testing approach after reviewing sample sizes and skewness of data. Otherwise, our general analytic approach for the primary outcome will be standard analyses of covariance (ANCOVAs) on the 16-week outcome data, with the baseline value of each respective outcome variable serving as a covariate. For the secondary aims, analyses will use chi-square tests or logistic regression analyses to examine group differences for data collected at 16 and 32 weeks.