Improving Aging in Place for Older Adults in Subsidized Housing
Phase: NA
Conditions: Physical Disability, Cognitive Impairment, Physical Activity
Sponsor: University of Pennsylvania

 
 
 
 
 
 
 
 
Improving Aging in Place for Older Adults Living in Subsidized Housing 
NCT04212442 
July 1, 2020 
 
 
 

Aim 3: Determine the feasibility and preliminary effectiveness of the adapted Function-Focused Care 
intervention in subsidized housing residents at high risk for nursing home admission. We will conduct a 
2-month pilot test of the adapted Function-Focused Care intervention in 15 subsidized apartment buildings for 
older adults. We will use a pre-to-post study design to examine the change in outcome measures from 
baseline to 2 months. Implementation outcomes will include feasibility and acceptability. Preliminary 
effectiveness outcomes will include resident function (primary outcome), with secondary outcomes of quality of 
life and health care utilization. Because function declines over time, our design will incorporate a waitlist 
control, in which half of the sites are cluster randomized to receive the intervention in months 0-2 while the 
other sites are randomized to receive usual care. The waitlist sites will then receive the intervention in months 
2-4. The waitlist period will provide a baseline rate of functional decline that will serve as a comparison for 
functional outcomes (see Figure 3 for study flow). 
Study setting and population: We will pilot the intervention in 15 subsidized apartment buildings for older 
adults. 
Eligibility: Residents living at any of the sites will be invited to participate. If a resident wishes to participate but 
does not pass consent verification,67 they will be asked to sign an assent to participate, and a proxy will be 
contacted to complete the consent process. Residents will 
receive sequential $50 incentives for participation at baseline, 3, 
and 6 months (i.e., up to $150 total). 
Intervention: The intervention will be based on the extensively-
tested Function-Focused Care intervention. Function-Focused 
Care is an approach to care that educates home care workers in 
how to help older adults to participate in functional and physical 
activity throughout the day.42 It includes the following 4 steps: (1) 
environmental and policy assessments; (2) education; (3) 
establishing resident service plans; and (4) ongoing mentoring 
and motivating for home care workers and residents (Table 2). 
While Function-Focused Care for assisted living educates home 
care workers,35 its adaptation for home settings educates dyads 
of older adults and family caregivers.47 We anticipate that 
modifications for subsidized housing may include education for 
resident-family caregiver dyads, among residents who have such support. 
A research Function-Focused Care Nurse will coordinate and implement the intervention with support 
from our interdisciplinary research team. The nurse will receive extensive training in the intervention. This will 
include a 1-week in-person training with Dr. Resnick and her team at the University of Maryland in Year 1, 
followed by weekly web-based training during the first 6 months of Year 2 and as-needed check-ins in Years 2 
and 3. Based on the successful implementation model for assisted living,35 the nurse will work with each site 
16 hours per week for the first 3 months of the intervention and 8 hours per week for the next 3 months. To 
ensure that the intervention can be sustained over time, we will work with each site to identify a staff 
“champion” who will work with the nurse to learn how to maintain this approach. Working with the champion, 
the nurse will implement the 4 steps of the intervention (Table 2). As noted above, the approach for each step 
may be adapted based on stakeholder feedback, e.g., to incorporate family caregivers. Steps will be 
implemented sequentially and continue throughout the intervention, including ongoing mentorship and 
motivation for residents and caregivers. This will include observing caregiver performance, giving positive 
encouragement for providing Function-Focused Care, and reinforcing benefits of the intervention. Mentorship 
will occur in-person. 
Table 2. Component 
Description of the intervention 
I: Environmental 
and policy 
assessments 
Site champion works with research nurse to complete assessments using standard evaluation forms. 
Findings are used to identify and recommend feasible interventions to alter the environment, policy, and 
procedures to optimize resident function and physical activity (e.g., make pleasant walking areas) 
II: Education 
Research nurse educates housing staff (e.g., service coordinators), residents, and families in principles of 
Function-Focused Care (FFC), using established materials and adult learning techniques. 
III: Establishing 
goals 
Research nurse works with residents to complete Capability Assessments/Goal Attainment Forms with 
eligible residents. Goals established based on assessments and resident input. 
IV: Mentoring and 
motivating 
Research nurse works to motivate residents to participate in FFC throughout study period by using 
evidence-based approaches (e.g., observing performance of caregivers and providing one-on-one 
mentoring to incorporate FFC into routine care; providing positive reinforcement for incorporating FFC) 
Waitlist control: At the waitlist control site, residents will be screened for risk of nursing home admission and 

enrolled as described in Aim 2. Residents will be referred for whatever services are customary per usual facility 
protocols based on results of these screenings, but for the next 2 months, will not be enrolled in the Function-
Focused Care intervention. 
Outcome measures: Outcomes are shown in Table 3. Measures will be collected at baseline and 2 months at 
both sites, and at 4 months at the waitlist control site (i.e., 2 months after intervention initiation at the control 
site). Measures correspond to the outcome domains assessed in the original Function-Focused Care trial35 and 
were selected because they have well-established validity and reliability. Measures of feasibility will include 
standard measures of recruitment, retention, and refusal. We will assess intervention fidelity once per resident 
by evaluating home care workers during care interactions using a fidelity checklist.79 Acceptability for residents, 
workers, and leaders will be assessed in both sites using similar approaches to Aim 2.77 
Resident outcomes include key factors that 
contribute to aging in place, including a primary 
outcome of functional status and secondary 
outcomes of quality of life, depression, and health 
care utilization. We will measure function using 2 
measures. The Short Physical Performance Battery 
(SPPB) is an objective measure of lower extremity 
functioning in older adults which has excellent 
reliability, validity, and responsiveness (range, 0-12 
points).80,92 We will also measure self-reported ability 
to perform 8 ADLs using the Yale ADL scale (range, 
0-16).68-71 We will assess quality of life using the 
Quality of Life in Alzheimer’s Disease (QOL-AD) 
scale81 and depression using the Patient Health 
Questionnaire (PHQ-9).82 Health care utilization will 
be assessed by self-report. Other outcomes will 
include adverse events and attitudes about function 
and physical activity (see Table 3).83-87 Home care 
worker outcomes will include knowledge88 and attitudes about Function-Focused Care87 and job satisfaction.89 
For family caregivers, outcomes will include quality of life,90 depression,82 and caregiver burden.91 
Analysis plan and power calculation: We will analyze measures of feasibility using similar methods to Aim 2. 
We will define the intervention as feasible if residents complete ≥75% of checklist items. For other outcomes, 
we will assess change from baseline to 2 months and compare the changes between intervention and waitlist 
groups. For continuous outcomes, the change will also be continuous; for dichotomous outcomes, the change 
can be defined as a four-category variable (0-0, 0-1, 1-0, and 1-1 for pre and post outcomes). We will then 
compare the change between intervention and waitlist groups using the t-test or Wilcoxon signed rank sum test 
for continuous variables and Chi-square or Fischer’s exact test for dichotomous variables. 
 
Because this is a pilot feasibility study, the sample size need only be large enough to determine key 
parameters such as recruitment, retention, and refusal rates. Given the pool of potential participants, we are 
confident that we can recruit enough participants to not only determine feasibility but also determine point 
estimates and standard deviations for projected sample size for a follow-up randomized controlled trial. We 
plan to recruit a total of 70 participants in the overall study. To estimate preliminary effect sizes, the mean 
scores for continuous outcomes or proportions for dichotomous outcomes will be compared among participants 
in the intervention vs. waitlist control conditions. If we assume that the correlation between pre and post 
continuous measures from baseline to 6 months is 0.8, then the SD for the change is 0.6 SD for the continuous 
measures. With 70 residents, we will have 80% power (2-sided alpha of 0.05) to detect a 0.66 SD change in 
the mean of continuous measures from baseline to 2 months, assuming a 20% dropout. Thus, for our primary 
outcomes, we should have sufficient power to detect a mean 1.78-point increase in SPPB score 
(SD~2.7)91 and a mean 1.45-point increase in ADL/IADL score (SD~2.2).76 
 
Potential problems and alternative approaches: Potential problems include staff turnover, resident loss to 
follow-up, and a relatively limited sample size and follow-up period. We will train new staff and champions and 
use best practices to minimize loss to follow-up, including obtaining multiple types of contact information at 
baseline and providing sequential incentives for participation. Also, our implementation protocol will incorporate 
stakeholder input on barriers and facilitators to implementation identified in Aim 1. Although this pilot study has 
a limited sample size, it will provide preliminary data to support a definitive R01-level study. 
 
Table 3. Outcomes 
Data source/measure 
Feasibility 
 
Recruitment, retention, and 
refusal rates; intervention fidelity 
Facility observations; 
Restorative Care Checklist79 
Acceptability 
 
Satisfaction, usability, burden 
Stakeholder interviews 
Resident outcomes 
 
Function (co-primary outcomes) 
SPPB,80 Yale ADL scale68-71 
Quality of life, depression 
QOL-AD,81 PHQ-982 
Health care utilization 
No. hospital/nursing home 
admissions; length of stay 
Adverse events 
No. falls, fall-related injuries 
Beliefs about function and 
physical activity 
Self-efficacy/Expectations for 
Functional Activity Scales83-87 
Caregiver outcomes 
 
Knowledge of intervention 
11-item scale88 
Self-efficacy and outcome 
expectations 
Self-efficacy/Expectations for 
Restorative Care Activities87 
Job satisfaction  
Job Attitude Scale89 
Family caregivers: QOL, 
depression, caregiver burden 
EQ-5D,90 PHQ-9,82 brief Zarit 
Caregiver Burden scale91