NCT04212442

Improving Aging in Place in Subsidized Housing

Completed NA Results posted Last updated 15 November 2024

What this trial tests

NA trial testing Independent Living Program for Affordable Housing. in Physical Disability in 75 participants. Completed in 2 March 2023.

Timeline

13 January 2020

Primary endpoint
24 January 2023

2 March 2023

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	75
Start date	13 January 2020
Primary completion	24 January 2023
Estimated completion	2 March 2023
Sites	13 locations across United States

Drugs / interventions tested

• Independent Living Program for Affordable Housing.

Conditions studied

• Physical Disability — all drugs for Physical Disability →
• Cognitive Impairment — all drugs for Cognitive Impairment →
• Physical Activity — all drugs for Physical Activity →

Sponsor

University of Pennsylvania

Who can join

62 and older, any sex, with Physical Disability or Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Precipitating Events Project (PEP) Functional Status Scale From Baseline to 2 Months for Immediate Intervention Sites and Waitlist Control Sites Primary · Baseline, 2 months

Self-reported ability to perform 7 ADLs, 5 IADLs, and 3 mobility tasks (Range, 0-30; higher scores indicate more functional impairment)

Group	Value	95% CI
Immediate Intervention	-1.3	± 1.7
Wait-list Control	0.6	± 2.6

Change in Average Step Counts From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites Primary · Measured continuously from 0-2 months

Measured using Fitbit

Group	Value	95% CI
Immediate Intervention	9,706	± 17,546
Wait-list Control	3,880	± 17,186

Change in Physical Activity Scale for the Elderly (PASE) Score From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites Primary · Baseline, 2 months

Self-reported physical activity (Range, 0-793; higher scores indicate greater physical activity)

Group	Value	95% CI
Immediate Intervention	4.52	± 38.95
Wait-list Control	16.25	± 46.00

Feasibility of Study Recruitment, Measured as Percentage of Eligible Participants Recruited Primary · 0-4 months

Assessed using participant responses to invitation to participate in the study (enrolled vs. refused)

Group	Value	95% CI
Immediate Intervention	47
Wait-list Control	28

Feasibility of Study Retention, Measured as Percentage of Participants Retained Over Study Follow-up Primary · 0-4 months

Assessed as percentage of participants who remain enrolled in the study

Group	Value	95% CI
Immediate Intervention	42
Wait-list Control	23

Acceptability Assessed Using a Survey Question Primary · 2 months

Self-reported acceptability of the intervention (5-point Likert scale ranging from very unacceptable (1) to very acceptable (5); higher numbers indicate higher acceptability)

Group	Value	95% CI
Immediate Intervention	4.0	3.0 – 5.0
Wait-list Control	5.0	4.0 – 5.0

Number of Participants With High Fidelity to Treatment Protocol, Measured Using Fidelity Checklist Primary · 0-4 months

Number of participants with \>80% fidelity to treatment protocol, measured using fidelity checklist including each study protocol task

Group	Value	95% CI
Immediate Intervention	37
Wait-list Control	21

Fidelity to Motivational Interviewing, Measured Using the Motivational Interviewing Treatment Integrity Scale (MITI 4) Primary · 2 months

Assessed by psychologist (4 global scores, scored on a 5-point Likert scale from 1 (low) to 5 (high))

Cultivating change

Group	Value	95% CI
Immediate Intervention	4.0	3.1 – 4.9
Wait-list Control	4.0	3.1 – 4.9

Softening sustain

Group	Value	95% CI
Immediate Intervention	3.8	3.5 – 4.4
Wait-list Control	3.8	3.5 – 4.4

Partnership

Group	Value	95% CI
Immediate Intervention	4.3	3.6 – 4.9
Wait-list Control	4.3	3.6 – 4.9

Empathy

Group	Value	95% CI
Immediate Intervention	4.3	3.6 – 4.9
Wait-list Control	4.3	3.6 – 4.9

Change in EuroQol 5 Dimensions (EQ-5D-5L) Scale From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites Secondary · Baseline, 2 months

Self-reported measure (Range, 11111-55555, converted to a single index utility score ranging from of 0-1; higher scores indicate better quality of life)

Group	Value	95% CI
Immediate Intervention	0.09	± 0.27
Wait-list Control	-0.05	± 0.34

Change in Geriatric Depression Scale Short Form (GDS Short Form) Score From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites Secondary · Baseline, 2 months

Self-reported measure of depressive symptoms (Range, 0-15; score of 5-8 suggests mild depression, 9-11 moderate depression, and 12-15 severe depression)

Group	Value	95% CI
Immediate Intervention	-1.26	± 2.23
Wait-list Control	0.42	± 2.02

Percentage of Participants With a Hospitalization During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites) Secondary · Baseline, 2 months

Self-reported hospitalization

Baseline

Group	Value	95% CI
Immediate Intervention	4
Wait-list Control	2

Follow-up

Group	Value	95% CI
Immediate Intervention	1
Wait-list Control	1

Change in Number of Hospitalizations During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites) Secondary · Baseline, 2 months

Self-reported number of hospitalizations

Group	Value	95% CI
Immediate Intervention	-0.18	± 0.61
Wait-list Control	-0.08	± 0.28

Adverse events — posted to ClinicalTrials.gov

Time frame: 0-2 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Immediate Intervention

Serious: 0/47 (0%)

Deaths: 0/47

Wait-list Control

Serious: 0/28 (0%)

Deaths: 0/28

Other adverse events (1 terms — click to expand)

Reaction	System	Immediate Intervention	Wait-list Control
Fall related to participating in intervention	Injury, poisoning and procedural complications	—	—

Data from ClinicalTrials.gov NCT04212442 adverse events section.

Sponsor's own description

This pilot study will evaluate the feasibility and preliminary effectiveness of an adapted version of the Function Focused Care intervention, delivered by telephone, for improving aging in place for older adults living in subsidized housing. The study will include participants with and without mild cognitive impairment or mild dementia and will examine whether the study outcomes differ by cognitive status. Findings from this study will provide new information about how to optimize function and physical activity among older adults with and without cognitive impairment living in subsidized housing.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.