Trial Outcomes & Findings for Home Hazard Removal Program to Reduce Falls (NCT NCT02392013)
NCT ID: NCT02392013
Last Updated: 2025-08-27
Results Overview
Prospective daily reporting of falls using a calendar
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
310 participants
Primary outcome timeframe
12 months
Results posted on
2025-08-27
Participant Flow
No significant events occurred after participant enrollment but prior to randomization.
Participant milestones
| Measure |
Home Modification Group
A tailored home-modification (home-hazard removal) intervention delivered in the home by occupational therapists over three visits and with a booster session at six months.
Home Modification: Removal of home barriers or hazards.
|
Usual Care Group
Usual care by an Area Agency on Aging
|
|---|---|---|
|
Allocation
STARTED
|
155
|
155
|
|
Allocation
COMPLETED
|
140
|
143
|
|
Allocation
NOT COMPLETED
|
15
|
12
|
|
Follow-up
STARTED
|
140
|
143
|
|
Follow-up
COMPLETED
|
127
|
126
|
|
Follow-up
NOT COMPLETED
|
13
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Note. Some variables had a small amount of missing data because the participant refused a response.
Baseline characteristics by cohort
| Measure |
Home Modification Group
n=155 Participants
A tailored home-modification (home-hazard removal) intervention delivered in the home by occupational therapists over three visits and with a booster session at six months.
Home Modification: Removal of home barriers or hazards.
|
Usual Care Group
n=155 Participants
Usual care by an Area Agency on Aging
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.1 years
STANDARD_DEVIATION 7.7 • n=155 Participants
|
74.7 years
STANDARD_DEVIATION 7.4 • n=155 Participants
|
75 years
STANDARD_DEVIATION 7.4 • n=310 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=155 Participants
|
122 Participants
n=155 Participants
|
244 Participants
n=310 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=155 Participants
|
33 Participants
n=155 Participants
|
66 Participants
n=310 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=155 Participants
|
0 Participants
n=155 Participants
|
0 Participants
n=310 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=155 Participants
|
1 Participants
n=155 Participants
|
1 Participants
n=310 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=155 Participants
|
0 Participants
n=155 Participants
|
0 Participants
n=310 Participants
|
|
Race (NIH/OMB)
Black or African American
|
83 Participants
n=155 Participants
|
87 Participants
n=155 Participants
|
170 Participants
n=310 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=155 Participants
|
67 Participants
n=155 Participants
|
139 Participants
n=310 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=155 Participants
|
0 Participants
n=155 Participants
|
0 Participants
n=310 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=155 Participants
|
0 Participants
n=155 Participants
|
0 Participants
n=310 Participants
|
|
Region of Enrollment
United States
|
155 participants
n=155 Participants
|
155 participants
n=155 Participants
|
310 participants
n=310 Participants
|
|
Marital Status
Single
|
24 Participants
n=151 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
27 Participants
n=148 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
51 Participants
n=299 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
|
Marital Status
Married/Partner
|
29 Participants
n=151 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
30 Participants
n=148 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
59 Participants
n=299 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
|
Marital Status
Divorced
|
35 Participants
n=151 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
38 Participants
n=148 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
73 Participants
n=299 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
|
Marital Status
Separated
|
3 Participants
n=151 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
0 Participants
n=148 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
3 Participants
n=299 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
|
Marital Status
Widowed
|
60 Participants
n=151 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
53 Participants
n=148 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
113 Participants
n=299 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
|
Years of Education
|
13.6 years
STANDARD_DEVIATION 2.8 • n=150 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
13.5 years
STANDARD_DEVIATION 3.5 • n=139 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
13.6 years
STANDARD_DEVIATION 3.1 • n=289 Participants • Note. Some variables had a small amount of missing data because the participant refused a response.
|
|
Living Status
Alone
|
44 Participants
n=155 Participants
|
40 Participants
n=155 Participants
|
84 Participants
n=310 Participants
|
|
Living Status
With someone
|
111 Participants
n=155 Participants
|
115 Participants
n=155 Participants
|
226 Participants
n=310 Participants
|
|
Previous Falls
|
1.6 falls
STANDARD_DEVIATION 2.4 • n=155 Participants
|
1.8 falls
STANDARD_DEVIATION 4.9 • n=155 Participants
|
1.7 falls
STANDARD_DEVIATION 3.8 • n=310 Participants
|
|
Falls behavior
|
2.8 units on a scale
STANDARD_DEVIATION .4 • n=155 Participants
|
2.8 units on a scale
STANDARD_DEVIATION .4 • n=155 Participants
|
2.8 units on a scale
STANDARD_DEVIATION .4 • n=310 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 135 intervention participants and 140 control participants were assessed for falls. This is different from the participant flow module, which shows that 127 intervention participants and 126 control participants completed follow-up, but the numbers in the participant flow module also took into consideration completion of secondary outcome measures.
Prospective daily reporting of falls using a calendar
Outcome measures
| Measure |
Home Modification Group
n=135 Participants
A tailored home-modification (home-hazard removal) intervention delivered in the home by occupational therapists over three visits and with a booster session at six months.
Home Modification: Removal of home barriers or hazards.
|
Usual Care Group
n=140 Participants
Usual care by an Area Agency on Aging
|
|---|---|---|
|
Number of Falls
|
201 falls
|
316 falls
|
SECONDARY outcome
Timeframe: 12 monthsParticipant daily activity performance will be measured by the Older Americans Resources and Services (OARS) ADL Scale. OARS = Older Americans Resources and Services scores range from 0-28 with higher scores indicating more independence in daily activities
Outcome measures
| Measure |
Home Modification Group
n=127 Participants
A tailored home-modification (home-hazard removal) intervention delivered in the home by occupational therapists over three visits and with a booster session at six months.
Home Modification: Removal of home barriers or hazards.
|
Usual Care Group
n=126 Participants
Usual care by an Area Agency on Aging
|
|---|---|---|
|
Daily Activity Performance.
|
21.18 score on a scale
Standard Deviation 4.40
|
22.10 score on a scale
Standard Deviation 4.14
|
SECONDARY outcome
Timeframe: 12 monthsConcern about falling was measured using the Short Falls Efficacy Scale-International (FES-I). Respondents rate their level of concern about falling when they perform 7 different activities. Response options range from 1 (not at all concerned) to 4 (very concerned) . Scores are summed across items, and total scores range from 7 (no concern) to 28 (severe concern).
Outcome measures
| Measure |
Home Modification Group
n=127 Participants
A tailored home-modification (home-hazard removal) intervention delivered in the home by occupational therapists over three visits and with a booster session at six months.
Home Modification: Removal of home barriers or hazards.
|
Usual Care Group
n=126 Participants
Usual care by an Area Agency on Aging
|
|---|---|---|
|
Fear of Falling
|
14.96 score on a scale
Standard Deviation 6.23
|
14.59 score on a scale
Standard Deviation 5.93
|
SECONDARY outcome
Timeframe: 12 monthsParticipant self-reported health will be measured using the SF-36. Patients rate responses that are then scored and transformed to a 0-100 scale where higher scores indicate greater quality of life.
Outcome measures
| Measure |
Home Modification Group
n=127 Participants
A tailored home-modification (home-hazard removal) intervention delivered in the home by occupational therapists over three visits and with a booster session at six months.
Home Modification: Removal of home barriers or hazards.
|
Usual Care Group
n=126 Participants
Usual care by an Area Agency on Aging
|
|---|---|---|
|
Health-related Quality of Life.
|
42.26 score on a scale
Standard Deviation 11.01
|
43.74 score on a scale
Standard Deviation 11.10
|
Adverse Events
Home Modification Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place