Accidental Falls
Conditions
Keywords
older adult falls, home hazards, home barriers
Brief summary
This study evaluates the effectiveness and implementation of a home-hazard removal program to reduce falls in older adults through a community program delivered through the aging services network. The investigators will conduct a hybrid effectiveness/implementation trial of 300 older adults at risk for a fall who will be randomized to a home-hazard removal program or usual care and then followed for 12 months. Investigators will look at the number of falls at 6 months and 12 months.
Detailed description
The investigators will randomly select a sample of older adults from the large observational cohort of older adults assessed annually by an Area Agendy on Aging via the National Aging Program Information System (NAPIS). The eligibility criteria include age 65 years or older and self-report of one previous fall or more in the preceding 12 months or self-report as worried about falling. We will conduct baseline assessments and randomize participants to receive an home hazard removal program or usual care. Outcomes (falls, fall self-efficacy) will be assessed by a blinded rater at baseline and 12 months after intervention. All assessments and study visits will occur in participants' homes.
Interventions
OTHERHome Modification
Removal of home barriers or hazards.
Sponsors
US Department of Housing and Urban Development
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Individuals aged 65 years or older and self-report of one previous fall or more in the preceding 12 months or self-report as worried about falling.
Exclusion criteria
* Individuals residing in nursing homes or individuals with severe cognitive impairment who are unable to give consent to participate (as determined by a score of greater than 10 on the SBT for memory10).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Falls | 12 months | Prospective daily reporting of falls using a calendar |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Activity Performance. | 12 months | Participant 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 |
| Fear of Falling | 12 months | Concern 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). |
| Health-related Quality of Life. | 12 months | Participant 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. |
Countries
United States
Participant flow
Pre-assignment details
No significant events occurred after participant enrollment but prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 155 |
| Usual Care Group Usual care by an Area Agency on Aging | 155 |
| Total | 310 |
Baseline characteristics
| Characteristic | Usual Care Group | Home Modification Group | Total |
|---|---|---|---|
| Age, Continuous | 74.7 years STANDARD_DEVIATION 7.4 | 75.1 years STANDARD_DEVIATION 7.7 | 75 years STANDARD_DEVIATION 7.4 |
| Falls behavior | 2.8 units on a scale STANDARD_DEVIATION 0.4 | 2.8 units on a scale STANDARD_DEVIATION 0.4 | 2.8 units on a scale STANDARD_DEVIATION 0.4 |
| Living Status Alone | 40 Participants | 44 Participants | 84 Participants |
| Living Status With someone | 115 Participants | 111 Participants | 226 Participants |
| Marital Status Divorced | 38 Participants | 35 Participants | 73 Participants |
| Marital Status Married/Partner | 30 Participants | 29 Participants | 59 Participants |
| Marital Status Separated | 0 Participants | 3 Participants | 3 Participants |
| Marital Status Single | 27 Participants | 24 Participants | 51 Participants |
| Marital Status Widowed | 53 Participants | 60 Participants | 113 Participants |
| Previous Falls | 1.8 falls STANDARD_DEVIATION 4.9 | 1.6 falls STANDARD_DEVIATION 2.4 | 1.7 falls STANDARD_DEVIATION 3.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 87 Participants | 83 Participants | 170 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 67 Participants | 72 Participants | 139 Participants |
| Region of Enrollment United States | 155 participants | 155 participants | 310 participants |
| Sex: Female, Male Female | 122 Participants | 122 Participants | 244 Participants |
| Sex: Female, Male Male | 33 Participants | 33 Participants | 66 Participants |
| Years of Education | 13.5 years STANDARD_DEVIATION 3.5 | 13.6 years STANDARD_DEVIATION 2.8 | 13.6 years STANDARD_DEVIATION 3.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 155 | 6 / 155 |
| other Total, other adverse events | 0 / 155 | 0 / 155 |
| serious Total, serious adverse events | 0 / 155 | 0 / 155 |
Outcome results
Primary
Number of Falls
Prospective daily reporting of falls using a calendar
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Modification Group | Number of Falls | 201 falls |
| Usual Care Group | Number of Falls | 316 falls |
Secondary
Daily Activity Performance.
Participant 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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Modification Group | Daily Activity Performance. | 21.18 score on a scale | Standard Deviation 4.4 |
| Usual Care Group | Daily Activity Performance. | 22.10 score on a scale | Standard Deviation 4.14 |
Secondary
Fear of Falling
Concern 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).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Modification Group | Fear of Falling | 14.96 score on a scale | Standard Deviation 6.23 |
| Usual Care Group | Fear of Falling | 14.59 score on a scale | Standard Deviation 5.93 |
Secondary
Health-related Quality of Life.
Participant 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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Modification Group | Health-related Quality of Life. | 42.26 score on a scale | Standard Deviation 11.01 |
| Usual Care Group | Health-related Quality of Life. | 43.74 score on a scale | Standard Deviation 11.1 |