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| Name | Class |
|---|---|
| US Department of Housing and Urban Development | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Modification Group | Experimental | 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. |
|
| Usual Care Group | No Intervention | Usual care by an Area Agency on Aging |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Modification | Other | Removal of home barriers or hazards. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Falls | Prospective daily reporting of falls using a calendar | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Fear of Falling |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan L Stark, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Occupational Therapy Program at Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34463746 | Derived | Stark S, Keglovits M, Somerville E, Hu YL, Barker A, Sykora D, Yan Y. Home Hazard Removal to Reduce Falls Among Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2122044. doi: 10.1001/jamanetworkopen.2021.22044. | |
| 28427336 | Derived | Stark S, Somerville E, Keglovits M, Conte J, Li M, Hu YL, Yan Y. Protocol for the home hazards removal program (HARP) study: a pragmatic, randomized clinical trial and implementation study. BMC Geriatr. 2017 Apr 20;17(1):90. doi: 10.1186/s12877-017-0478-4. |
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No significant events occurred after participant enrollment but prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care Group | Usual care by an Area Agency on Aging |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allocation |
| |||||||||||||
| Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Usual Care Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Falls | Prospective daily reporting of falls using a calendar | 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. | Posted | Number | falls | 12 months |
|
Up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susy Stark | Washington University in St. Louis | 3142734114 | sstark@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2014 | Oct 18, 2021 | Prot_SAP_000.pdf |
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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). |
| 12 months |
| 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. | 12 months |
| NOT COMPLETED |
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Usual care by an Area Agency on Aging |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Marital Status | Note. Some variables had a small amount of missing data because the participant refused a response. | Count of Participants | Participants |
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| Years of Education | Note. Some variables had a small amount of missing data because the participant refused a response. | Mean | Standard Deviation | years |
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| Living Status | Count of Participants | Participants |
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| Previous Falls | Mean | Standard Deviation | falls |
|
| Falls behavior | Fall prevention behavior was measured using the Falls Behavioral (FaB) Scale for the Older Person. This scale assesses the practice of 30 behaviors that could protect against falling. Response options are 1 (never), 2 (sometimes), 3 (often), and 4 (always). The average score across items is calculated, with higher scored indicating safer behaviors. | Mean | Standard Deviation | units on a scale |
|
Usual care by an Area Agency on Aging |
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 4 |
| 155 |
| 0 |
| 155 |
| 0 |
| 155 |
| EG001 | Usual Care Group | Usual care by an Area Agency on Aging | 6 | 155 | 0 | 155 | 0 | 155 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Divorced |
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| Separated |
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| Widowed |
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