Trial Outcomes & Findings for Dissemination of Injury Interventions (NCT NCT00729521)
NCT ID: NCT00729521
Last Updated: 2015-02-05
Results Overview
Rates of fall injury diagnoses per 100 person-years (P-Y) were computed for the communities in each of the study groups for a 2 year baseline period, 2007-2008, and for a 2 year follow-up period corresponding to years 2010-2011. Change in fall injury rates and their 95% confidence intervals (CI) are reported. A mixed-effects Poisson regression model was used to test the presence of an interaction effect on the fall rate between study group and time period (baseline or follow-up). The test is intended to detect a differential time effect by study group. This model, with main effects for study group and time period and an interaction term, will be referred to as the primary model. Model coefficients and incidence rate ratios (IRR) with 95% confidence intervals (CI) are reported.
COMPLETED
NA
35037 participants
2007-2008; 2010-2011
2015-02-05
Participant Flow
20 interested communities were randomized to one of the three groups using a block randomization method, taking into account whether the lead agency was a health department or aging agency and whether the community had 0 or 1 or more Stepping On fall prevention program leaders already.
Participant milestones
| Measure |
Control
a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
|
Standard Program
a "Standard Program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community;
Standard Program: a "Standard Program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community;
|
Facilitative System
a "Facilitative System" group receiving facilitative system support in addition to the resources provided the Standard Program group
facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12494
|
14842
|
7701
|
|
Overall Study
COMPLETED
|
12494
|
14842
|
7701
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dissemination of Injury Interventions
Baseline characteristics by cohort
| Measure |
Control
n=12494 Participants
a control group of 10 communities and their residents over 65 years of age receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
|
Standard Program
n=14842 Participants
a "Standard Program" group of five communities and their residents over 65 years of age receiving modest funding to implement an "evidence-based" fall prevention program in their local community;
Standard Program: a "Standard Program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community;
|
Facilitative System
n=7701 Participants
a "Facilitative System" group of five communities and their residents over 65 years of age receiving support in addition to the resources provided the Standard Program group
facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation.
|
Total
n=35037 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
12494 Participants
n=5 Participants
|
14842 Participants
n=7 Participants
|
7701 Participants
n=5 Participants
|
35037 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Not collected
|
NA participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
NA participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2007-2008; 2010-2011Population: Population of residents aged 65 and older for participating communities in each study arm for 2007-2008 baseline period and 2010-2011 follow-up period.
Rates of fall injury diagnoses per 100 person-years (P-Y) were computed for the communities in each of the study groups for a 2 year baseline period, 2007-2008, and for a 2 year follow-up period corresponding to years 2010-2011. Change in fall injury rates and their 95% confidence intervals (CI) are reported. A mixed-effects Poisson regression model was used to test the presence of an interaction effect on the fall rate between study group and time period (baseline or follow-up). The test is intended to detect a differential time effect by study group. This model, with main effects for study group and time period and an interaction term, will be referred to as the primary model. Model coefficients and incidence rate ratios (IRR) with 95% confidence intervals (CI) are reported.
Outcome measures
| Measure |
Control
n=12494 Participants
a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
|
Standard Program
n=14842 Participants
a "Standard Program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community;
Standard Program: a "Standard Program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community;
|
Facilitative System
n=7701 Participants
a "Facilitative System" group receiving facilitative system support in addition to the resources provided the Standard Program group
facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation.
|
|---|---|---|---|
|
Emergency Department and In-patient Hospitalization for Fall Injury
Fall Injury Rate per 100 P-Y 2010-2011
|
5.8 Fall Injury Rate per 100 person years
Interval 5.7 to 5.9
|
5.3 Fall Injury Rate per 100 person years
Interval 5.2 to 5.5
|
5.6 Fall Injury Rate per 100 person years
Interval 5.4 to 5.8
|
|
Emergency Department and In-patient Hospitalization for Fall Injury
Fall Injury Rate per 100 P-Y, 2007-2008
|
5.8 Fall Injury Rate per 100 person years
Interval 5.7 to 5.9
|
5.9 Fall Injury Rate per 100 person years
Interval 5.8 to 6.0
|
6.1 Fall Injury Rate per 100 person years
Interval 5.9 to 6.3
|
Adverse Events
Control
Standard Program
Facilitative System
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