Trial Outcomes & Findings for Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia (NCT NCT05777772)
NCT ID: NCT05777772
Last Updated: 2024-05-07
Results Overview
Number of older adult participants with dementia with a fall-related healthcare visit
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
123 participants
Primary outcome timeframe
Through study completion, up to 6 months
Results posted on
2024-05-07
Participant Flow
Participant milestones
| Measure |
Educational Intervention
Educational Intervention
STOP Falls D Educational Intervention: This is one-arm, health-system embedded pragmatic pilot trial
|
Care Partners
Persons who help care for the older person with dementia
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
9
|
|
Overall Study
COMPLETED
|
114
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exact age was not collected for care partners. Age categories were collected.
Baseline characteristics by cohort
| Measure |
Educational Intervention Group
n=114 Participants
Educational Intervention
STOP Falls D Educational Intervention: This is one-arm, health-system embedded pragmatic pilot trial
|
Care Partners
n=9 Participants
Care partners of older people with dementia
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=114 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=123 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=114 Participants
|
3 Participants
n=9 Participants
|
10 Participants
n=123 Participants
|
|
Age, Categorical
>=65 years
|
107 Participants
n=114 Participants
|
6 Participants
n=9 Participants
|
113 Participants
n=123 Participants
|
|
Age, Continuous
|
79.9 years
STANDARD_DEVIATION 9.1 • n=114 Participants • Exact age was not collected for care partners. Age categories were collected.
|
—
|
79.9 years
STANDARD_DEVIATION 9.1 • n=114 Participants • Exact age was not collected for care partners. Age categories were collected.
|
|
Sex: Female, Male
Female
|
82 Participants
n=114 Participants
|
6 Participants
n=9 Participants
|
88 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=114 Participants
|
3 Participants
n=9 Participants
|
35 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=114 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=114 Participants
|
0 Participants
n=9 Participants
|
6 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=114 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=114 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
99 Participants
n=114 Participants
|
9 Participants
n=9 Participants
|
108 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=114 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=114 Participants
|
0 Participants
n=9 Participants
|
4 Participants
n=123 Participants
|
|
Region of Enrollment
United States
|
114 Participants
n=114 Participants
|
9 Participants
n=9 Participants
|
123 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: Through study completion, up to 6 monthsNumber of older adult participants with dementia with a fall-related healthcare visit
Outcome measures
| Measure |
Educational Intervention
n=114 Participants
Educational Intervention
STOP Falls D Educational Intervention: This is one-arm, health-system embedded pragmatic pilot trial
|
|---|---|
|
Number of Participants With Dementia With Medically Treated Falls
|
24 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 6 monthsNumber of older adult participants with dementia with an emergency department visit or hospitalization for any reason
Outcome measures
| Measure |
Educational Intervention
n=114 Participants
Educational Intervention
STOP Falls D Educational Intervention: This is one-arm, health-system embedded pragmatic pilot trial
|
|---|---|
|
Number of Participants With Dementia With All-cause Emergency Department Visits or Hospitalizations
|
29 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 6 monthsNumber of older adult participants with dementia admitted to a skilled nursing facility
Outcome measures
| Measure |
Educational Intervention
n=114 Participants
Educational Intervention
STOP Falls D Educational Intervention: This is one-arm, health-system embedded pragmatic pilot trial
|
|---|---|
|
Number of Participants With Dementia With Skilled Nursing Facility Placement
|
5 Participants
|
Adverse Events
Educational Intervention
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