Trial Outcomes & Findings for Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI) (NCT NCT04612842)
NCT ID: NCT04612842
Last Updated: 2024-08-13
Results Overview
A 7-item scale, 1-4 self-report rating, widely used to measure levels of concern related to preventing falls. Minimum value is 7 and maximum value is 28. Higher FES-I scores is a worse value since it has been positively correlated with decreased activities, future falls, and injury.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
3-, 6-, and 12-months
Results posted on
2024-08-13
Participant Flow
Participant milestones
| Measure |
Motivational Interviewing (MI) Group
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
|
Control Group
The control group participants will take part in study measurements (self-report and physiologic assessment) for 12-months. Primary assessment measures are at baseline, 6-, and 12-months and will be conducted via phone survey, video assessment, or mail-in calendar.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
99
|
|
Overall Study
Baseline Assessment
|
90
|
95
|
|
Overall Study
6-month Assessment
|
69
|
81
|
|
Overall Study
12-month Assessment
|
53
|
71
|
|
Overall Study
COMPLETED
|
53
|
71
|
|
Overall Study
NOT COMPLETED
|
48
|
28
|
Reasons for withdrawal
| Measure |
Motivational Interviewing (MI) Group
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
|
Control Group
The control group participants will take part in study measurements (self-report and physiologic assessment) for 12-months. Primary assessment measures are at baseline, 6-, and 12-months and will be conducted via phone survey, video assessment, or mail-in calendar.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
11
|
|
Overall Study
Withdrawal by Subject
|
26
|
15
|
|
Overall Study
Death
|
2
|
2
|
Baseline Characteristics
Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
Baseline characteristics by cohort
| Measure |
Motivational Interviewing (MI) Group
n=90 Participants
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=95 Participants
The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=90 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=185 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=90 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=185 Participants
|
|
Age, Categorical
>=65 years
|
90 Participants
n=90 Participants
|
95 Participants
n=95 Participants
|
185 Participants
n=185 Participants
|
|
Age, Continuous
|
79.1 Years
STANDARD_DEVIATION 7.6 • n=90 Participants
|
80.9 Years
STANDARD_DEVIATION 7.7 • n=95 Participants
|
80.1 Years
STANDARD_DEVIATION 7.7 • n=185 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=90 Participants
|
65 Participants
n=95 Participants
|
125 Participants
n=185 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=90 Participants
|
30 Participants
n=95 Participants
|
60 Participants
n=185 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=90 Participants
|
1 Participants
n=95 Participants
|
1 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=90 Participants
|
3 Participants
n=95 Participants
|
5 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=90 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=90 Participants
|
3 Participants
n=95 Participants
|
3 Participants
n=185 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=90 Participants
|
86 Participants
n=95 Participants
|
171 Participants
n=185 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=90 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=90 Participants
|
2 Participants
n=95 Participants
|
5 Participants
n=185 Participants
|
|
Region of Enrollment
United States
|
90 participants
n=90 Participants
|
95 participants
n=95 Participants
|
185 participants
n=185 Participants
|
|
Balance Measure
Semi-tandem stand balance
|
9.96 units on a scale
STANDARD_DEVIATION 0.28 • n=52 Participants • Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
9.74 units on a scale
STANDARD_DEVIATION 1.37 • n=47 Participants • Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
9.86 units on a scale
STANDARD_DEVIATION 0.97 • n=99 Participants • Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
|
Balance Measure
Tandem stand balance
|
9.33 units on a scale
STANDARD_DEVIATION 1.83 • n=51 Participants • Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
8.13 units on a scale
STANDARD_DEVIATION 3.35 • n=45 Participants • Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
8.77 units on a scale
STANDARD_DEVIATION 2.7 • n=96 Participants • Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
|
Balance Measure
1-legged stand balance
|
6.71 units on a scale
STANDARD_DEVIATION 3.88 • n=48 Participants • Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
5.71 units on a scale
STANDARD_DEVIATION 3.86 • n=42 Participants • Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
6.24 units on a scale
STANDARD_DEVIATION 3.88 • n=90 Participants • Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
|
Balance Measure
Side-by-side stand balance
|
10 units on a scale
STANDARD_DEVIATION 0 • n=52 Participants • Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
9.96 units on a scale
STANDARD_DEVIATION 0.295 • n=47 Participants • Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
9.98 units on a scale
STANDARD_DEVIATION 0.20 • n=99 Participants • Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
|
Fall Efficacy Scale International- Short
|
13.33 units on a scale
STANDARD_DEVIATION 4.46 • n=90 Participants
|
13.83 units on a scale
STANDARD_DEVIATION 5.59 • n=95 Participants
|
13.59 units on a scale
STANDARD_DEVIATION 5.07 • n=185 Participants
|
|
Patient Activation Measure
|
67.61 units on a scale
STANDARD_DEVIATION 12.86 • n=90 Participants
|
66.69 units on a scale
STANDARD_DEVIATION 13.89 • n=95 Participants
|
67.14 units on a scale
STANDARD_DEVIATION 13.37 • n=185 Participants
|
|
Falls Behavioral Scale
|
3.04 units on a scale
STANDARD_DEVIATION 0.46 • n=90 Participants
|
2.96 units on a scale
STANDARD_DEVIATION 0.46 • n=95 Participants
|
3.00 units on a scale
STANDARD_DEVIATION 0.46 • n=185 Participants
|
|
30-second Sit-to-Stand
|
10 units on a scale
STANDARD_DEVIATION 0.57 • n=49 Participants • Some participants were unable to complete the physical function assessments which are secondary measures (4-stage balance test and 30-second sit-to-stand) because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
10.16 units on a scale
STANDARD_DEVIATION 0.6 • n=45 Participants • Some participants were unable to complete the physical function assessments which are secondary measures (4-stage balance test and 30-second sit-to-stand) because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
10.1 units on a scale
STANDARD_DEVIATION 4.00 • n=94 Participants • Some participants were unable to complete the physical function assessments which are secondary measures (4-stage balance test and 30-second sit-to-stand) because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB).
|
PRIMARY outcome
Timeframe: 3-, 6-, and 12-monthsPopulation: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below looks different from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
A 7-item scale, 1-4 self-report rating, widely used to measure levels of concern related to preventing falls. Minimum value is 7 and maximum value is 28. Higher FES-I scores is a worse value since it has been positively correlated with decreased activities, future falls, and injury.
Outcome measures
| Measure |
Motivational Interviewing (MI) Group
n=88 Participants
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=94 Participants
The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit.
|
|---|---|---|
|
Falls Self-Efficacy Scale-International (FES-I) Results
3-months
|
13.07 units on a scale
Standard Error 0.57
|
13.71 units on a scale
Standard Error 0.54
|
|
Falls Self-Efficacy Scale-International (FES-I) Results
6-months
|
13.41 units on a scale
Standard Error 0.59
|
14.35 units on a scale
Standard Error 0.56
|
|
Falls Self-Efficacy Scale-International (FES-I) Results
12-months
|
13.01 units on a scale
Standard Error 0.67
|
13.82 units on a scale
Standard Error 0.53
|
PRIMARY outcome
Timeframe: 3-, 6-, and 12-monthsPopulation: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below looks different from the participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
A 24-item, 1-4 self-report rating to measure frequency of protective strategies to prevent falling and risky behaviors that facilitate a fall. The average value is calculated with a minimum value of 1 and maximum value of 4. Higher FAB score is a better value since it indicates more consistent fall protective behaviors.
Outcome measures
| Measure |
Motivational Interviewing (MI) Group
n=90 Participants
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=93 Participants
The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit.
|
|---|---|---|
|
Fall Behavioral (FAB) Scale Results
3-months
|
3.16 units on a scale
Standard Error 0.05
|
3.08 units on a scale
Standard Error 0.05
|
|
Fall Behavioral (FAB) Scale Results
6-months
|
3.23 units on a scale
Standard Error 0.05
|
3.11 units on a scale
Standard Error 0.05
|
|
Fall Behavioral (FAB) Scale Results
12-months
|
3.17 units on a scale
Standard Error 0.05
|
3.14 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: 3-, 6-, and 12-monthsPopulation: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
100-point, quantifiable scale determining patient engagement in healthcare. Minimum value is 0 and the maximum value is 100. Higher value is a better value since it is indicative of participant's activation with their healthcare.
Outcome measures
| Measure |
Motivational Interviewing (MI) Group
n=90 Participants
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=95 Participants
The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit.
|
|---|---|---|
|
Patient Activation Measure Results
3-months
|
70.6 score on a scale
Standard Error 1.5
|
71.59 score on a scale
Standard Error 1.44
|
|
Patient Activation Measure Results
6-months
|
70.23 score on a scale
Standard Error 1.52
|
67.33 score on a scale
Standard Error 1.45
|
|
Patient Activation Measure Results
12-months
|
70.44 score on a scale
Standard Error 1.83
|
68.21 score on a scale
Standard Error 1.63
|
SECONDARY outcome
Timeframe: 3-, 6-, and 12-monthsPopulation: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
1-item 10-point scale response. Often used in motivational interviewing sessions to gauge an individual's readiness to engage in certain health behaviors. Higher levels of confidence are known to be associated with an increased rate of behavior change.
Outcome measures
| Measure |
Motivational Interviewing (MI) Group
n=90 Participants
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=95 Participants
The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit.
|
|---|---|---|
|
Level of Confidence to Prevent Falls
3-months
|
8.09 units on a scale
Standard Error 0.18
|
7.74 units on a scale
Standard Error 0.17
|
|
Level of Confidence to Prevent Falls
6-months
|
8.04 units on a scale
Standard Error 0.18
|
7.79 units on a scale
Standard Error 0.17
|
|
Level of Confidence to Prevent Falls
12-months
|
7.56 units on a scale
Standard Error 0.24
|
7.67 units on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: 3-, 6-, and 12-monthsPopulation: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
1-item 10-point scale response. Often used in motivational interviewing sessions to gauge an individual's readiness to engage in certain health behaviors. Higher levels of importance are known to be associated with an increased rate of behavior change.
Outcome measures
| Measure |
Motivational Interviewing (MI) Group
n=90 Participants
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=95 Participants
The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit.
|
|---|---|---|
|
Level of Importance to Prevent Falls
6-months
|
9.62 units on a scale
Standard Error 0.12
|
9.63 units on a scale
Standard Error 0.10
|
|
Level of Importance to Prevent Falls
3-months
|
9.68 units on a scale
Standard Error 0.12
|
9.41 units on a scale
Standard Error 0.11
|
|
Level of Importance to Prevent Falls
12-months
|
9.60 units on a scale
Standard Error 0.12
|
9.59 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: 6- monthsPopulation: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
Duration that participants can hold feet side-by-side stand (heel to toe standing positions) will be measured up to 10 seconds. Minimum value is 0 seconds and maximum score is 10 seconds. Higher value is a better value since it is indicative of participants' ability to hold balance.
Outcome measures
| Measure |
Motivational Interviewing (MI) Group
n=52 Participants
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=47 Participants
The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit.
|
|---|---|---|
|
Balance Measure (Feet Side by Side)
|
10 seconds
Standard Error 0
|
10 seconds
Standard Error 0
|
SECONDARY outcome
Timeframe: 6- monthsPopulation: The number analyzed differed by time point because of the loss to follow-up and participant withdrawal as indicated in the participant flow data, and participants' willingness and ability to participate in the measurements.
Duration that participants can hold semi-tandem stand (heel to toe standing positions) will be measured up to 10 seconds. Minimum value is 0 seconds and maximum score is 10 seconds. Higher value is a better value since it is indicative of participants' ability to hold balance.
Outcome measures
| Measure |
Motivational Interviewing (MI) Group
n=52 Participants
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=47 Participants
The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit.
|
|---|---|---|
|
Balance Measure (Semi-tandem Stand)
|
10 seconds
Standard Deviation 0.17
|
9.79 seconds
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
Individuals are asked to hold a tandem stand (one foot in front of the other- heel touching toe). The minimum is 0 and the maximum is 10. A higher number is a better outcome.
Outcome measures
| Measure |
Motivational Interviewing (MI) Group
n=52 Participants
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=46 Participants
The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit.
|
|---|---|---|
|
Balance Measure (Tandem Stand)
|
8.46 units on a scale
Standard Error 0.56
|
7.47 units on a scale
Standard Error 0.55
|
SECONDARY outcome
Timeframe: 6- monthsPopulation: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
Individuals are asked to hold a balance position for 10 sections without moving their feet or needing support. This position require standing on one foot. The minimum is 0 and the maximum is 10. A higher number is a better outcome.
Outcome measures
| Measure |
Motivational Interviewing (MI) Group
n=50 Participants
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=44 Participants
The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit.
|
|---|---|---|
|
Balance Measure (One-leg Stand)
|
6.84 seconds
Standard Error 0.68
|
5.28 seconds
Standard Error 0.67
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: Some participants were unable to complete the physical assessment due to physical limitations, access to a video platform, or a support person.
Instances that participants can stand from a sitting position will be measured. Minimum value is 0 times. Higher value is a better value since it is indicative of participants' ability to sit-to-stand.
Outcome measures
| Measure |
Motivational Interviewing (MI) Group
n=49 Participants
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=45 Participants
The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit.
|
|---|---|---|
|
30-second Sit-to-stand Assessment
|
11.01 units on a scale
Standard Deviation 0.64
|
9.5 units on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: 1-yearPopulation: One participant in the MI group had an unreliable reporting of falls due to his unstable memory (ID 1277). Based on the discussion with the Safety Monitoring Council, his data was considered an outlier and removed from the analysis.
Individuals were asked to mail-in reports of falls every month. Participants reporting a fall at least once are counted as a faller. Minimum value is 0. Higher value is worse value as it is indicative that there were more participants who fell during the year.
Outcome measures
| Measure |
Motivational Interviewing (MI) Group
n=90 Participants
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=95 Participants
The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit.
|
|---|---|---|
|
Number of Participants With Self-reported Falls
|
56 Participants
|
50 Participants
|
Adverse Events
Motivational Interviewing (MI) Group
Serious events: 11 serious events
Other events: 54 other events
Deaths: 2 deaths
Control Group
Serious events: 13 serious events
Other events: 62 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Motivational Interviewing (MI) Group
n=101 participants at risk
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions within 6-months. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=99 participants at risk
The control group participants will take part in study measurements and routine clinical care.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Falls (major)
|
3.0%
3/101 • Number of events 3 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
7.1%
7/99 • Number of events 7 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Metabolism and nutrition disorders
Death
|
2.0%
2/101 • Number of events 2 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
2.0%
2/99 • Number of events 2 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Musculoskeletal and connective tissue disorders
Hip surgery
|
0.99%
1/101 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
0.00%
0/99 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/101 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
1.0%
1/99 • Number of events 2 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.99%
1/101 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
0.00%
0/99 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/101 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
1.0%
1/99 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Vascular disorders
Heart surgery
|
0.00%
0/101 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
1.0%
1/99 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.99%
1/101 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
0.00%
0/99 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Injury, poisoning and procedural complications
Skiing injury
|
0.99%
1/101 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
0.00%
0/99 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Nervous system disorders
Neurosurgery
|
0.99%
1/101 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
0.00%
0/99 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Infections and infestations
COVID
|
0.99%
1/101 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
0.00%
0/99 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/101 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
1.0%
1/99 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
Other adverse events
| Measure |
Motivational Interviewing (MI) Group
n=101 participants at risk
The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions within 6-months. MI is an evidence-based communication approach for various health behavior change.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change.
|
Control Group
n=99 participants at risk
The control group participants will take part in study measurements and routine clinical care.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Falls
|
48.5%
49/101 • Number of events 134 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
56.6%
56/99 • Number of events 155 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Injury, poisoning and procedural complications
Car/bike accident
|
0.99%
1/101 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
1.0%
1/99 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Eye disorders
Shunt
|
0.00%
0/101 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
1.0%
1/99 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Musculoskeletal and connective tissue disorders
Hammer toe
|
0.00%
0/101 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
1.0%
1/99 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/101 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
1.0%
1/99 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Renal and urinary disorders
Bladder infection
|
0.99%
1/101 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
0.00%
0/99 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Gastrointestinal disorders
Gut pain
|
0.99%
1/101 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
0.00%
0/99 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer removal
|
0.99%
1/101 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
0.00%
0/99 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff surgery
|
0.00%
0/101 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
1.0%
1/99 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Ear and labyrinth disorders
Nose surgery
|
0.00%
0/101 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
1.0%
1/99 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
|
Nervous system disorders
Headaches
|
0.99%
1/101 • Number of events 1 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
0.00%
0/99 • 12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
|
Additional Information
Dr. Hiroko Kiyoshi-Teo (Assistant Professor)
Oregon Health & Science University
Phone: 5034943858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place