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Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI)

Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04612842
Enrollment
200
Registered
2020-11-03
Start date
2020-09-09
Completion date
2023-09-28
Last updated
2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Coping Behavior, Fall, Motivation

Keywords

Fall prevention, Motivational Interviewing

Brief summary

This mixed-methods, two-arm, randomized controlled trial will evaluate the impact of Motivational Interviewing (MI) as a follow-up care to patients who received fall prevention recommendations at Oregon Health & Science University Internal Medicine and Geriatrics Clinic provided over 12 months.

Detailed description

The goal of this mixed-methods, two-arm, randomized controlled trial of MI intervention for fall prevention is to evaluate the impact of Motivational Interviewing (MI) as a follow-up care to patients who received fall prevention recommendations at Oregon Health & Science University Internal Medicine and Geriatrics Clinic provided over 12-months. Older adult participants (older than 65) who are at increased risk for falling will be enrolled into the study. Patients will be randomly assigned to two groups: MI and the standard of care group. All participants will have a baseline and 6-months study visit that will include self-report and physiologic assessment. In addition, all participants will receive study measurement phone call at 3-, and 12-months. MI will be provided via video, phone, or in-person one week after the initial visit and then monthly for 6 months. All MI sessions will be recorded and encounter notes will be completed. Purposefully selected participants' MI sessions will be transcribed for qualitative analysis.

Interventions

BEHAVIORALMotivational Interviewing

The PI and two study staff members (interventionists) will conduct study visits and phone calls. The same person will complete participant follow-ups to establish rapport and consistency. All of the study encounters will be audio recorded with participants' permission and study encounter 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 a specific fall prevention behavior, the participant's goal with this behavior, readiness to change, specific plan to move toward the goal, barriers and facilitators, and the participant's commitment level to change.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Oregon Health & Science University (OHSU) Internal Medicine and Geriatrics Clinic patients * 65 years old or older * Moderate-to-high risk for falling using the STEADI fall screening and management algorithm * Cognitively oriented (Mini-Cog≥ 3) * Able to converse audibly and coherently in English * Living independently in the community * Able to receive study phone calls * Ambulatory with or without assistive device use

Exclusion criteria

* Cognitively impaired patients (Mini-Cog\< 2) * Patients who have sensory difficulty with verbal communication (hard-of-hearing despite the use of hearing aids or speech is hard to understand despite a talking device) * Living in institutions with 24-hour care such as skilled nursing facilities * Unable to stand without assistance by others * Life-expectancy of less than 3-months * Patients participating in other studies that may impact fall-related behavior change

Design outcomes

Primary

MeasureTime frameDescription
Falls Self-Efficacy Scale-International (FES-I) Results3-, 6-, and 12-monthsA 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.
Fall Behavioral (FAB) Scale Results3-, 6-, and 12-monthsA 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.

Secondary

MeasureTime frameDescription
Level of Importance to Prevent Falls3-, 6-, and 12-months1-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.
Balance Measure (Feet Side by Side)6- monthsDuration 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.
Balance Measure (Semi-tandem Stand)6- monthsDuration 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.
Patient Activation Measure Results3-, 6-, and 12-months100-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.
Balance Measure (One-leg Stand)6- monthsIndividuals 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.
30-second Sit-to-stand Assessment6-monthsInstances 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.
Number of Participants With Self-reported Falls1-yearIndividuals 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.
Balance Measure (Tandem Stand)6-monthsIndividuals 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.
Level of Confidence to Prevent Falls3-, 6-, and 12-months1-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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
90
Control Group
The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit.
95
Total185

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath22
Overall StudyLost to Follow-up2011
Overall StudyWithdrawal by Subject2615

Baseline characteristics

CharacteristicMotivational Interviewing (MI) GroupControl GroupTotal
30-second Sit-to-Stand10 units on a scale
STANDARD_DEVIATION 0.57
10.16 units on a scale
STANDARD_DEVIATION 0.6
10.1 units on a scale
STANDARD_DEVIATION 4
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
90 Participants95 Participants185 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous79.1 Years
STANDARD_DEVIATION 7.6
80.9 Years
STANDARD_DEVIATION 7.7
80.1 Years
STANDARD_DEVIATION 7.7
Balance Measure
1-legged stand balance
6.71 units on a scale
STANDARD_DEVIATION 3.88
5.71 units on a scale
STANDARD_DEVIATION 3.86
6.24 units on a scale
STANDARD_DEVIATION 3.88
Balance Measure
Semi-tandem stand balance
9.96 units on a scale
STANDARD_DEVIATION 0.28
9.74 units on a scale
STANDARD_DEVIATION 1.37
9.86 units on a scale
STANDARD_DEVIATION 0.97
Balance Measure
Side-by-side stand balance
10 units on a scale
STANDARD_DEVIATION 0
9.96 units on a scale
STANDARD_DEVIATION 0.295
9.98 units on a scale
STANDARD_DEVIATION 0.2
Balance Measure
Tandem stand balance
9.33 units on a scale
STANDARD_DEVIATION 1.83
8.13 units on a scale
STANDARD_DEVIATION 3.35
8.77 units on a scale
STANDARD_DEVIATION 2.7
Fall Efficacy Scale International- Short13.33 units on a scale
STANDARD_DEVIATION 4.46
13.83 units on a scale
STANDARD_DEVIATION 5.59
13.59 units on a scale
STANDARD_DEVIATION 5.07
Falls Behavioral Scale3.04 units on a scale
STANDARD_DEVIATION 0.46
2.96 units on a scale
STANDARD_DEVIATION 0.46
3.00 units on a scale
STANDARD_DEVIATION 0.46
Patient Activation Measure67.61 units on a scale
STANDARD_DEVIATION 12.86
66.69 units on a scale
STANDARD_DEVIATION 13.89
67.14 units on a scale
STANDARD_DEVIATION 13.37
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants3 Participants5 Participants
Race (NIH/OMB)
Black or African American
0 Participants3 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants2 Participants5 Participants
Race (NIH/OMB)
White
85 Participants86 Participants171 Participants
Region of Enrollment
United States
90 participants95 participants185 participants
Sex: Female, Male
Female
60 Participants65 Participants125 Participants
Sex: Female, Male
Male
30 Participants30 Participants60 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 1012 / 99
other
Total, other adverse events
54 / 10162 / 99
serious
Total, serious adverse events
11 / 10113 / 99

Outcome results

Primary

Fall Behavioral (FAB) Scale Results

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.

Time frame: 3-, 6-, and 12-months

Population: 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.)

ArmMeasureGroupValue (MEAN)Dispersion
Motivational Interviewing (MI) GroupFall Behavioral (FAB) Scale Results3-months3.16 units on a scaleStandard Error 0.05
Motivational Interviewing (MI) GroupFall Behavioral (FAB) Scale Results6-months3.23 units on a scaleStandard Error 0.05
Motivational Interviewing (MI) GroupFall Behavioral (FAB) Scale Results12-months3.17 units on a scaleStandard Error 0.05
Control GroupFall Behavioral (FAB) Scale Results3-months3.08 units on a scaleStandard Error 0.05
Control GroupFall Behavioral (FAB) Scale Results6-months3.11 units on a scaleStandard Error 0.05
Control GroupFall Behavioral (FAB) Scale Results12-months3.14 units on a scaleStandard Error 0.05
Primary

Falls Self-Efficacy Scale-International (FES-I) Results

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.

Time frame: 3-, 6-, and 12-months

Population: 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.)

ArmMeasureGroupValue (MEAN)Dispersion
Motivational Interviewing (MI) GroupFalls Self-Efficacy Scale-International (FES-I) Results3-months13.07 units on a scaleStandard Error 0.57
Motivational Interviewing (MI) GroupFalls Self-Efficacy Scale-International (FES-I) Results6-months13.41 units on a scaleStandard Error 0.59
Motivational Interviewing (MI) GroupFalls Self-Efficacy Scale-International (FES-I) Results12-months13.01 units on a scaleStandard Error 0.67
Control GroupFalls Self-Efficacy Scale-International (FES-I) Results3-months13.71 units on a scaleStandard Error 0.54
Control GroupFalls Self-Efficacy Scale-International (FES-I) Results6-months14.35 units on a scaleStandard Error 0.56
Control GroupFalls Self-Efficacy Scale-International (FES-I) Results12-months13.82 units on a scaleStandard Error 0.53
p-value: <0.05Mixed Models Analysis
Secondary

30-second Sit-to-stand Assessment

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.

Time frame: 6-months

Population: Some participants were unable to complete the physical assessment due to physical limitations, access to a video platform, or a support person.

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing (MI) Group30-second Sit-to-stand Assessment11.01 units on a scaleStandard Deviation 0.64
Control Group30-second Sit-to-stand Assessment9.5 units on a scaleStandard Deviation 0.61
Secondary

Balance Measure (Feet Side by Side)

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.

Time frame: 6- months

Population: 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.)

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing (MI) GroupBalance Measure (Feet Side by Side)10 secondsStandard Error 0
Control GroupBalance Measure (Feet Side by Side)10 secondsStandard Error 0
Secondary

Balance Measure (One-leg Stand)

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.

Time frame: 6- months

Population: 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.)

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing (MI) GroupBalance Measure (One-leg Stand)6.84 secondsStandard Error 0.68
Control GroupBalance Measure (One-leg Stand)5.28 secondsStandard Error 0.67
Secondary

Balance Measure (Semi-tandem Stand)

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.

Time frame: 6- months

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing (MI) GroupBalance Measure (Semi-tandem Stand)10 secondsStandard Deviation 0.17
Control GroupBalance Measure (Semi-tandem Stand)9.79 secondsStandard Deviation 0.15
Secondary

Balance Measure (Tandem Stand)

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.

Time frame: 6-months

Population: 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.)

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing (MI) GroupBalance Measure (Tandem Stand)8.46 units on a scaleStandard Error 0.56
Control GroupBalance Measure (Tandem Stand)7.47 units on a scaleStandard Error 0.55
Secondary

Level of Confidence to Prevent Falls

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.

Time frame: 3-, 6-, and 12-months

Population: 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.)

ArmMeasureGroupValue (MEAN)Dispersion
Motivational Interviewing (MI) GroupLevel of Confidence to Prevent Falls3-months8.09 units on a scaleStandard Error 0.18
Motivational Interviewing (MI) GroupLevel of Confidence to Prevent Falls6-months8.04 units on a scaleStandard Error 0.18
Motivational Interviewing (MI) GroupLevel of Confidence to Prevent Falls12-months7.56 units on a scaleStandard Error 0.24
Control GroupLevel of Confidence to Prevent Falls3-months7.74 units on a scaleStandard Error 0.17
Control GroupLevel of Confidence to Prevent Falls6-months7.79 units on a scaleStandard Error 0.17
Control GroupLevel of Confidence to Prevent Falls12-months7.67 units on a scaleStandard Error 0.21
Secondary

Level of Importance to Prevent Falls

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.

Time frame: 3-, 6-, and 12-months

Population: 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.)

ArmMeasureGroupValue (MEAN)Dispersion
Motivational Interviewing (MI) GroupLevel of Importance to Prevent Falls6-months9.62 units on a scaleStandard Error 0.12
Motivational Interviewing (MI) GroupLevel of Importance to Prevent Falls3-months9.68 units on a scaleStandard Error 0.12
Motivational Interviewing (MI) GroupLevel of Importance to Prevent Falls12-months9.60 units on a scaleStandard Error 0.12
Control GroupLevel of Importance to Prevent Falls3-months9.41 units on a scaleStandard Error 0.11
Control GroupLevel of Importance to Prevent Falls6-months9.63 units on a scaleStandard Error 0.1
Control GroupLevel of Importance to Prevent Falls12-months9.59 units on a scaleStandard Error 0.11
Secondary

Number of Participants With Self-reported Falls

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.

Time frame: 1-year

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Motivational Interviewing (MI) GroupNumber of Participants With Self-reported Falls56 Participants
Control GroupNumber of Participants With Self-reported Falls50 Participants
Secondary

Patient Activation Measure Results

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.

Time frame: 3-, 6-, and 12-months

Population: 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.)

ArmMeasureGroupValue (MEAN)Dispersion
Motivational Interviewing (MI) GroupPatient Activation Measure Results3-months70.6 score on a scaleStandard Error 1.5
Motivational Interviewing (MI) GroupPatient Activation Measure Results6-months70.23 score on a scaleStandard Error 1.52
Motivational Interviewing (MI) GroupPatient Activation Measure Results12-months70.44 score on a scaleStandard Error 1.83
Control GroupPatient Activation Measure Results3-months71.59 score on a scaleStandard Error 1.44
Control GroupPatient Activation Measure Results6-months67.33 score on a scaleStandard Error 1.45
Control GroupPatient Activation Measure Results12-months68.21 score on a scaleStandard Error 1.63

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026