NCT04612842

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

Completed NA Results posted Last updated 13 August 2024

What this trial tests

NA trial testing Motivational Interviewing in Fall in 200 participants. Completed in 28 September 2023.

Timeline

9 September 2020

Primary endpoint
24 March 2023

28 September 2023

Quick facts

Lead sponsor	Oregon Health and Science University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	200
Start date	9 September 2020
Primary completion	24 March 2023
Estimated completion	28 September 2023
Sites	1 location across United States

Drugs / interventions tested

• Motivational Interviewing

Conditions studied

• Fall — all drugs for Fall →
• Motivation — all drugs for Motivation →
• Behavior — all drugs for Behavior →
• Coping Behavior — all drugs for Coping Behavior →

Sponsor

Oregon Health and Science University

Who can join

65 and older, any sex, with Fall or Motivation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Falls Self-Efficacy Scale-International (FES-I) Results Primary · 3-, 6-, and 12-months

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.

3-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	13.07	± 0.57
Control Group	13.71	± 0.54

6-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	13.41	± 0.59
Control Group	14.35	± 0.56

12-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	13.01	± 0.67
Control Group	13.82	± 0.53

Fall Behavioral (FAB) Scale Results Primary · 3-, 6-, and 12-months

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.

3-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	3.16	± 0.05
Control Group	3.08	± 0.05

6-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	3.23	± 0.05
Control Group	3.11	± 0.05

12-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	3.17	± 0.05
Control Group	3.14	± 0.05

Patient Activation Measure Results Secondary · 3-, 6-, and 12-months

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.

3-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	70.6	± 1.5
Control Group	71.59	± 1.44

6-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	70.23	± 1.52
Control Group	67.33	± 1.45

12-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	70.44	± 1.83
Control Group	68.21	± 1.63

Level of Confidence to Prevent Falls Secondary · 3-, 6-, and 12-months

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.

3-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	8.09	± 0.18
Control Group	7.74	± 0.17

6-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	8.04	± 0.18
Control Group	7.79	± 0.17

12-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	7.56	± 0.24
Control Group	7.67	± 0.21

Level of Importance to Prevent Falls Secondary · 3-, 6-, and 12-months

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.

3-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	9.68	± 0.12
Control Group	9.41	± 0.11

6-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	9.62	± 0.12
Control Group	9.63	± 0.10

12-months

Group	Value	95% CI
Motivational Interviewing (MI) Group	9.60	± 0.12
Control Group	9.59	± 0.11

Balance Measure (Feet Side by Side) Secondary · 6- months

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.

Group	Value	95% CI
Motivational Interviewing (MI) Group	10	± 0
Control Group	10	± 0

Balance Measure (Semi-tandem Stand) Secondary · 6- months

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.

Group	Value	95% CI
Motivational Interviewing (MI) Group	10	± 0.17
Control Group	9.79	± 0.15

Balance Measure (Tandem Stand) Secondary · 6-months

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.

Group	Value	95% CI
Motivational Interviewing (MI) Group	8.46	± 0.56
Control Group	7.47	± 0.55

Balance Measure (One-leg Stand) Secondary · 6- months

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.

Group	Value	95% CI
Motivational Interviewing (MI) Group	6.84	± 0.68
Control Group	5.28	± 0.67

30-second Sit-to-stand Assessment Secondary · 6-months

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.

Group	Value	95% CI
Motivational Interviewing (MI) Group	11.01	± 0.64
Control Group	9.5	± 0.61

Number of Participants With Self-reported Falls Secondary · 1-year

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.

Group	Value	95% CI
Motivational Interviewing (MI) Group	56
Control Group	50

Adverse events — posted to ClinicalTrials.gov

Time frame: 12-months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Motivational Interviewing (MI) Group

Serious: 11/101 (11%)

Deaths: 2/101

Control Group

Serious: 13/99 (13%)

Deaths: 2/99

Serious adverse events (12 terms)

Reaction	System	Motivational Interviewing …	Control Group
Falls (major)	Injury, poisoning and procedural complications	—	—
Death	Metabolism and nutrition disorders	—	—
Hip surgery	Musculoskeletal and connective tissue disorders	—	—
Orthostatic hypotension	Vascular disorders	—	—
Inguinal hernia	Gastrointestinal disorders	—	—
Urinary tract infection	Renal and urinary disorders	—	—
Heart surgery	Vascular disorders	—	—
Bowel obstruction	Gastrointestinal disorders	—	—
Skiing injury	Injury, poisoning and procedural complications	—	—
Neurosurgery	Nervous system disorders	—	—
COVID	Infections and infestations	—	—
Deep vein thrombosis	Vascular disorders	—	—

Other adverse events (11 terms — click to expand)

Reaction	System	Motivational Interviewing …	Control Group
Falls	Injury, poisoning and procedural complications	—	—
Car/bike accident	Injury, poisoning and procedural complications	—	—
Shunt	Eye disorders	—	—
Hammer toe	Musculoskeletal and connective tissue disorders	—	—
Leg pain	Musculoskeletal and connective tissue disorders	—	—
Bladder infection	Renal and urinary disorders	—	—
Gut pain	Gastrointestinal disorders	—	—
Cancer removal	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Rotator cuff surgery	Musculoskeletal and connective tissue disorders	—	—
Nose surgery	Ear and labyrinth disorders	—	—
Headaches	Nervous system disorders	—	—

Most-reported serious reactions: Falls (major), Death, Hip surgery, Orthostatic hypotension, Inguinal hernia, Urinary tract infection, Heart surgery, Bowel obstruction.

Data from ClinicalTrials.gov NCT04612842 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychological and educational interventions for preventing falls in older people living in the community.
   Drahota A, Udell JE, Mackenzie H, Pugh MT. · · 2024 · cited 9× · PMID 39360568 · DOI 10.1002/14651858.cd013480.pub2
2. Motivational Interviewing for Fall Prevention (MI-FP) pilot study: Older Adults' readiness to participate in fall prevention.
   Kiyoshi-Teo H, De Lima B, Cohen DJ, Dieckmann N, et al · · 2023 · cited 6× · PMID 37847939 · DOI 10.1016/j.gerinurse.2023.09.017
3. Impact of Documented Fall-Risk, Self-Reported Health and Confidence to Prevent Falls on Concern About Falling Among Community-Dwelling Older Adults: Secondary Analysis of a Randomized Clinical Trial.
   Kiyoshi-Teo H, De Lima B, Dieckmann NF, Vincenzo JL, et al · · 2024 · cited 3× · PMID 39011313 · DOI 10.2147/cia.s453789
4. Perspectives: How to Apply Motivational Interviewing for Older Adult Fall Prevention.
   Kiyoshi-Teo H, Lemon E, Dennis A, Smith R, et al · · 2026 · cited 1× · PMID 41948536 · DOI 10.1177/15598276231185551