NCT04612842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

July 1, 2024

Enrollment Period

2.5 years

First QC Date

October 8, 2020

Results QC Date

May 14, 2024

Last Update Submit

July 22, 2024

Conditions

Keywords

Fall preventionMotivational Interviewing

Outcome Measures

Primary Outcomes (2)

  • 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.

    3-, 6-, and 12-months

  • 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.

    3-, 6-, and 12-months

Secondary Outcomes (9)

  • Patient Activation Measure Results

    3-, 6-, and 12-months

  • Level of Confidence to Prevent Falls

    3-, 6-, and 12-months

  • Level of Importance to Prevent Falls

    3-, 6-, and 12-months

  • Balance Measure (Feet Side by Side)

    6- months

  • Balance Measure (Semi-tandem Stand)

    6- months

  • +4 more secondary outcomes

Study Arms (2)

Motivational Interviewing (MI) goup

EXPERIMENTAL

The MI experimental group will receive the same 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.

Behavioral: Motivational Interviewing

Control group

NO INTERVENTION

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.

Interventions

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.

Motivational Interviewing (MI) goup

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Oregon Health \& Science University (OHSU) Internal Medicine and Geriatrics Clinic patients
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Behavior

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

Study enrollment \& data collection were conducted during the COVID-19 pandemic in Oregon.

Results Point of Contact

Title
Dr. Hiroko Kiyoshi-Teo (Assistant Professor)
Organization
Oregon Health & Science University

Study Officials

  • Hiroko Kiyoshi-Teo, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2020

First Posted

November 3, 2020

Study Start

September 9, 2020

Primary Completion

March 24, 2023

Study Completion

September 28, 2023

Last Updated

August 13, 2024

Results First Posted

August 13, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations