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Clinical Trials/NCT04612842
NCT04612842
Completed
Not Applicable

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

Oregon Health and Science University1 site in 1 country200 target enrollmentSeptember 9, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fall
Sponsor
Oregon Health and Science University
Enrollment
200
Locations
1
Primary Endpoint
Falls Self-Efficacy Scale-International (FES-I) Results
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 9, 2020
End Date
September 28, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hiroko Kiyoshi-Teo

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Fall Behavioral (FAB) Scale Results

Time Frame: 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.

Secondary Outcomes

  • Level of Importance to Prevent Falls(3-, 6-, and 12-months)
  • Balance Measure (Tandem Stand)(6-months)
  • Patient Activation Measure Results(3-, 6-, and 12-months)
  • Balance Measure (Semi-tandem Stand)(6- months)
  • Balance Measure (One-leg Stand)(6- months)
  • Level of Confidence to Prevent Falls(3-, 6-, and 12-months)
  • Balance Measure (Feet Side by Side)(6- months)
  • 30-second Sit-to-stand Assessment(6-months)
  • Number of Participants With Self-reported Falls(1-year)

Study Sites (1)

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