Clinical trial NCT04612842: Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI)
Official title: Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Motivation
Behavior
Coping Behavior
Keywords: Fall prevention
Motivational Interviewing
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-11-03
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Falls Self-Efficacy Scale-International (FES-I) Results
timeFrame: 3-, 6-, and 12-months
measure: Fall Behavioral (FAB) Scale Results
timeFrame: 3-, 6-, and 12-months
Secondary outcomes:
measure: Patient Activation Measure Results
timeFrame: 3-, 6-, and 12-months
measure: Level of Confidence to Prevent Falls
timeFrame: 3-, 6-, and 12-months
measure: Level of Importance to Prevent Falls
timeFrame: 3-, 6-, and 12-months
measure: Balance Measure (Feet Side by Side)
timeFrame: 6- months
measure: Balance Measure (Semi-tandem Stand)
timeFrame: 6- months
measure: Balance Measure (Tandem Stand)
timeFrame: 6-months
measure: Balance Measure (One-leg Stand)
timeFrame: 6- months
measure: 30-second Sit-to-stand Assessment
timeFrame: 6-months
measure: Number of Participants With Self-reported Falls
timeFrame: 1-year
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Hiroko Kiyoshi-Teo, PhD
role: PRINCIPAL_INVESTIGATOR
References: