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

Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04612842
• Other study ID #: IRB00008993
• Secondary ID: K23NR018672
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: September 29, 2023

Study information

• Verified date: July 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 29, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior
• Coping Behavior
• Fall
• Motivation

Intervention

Behavioral:
• Motivational 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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure change with patient engagement with fall prevention recommendations questionnaire	A 64-item, 1-10 self-report rating to measure patient engagement with fall prevention recommendations (medication, exercise, blood pressure, vision, and environment). Higher value indicates more confidence in making change in the future.	baseline, 3-months, 6-months, and 12-months
Primary	Measure change with Falls Self-Efficacy Scale-International (FES-I) scale	A 7-item scale, 1-4 self-report rating, widely used to measure levels of concern related to preventing falls. Minimum value is 0 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.	baseline, 3-months, 6-months, and 12-months
Primary	Measure change with Fall Behavioral (FAB) scale	A 24-item, 1-4 self-report rating to measure frequency of protective strategies to prevent falling and risky behaviors that facilitate a fall. Minimum value is 0 and maximum value is 4. Higher FAB score is a better value since it indicates more consistent fall protective behaviors.	baseline, 3-months, 6-months, and 12-months
Secondary	Measure change with 4-stage balance physiologic assessment	Duration that participants can hold 4 different standing positions will be measured. 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.	Baseline, 3-months, 6-months, and 12-months
Secondary	Measure change with 30-second sit-to-stand physiologic 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.	Baseline, 3-months, 6-months, and 12-months
Secondary	Measure change with Patient Activation Measure scale	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.	Baseline, 3-months, 6-months, and 12-months
Secondary	Measure change with self-reported fall rates	Mail-in monthly fall dairy. Count of falls per month. Minimum value is 0. Higher value is worse value since it is indicative that participants are falling frequently.	Monthly for 1-year