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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04612842
Other study ID # IRB00008993
Secondary ID K23NR018672
Status Completed
Phase N/A
First received
Last updated
Start date September 9, 2020
Est. completion date September 28, 2023

Study information

Verified date May 2024
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 200
Est. completion date September 28, 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

Study Design


Related Conditions & MeSH terms


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
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