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Completed

NCT Number: NCT04612842

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

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.

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Key information

Conditions

Fall Behavior Coping Behavior Motivation

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  1. Patient Activation Measure Results

    Time frame: 3-, 6-, and 12-months

    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.

  2. Level of Confidence to Prevent Falls

    Time frame: 3-, 6-, and 12-months

    1-item 10-point scale response. Often used in motivational interviewing sessions to gauge an individual's readiness to engage in certain health behaviors. Higher levels of confidence are known to be associated with an increased rate of behavior change.

  3. Level of Importance to Prevent Falls

    Time frame: 3-, 6-, and 12-months

    1-item 10-point scale response. Often used in motivational interviewing sessions to gauge an individual's readiness to engage in certain health behaviors. Higher levels of importance are known to be associated with an increased rate of behavior change.

  4. Balance Measure (Feet Side by Side)

    Time frame: 6- months

    Duration that participants can hold feet side-by-side stand (heel to toe standing positions) will be measured up to 10 seconds. 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.

  5. Balance Measure (Semi-tandem Stand)

    Time frame: 6- months

    Duration that participants can hold semi-tandem stand (heel to toe standing positions) will be measured up to 10 seconds. 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.

  6. Balance Measure (Tandem Stand)

    Time frame: 6-months

    Individuals are asked to hold a tandem stand (one foot in front of the other- heel touching toe). The minimum is 0 and the maximum is 10. A higher number is a better outcome.

  7. Balance Measure (One-leg Stand)

    Time frame: 6- months

    Individuals are asked to hold a balance position for 10 sections without moving their feet or needing support. This position require standing on one foot. The minimum is 0 and the maximum is 10. A higher number is a better outcome.

  8. 30-second Sit-to-stand Assessment

    Time frame: 6-months

    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.

  9. Number of Participants With Self-reported Falls

    Time frame: 1-year

    Individuals were asked to mail-in reports of falls every month. Participants reporting a fall at least once are counted as a faller. Minimum value is 0. Higher value is worse value as it is indicative that there were more participants who fell during the year.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2020
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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