FallNCT04612842
Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI)
A study testing Motivational Interviewing in people with Fall and Motivation, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall, Motivation, Behavior
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2020to 28 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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.
Read the 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.
- Conditions
- Fall, Motivation, Behavior, Coping Behavior
- Being tested
- Motivational Interviewing
- Keywords
- Fall prevention, Motivational Interviewing
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing (MI) goup | Experimental | The MI experimental group will receive the same measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change. Receives: Behavioral: Motivational Interviewing |
| Control group | No intervention | The control group participants will take part in study measurements (self-report and physiologic assessment) for 12-months. Primary assessment measures are at baseline, 6-, and 12-months and will be conducted via phone survey, video assessment, or mail-in calendar. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls Self-Efficacy Scale-International (FES-I) Results
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.
Measured: 3-, 6-, and 12-months
Fall Behavioral (FAB) Scale Results
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.
Measured: 3-, 6-, and 12-months
Secondary outcomes (9)
Patient Activation Measure Results
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.
Measured: 3-, 6-, and 12-months
Level of Confidence to Prevent Falls
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.
Measured: 3-, 6-, and 12-months
Level of Importance to Prevent Falls
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.
Measured: 3-, 6-, and 12-months
Balance Measure (Feet Side by Side)
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.
Measured: 6- months
Balance Measure (Semi-tandem Stand)
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.
Measured: 6- months
Balance Measure (Tandem Stand)
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.
Measured: 6-months
Balance Measure (One-leg Stand)
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.
Measured: 6- months
30-second Sit-to-stand 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.
Measured: 6-months
Number of Participants With Self-reported Falls
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.
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start9 Sep 2020
- Primary completion24 Mar 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Hiroko Kiyoshi-Teo, Oregon Health and Science University
- Investigators
- Hiroko Kiyoshi-Teo, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612842
- Sponsor's protocol ID
- IRB00008993
- Other IDs
- K23NR018672
- Status last verified
- Jul 2024
- First submitted
- 8 Oct 2020
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI)
- ClinicalTrials.gov ID
- NCT04612842
- Acronym / sponsor ID
- IRB00008993
- Conditions
- Fall, Motivation, Behavior, Coping Behavior
- Keywords
- Fall prevention, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing (MI) goup | Experimental | Behavioral: Motivational InterviewingThe MI experimental group will receive the same measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change. |
| Control group | No intervention | –The control group participants will take part in study measurements (self-report and physiologic assessment) for 12-months. Primary assessment measures are at baseline, 6-, and 12-months and will be conducted via phone survey, video assessment, or mail-in calendar. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingThe 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. | Behavioural | Motivational Interviewing (MI) goup |
Primary outcome
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.
9 secondary outcomes
Patient Activation Measure Results
Time frame: 3-, 6-, and 12-months
Level of Confidence to Prevent Falls
Time frame: 3-, 6-, and 12-months
Level of Importance to Prevent Falls
Time frame: 3-, 6-, and 12-months
Balance Measure (Feet Side by Side)
Time frame: 6- months
Balance Measure (Semi-tandem Stand)
Time frame: 6- months
Balance Measure (Tandem Stand)
Time frame: 6-months
Balance Measure (One-leg Stand)
Time frame: 6- months
30-second Sit-to-stand Assessment
Time frame: 6-months
Number of Participants With Self-reported Falls
Time frame: 1-year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroko Kiyoshi-Teo, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Fall and Motivation, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls Self-Efficacy Scale-International (FES-I) Results (time frame: 3-, 6-, and 12-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.