Behavior Clinical Trial
Official title:
Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI)
Verified date | May 2024 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | National Institute of Nursing Research (NINR) |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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