NCT06931067

Brief Summary

The goal of this study is to see if OTAGO instructors, who have been trained in a special communication method called motivational interviewing, can help older adults start and stick with the OTAGO exercise program. The results will help guide future research on how behavior change techniques can support other fall prevention strategies.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

April 9, 2025

Last Update Submit

April 9, 2025

Conditions

Keywords

OTAGOOEPMotivational interviewingbehavior change

Outcome Measures

Primary Outcomes (1)

  • OTAGO exercise adherence

    Number of instructed OTAGO exercises completed in a week

    Baseline, 6-months & 12 months

Secondary Outcomes (3)

  • 4-stage balance test

    Baseline & 6-months

  • Sit-to-stand test

    Baseline & 6-months

  • Falls Efficacy Scale Short International

    Baseline, 6-months, and 12-months

Study Arms (1)

Intervention arm

EXPERIMENTAL

OTAGO exercise home visits will be offered 7 times with 2 phone-based check-ins during the 6-month period. As part of OTAGO home visits, participants will receive OTAGO exercise instruction and MI. Each home visit will be approximately an hour.

Behavioral: OTAGO Exercise Program with motivational interviewing

Interventions

OTAGO exercise home visits will be offered 7 times with 2 phone-based check-ins during the 6-month period. As part of OTAGO home visits, participants will receive OTAGO exercise instruction and MI. Each home visit will be approximately an hour.

Intervention arm

Eligibility Criteria

Age60 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥60
  • At high fall risk: At least one "Yes" to 1) had a fall in the past year; 2) answer "difficult" to the question "do you find it hard to stand without using your hands"; 3) worry about falling
  • Able to converse audibly and coherently in English
  • Ambulatory with or without assistive device use
  • Self-report challenges navigating the environment outside of the home
  • At least one "some or much difficulty" or "unable to do" to:Walking one block?; Stepping up onto a curb?; Getting out of a straight back chair? Climbing one flight of stairs? Getting out of the house

You may not qualify if:

  • o Receiving ongoing physical therapy with a primary focus on improving balance and strength of lower extremities
  • Experiencing acute health issues such as fracture, pain, or infection that prohibits them from participating in exercises
  • Able to stand on one foot for more than 10 seconds without holding onto something
  • item Callahan cognitive assessment over the phone: Patients with scores of 2 or less, positive for dementia criteria, will be excluded.
  • Patients participating in other studies that may impact fall-related behavior change.
  • Participants engaged in routine moderate or vigorous physical activities that require lower extremity balance and strength (e.g., \>100 minutes/week for more than 3 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Motor ActivityPatient Participation

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

BehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Hiroko Kiyoshi-Teo, PhD, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2025

First Posted

April 16, 2025

Study Start

February 20, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

De-identified study IPD may be shared upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After the completion of all study data collection, analysis, and publication. IPD will be available for 5 years.
Access Criteria
Individuals interested in IPD must contact the PI.

Locations