Digital Fall Prevention Study

NCT05432674 | Completed Phase 1

• 1 other identifier: 2022P000630
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The Digital Fall Prevention Study is a single-group unblinded study to explore the feasibility and acceptability of a 3-month fall prevention exercise program delivered digitally via a tablet interface. Evidence-based exercise programs and motivational techniques will be used along with new wearable technology to predict fall risk.

Conditions

Fall

Keywords

exercise; fall prevention

Outcome Measures

Primary Outcomes (5)

• Acceptability and adherence to exercise program

  Percentage of scheduled exercise sessions complete (70% of sessions completed = acceptable adherence)

  over the 12 weeks of the intervention

• Feasibility of Intervention Measure (FIM)

  a self-report measure of the intervention feasibility, score range is 1-5, higher score = greater feasibility

  at final (12-week) assessment

• Acceptability of Intervention Measure (AIM)

  a self-report measure of acceptability of the intervention, score range is 1-5, higher score = greater acceptability

  at final (12-week) assessment

• Fall Efficacy Scale - International (FES-I)

  fear of falling measure, score range from 16-64, higher score=less fear of falling

  change from baseline to 12-weeks

• Intervention Appropriateness Measure (IAM)

  a self-report measure of the intervention appropriateness, score range is 1-5, higher score = greater appropriateness

  at final (12-week) assessment

Secondary Outcomes (9)

• Montreal Cognitive Assessment (MoCA)

  change from baseline to 12-weeks

• Digit Symbol Substitution Test

  change from baseline to 12-weeks

• Fried Frailty Index (FFI)

  change from baseline to 12-weeks

• Grip Strength of dominant hand

  change from baseline to 12-weeks

• Physical Activity Scale for the Elderly (PASE)

  change from baseline to 12-weeks

Study Arms (1)

Digital Fall Prevention

EXPERIMENTAL

Subjects will participate in Digital Fall Prevention intervention for 12 weeks

Combination Product: Digital Fall Prevention

Interventions

Digital Fall Prevention COMBINATION_PRODUCT

Exercises delivered through a tablet and remote motivational calls

Digital Fall Prevention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Male and females who are 65 years or older
• Short Physical Performance Battery (SPPB)7 ≥ 5
• the Montreal Cognitive Assessment (MoCA)8 \> 17
• Increased risk for falls based on a self-reported answer of yes to one or more of these questions:
• Have you fallen and hurt yourself in the past year?
• Have you fallen two or more times in the past year?
• Are you afraid that you might fall because of balance or walking problems?
• Access to Wi-Fi in their home (or willingness to use cellular service if provided)

You may not qualify if:

• Unable or unwilling to provide informed consent
• MI, acute coronary syndrome, revascularization surgery, or stroke in the last 6 months
• Chest pain or untreated/uncontrolled CVD
• Hip/knee fracture/replacement or spinal surgery in past 6 months
• Pulmonary decompensation that would prevent participation in the exercise program
• Planned orthopedic surgery that would limit participation in the study
• Planned to be away from tablet access for \> 7 days during the length of the study
• Unable to attend in-person pre- or post-study clinic visit
• Enrolled in a formal exercise program and/or physical therapy that takes place 3 or more times per week
• Vision or hearing impairments that would make it difficult to participate in the intervention
• Non-English speaking or other language limitations that would make it difficult to participate in the intervention
• Reside in a nursing home
• Unable to walk independently (with or without a walking aid)
• Not appropriate for study based on clinician exam or discretion (clinician will specify reason)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Best Buy Health, Inc: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kieran F Reid, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Director, Research Division of Men's Health, Aging and Metabolism

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 27, 2022
• Study Start: June 30, 2022
• Primary Completion: May 25, 2023
• Study Completion: June 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)