Clinical trial NCT05432674: Digital Fall Prevention Study
Official title: Digital Fall Prevention Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fall
Keywords: exercise
fall prevention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Best Buy Health, Inc
First posted: 2022-06-27
Enrollment: 23
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: The goal of this study is to demonstrate the feasibility and acceptability of a digital fall prevention exercise program and to explore whether there is benefit from participating in such programs. This study will include 30 older adults who are at higher risk of falling or have a fear of falling and living at home. All participants will receive the intervention. All participants will be assessed pre- and post-intervention on measures of sensor-based fall risk, sensor-based frailty, falls self-efficacy, technology readiness, feasibility and acceptability, utilization and participation, frailty, grip strength, depression, anxiety, and physical activity (both self-report and using wearable sensors).

The overall hypothesis is that a prototype system consisting of wearable sensors and a tablet will be feasible and acceptable in a population of older adults with increased risk for falls and fall-related injuries or with a fear of falling.

Aim 1: To determine the feasibility and acceptability of a self-guided, digitally delivered, in-home exercise program for older adults with elevated fall risk.

* Hypothesis 1a): The technology (wearable sensor and tablet) and digitally delivered fall prevention exercises will be feasible and acceptable to older people at risk for falls.
* Hypothesis 1b): The technology (wearable sensor and tablet) and digitally delivered fall prevention exercise program will reduce a user's concern of falling

Aim 2: To determine the clinical effects of implementing a fall prevention intervention program via the remote platform.

• Hypothesis 2): Participants who adhere to the program, completing at least 70% of the video exercise sessions, will see a pre- to post-intervention reduction in quantitative measures of fall risk.

Exploratory Aim 1: Investigate differences in frailty, cognitive status, physical function, mental health status and technology readiness between participants who successfully adhere to the study program versus those that do not.

The study will take place in two settings. The first setting is at the Men's Health, Aging, and Metabolism research division at Brigham and Women's Hospital, including the Laboratory of Exercise Physiology and Physical Performance (LEPPP) at 221 Longwood Ave, Boston, MA 02115. The second will be in the homes of older adults within the general community who meet the inclusion criteria.

Intervention

Participants who enroll in the study will receive a wearable device, a tablet, a tablet stand, and ankle weights for home use, along with instructions and charging accessories. Participants will participate in a 3-month moderate-intensity exercise intervention, which will be supported by a LEPPP study staff member trained and certified in the intervention and delivered remotely through the tablet. The program is designed to gradually progress in intensity and exercise duration over a 12-week period. The exercise intervention parameters will be tailored to individual ability and progressed by the study interventionist based on feedback from participants, motivational coaching calls, and post-exercise surveys.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Acceptability and adherence to exercise program
timeFrame: over the 12 weeks of the intervention
measure: Feasibility of Intervention Measure (FIM)
timeFrame: at final (12-week) assessment
measure: Acceptability of Intervention Measure (AIM)
timeFrame: at final (12-week) assessment
measure: Fall Efficacy Scale - International (FES-I)
timeFrame: change from baseline to 12-weeks
measure: Intervention Appropriateness Measure (IAM)
timeFrame: at final (12-week) assessment
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: change from baseline to 12-weeks
measure: Digit Symbol Substitution Test
timeFrame: change from baseline to 12-weeks
measure: Fried Frailty Index (FFI)
timeFrame: change from baseline to 12-weeks
measure: Grip Strength of dominant hand
timeFrame: change from baseline to 12-weeks
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: change from baseline to 12-weeks
measure: Sensor based fall risk assessment
timeFrame: change from baseline to 12-weeks
measure: Sensor based frailty assessment
timeFrame: change from baseline to 12-weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: change from baseline to 12-weeks
measure: Technology Acceptance Model (TAM)
timeFrame: at final (12-week) assessment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Kieran F Reid, PhD
role: PRINCIPAL_INVESTIGATOR
References: