FallPhase 1/2NCT05432674
Digital Fall Prevention Study
A Phase 1/2 study testing Digital Fall Prevention in people with Fall, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- Digital Fall Prevention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2022to 1 Jun 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Digital Fall Prevention Feasibility Study
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.
Read the 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.
- Conditions
- Fall
- Being tested
- Digital Fall Prevention
- Keywords
- exercise, fall prevention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Fall PreventionCombination product
Exercises delivered through a tablet and remote motivational calls
| Study group | Role | What they receive |
|---|---|---|
| Digital Fall Prevention | Experimental | Subjects will participate in Digital Fall Prevention intervention for 12 weeks Receives: Combination Product: Digital Fall Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and adherence to exercise program
Percentage of scheduled exercise sessions complete (70% of sessions completed = acceptable adherence)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at final (12-week) assessment
Secondary outcomes (9)
Montreal Cognitive Assessment (MoCA)
cognitive status assessment, score range 0-30, higher score=better cognition
Measured: change from baseline to 12-weeks
Digit Symbol Substitution Test
cognitive assessment
Measured: change from baseline to 12-weeks
Fried Frailty Index (FFI)
measure of frailty in older people, index range from 1-5, higher score=increased frailty
Measured: change from baseline to 12-weeks
Grip Strength of dominant hand
maximal isometric contraction of hand measured using a Jamar Handheld Dynamometer in kilograms
Strength (force) will be measured in kilograms.
Measured: change from baseline to 12-weeks
Physical Activity Scale for the Elderly (PASE)
self-report physical activity scale, score range 0 to 400, higher score=more activity
Measured: change from baseline to 12-weeks
Sensor based fall risk assessment
fall risk assessed using a sensor and computer based program
Measured: change from baseline to 12-weeks
Sensor based frailty assessment
frailty assessed using a sensor and computer based program
Measured: change from baseline to 12-weeks
Short Physical Performance Battery (SPPB)
physical performance mobility test
Measured: change from baseline to 12-weeks
Technology Acceptance Model (TAM)
a self-report measure of the acceptance of the technology used in the intervention
Measured: at final (12-week) assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start30 Jun 2022
- Primary completion25 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Best Buy Health, Inc
- Responsible party
- Principal investigator, Nancy Latham, Brigham and Women's Hospital
- Investigators
- Kieran F Reid, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432674
- Sponsor's protocol ID
- 2022P000630
- Status last verified
- Jul 2023
- First submitted
- 17 Jun 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Fall Prevention Feasibility Study
- ClinicalTrials.gov ID
- NCT05432674
- Acronym / sponsor ID
- 2022P000630
- Conditions
- Fall
- Keywords
- exercise, fall prevention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Best Buy Health, Inc
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Fall Prevention | Experimental | Combination Product: Digital Fall PreventionSubjects will participate in Digital Fall Prevention intervention for 12 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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:
- Access to Wi-Fi in their home (or willingness to use cellular service if provided)
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Digital Fall PreventionExercises delivered through a tablet and remote motivational calls | Combination product | Digital Fall Prevention |
Primary outcome
Acceptability and adherence to exercise program
Time frame: over the 12 weeks of the intervention
Percentage of scheduled exercise sessions complete (70% of sessions completed = acceptable adherence)
Feasibility of Intervention Measure (FIM)
Time frame: at final (12-week) assessment
a self-report measure of the intervention feasibility, score range is 1-5, higher score = greater feasibility
Acceptability of Intervention Measure (AIM)
Time frame: at final (12-week) assessment
a self-report measure of acceptability of the intervention, score range is 1-5, higher score = greater acceptability
Fall Efficacy Scale - International (FES-I)
Time frame: change from baseline to 12-weeks
fear of falling measure, score range from 16-64, higher score=less fear of falling
Intervention Appropriateness Measure (IAM)
Time frame: at final (12-week) assessment
a self-report measure of the intervention appropriateness, score range is 1-5, higher score = greater appropriateness
9 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: change from baseline to 12-weeks
Digit Symbol Substitution Test
Time frame: change from baseline to 12-weeks
Fried Frailty Index (FFI)
Time frame: change from baseline to 12-weeks
Grip Strength of dominant hand
Time frame: change from baseline to 12-weeks
Physical Activity Scale for the Elderly (PASE)
Time frame: change from baseline to 12-weeks
Sensor based fall risk assessment
Time frame: change from baseline to 12-weeks
Sensor based frailty assessment
Time frame: change from baseline to 12-weeks
Short Physical Performance Battery (SPPB)
Time frame: change from baseline to 12-weeks
Technology Acceptance Model (TAM)
Time frame: at final (12-week) assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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.
Kieran F Reid, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Digital Fall Prevention in people with Fall, run by Brigham and Women's Hospital 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 14 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 27 Jul 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptability and adherence to exercise program (time frame: over the 12 weeks of the intervention). The study lists 5 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 27 Jul 2023.