Clinical trial
Digital Fall Prevention Feasibility Study
Name
2022P000630
Description
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.
Trial arms
Trial start
2022-06-30
Estimated PCD
2023-05-25
Trial end
2023-06-01
Status
Completed
Phase
Early phase I
Treatment
Digital Fall Prevention
Exercises delivered through a tablet and remote motivational calls
Arms:
Digital Fall Prevention
Size
23
Primary endpoint
Acceptability and adherence to exercise program
over the 12 weeks of the intervention
Feasibility of Intervention Measure (FIM)
at final (12-week) assessment
Acceptability of Intervention Measure (AIM)
at final (12-week) assessment
Fall Efficacy Scale - International (FES-I)
change from baseline to 12-weeks
Intervention Appropriateness Measure (IAM)
at final (12-week) assessment
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 23, 'type': 'ACTUAL'}}
Updated at
2023-07-27
1 organization
1 product
1 indication
Organization
Brigham and Women's HospitalProduct
Digital Fall PreventionIndication
Falls