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

Indication
Falls