Health in Motion Pragmatic Clinical Trial - WRAPAROUND

September 29, 2024 updated by: Blue Marble Rehab Inc

Health in Motion- A Digital Fall Prevention Program Designed to be Delivered as a Wraparound Program

Falls among older adults are a serious public health concern, and injuries resulting from falls can cause significant loss of independence, premature death, and higher caregiver burden. Home-based fall prevention programs, such as the Otago Exercise Program, educate older adults about the importance of identifying fall risk and provide strategies for reducing fall risk; however, many are costly and are not scalable, accessible, or sustainable. This project will compare a digital fall prevention program used in a group setting in the community with traditional community-based fall prevention programs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will involve 2 groups. Group 1 will participate in traditional human-led community based fall prevention programs and Group 2 will participate in avatar-led community-based fall prevention program. Metrics of effectiveness include the rate of falls, fall risk, fear of falling, and falls efficacy. Economic benefit will be measured using the European Quality of Life 5-Dimensional Questionnaire, along with hospital and clinical visits. The primary outcome is the incidence of falls (rate in person-months).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Altadena, California, United States, 91001
        • Sheryl Flynn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age of 55 and older
  • Score >30 on the TICS (Telephone Interview for Cognitive Screen) or if lower than 30 has assistance to participate

Exclusion Criteria:

  • any person who has been told by their physician that they should not exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Human-led fall prevention programs
Participants will complete any human-led fall prevention program of their choice, in a group setting either in-person or via Zoom.
Behavioral: Human-led fall prevention program
Human-led evidence-based fall prevention programs include Matter of Balance, Tai Chi Moving for Better Balance, Walk with Ease, or Arthritis Exercise
Experimental: Avatar-led fall prevention program
Participants will complete an avatar-led fall prevention program at their local community center or community room of their housing complex
Behavioral: Avatar-led fall prevention program
The avatar-led fall prevention program consists of the Otago Exercise Program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of falls
Time Frame: change from baseline to end of intervention (about 3 months)
number of falls during the intervention compared with the self-reported falls at baseline
change from baseline to end of intervention (about 3 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Timed Up and Go Test
Time Frame: change from baseline to end of intervention (about 3 months)
Time taken to stand up from a seated position, walk 10 feet, turn around, return to the chair, sit down
change from baseline to end of intervention (about 3 months)
4 Stage Balance Test
Time Frame: change from baseline to end of intervention (about 3 months)
This test measures the ability to stand for 10 seconds in 4 progressively more challenging positions from standing with feet side by side to standing on one leg. The score is equal to the total time taken to achieve the highest level. The maximum score is 40. If a participant is not able to stand with their feet in tandem, they are considered at higher risk of falling.
change from baseline to end of intervention (about 3 months)
One Leg Stand Test
Time Frame: change from baseline to end of intervention (about 3 months)
This test measures the ability to stand for on one leg for up to 30 seconds. If a participant is not able to stand for 5 seconds, they are considered at higher risk of falling.
change from baseline to end of intervention (about 3 months)
30 Second Sit to Stand Test
Time Frame: change from baseline to end of intervention (about 3 months)
This test measures the number of times a participant can stand up from a seated position in 30 seconds.
change from baseline to end of intervention (about 3 months)
Fall Risk Questionnaire
Time Frame: change from baseline to end of intervention (about 3 months)
This is a multi-factorial questionnaire that can be used to predict fall risk. Questions relate to history of falls, gait/balance, muscle weakness, incontinence, sensation/proprioception, depression, vision and medications. The highest (worst) score = 14. A score of 0-3 denotes low fall risk and scores from 4-14 denote higher fall risk.
change from baseline to end of intervention (about 3 months)
Activities Specific Balance Confidence Scale (5 level)
Time Frame: change from baseline to end of intervention (about 3 months)
This questionnaire measures the participant's confidence in performing activities of daily living in which each item is rated from 0% (no confidence) to 100% (complete confidence). It correlates with other measures of self-efficacy and balance measures.
change from baseline to end of intervention (about 3 months)
Veteran Rand-12 (VR-12)
Time Frame: change from baseline to end of intervention (about 3 months)
This questionnaire measures quality of life over the past 4 weeks.
change from baseline to end of intervention (about 3 months)
European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
Time Frame: change from baseline to end of intervention (about 3 months)
This is a standardized measure of health status for clinical and economic appraisal. The test is a self report health state that domains including mobility, self-care, anxiety/depression, pain/discomfort) using a 5 point scale and a visual analog scale (VAS).
change from baseline to end of intervention (about 3 months)
Trail Making Test
Time Frame: change from baseline to end of intervention (about 3 months)
This is a standardized test of cognitive function. The test consists of two Trails, Trail A and Trail B. Trail A requires the participant to tap on 25 numbers on the screen in order from smallest to largest (1, 2, 3, etc). Trail B requires participants to tap on alternative numbers and letters in consecutive order from smallest/first to largest/last (1, A, 2, B, 3, C etc).
change from baseline to end of intervention (about 3 months)
modified Fear of Falling Avoidance Behavior Questionnaire (mFFABQ)
Time Frame: change from baseline to end of intervention (about 3 months)
This is a standardized self-report assessment that measures behaviors that may be avoided due to a fear of falling. The item scores are summed to form a total score ranging from 0 to 56. Higher scores indicate a higher level of fear of falling avoidance behavior
change from baseline to end of intervention (about 3 months)
Upstream Social Isolation Risk Scale (USIR-S)
Time Frame: change from baseline to end of intervention (about 3 months)
A standardized assessment of social isolation. Lower scores indicate lower risk of social isolation.
change from baseline to end of intervention (about 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Blue Marble Rehab Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)
Partners In Care Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AG043191-4. v1-wraparound
  • 2R44AG043191-04A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual data will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings