AgingNCT06619496
Health in Motion Pragmatic Clinical Trial - WRAPAROUND
A study testing Human-led fall prevention program and Avatar-led fall prevention program in people with Aging, run by Blue Marble Rehab Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Human-led fall prevention program and Avatar-led fall prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2022to 1 Jul 2024
- Phase
- Interventional
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age of 55 and older
- Score >30 on the TICS (Telephone Interview for Cognitive Screen) or if lower than 30 has assistance to participate
Who cannot join
- any person who has been told by their physician that they should not exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Aging
- Being tested
- Human-led fall prevention program, Avatar-led fall prevention program
- Keywords
- fall, fall prevention, fall injury, fear of falling, fall efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human-led fall prevention programBehavioural
Human-led evidence-based fall prevention programs include Matter of Balance, Tai Chi Moving for Better Balance, Walk with Ease, or Arthritis Exercise
Avatar-led fall prevention programBehavioural
The avatar-led fall prevention program consists of the Otago Exercise Program
| Study group | Role | What they receive |
|---|---|---|
| Human-led fall prevention programs | Active comparator | Participants will complete any human-led fall prevention program of their choice, in a group setting either in-person or via Zoom. Receives: Behavioral: Human-led fall prevention program |
| Avatar-led fall prevention program | Experimental | Participants will complete an avatar-led fall prevention program at their local community center or community room of their housing complex Receives: Behavioral: Avatar-led fall prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of falls
number of falls during the intervention compared with the self-reported falls at baseline
Measured: change from baseline to end of intervention (about 3 months)
Secondary outcomes (11)
Timed Up and Go Test
Time taken to stand up from a seated position, walk 10 feet, turn around, return to the chair, sit down
Measured: change from baseline to end of intervention (about 3 months)
4 Stage Balance Test
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.
Measured: change from baseline to end of intervention (about 3 months)
One Leg Stand Test
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.
Measured: change from baseline to end of intervention (about 3 months)
30 Second Sit to Stand Test
This test measures the number of times a participant can stand up from a seated position in 30 seconds.
Measured: change from baseline to end of intervention (about 3 months)
Fall Risk Questionnaire
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.
Measured: change from baseline to end of intervention (about 3 months)
Activities Specific Balance Confidence Scale (5 level)
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.
Measured: change from baseline to end of intervention (about 3 months)
Veteran Rand-12 (VR-12)
This questionnaire measures quality of life over the past 4 weeks.
Measured: change from baseline to end of intervention (about 3 months)
European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
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).
Measured: change from baseline to end of intervention (about 3 months)
Trail Making Test
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).
Measured: change from baseline to end of intervention (about 3 months)
modified Fear of Falling Avoidance Behavior Questionnaire (mFFABQ)
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
Measured: change from baseline to end of intervention (about 3 months)
Upstream Social Isolation Risk Scale (USIR-S)
A standardized assessment of social isolation. Lower scores indicate lower risk of social isolation.
Measured: change from baseline to end of intervention (about 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start24 Oct 2022
- Primary completion14 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- comparative prospective observational cohort study
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blue Marble Rehab Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Partners In Care Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619496
- Sponsor's protocol ID
- AG043191-4. v1-wraparound
- Other IDs
- 2R44AG043191-04A1
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health in Motion- A Digital Fall Prevention Program Designed to be Delivered as a Wraparound Program
- ClinicalTrials.gov ID
- NCT06619496
- Acronym / sponsor ID
- AG043191-4. v1-wraparound
- Conditions
- Aging
- Keywords
- fall, fall prevention, fall injury, fear of falling, fall efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Blue Marble Rehab IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Partners In Care Foundation
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 1 Oct 2024 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparative prospective observational cohort study
| Arm | Type | Receives |
|---|---|---|
| Human-led fall prevention programs | Active comparator | Behavioral: Human-led fall prevention programParticipants will complete any human-led fall prevention program of their choice, in a group setting either in-person or via Zoom. |
| Avatar-led fall prevention program | Experimental | Behavioral: Avatar-led fall prevention programParticipants will complete an avatar-led fall prevention program at their local community center or community room of their housing complex |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age of 55 and older
- Score >30 on the TICS (Telephone Interview for Cognitive Screen) or if lower than 30 has assistance to participate
Key exclusion criteria (1 listed)
- any person who has been told by their physician that they should not exercise
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 |
|---|---|---|
| Human-led fall prevention programHuman-led evidence-based fall prevention programs include Matter of Balance, Tai Chi Moving for Better Balance, Walk with Ease, or Arthritis Exercise | Behavioural | Human-led fall prevention programs |
| Avatar-led fall prevention programThe avatar-led fall prevention program consists of the Otago Exercise Program | Behavioural | Avatar-led fall prevention program |
Primary outcome
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
11 secondary outcomes
Timed Up and Go Test
Time frame: 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)
One Leg Stand Test
Time frame: 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)
Fall Risk Questionnaire
Time frame: 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)
Veteran Rand-12 (VR-12)
Time frame: 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)
Trail Making Test
Time frame: 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)
Upstream Social Isolation Risk Scale (USIR-S)
Time frame: change from baseline to end of intervention (about 3 months)
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 1 Oct 2024.
- Individual participant dataSharing planned: No. Individual data will not be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human-led fall prevention program and Avatar-led fall prevention program in people with Aging, run by Blue Marble Rehab Inc 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 2 inclusion and 1 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 1 Oct 2024. 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.
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?
Rate of falls (time frame: change from baseline to end of intervention (about 3 months)). 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 1 Oct 2024.