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Prevention Focused Home-Based Physical Therapy Utilizing Community Partnership Referrals

Prevention Focused Home-Based Physical Therapy Utilizing Community Partnership Referrals

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04814459
Enrollment
144
Registered
2021-03-24
Start date
2019-01-01
Completion date
2021-05-15
Last updated
2021-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall, Risk Reduction

Keywords

Older adults

Brief summary

This novel study supports the positive benefits of Home Based Older Persons Upstreaming Physical Therapy (HOP-UP-PT) to older adults identified as at-risk by their local senior center after participating in a prevention-focused multimodal program provided by physical therapists in their home.

Detailed description

The purpose of this study was to describe the outcomes of Home Based Older Persons Upstreaming Physical Therapy (HOP-UP-PT) program participants and then to compare these outcomes to non-participants. 144 participants (n=72 per group) will be randomized to either the HOP-UP-PT intervention group or the Normal level of activity group. Six Michigan senior centers will refer adults ≥ 65 years who were at-risk for functional decline or falls. Licensed physical therapists will deliver physical, environmental, and health interventions within their approved scope of practice to the HOP-UP-PT intervention group during nine encounters (six in-person, three telerehabilitation) delivered over seven months. The Normal level of activity group participants are told to continue their usual physical activity routines during the same timeframe. Baseline and re-assessments are conducted at 0-, 3-, and 7-months for both the HOP-UP-PT intervention group and Normal level of activity group. Descriptions and comparisons from each assessment encounter will be analyzed.

Interventions

OTHERHOP-UP-PT Program

Interventions provided to EG participants included; (1) the Otago Exercise Program (OEP) which is a well-established exercise program with evidence that it reduces falls among community-dwelling older adults, (2) motivational interviewing (MI) to optimize positive health behaviors, and (3) home and environmental modification recommendations aimed at safety. Participants were provided with and educated on the use of a wrist-worn activity tracker and an automated BP monitor unit. Finally, when follow up items were identified (e.g., orthostatic hypotension, community exercise classes), these referrals were made and documented.

Sponsors

Michigan Health Endowment Fund
CollaboratorOTHER
Oakland University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Experimental group (EG) participated in the 7-month HOP-UP-PT control group (CG) included only baseline, 3-month, and 7-month assessments. The CG was instructed to continue their normal level of activity throughout the 7-months after which they were offered the opportunity to receive the HOP-UP-PT program. This study reports only the 7-month time frame during which the EG and CG can be directly compared.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Greater than or equal to 65 years of age * Senior Community Center staff identified them as 'at-risk' for decline in community dwelling status due to physical, social, economic, or community-related barriers * Willingness to participate

Exclusion criteria

* Received physical therapy services within the prior two months in any setting * Had been hospitalized within the prior two months * Were currently receiving palliative or hospice care * Mini Cog score less than 4 and Trail Making Part B score greater than 273 seconds * Outcomes American College of Sports Medicine exercise pre-participation health screening indicating physician clearance needed for participation and after evaluation the physician will not clear

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Reported Falls7 monthsRecord of falls in prior year, and between each subsequent visit.
Modified Short Physical Performance Battery (SPPB)7 MonthsThe Modified SPPB uses a 0-12 scale (0 = lowest function, 12 = highest function), calculated using collective outcomes of The Four Test Balance Scale (0= unable to perform, 1 = able to stand: feet together \>10 sec, 2 = semi-tandem \>10 sec, 4 = tandem stance \>10 sec, higher score is better balance), 5 Time Sit to Stand (0 = \>60 sec, 1=16.7 to 60 sec, 2 = 13.7 to 16.69 sec, 3 = 11.2 to 13.69 sec, and 4 = \<11.19 sec, faster time is higher function), and the 3-meter gait speed test (0 = unable to perform, 1= \> 6.52 sec, 2 = 4.66 to 6.52 sec, 3 = 3.62 to 4.65 sec, and 4 = \< 3.62 sec, faster time is higher function). Each of the three categories has a highest score of 4 and are summed together for a highest total Modified SPPB score of 12.
Timed Up and Go7 MonthsThe Timed Up and Go (TUG) is a times assessment of sit to stand transfer, 20 foot bought of ambulation with a 180 degree turn at 10 feet concluding with a stand to sit transfer.
Stopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk Categorization7 MonthsLow, moderate, and high risk was determined relative to results of the stay independent brochure, subjective report of falls and fall risk and brochure questions, as well as gait, strength, and balance assessment. The Stopping Elderly Accidents, Death & Injuries (STEADI) Algorithm underwent revisions since the study onset, the 2015 version was utilized as a guide for key outcome metrics reported in this study. Low STEADI risk =0, moderate STEADI risk =1, and high STEADI risk = 2. Low risk participants were categorized based on no responses to falls or fall risk questions as well as no gait, strength, or balance problems. Moderate risk participants were categorized by answering yes to key questions as well as demonstrating some gait, strength, or balance problems, and had a fall without injury. High risk participants were categorized by answering yes to key questions, demonstrating gait, strength, or balance problems, and had 2 or more falls or 1 fall with an injury.

Secondary

MeasureTime frameDescription
Home Falls and Accidents Screening Tool (Home FAST)7 MonthsThe tool evaluates 25 home safety domains and includes questions related to lighting, floor surfaces, and properly fitted foot wear. The original tool design was not scored but the investigators have added a scoring system (13 = safest environment to 50 = least safe environment) to quantify each question pertaining to the home environment. 13 home safety questions are scored as either Yes (indicating the recommended safety modifications was present) or No (indicating the recommended safety modifications had not been met). An additional 12 questions have an N/A option to be used in circumstances where a condition was not met (e.g., participant does not have a pet or stairs in the home). The investigators coded the responses as YES=1 point, NO= 2 points, an N/A= null within that category and not included during calculation. Therefore, overall Home FAST scores that decrease over time would suggest diminished home fall and accident risks related to their environment.
Body Mass Index7 MonthsAssessment of body fat calculated from height and weight.
Stay Independent Questionnaire3 MonthsThis questionnaire scores a fall risk on a scale from zero to 14, with 4 or more indicating a possible fall risk. Zero is the lowest fall risk score, 14 is a highest fall risk score.
Number of Participants With Orthostatic Hypotension7 monthsBlood pressure was measured sequentially in supine, seated and standing and orthostatic hypotension was determined by the following parameters: a systolic blood pressure decrease of greater than or equal to 20 mm Hg or a diastolic blood pressure decrease of greater than or equal to 10 mm Hg between any of the three positions after three minutes in that position.
Blood Pressure7 MonthsAssessment of mean resting blood pressure in seated position.
Modified Falls Efficacy Scale3 MonthsMeasures fear of falling for 10 indoor and 4 outdoor activities. For each statement the participant circles a number that corresponds to their level of confidence, with zero being no confidence and 10 being extreme confidence. Once all 14 items are scored, they are added for a total score maximum of 140 which is then divided by 14. A number closer to 14 equates to more confidence, and a number closer to zero equates to less confidence.
Health Behavior Questionnaire3 MonthsAssessment of current behaviors related to physical activity, consuming fruits and vegetables, not smoking, and being at a recommended weight. Patients are categorized using the five levels of the trans-theoretical model of behavior change. The pre-contemplating stage, or not ready for change is scored a 5. The contemplation stage or considering making a change in the next 6 months is scored a four. The preparation or preparing to make the change in the next 6 months is scored a 3. The action stage indicates the participant has made the change and is scored. The maintenance stage indicates the participants have maintained the change for at least 6 months and are scored a 1.
Functional Comorbidity Index7 MonthsSelf-assessment of disease comorbidity with physical function as the outcome. 18 diagnoses are listed and if the participant has been diagnosed with the condition it would be marked at a 1 and if they do not have the condition it would be marked as a zero. Zero would be the fewest amount of co-morbidities and 18 would be the highest amount of co-morbidities.

Countries

United States

Participant flow

Participants by arm

ArmCount
HOP-UP-PT Program
HOP-UP-PT Program group will participate in the 7-month HOP-UP-PT program HOP-UP-PT Program: Interventions provided to HOP-UP-PT program participants included; (1) the Otago Exercise Program (OEP) which is a well-established exercise program with evidence that it reduces falls among community-dwelling older adults, (2) motivational interviewing (MI) to optimize positive health behaviors, and (3) home and environmental modification recommendations aimed at safety. Participants were provided with and educated on the use of a wrist-worn activity tracker and an automated BP monitor unit. Finally, when follow up items were identified (e.g., orthostatic hypotension, community exercise classes), these referrals were made and documented.
72
Normal Level of Activity
Normal Level of Activity group will be instructed to continue their normal level of activity throughout the 7-months after which they will be offered the opportunity to receive the HOP-UP-PT program
72
Total144

Baseline characteristics

CharacteristicNormal Level of ActivityTotalHOP-UP-PT Program
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
72 Participants144 Participants72 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous77.2 years
STANDARD_DEVIATION 8.2
76.9 years
STANDARD_DEVIATION 7.6
76.6 years
STANDARD_DEVIATION 7
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
72 Participants144 Participants72 Participants
Sex: Female, Male
Female
53 Participants110 Participants57 Participants
Sex: Female, Male
Male
19 Participants34 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 720 / 72
other
Total, other adverse events
0 / 720 / 72
serious
Total, serious adverse events
0 / 720 / 72

Outcome results

Primary

Modified Short Physical Performance Battery (SPPB)

The Modified SPPB uses a 0-12 scale (0 = lowest function, 12 = highest function), calculated using collective outcomes of The Four Test Balance Scale (0= unable to perform, 1 = able to stand: feet together \>10 sec, 2 = semi-tandem \>10 sec, 4 = tandem stance \>10 sec, higher score is better balance), 5 Time Sit to Stand (0 = \>60 sec, 1=16.7 to 60 sec, 2 = 13.7 to 16.69 sec, 3 = 11.2 to 13.69 sec, and 4 = \<11.19 sec, faster time is higher function), and the 3-meter gait speed test (0 = unable to perform, 1= \> 6.52 sec, 2 = 4.66 to 6.52 sec, 3 = 3.62 to 4.65 sec, and 4 = \< 3.62 sec, faster time is higher function). Each of the three categories has a highest score of 4 and are summed together for a highest total Modified SPPB score of 12.

Time frame: 7 Months

Population: Data collectors did not complete all measures to calculate this score at the baseline assessment due to variations in patient care delivery. Additionally, participants that were dis-enrolled reduced the data for analysis at the 3 and 7 month encounters.

ArmMeasureGroupValue (MEAN)Dispersion
HOP-UP-PT ProgramModified Short Physical Performance Battery (SPPB)Baseline (all participants)8.44 score on a scaleStandard Deviation 2.66
HOP-UP-PT ProgramModified Short Physical Performance Battery (SPPB)Baseline (Moderate and high STEADI Risk)7.64 score on a scaleStandard Deviation 2.82
HOP-UP-PT ProgramModified Short Physical Performance Battery (SPPB)3 Month (all participants)9.29 score on a scaleStandard Deviation 2.49
HOP-UP-PT ProgramModified Short Physical Performance Battery (SPPB)3 Month (Moderate and High STEADI Risk)8.24 score on a scaleStandard Deviation 2.43
HOP-UP-PT ProgramModified Short Physical Performance Battery (SPPB)7 Month (all participants)9.50 score on a scaleStandard Deviation 2.22
HOP-UP-PT ProgramModified Short Physical Performance Battery (SPPB)7 Month (Moderate and High STEADI Risk)7.64 score on a scaleStandard Deviation 2.17
Normal Level of ActivityModified Short Physical Performance Battery (SPPB)7 Month (all participants)8.96 score on a scaleStandard Deviation 2.63
Normal Level of ActivityModified Short Physical Performance Battery (SPPB)Baseline (all participants)7.34 score on a scaleStandard Deviation 2.85
Normal Level of ActivityModified Short Physical Performance Battery (SPPB)3 Month (Moderate and High STEADI Risk)6.60 score on a scaleStandard Deviation 2.95
Normal Level of ActivityModified Short Physical Performance Battery (SPPB)Baseline (Moderate and high STEADI Risk)6.18 score on a scaleStandard Deviation 2.86
Normal Level of ActivityModified Short Physical Performance Battery (SPPB)7 Month (Moderate and High STEADI Risk)7.25 score on a scaleStandard Deviation 2.67
Normal Level of ActivityModified Short Physical Performance Battery (SPPB)3 Month (all participants)8.04 score on a scaleStandard Deviation 2.97
Primary

Number of Participants With Reported Falls

Record of falls in prior year, and between each subsequent visit.

Time frame: 7 months

Population: Inclusive of low, moderate, and high STEADI fall risk

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HOP-UP-PT ProgramNumber of Participants With Reported FallsBaseline (All Participants)37 Participants
HOP-UP-PT ProgramNumber of Participants With Reported Falls3 Month (Moderate and Hight STEADI Risk)5 Participants
HOP-UP-PT ProgramNumber of Participants With Reported FallsBaseline (Moderat and High STEADI Risk)29 Participants
HOP-UP-PT ProgramNumber of Participants With Reported Falls3 Month (All Participants)5 Participants
HOP-UP-PT ProgramNumber of Participants With Reported Falls7 months (All Participants)7 Participants
HOP-UP-PT ProgramNumber of Participants With Reported Falls7 Month (Moderate and High STEADI Risk)1 Participants
Normal Level of ActivityNumber of Participants With Reported Falls7 months (All Participants)15 Participants
Normal Level of ActivityNumber of Participants With Reported Falls3 Month (All Participants)3 Participants
Normal Level of ActivityNumber of Participants With Reported Falls3 Month (Moderate and Hight STEADI Risk)2 Participants
Normal Level of ActivityNumber of Participants With Reported FallsBaseline (All Participants)34 Participants
Normal Level of ActivityNumber of Participants With Reported Falls7 Month (Moderate and High STEADI Risk)11 Participants
Normal Level of ActivityNumber of Participants With Reported FallsBaseline (Moderat and High STEADI Risk)24 Participants
Primary

Stopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk Categorization

Low, moderate, and high risk was determined relative to results of the stay independent brochure, subjective report of falls and fall risk and brochure questions, as well as gait, strength, and balance assessment. The Stopping Elderly Accidents, Death & Injuries (STEADI) Algorithm underwent revisions since the study onset, the 2015 version was utilized as a guide for key outcome metrics reported in this study. Low STEADI risk =0, moderate STEADI risk =1, and high STEADI risk = 2. Low risk participants were categorized based on no responses to falls or fall risk questions as well as no gait, strength, or balance problems. Moderate risk participants were categorized by answering yes to key questions as well as demonstrating some gait, strength, or balance problems, and had a fall without injury. High risk participants were categorized by answering yes to key questions, demonstrating gait, strength, or balance problems, and had 2 or more falls or 1 fall with an injury.

Time frame: 7 Months

Population: Data collectors did not complete all measures to calculate this score at the baseline assessment due to variations in patient care delivery. Additionally, participants that were dis-enrolled reduced the data for analysis at the 3 and 7 month encounters.

ArmMeasureGroupValue (MEAN)Dispersion
HOP-UP-PT ProgramStopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk CategorizationBaseline (All participants)0.8 score on a scaleStandard Deviation 0.7
HOP-UP-PT ProgramStopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk Categorization3 Month (All participants)0.6 score on a scaleStandard Deviation 0.7
HOP-UP-PT ProgramStopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk Categorization7 Month (All Participants)0.4 score on a scaleStandard Deviation 0.6
Normal Level of ActivityStopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk CategorizationBaseline (All participants)0.7 score on a scaleStandard Deviation 0.7
Normal Level of ActivityStopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk Categorization3 Month (All participants)0.7 score on a scaleStandard Deviation 0.6
Normal Level of ActivityStopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk Categorization7 Month (All Participants)0.6 score on a scaleStandard Deviation 0.7
Primary

Timed Up and Go

The Timed Up and Go (TUG) is a times assessment of sit to stand transfer, 20 foot bought of ambulation with a 180 degree turn at 10 feet concluding with a stand to sit transfer.

Time frame: 7 Months

Population: Participants that were dis-enrolled reduced the data available for analysis at the 3 and 7 month encounters.

ArmMeasureGroupValue (MEAN)Dispersion
HOP-UP-PT ProgramTimed Up and GoBaseline (All participants)11.5 secondsStandard Deviation 4.6
HOP-UP-PT ProgramTimed Up and GoBaseline (Moderate and High STEADI Risk)12.9 secondsStandard Deviation 5.3
HOP-UP-PT ProgramTimed Up and Go3 Month (All participants)10.7 secondsStandard Deviation 3.7
HOP-UP-PT ProgramTimed Up and Go3 Month (Moderate and High STEADI Risk)12.0 secondsStandard Deviation 4.3
HOP-UP-PT ProgramTimed Up and Go7 Month (All participants)10.6 secondsStandard Deviation 3.7
HOP-UP-PT ProgramTimed Up and Go7 Month (Moderate and High STEADI Risk)13.8 secondsStandard Deviation 4.3
Normal Level of ActivityTimed Up and Go7 Month (All participants)11.9 secondsStandard Deviation 5.4
Normal Level of ActivityTimed Up and GoBaseline (All participants)13.3 secondsStandard Deviation 6
Normal Level of ActivityTimed Up and Go3 Month (Moderate and High STEADI Risk)15.4 secondsStandard Deviation 7.5
Normal Level of ActivityTimed Up and GoBaseline (Moderate and High STEADI Risk)15.7 secondsStandard Deviation 6.8
Normal Level of ActivityTimed Up and Go7 Month (Moderate and High STEADI Risk)14.6 secondsStandard Deviation 6.8
Normal Level of ActivityTimed Up and Go3 Month (All participants)13.0 secondsStandard Deviation 6.3
Secondary

Blood Pressure

Assessment of mean resting blood pressure in seated position.

Time frame: 7 Months

Population: Data collectors did not complete all measures to calculate this score at the baseline assessment due to variations in patient care delivery. Additionally, participants that were dis-enrolled reduced the data for analysis at the 3 and 7 month encounters.

ArmMeasureGroupValue (MEAN)Dispersion
HOP-UP-PT ProgramBlood PressureBaseline (All participants) Systolic133 mm HgStandard Deviation 20
HOP-UP-PT ProgramBlood PressureBaseline (All participants) Diastolic76 mm HgStandard Deviation 10
HOP-UP-PT ProgramBlood PressureBaseline (Moderate and High STEADI Risk) Systolic133 mm HgStandard Deviation 22
HOP-UP-PT ProgramBlood PressureBaseline (Moderate and High STEADI Risk) Diastolic76 mm HgStandard Deviation 10
HOP-UP-PT ProgramBlood Pressure3 Month (All participants) Systolic125 mm HgStandard Deviation 15
HOP-UP-PT ProgramBlood Pressure3 Month (All participants) Diastolic76 mm HgStandard Deviation 15
HOP-UP-PT ProgramBlood Pressure3 Month (Moderate and High STEADI Risk) Systolic123 mm HgStandard Deviation 13
HOP-UP-PT ProgramBlood Pressure3 Month (Moderate and High STEADI Risk) Diastolic74 mm HgStandard Deviation 8
HOP-UP-PT ProgramBlood Pressure7 Month (All participants) Systolic128 mm HgStandard Deviation 19
HOP-UP-PT ProgramBlood Pressure7 Month (All participants) Diastolic76 mm HgStandard Deviation 10
HOP-UP-PT ProgramBlood Pressure7 Month (Moderate and High STEADI Risk) Systolic127 mm HgStandard Deviation 18
HOP-UP-PT ProgramBlood Pressure7 Month (Moderate and High STEADI Risk) Diastolic75 mm HgStandard Deviation 10
Normal Level of ActivityBlood Pressure7 Month (Moderate and High STEADI Risk) Systolic126 mm HgStandard Deviation 16
Normal Level of ActivityBlood PressureBaseline (All participants) Systolic131 mm HgStandard Deviation 15
Normal Level of ActivityBlood Pressure3 Month (Moderate and High STEADI Risk) Systolic123 mm HgStandard Deviation 21
Normal Level of ActivityBlood PressureBaseline (All participants) Diastolic78 mm HgStandard Deviation 10
Normal Level of ActivityBlood Pressure7 Month (All participants) Diastolic75 mm HgStandard Deviation 10
Normal Level of ActivityBlood PressureBaseline (Moderate and High STEADI Risk) Systolic132 mm HgStandard Deviation 15
Normal Level of ActivityBlood Pressure3 Month (Moderate and High STEADI Risk) Diastolic74 mm HgStandard Deviation 7
Normal Level of ActivityBlood PressureBaseline (Moderate and High STEADI Risk) Diastolic79 mm HgStandard Deviation 12
Normal Level of ActivityBlood Pressure7 Month (Moderate and High STEADI Risk) Diastolic75 mm HgStandard Deviation 11
Normal Level of ActivityBlood Pressure3 Month (All participants) Systolic125 mm HgStandard Deviation 22
Normal Level of ActivityBlood Pressure7 Month (All participants) Systolic128 mm HgStandard Deviation 16
Normal Level of ActivityBlood Pressure3 Month (All participants) Diastolic75 mm HgStandard Deviation 10
Secondary

Body Mass Index

Assessment of body fat calculated from height and weight.

Time frame: 7 Months

Population: Data collectors did not complete all measures to calculate this score at the baseline assessment due to variations in patient care delivery. Additionally, participants that were dis-enrolled reduced the data for analysis at the 3 and 7 month encounters.

ArmMeasureGroupValue (MEAN)Dispersion
HOP-UP-PT ProgramBody Mass Index7 Month (All participants)29.5 kg/m^2Standard Deviation 5.2
HOP-UP-PT ProgramBody Mass IndexBaseline (Moderate and High STEADI Risk)30.2 kg/m^2Standard Deviation 5.4
HOP-UP-PT ProgramBody Mass Index7 Month (Moderate and High STEADI Risk)32.7 kg/m^2Standard Deviation 1.1
HOP-UP-PT ProgramBody Mass IndexBaseline (All participants)29.9 kg/m^2Standard Deviation 5.4
Normal Level of ActivityBody Mass Index7 Month (Moderate and High STEADI Risk)30.9 kg/m^2Standard Deviation 6
Normal Level of ActivityBody Mass IndexBaseline (Moderate and High STEADI Risk)29.2 kg/m^2Standard Deviation 5.6
Normal Level of ActivityBody Mass Index7 Month (All participants)35.1 kg/m^2Standard Deviation 4.1
Normal Level of ActivityBody Mass IndexBaseline (All participants)28.6 kg/m^2Standard Deviation 5.4
Secondary

Functional Comorbidity Index

Self-assessment of disease comorbidity with physical function as the outcome. 18 diagnoses are listed and if the participant has been diagnosed with the condition it would be marked at a 1 and if they do not have the condition it would be marked as a zero. Zero would be the fewest amount of co-morbidities and 18 would be the highest amount of co-morbidities.

Time frame: 7 Months

Population: Data collectors did not complete all measures to calculate this score at the baseline assessment due to variations in patient care delivery. Additionally, participants that were dis-enrolled reduced the data for analysis at the 3 and 7 month encounters.

ArmMeasureGroupValue (MEAN)Dispersion
HOP-UP-PT ProgramFunctional Comorbidity IndexBaseline (All participants)4.0 score on a scaleStandard Deviation 2.1
HOP-UP-PT ProgramFunctional Comorbidity IndexBaseline (Moderate and High STEADI Risk)4.7 score on a scaleStandard Deviation 2.1
HOP-UP-PT ProgramFunctional Comorbidity Index3 Month (All participants)4.1 score on a scaleStandard Deviation 2.2
HOP-UP-PT ProgramFunctional Comorbidity Index3 Month (Moderate and High STEADI Risk)5.1 score on a scaleStandard Deviation 2.43
HOP-UP-PT ProgramFunctional Comorbidity Index7 Month (All participants)3.8 score on a scaleStandard Deviation 2.6
HOP-UP-PT ProgramFunctional Comorbidity Index7 Month (Moderate and High STEADI Risk)5.0 score on a scaleStandard Deviation 1
Normal Level of ActivityFunctional Comorbidity Index7 Month (All participants)4.0 score on a scaleStandard Deviation 2.4
Normal Level of ActivityFunctional Comorbidity IndexBaseline (All participants)3.9 score on a scaleStandard Deviation 2.3
Normal Level of ActivityFunctional Comorbidity Index3 Month (Moderate and High STEADI Risk)5.1 score on a scaleStandard Deviation 3.3
Normal Level of ActivityFunctional Comorbidity IndexBaseline (Moderate and High STEADI Risk)4.4 score on a scaleStandard Deviation 2.4
Normal Level of ActivityFunctional Comorbidity Index7 Month (Moderate and High STEADI Risk)4.6 score on a scaleStandard Deviation 2.8
Normal Level of ActivityFunctional Comorbidity Index3 Month (All participants)4.5 score on a scaleStandard Deviation 2.8
Secondary

Health Behavior Questionnaire

Assessment of current behaviors related to physical activity, consuming fruits and vegetables, not smoking, and being at a recommended weight. Patients are categorized using the five levels of the trans-theoretical model of behavior change. The pre-contemplating stage, or not ready for change is scored a 5. The contemplation stage or considering making a change in the next 6 months is scored a four. The preparation or preparing to make the change in the next 6 months is scored a 3. The action stage indicates the participant has made the change and is scored. The maintenance stage indicates the participants have maintained the change for at least 6 months and are scored a 1.

Time frame: 3 Months

Population: There is missing data at baseline and 7 month assessment due to data collectors not completing all tests due to variation in patient care performance. Additionally, participants that were dis-enrolled reduced the data available for analysis at the 3 and 7 month encounters.

ArmMeasureGroupValue (MEAN)Dispersion
HOP-UP-PT ProgramHealth Behavior QuestionnaireBaseline (All participants) Physical Activity2.0 score on a scaleStandard Deviation 1.2
HOP-UP-PT ProgramHealth Behavior QuestionnaireBaseline (All participants) Fruit and Vegetable Consumption2.2 score on a scaleStandard Deviation 1.3
HOP-UP-PT ProgramHealth Behavior QuestionnaireBaseline (All participants) Smoking Habits1.1 score on a scaleStandard Deviation 0.5
HOP-UP-PT ProgramHealth Behavior QuestionnaireBaseline (All participants) Recommended Weight2.2 score on a scaleStandard Deviation 1.3
HOP-UP-PT ProgramHealth Behavior Questionnaire3 Month (All participants) Physical Activity1.7 score on a scaleStandard Deviation 1
HOP-UP-PT ProgramHealth Behavior Questionnaire3 Month (All participants) Fruit and Vegetable2.0 score on a scaleStandard Deviation 1.2
HOP-UP-PT ProgramHealth Behavior Questionnaire3 Month (All participants) Smoking1.0 score on a scaleStandard Deviation 0.3
HOP-UP-PT ProgramHealth Behavior Questionnaire3 Month (All participants) Recommended Weight1.9 score on a scaleStandard Deviation 1.2
HOP-UP-PT ProgramHealth Behavior QuestionnaireBaseline (Moderate and High STEADI Risk) Physical Activity2.3 score on a scaleStandard Deviation 1.4
HOP-UP-PT ProgramHealth Behavior QuestionnaireBaseline (Moderate and High STEADI Risk) Fruit and Vegetable2.2 score on a scaleStandard Deviation 1.3
HOP-UP-PT ProgramHealth Behavior QuestionnaireBaseline (Moderate and High STEADI Risk) Smoking1.1 score on a scaleStandard Deviation 0.6
HOP-UP-PT ProgramHealth Behavior QuestionnaireBaseline (Moderate and High STEADI Risk) Recommended Weight2.3 score on a scaleStandard Deviation 1.3
HOP-UP-PT ProgramHealth Behavior Questionnaire3 Month (Moderate and High STEADI Risk) Physical Activity2.2 score on a scaleStandard Deviation 1.2
HOP-UP-PT ProgramHealth Behavior Questionnaire3 Month (Moderate and High STEADI Risk) Fruit and Vegetable2.6 score on a scaleStandard Deviation 1.2
HOP-UP-PT ProgramHealth Behavior Questionnaire3 Month (Moderate and High STEADI Risk) Smoking1.0 score on a scaleStandard Deviation 0
HOP-UP-PT ProgramHealth Behavior Questionnaire3 Month (Moderate and High STEADI Risk) Recommended Weight2.0 score on a scaleStandard Deviation 1.4
Normal Level of ActivityHealth Behavior Questionnaire3 Month (Moderate and High STEADI Risk) Recommended Weight2.0 score on a scaleStandard Deviation 1.4
Normal Level of ActivityHealth Behavior QuestionnaireBaseline (All participants) Physical Activity1.9 score on a scaleStandard Deviation 1.3
Normal Level of ActivityHealth Behavior QuestionnaireBaseline (Moderate and High STEADI Risk) Physical Activity2.3 score on a scaleStandard Deviation 1.5
Normal Level of ActivityHealth Behavior QuestionnaireBaseline (All participants) Fruit and Vegetable Consumption2.4 score on a scaleStandard Deviation 1.5
Normal Level of ActivityHealth Behavior Questionnaire3 Month (Moderate and High STEADI Risk) Physical Activity2.6 score on a scaleStandard Deviation 1.6
Normal Level of ActivityHealth Behavior QuestionnaireBaseline (All participants) Smoking Habits1.1 score on a scaleStandard Deviation 0.04
Normal Level of ActivityHealth Behavior QuestionnaireBaseline (Moderate and High STEADI Risk) Fruit and Vegetable2.7 score on a scaleStandard Deviation 1.6
Normal Level of ActivityHealth Behavior QuestionnaireBaseline (All participants) Recommended Weight2.2 score on a scaleStandard Deviation 1.5
Normal Level of ActivityHealth Behavior Questionnaire3 Month (Moderate and High STEADI Risk) Smoking1.0 score on a scaleStandard Deviation 0
Normal Level of ActivityHealth Behavior Questionnaire3 Month (All participants) Physical Activity2.2 score on a scaleStandard Deviation 1.5
Normal Level of ActivityHealth Behavior QuestionnaireBaseline (Moderate and High STEADI Risk) Smoking1.1 score on a scaleStandard Deviation 0.5
Normal Level of ActivityHealth Behavior Questionnaire3 Month (All participants) Fruit and Vegetable2.2 score on a scaleStandard Deviation 1.5
Normal Level of ActivityHealth Behavior Questionnaire3 Month (Moderate and High STEADI Risk) Fruit and Vegetable2.3 score on a scaleStandard Deviation 1.6
Normal Level of ActivityHealth Behavior Questionnaire3 Month (All participants) Smoking1.1 score on a scaleStandard Deviation 0.4
Normal Level of ActivityHealth Behavior QuestionnaireBaseline (Moderate and High STEADI Risk) Recommended Weight2.5 score on a scaleStandard Deviation 1.5
Normal Level of ActivityHealth Behavior Questionnaire3 Month (All participants) Recommended Weight1.9 score on a scaleStandard Deviation 1.2
Secondary

Home Falls and Accidents Screening Tool (Home FAST)

The tool evaluates 25 home safety domains and includes questions related to lighting, floor surfaces, and properly fitted foot wear. The original tool design was not scored but the investigators have added a scoring system (13 = safest environment to 50 = least safe environment) to quantify each question pertaining to the home environment. 13 home safety questions are scored as either Yes (indicating the recommended safety modifications was present) or No (indicating the recommended safety modifications had not been met). An additional 12 questions have an N/A option to be used in circumstances where a condition was not met (e.g., participant does not have a pet or stairs in the home). The investigators coded the responses as YES=1 point, NO= 2 points, an N/A= null within that category and not included during calculation. Therefore, overall Home FAST scores that decrease over time would suggest diminished home fall and accident risks related to their environment.

Time frame: 7 Months

Population: Data collectors did not complete all measures to calculate this score at the baseline assessment due to variations in patient care delivery. Additionally, participants that were dis-enrolled reduced the data for analysis at the 3 and 7 month encounters.

ArmMeasureGroupValue (MEAN)Dispersion
HOP-UP-PT ProgramHome Falls and Accidents Screening Tool (Home FAST)Baseline (All participants)25.7 score on a scaleStandard Deviation 6.2
HOP-UP-PT ProgramHome Falls and Accidents Screening Tool (Home FAST)Baseline (Moderate and High STEADI Risk)25.5 score on a scaleStandard Deviation 6.7
HOP-UP-PT ProgramHome Falls and Accidents Screening Tool (Home FAST)3 Month (All participants)25.6 score on a scaleStandard Deviation 5.7
HOP-UP-PT ProgramHome Falls and Accidents Screening Tool (Home FAST)3 Month (Moderate and High STEADI Risk)25.4 score on a scaleStandard Deviation 6.2
HOP-UP-PT ProgramHome Falls and Accidents Screening Tool (Home FAST)7 Month (All participants)26.0 score on a scaleStandard Deviation 5
HOP-UP-PT ProgramHome Falls and Accidents Screening Tool (Home FAST)7 Month (Moderate and High STEADI Risk)26.9 score on a scaleStandard Deviation 5.7
Normal Level of ActivityHome Falls and Accidents Screening Tool (Home FAST)7 Month (All participants)25.6 score on a scaleStandard Deviation 5.9
Normal Level of ActivityHome Falls and Accidents Screening Tool (Home FAST)Baseline (All participants)25.9 score on a scaleStandard Deviation 7.8
Normal Level of ActivityHome Falls and Accidents Screening Tool (Home FAST)3 Month (Moderate and High STEADI Risk)26.3 score on a scaleStandard Deviation 8.5
Normal Level of ActivityHome Falls and Accidents Screening Tool (Home FAST)Baseline (Moderate and High STEADI Risk)24.9 score on a scaleStandard Deviation 8.6
Normal Level of ActivityHome Falls and Accidents Screening Tool (Home FAST)7 Month (Moderate and High STEADI Risk)23.4 score on a scaleStandard Deviation 5.5
Normal Level of ActivityHome Falls and Accidents Screening Tool (Home FAST)3 Month (All participants)26.8 score on a scaleStandard Deviation 7.3
Secondary

Modified Falls Efficacy Scale

Measures fear of falling for 10 indoor and 4 outdoor activities. For each statement the participant circles a number that corresponds to their level of confidence, with zero being no confidence and 10 being extreme confidence. Once all 14 items are scored, they are added for a total score maximum of 140 which is then divided by 14. A number closer to 14 equates to more confidence, and a number closer to zero equates to less confidence.

Time frame: 3 Months

Population: There is missing data at baseline and 7 month assessment due to data collectors not completing all tests due to variation in patient care performance. Additionally, participants that were dis-enrolled reduced the data available for analysis at the 3 and 7 month encounters.

ArmMeasureGroupValue (MEAN)Dispersion
HOP-UP-PT ProgramModified Falls Efficacy ScaleBaseline (All participants)9.2 score on a scaleStandard Deviation 1.7
HOP-UP-PT ProgramModified Falls Efficacy ScaleBaseline (Moderate and High STEADI Risk)8.6 score on a scaleStandard Deviation 1.8
HOP-UP-PT ProgramModified Falls Efficacy Scale3 Month (All participants)9.7 score on a scaleStandard Deviation 1.1
HOP-UP-PT ProgramModified Falls Efficacy Scale3 Month (Moderate and High STEADI Risk)9.6 score on a scaleStandard Deviation 1.2
Normal Level of ActivityModified Falls Efficacy Scale3 Month (Moderate and High STEADI Risk)8.7 score on a scaleStandard Deviation 2.1
Normal Level of ActivityModified Falls Efficacy ScaleBaseline (All participants)9.0 score on a scaleStandard Deviation 1.8
Normal Level of ActivityModified Falls Efficacy Scale3 Month (All participants)9.2 score on a scaleStandard Deviation 1.7
Normal Level of ActivityModified Falls Efficacy ScaleBaseline (Moderate and High STEADI Risk)8.4 score on a scaleStandard Deviation 2.3
Secondary

Number of Participants With Orthostatic Hypotension

Blood pressure was measured sequentially in supine, seated and standing and orthostatic hypotension was determined by the following parameters: a systolic blood pressure decrease of greater than or equal to 20 mm Hg or a diastolic blood pressure decrease of greater than or equal to 10 mm Hg between any of the three positions after three minutes in that position.

Time frame: 7 months

Population: Data collectors did not complete all measures to calculate this score at the baseline assessment due to variations in patient care delivery. Additionally, participants that were dis-enrolled reduced the data for analysis at the 3 and 7 month encounters.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HOP-UP-PT ProgramNumber of Participants With Orthostatic HypotensionBaseline (All participants)13 Participants
HOP-UP-PT ProgramNumber of Participants With Orthostatic HypotensionBaseline (Moderate and High Fall Risk Participants)10 Participants
HOP-UP-PT ProgramNumber of Participants With Orthostatic Hypotension3 Month (All Participants13 Participants
HOP-UP-PT ProgramNumber of Participants With Orthostatic Hypotension3 Month (Moderate and High Fall Risk Participants)4 Participants
HOP-UP-PT ProgramNumber of Participants With Orthostatic Hypotension7 Month (All Participants)10 Participants
HOP-UP-PT ProgramNumber of Participants With Orthostatic Hypotension7 Month (Moderate and High Fall Risk Participants)4 Participants
Normal Level of ActivityNumber of Participants With Orthostatic Hypotension7 Month (All Participants)5 Participants
Normal Level of ActivityNumber of Participants With Orthostatic HypotensionBaseline (All participants)16 Participants
Normal Level of ActivityNumber of Participants With Orthostatic Hypotension3 Month (Moderate and High Fall Risk Participants)3 Participants
Normal Level of ActivityNumber of Participants With Orthostatic HypotensionBaseline (Moderate and High Fall Risk Participants)12 Participants
Normal Level of ActivityNumber of Participants With Orthostatic Hypotension7 Month (Moderate and High Fall Risk Participants)2 Participants
Normal Level of ActivityNumber of Participants With Orthostatic Hypotension3 Month (All Participants7 Participants
Secondary

Stay Independent Questionnaire

This questionnaire scores a fall risk on a scale from zero to 14, with 4 or more indicating a possible fall risk. Zero is the lowest fall risk score, 14 is a highest fall risk score.

Time frame: 3 Months

Population: There is missing data at baseline and 7 month assessment due to data collectors not completing all tests due to variation in patient care performance. Additionally, participants that were dis-enrolled reduced the data available for analysis at the 3 and 7 month encounters.

ArmMeasureGroupValue (MEAN)Dispersion
HOP-UP-PT ProgramStay Independent Questionnaire3 Months (All participants)3.3 score on a scaleStandard Deviation 2.9
HOP-UP-PT ProgramStay Independent QuestionnaireBaseline (Moderate and High STEADI Risk)6.4 score on a scaleStandard Deviation 2.7
HOP-UP-PT ProgramStay Independent Questionnaire3 Month (Moderate and High STEADI Risk)5.0 score on a scaleStandard Deviation 3
HOP-UP-PT ProgramStay Independent QuestionnaireBaseline (All participants)4.8 score on a scaleStandard Deviation 3
Normal Level of ActivityStay Independent Questionnaire3 Month (Moderate and High STEADI Risk)5.2 score on a scaleStandard Deviation 2.6
Normal Level of ActivityStay Independent QuestionnaireBaseline (Moderate and High STEADI Risk)6.2 score on a scaleStandard Deviation 2.5
Normal Level of ActivityStay Independent Questionnaire3 Months (All participants)4.2 score on a scaleStandard Deviation 2.8
Normal Level of ActivityStay Independent QuestionnaireBaseline (All participants)4.7 score on a scaleStandard Deviation 3.2

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026