Prevention Focused Home-Based Physical Therapy Utilizing Community Partnership Referrals

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention Focused Home-Based Physical Therapy Utilizing Community Partnership Referrals

Conditions
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Fall, Risk Reduction

Intervention / Treatment
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* Other: HOP-UP-PT Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HOP-UP-PT Program<br>HOP-UP-PT Program group will participate in the 7-month HOP-UP-PT program | Other: HOP-UP-PT Program<br>* 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.<br>|
| No Intervention: Normal Level of Activity<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Reported Falls | Record of falls in prior year, and between each subsequent visit. | 7 months | 
| 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. | 7 Months | 
| 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. | 7 Months | 
| 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. | 7 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 Months | 
| 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. | 3 Months | 
| 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. | 3 Months | 
| 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. | 7 Months | 
| 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. | 7 Months | 
| Body Mass Index | Assessment of body fat calculated from height and weight. | 7 Months | 
| Blood Pressure | Assessment of mean resting blood pressure in seated position. | 7 Months | 
| 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. | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older adults