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| Name | Class |
|---|---|
| Iowa Physical Therapy Foundation | OTHER |
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To investigate whether changes in trust between physical therapist and patient correlate to outcomes after receiving physical therapy care. We will be utilizing established questionnaires from the medical literature and one new generated questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient participants | patients with chronic low back pain receiving standard physical therapy care |
| |
| Physical Therapy clinician participants | Licensed physical therapist that is providing standard physical therapy care for a patient participant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard physical therapy care | Procedure | standard plan of care delivered to patient with chronic low back within scope of licensure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Care Assessment Survey | Measurement of trust of patient toward provider during clinical encounter. Minimum score of 8, maximal score of 40. Questions 1-7 are scored with a 5-point Likert scale, Question 8 is scored with a 11-point Likert scale. Higher score indicate better levels of trust. | through study completion, an average of 1 year |
| Change in Wake Forest Scale | Measurement of trust of patient toward provider during clinical encounter. 10 item scale using a 5-point Likert scale. Score range from 10-50, with higher score indicating higher levels of trust. | through study completion, an average of 1 year |
| Change in Trust in Physician Scale | Measurement of trust of patient toward provider during clinical encounter. 11 item scale using 5-point Likert scale. Score range from 11-55, with higher score indicating higher levels of trust. | through study completion, an average of 1 year |
| Change in Oswestry Disability Index 2.0 | Measurement of function for individuals with low back pain. 10 categories with 6 statements scoring (0-5) for function. Raw scores range from 0-50, they are divided by highest possible score to produce a percentage. Lower percentage demonstrates less disability. | through study completion, an average of 1 year |
| Change in Numeric Pain Rating Scale | Pain measurement scale. Measurement on 11-point scale from 0= no pain to 10= worst pain imaginable. Measure current, best in last 24 hours, and worst in last 24 hours and take average of all 3 measurements. Lower score represents lower pain rating. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| General Trust in Physician Scale | global trust measurement of patient, 11 item scale using 5 point Likert scale. Minimum score 11, maximum score 55. Higher values, higher levels of trust. No subscales. | through study completion, an average of 1 year |
| Change in Working Alliance Inventory - Short Revised |
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Inclusion Criteria:
Exclusion Criteria:
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patients coming to seek care for chronic low back at outpatient physical therapy clinics
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| Name | Affiliation | Role |
|---|---|---|
| Kory J Zimney, DPT | University of South Dakota | Principal Investigator |
| Emilio J Puentedura, DPT, PhD | University of Nevada, Las Vegas | Study Chair |
| Morey Kolber, PT, PhD | Nova Southeastern University | Study Director |
| Adriaan Louw, PT, PhD | International Spine and Pain Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| One Accord Physical Therapy Casa Grande | Casa Grande | Arizona | 85122 | United States | ||
| Foothills Sports Medicine Physical Therapy |
All data will be used as part of research project for dissertation purposes and not shared to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Participants | patients with chronic low back pain receiving standard physical therapy care Standard physical therapy care: standard plan of care delivered to patient with chronic low back within scope of licensure |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2024 |
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| Global Rate of Change |
Global measurement of change of status during care. 11-point scale used (-5=very much worse, 0 = unchanged, 5 = completely recovered). Higher score represents better recovery. |
| through study completion, an average of 1 year |
therapeutic alliance measurement. 12 item short form utilizing 5 point Likert scale. minimum score 12, maximum score 60. Higher score means higher therapeutic (working) alliance. |
| after initial visit and discontinuation of services, an average of 4-8 weeks. |
| Change in PT Survey of Patient Connection and Engagement | Questionnaire completed by PT regarding their perceptions of the patients connection and engagement during the course of care. 10 question survey, using 5 point Likert scale. minimum score 10, maximum score 50. Higher score demonstrates higher patient connection and engagement. | after 2nd visit and discontinuation of services, an average of 4-8 weeks. |
| Phoenix |
| Arizona |
| 85044 |
| United States |
| Butte Premier Physical Therapy | Chico | California | 95928 | United States |
| Signature Physical Therapy | San Clemente | California | 92673 | United States |
| Rock Valley Physical Therapy | Silvis | Illinois | 61282 | United States |
| Hackensack Meridian Health-Mountainside Medical Center | Montclair | New Jersey | 07042 | United States |
| Miriam Hospital Outpatient Rehab | Providence | Rhode Island | 02904 | United States |
| PRO Physical Therapy | Winchester | Virginia | 22601 | United States |
| Outpatient Physical Therapy | Kent | Washington | 98032 | United States |
| Kitsap Physical Therapy and Sports Clinic | Silverdale | Washington | 98383 | United States |
| Phileo Health | Altoona | Wisconsin | 54720 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Participants | patients with chronic low back pain receiving standard physical therapy care Standard physical therapy care: standard plan of care delivered to patient with chronic low back within scope of licensure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Patient Care Assessment Survey | Measurement of trust of patient toward provider during clinical encounter. Minimum score of 8, maximal score of 40. Questions 1-7 are scored with a 5-point Likert scale, Question 8 is scored with a 11-point Likert scale. Higher score indicate better levels of trust. | Posted | Mean | Standard Deviation | score on a scale | through study completion, an average of 1 year |
|
|
| ||||||||||||||||||||||||||
| Primary | Change in Wake Forest Scale | Measurement of trust of patient toward provider during clinical encounter. 10 item scale using a 5-point Likert scale. Score range from 10-50, with higher score indicating higher levels of trust. | Posted | Mean | Standard Deviation | score on a scale | through study completion, an average of 1 year |
|
| |||||||||||||||||||||||||||
| Primary | Change in Trust in Physician Scale | Measurement of trust of patient toward provider during clinical encounter. 11 item scale using 5-point Likert scale. Score range from 11-55, with higher score indicating higher levels of trust. | Posted | Mean | Standard Deviation | score on a scale | through study completion, an average of 1 year |
|
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| Primary | Change in Oswestry Disability Index 2.0 | Measurement of function for individuals with low back pain. 10 categories with 6 statements scoring (0-5) for function. Raw scores range from 0-50, they are divided by highest possible score to produce a percentage. Lower percentage demonstrates less disability. | Posted | Mean | Standard Deviation | score on a scale | through study completion, an average of 1 year |
|
| |||||||||||||||||||||||||||
| Primary | Change in Numeric Pain Rating Scale | Pain measurement scale. Measurement on 11-point scale from 0= no pain to 10= worst pain imaginable. Measure current, best in last 24 hours, and worst in last 24 hours and take average of all 3 measurements. Lower score represents lower pain rating. | Posted | Mean | Standard Deviation | score on a scale | through study completion, an average of 1 year |
|
| |||||||||||||||||||||||||||
| Primary | Global Rate of Change | Global measurement of change of status during care. 11-point scale used (-5=very much worse, 0 = unchanged, 5 = completely recovered). Higher score represents better recovery. | Posted | Mean | Standard Deviation | score on a scale | through study completion, an average of 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | General Trust in Physician Scale | global trust measurement of patient, 11 item scale using 5 point Likert scale. Minimum score 11, maximum score 55. Higher values, higher levels of trust. No subscales. | Posted | Mean | Standard Deviation | score on a scale | through study completion, an average of 1 year |
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| |||||||||||||||||||||||||||
| Secondary | Change in Working Alliance Inventory - Short Revised | therapeutic alliance measurement. 12 item short form utilizing 5 point Likert scale. minimum score 12, maximum score 60. Higher score means higher therapeutic (working) alliance. | Posted | Mean | Standard Deviation | score on a scale | after initial visit and discontinuation of services, an average of 4-8 weeks. |
|
| |||||||||||||||||||||||||||
| Secondary | Change in PT Survey of Patient Connection and Engagement | Questionnaire completed by PT regarding their perceptions of the patients connection and engagement during the course of care. 10 question survey, using 5 point Likert scale. minimum score 10, maximum score 50. Higher score demonstrates higher patient connection and engagement. | Posted | Mean | Standard Deviation | score on a scale | after 2nd visit and discontinuation of services, an average of 4-8 weeks. |
|
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Participants | patients with chronic low back pain receiving standard physical therapy care Standard physical therapy care: standard plan of care delivered to patient with chronic low back within scope of licensure | 0 | 29 | 0 | 29 | 0 | 29 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kory Zimney, PhD | USouthDakota | 6056586373 | kory.zimney@usd.edu |
| Oct 9, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 10, 2024 | Oct 9, 2024 | ICF_001.pdf |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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