Using "Store and Forward" Tele-health as an Adjunct to Traditional Outpatient or Home Health Physical Therapy

NCT02659280 | Completed

• 1 other identifier: MinneapolisMRF
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This study will take about 3-16 months. Participants will be inpatients in the Hennepin Health System that are transitioning into outpatient or home health Physical Therapy or current outpatient patients. Investigators will assess 24 participants for eligibility based on the study's inclusion criteria. If eligible, Investigators will attain informed consent and provide instruction on how to use a coaching app, Hudl Technique, and enter data in the Apple Health Kit (all participants will be gifted an iPad mini 4, cover and Hudl Technique app). Baseline Body Mass Index (BMI) will be taken and entered in the Apple Health Kit. Randomization (1:1) will occur by an outside statistician. 12 patients will be allotted to the control group (receive traditional Outpatient PT and have access to the Apple Health Kit and Hudl Technique with the gifted iPad). 12 patients will be the variable group (receive traditional Outpatient PT, have access to the Apple Health Kit and Hudl Technique with the gifted iPad, and have an adjunct Home Exercise Program which will be administered via tele-health "store and forward" technology 1x/wk). There will be an 8 week assessment in which investigators plan to measure 1) satisfaction with PT (via survey) 2) Home Exercise Program (HEP) compliance (via survey) 3) incidents of ED visits or hospital admissions 4) BMI (via patient report with option to put it in the Apple Health Kit). There will be a 24 week assessment in which investigators will measure the same 4 measurements. Investigators plan on performing this protocol for an additional 24 participants in late 2016/early 2017 (48 participants in total). Unfortunately, this will be a non-blinded (assessor, therapist and participant) study due to the nature of the intervention and how investigators received the funding. Casey Byron will be the Principal Investigator. Investigators would like the statistician to be blinded to group allocation until completion of the study (roughly 3/11/2017).

Conditions

Chronic Disease

Keywords

telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Improved compliance with Physical Therapy Home Exercise Program

  Subjects will have statistically significant improvement in the frequency of performing their Home Exercise Program (HEP). This will be measured via survey with the modified Patient Satisfaction for Outpatient Physical Therapy Survey.

  24 weeks

Study Arms (2)

Standard of Care Therapy

ACTIVE COMPARATOR

Home Health or Outpatient Physical therapy services (a minimum of 1x/week).

Other: Standard of Care

Adjunct Therapy

EXPERIMENTAL

Home Health or Outpatient Physical therapy services (a minimum of 1x/week) with an adjunct Home Exercise Program given up to 1x/wk via "Store and Forward" tele-health through the Hudl Technique app.

Other: Adjunct Therapy

Interventions

Adjunct Therapy OTHER

"Store and Forward" Tele-heath

Adjunct Therapy

Standard of Care OTHER

Standard of Care Outpatient Physical Therapy

Standard of Care Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hennepin Health System (HHS) will determine participant's eligibility in the pilot project if a participant meets the following stipulations
• The prospective participant must be an HHS outpatient or home health Physical Therapy (PT) patient.
• The prospective participant's primary PT must determine that the participant has adequate motor control to participate in a HEP (home exercise program) on their own.
• The prospective participant has adequate cognitive ability to use electronic assistive technology (iPad Mini
• The prospective participant will need to live greater than 100 miles from Minneapolis and/or needs to have financial hardship (as designated by being on Medical Assistance, Emergency Medical Assistance, Hennepin Care, Medicaid, Medical Assistance Cost Plan, Wavered services or have no health insurance).

You may not qualify if:

• Any participant less than the age of 18 years of age. Any participant who is pregnant or has reason to beleive they are pregnant,

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• Hennepin County Medical Center, Minneapolis: collaborator
• Medtronic: collaborator

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (2)

• Beattie PF, Pinto MB, Nelson MK, Nelson R. Patient satisfaction with outpatient physical therapy: instrument validation. Phys Ther. 2002 Jun;82(6):557-65.

  PMID: 12036397 BACKGROUND

• Van de Winckel A, Nawshin T, Byron C. Combining a Hudl App With Telehealth to Increase Home Exercise Program Adherence in People With Chronic Diseases Experiencing Financial Distress: Randomized Controlled Trial. JMIR Form Res. 2021 Mar 18;5(3):e22659. doi: 10.2196/22659.

  PMID: 33640865 DERIVED

MeSH Terms

Conditions

Chronic Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 20, 2016
• Study Start: March 16, 2016
• Primary Completion: October 24, 2017
• Study Completion: November 10, 2017
• Last Updated: March 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)