Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02659280
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
Hennepin County Medical Center, Minneapolis
Medtronic
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute

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).

Condition or disease Intervention/treatment Phase
Chronic Disease Other: Adjunct Therapy Other: Standard of Care Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Using "Store and Forward" Tele-health as an Adjunct to Traditional Outpatient or Home Health Physical Therapy
Actual Study Start Date : March 16, 2016
Actual Primary Completion Date : October 24, 2017
Actual Study Completion Date : November 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard of Care Therapy
Home Health or Outpatient Physical therapy services (a minimum of 1x/week).
Other: Standard of Care
Standard of Care Outpatient Physical Therapy

Experimental: Adjunct Therapy
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
"Store and Forward" Tele-heath




Primary Outcome Measures :
  1. Improved compliance with Physical Therapy Home Exercise Program [ Time Frame: 24 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659280


Locations
Layout table for location information
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Hennepin Healthcare Research Institute
Hennepin County Medical Center, Minneapolis
Medtronic
Publications:
Layout table for additonal information
Responsible Party: Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier: NCT02659280    
Other Study ID Numbers: MinneapolisMRF
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hennepin Healthcare Research Institute:
telerehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Disease
Disease Attributes
Pathologic Processes