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NCT02659280 · ClinicalTrials.gov registry record · NA
Using "Store and Forward" Tele-health as an Adjunct to Traditional Outpatient or Home Health Physical Therapy
A NA study, sponsored by Hennepin Healthcare Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 47
- Enrollment target
NCT02659280 is a NA study that has completed, run by Hennepin Healthcare Research Institute. The registered enrollment target is 47 participants.
The verdict
NCT02659280, a NA study, has completed, sponsored by Hennepin Healthcare Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 47 participants
- Enrollment target
Study 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).
Interventions
- OTHER Standard of Care
- OTHER Adjunct Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2016-03-16 |
| Est. Completion | 2017-11-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02659280
The ClinicalTrials.gov registry entry for NCT02659280 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hennepin Healthcare Research Institute, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT02659280 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02659280 about?
NCT02659280 is a clinical study titled "Using "Store and Forward" Tele-health as an Adjunct to Traditional Outpatient or Home Health Physical Therapy". 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 criter...
What is the current status of trial NCT02659280?
This trial is currently completed. It is a NA study. The enrollment target is 47 participants. The study started on 2016-03-16. Estimated completion is 2017-11-10.
What interventions are being tested in trial NCT02659280?
The interventions under investigation include: Standard of Care (OTHER), Adjunct Therapy (OTHER).
Who is sponsoring clinical trial NCT02659280?
This trial is sponsored by Hennepin Healthcare Research Institute, which has 63 total clinical trials registered on ClinicalTrials.gov.
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