NCT03428893

Brief Summary

Osteoarthritis is the leading cause of disability in the U.S, particularly in older adults. Exercise is an evidence-based treatment option that improves pain and disability outcomes in adults with osteoarthritis, but adherence to prescribed exercise is generally low. Technology such as mobile applications (apps) for smartphones and tablets offers the potential to support exercise adherence through evidence-based components and enhanced communication between physical therapists and patients. The investigators aim to test mobile app-supported physical therapy exercise prescription compared to standard care. The investigators propose to use a two-arm randomized control trial with subjects in the intervention receiving mobile app-supported physical therapy exercise prescription and the control group receiving usual care physical therapy exercise prescription (paper handouts and verbal instruction). No known studies have assessed the impact of technological integration on adherence with PT exercises for OA. Current approaches such as therapist drawn pictures, hand-written or print-ready instructions do not account for patient communication preferences or ability to translate drawings into physical action. Mobile technology offers a potential solution to patient-centered care but has not been evaluated. This study will provide valuable information on effectiveness and user perspectives to key stakeholders such as patients, health care administrators, physical therapists and app designers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.6 years

First QC Date

February 5, 2018

Last Update Submit

September 27, 2021

Conditions

Keywords

Exercise, mhealth, physical therapy

Outcome Measures

Primary Outcomes (1)

  • Exercise adherence

    Mean weekly exercise frequency over 6 and 12 weeks:0-21 with higher scores indicating more adherence.

    0, 6, and 12 weeks

Secondary Outcomes (6)

  • ShortMAC Physical Function Patient Reported Outcome MeasureRO

    0, 6 and 12 weeks

  • 2 minute walk test

    0, 6 and 12 weeks

  • Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)

    0, 6 and 12 weeks

  • Timed Up and Go (TUG) + Dual Task

    0, 6 and 12 weeks

  • Dynamic Balance: Four square balance test

    0, 6 and 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Mobile Application Group

EXPERIMENTAL

The mobile app group will receive physical therapy as determined by the physical therapist and agree to receive the home exercise prescription using a mobile app on their phone or personal tablet

Device: Mobile Application

Control

NO INTERVENTION

The control group will receive physical therapy as determined by the physical therapist based on clinical practice guidelines and will receive the home exercise program in the traditional way through paper exercise handouts

Interventions

Participants will receive usual care physical therapy guided by Clinical Practice Guidelines and based on individual symptoms and need over 7 in-person visits. Measures will be collected by the physical therapist related to leg strength, balance, fitness, and mobility as part of the usual care physical therapy evaluation and follow-up. The treating physical therapist will negotiate the physical therapy intervention based on patient preferences and goals and assessment findings. Using clinical practice guidelines, the intervention for the research participants is expected to address deficits in strength, mobility, balance, and cardiovascular endurance. Exercise prescription will be provided using the Wellpepper physical therapy exercise prescription mobile app.

Mobile Application Group

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-report of healthcare provider diagnosed osteoarthritis in the hips or knees
  • Ability to speak and read English
  • No diagnosis of serious mental illness
  • No diagnosis of serious or terminal illness (e.g., metastatic cancer, end stage renal failure)
  • Access to smartphone/tablet

You may not qualify if:

  • Cortisone injection to the joint with OA within the past 30 days
  • Undergoing physical therapy post-total joint replacement or in preparation for total joint replacement in the next 3 months
  • History of physical therapy for treatment of osteoarthritis in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dee Physical Therapy

South Burlington, Vermont, 05407, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, HipMotor Activity

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Nancy Gell, PT, PhD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 12, 2018

Study Start

January 8, 2018

Primary Completion

July 30, 2019

Study Completion

August 30, 2019

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations