NCT02498847

Brief Summary

Knee osteoarthritis (OA) affects 27 million US adults and is a leading cause of pain and disability. Non-pharmacological interventions are recommended but are underutilized. Exercise reduces pain and improves physical function, but benefits tend to wane without a component to facilitate behavior change. Cognitive behavioral therapy (CBT) has long term benefits on pain and physical function in individuals with OA, but is not typically offered in clinical care. CBT could be taught in the context of clinical care by occupational therapists (OT). OTs help people manage chronic conditions by teaching behavioral strategies that promote health and function. The purpose of this study is to test the feasibility and efficacy of an OT-delivered cognitive behavioral therapy program to help people manage their knee OA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P50-P75 for phase_1 knee-osteoarthritis

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

2 active sites

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

March 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

July 13, 2015

Last Update Submit

April 18, 2023

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Self-Reported Physical Function-WOMAC

    Western Ontario and McMaster University Arthritis Index (WOMAC) 17 items, participants rate difficulty in performing different activities on a 0 - 4 scale

    5 minutes

Secondary Outcomes (3)

  • Objective Physical Function- 6 minute walk test

    6 minutes

  • Pain - Brief Pain Inventory

    5 minutes

  • Patient Global Impression of Change

    <5 minutes

Study Arms (2)

ENGAGE intervention

EXPERIMENTAL

8 in-person weekly treatment sessions with an occupational therapist of 30 minutes - 1 hour duration intervention content provided on website, homework assigned each week after intervention period, monthly calls conducted to check on health status

Behavioral: ENGAGE

Usual Care

NO INTERVENTION

participated in usual care and received monthly calls to check on health status

Interventions

ENGAGEBEHAVIORAL

Participants are introduced to ENGAGE program by the study OT. The ENGAGE program is located on a website and has several modules. The modules include a video in which a health provider is featured. This health provider gives a short presentation on a topic related to OA, symptom management or lifestyle change. Within each module, there is downloadable homework and additional information which can be printed. The modules are: * What is Osteoarthritis? * Information about treatments * Exercise * Sleep hygiene * Relaxation * Pleasant Activity Scheduling * Goal setting * Problem Solving * Pacing * Communication

ENGAGE intervention

Eligibility Criteria

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

You may qualify if:

  • community-living
  • report of at least mild to moderate pain in knee with osteoarthritis
  • clinical determination of knee osteoarthritis
  • report of knee pain for \> 3 months duration
  • ambulatory with or without cane or walker
  • has internet access and can use computer

You may not qualify if:

  • severe physical impairment
  • current cancer treatment
  • knee injections or surgery in previous 3 months
  • using long-acting narcotics
  • shift workers
  • participation in rehabilitation or behavioral therapy for OA in the previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan Institute of Gerontology

Ann Arbor, Michigan, 48109-2007, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

engage 8200

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Susan L Murphy, ScD OTR

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 15, 2015

Study Start

March 1, 2013

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

April 19, 2023

Record last verified: 2023-04

Locations

US(2)