NCT01938274

Brief Summary

To pilot test an activity-focused intervention that educates patients undergoing total hip (THA) or total knee (TKA) arthroplasty due to osteoarthritis about the appropriate type, frequency, intensity, and duration of expected leisure activities after surgery and to determine if the intervention changed expectations.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
4.3 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2019

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

February 12, 2013

Last Update Submit

July 22, 2019

Conditions

Keywords

HipKneeOsteoarthritisArthroplastyPhysical ActivityExpectationsLeisure Activity

Outcome Measures

Primary Outcomes (1)

  • Change in type, frequency, intensity, and duration of expected leisure activities from pre- to post-intervention.

    The Historical Leisure Activity Questionnaire will be used to measure expected physical activity before and after the intervention

    One-week prior to the educational intervention (Pre) (approximately 3-4 weeks before surgery) and one-week after the educational intervention (Post) (approximately 1-2 weeks before surgery).

Secondary Outcomes (2)

  • Change in the proportion of patients who expect to meet nationally recommended physical activity levels 6 months after surgery.

    One-week prior to the educational intervention (Pre) (approximately 3-4 weeks before surgery) and one-week after the educational intervention (Post) (approximately 1-2 weeks before surgery).

  • Direction and magnitude of change expected in leisure activity between baseline (i.e., current activity) and 6 months

    Baseline (approximately 3-4 weeks before surgery)

Study Arms (2)

Educational intervention

EXPERIMENTAL

Patients in this group will receive a brief educational intervention to assist them in setting the appropriate expectations for leisure activity after surgery with respect to the type, amount, intensity, and duration of activity.

Other: Educational intervention

Control group

NO INTERVENTION

No intervention will be received. Patients will receive a written version of the education intervention at the end of the study.

Interventions

A 30-minute discussion and slide presentation with a trained member of the research team.

Educational intervention

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study includes male or female patients, aged 45 years and older who are scheduled for primary total hip or knee arthroplasty due to osteoarthritis.

You may not qualify if:

  • Patients will be excluded from the study if the surgery is being performed for diagnosis other than osteoarthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis, KneeOsteoarthritisMotor Activity

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Dina L. Jones, PT, PhD

    West Virginia University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2013

First Posted

September 10, 2013

Study Start

January 1, 2018

Primary Completion

December 1, 2018

Study Completion

July 22, 2019

Last Updated

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations