NCT06074224

Brief Summary

The investigators are interested in measuring the influence of addressing sleep in the orthopedic setting. This includes assessing patient experience measures (satisfaction with the visit, perceived empathy, communication effectiveness) as well as greater engagement in their healthcare (patient activation). The investigators will also see what factors might be associated with sleep disturbance and if addressing sleep leads to an intervention such as cognitive behavioral therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

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

February 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

September 28, 2023

Last Update Submit

July 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Jefferson Scale of Patient's Perceptions of Physician Empathy

    The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five 7-point scale questions and higher scores indicated greater perceived clinician empathy.

    through study completion, an average of 6 months

Study Arms (2)

Clinician with Scores

EXPERIMENTAL

The patients in the intervention group will include those for whom their clinician was given their sleep questionnaire result before the visit.

Other: Sleep assessment score

Clinician without Scores

ACTIVE COMPARATOR

The control group will include patients whose clinicians do not view the results, simulating usual care.

Other: No Score

Interventions

The patients in the intervention group will include those for whom their clinician was given their sleep questionnaire result before the visit.

Clinician with Scores

The patients in the control group will include those for whom their clinician was not given their sleep questionnaire result before the visit.

Clinician without Scores

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (18+)
  • Orthopedic new visit
  • Sleep disturbance score \> 3

You may not qualify if:

  • Inability to read.
  • Diminished cognition preventing completion of the questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Texas Health Austin (UTHA)

Austin, Texas, 78701, United States

Location

University of Texas Health Austin

Austin, Texas, 78701, United States

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • David Ring, MD

    Professor of orthopedic surgery at The university of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery and Perioperative Care Department

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 10, 2023

Study Start

February 1, 2022

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations