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Sleep Assessment: The Benefits of Identifying Sleep Disturbance Using a Sleep Questionnaire

Primary Purpose

Sleep Disturbance

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sleep assessment score

No Score

About this trial

This is an interventional basic science trial for Sleep Disturbance

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: Adult patients (18+) Orthopedic new visit Sleep disturbance score > 3 Exclusion criteria: Inability to read. Diminished cognition preventing completion of the questionnaires.

Sites / Locations

University of Texas Health Austin (UTHA)Recruiting
University of Texas Health AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clinician with Scores

Clinician without Scores

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT06074224

First Posted

September 28, 2023

Last Updated

October 5, 2023

Sponsor

University of Texas at Austin

1. Study Identification

Unique Protocol Identification Number

NCT06074224

Brief Title

Sleep Assessment: The Benefits of Identifying Sleep Disturbance Using a Sleep Questionnaire

Official Title

Sleep Assessment: The Benefits of Identifying Sleep Disturbance Using a Sleep Questionnaire

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

November 1, 2023 (Anticipated)

Study Completion Date

November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

All adult (18+ years old) new patients seeing a musculoskeletal specialist will be invited to enroll. For the purposes of this trial, The investigators will include people with lesser degrees of sleep disturbance including anyone with a score greater than 3. For people that are enrolled in the trial, the researcher will record the PSQI score and enter at the first page of survey filled out by the patient after meeting. P The patients in the intervention group will include those for whom their clinician was given their sleep questionnaire result before the visit. The control group will include patients whose clinicians do not view the results, simulating usual care. Patients in both groups will fill out a survey entailing demographics, sleep quality, JSPPPE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disturbance

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clinician with Scores

Arm Type

Experimental

Arm Description

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

Arm Title

Clinician without Scores

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Sleep assessment score

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

No Score

Intervention Description

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

Primary Outcome Measure Information:

Title

Jefferson Scale of Patient's Perceptions of Physician Empathy

Description

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

Time Frame

through study completion, an average of 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Adult patients (18+) Orthopedic new visit Sleep disturbance score > 3 Exclusion criteria: Inability to read. Diminished cognition preventing completion of the questionnaires.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sina Ramtin

Phone

5124955067

sina.ramtin@austin.utexas.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Ring, MD

Organizational Affiliation

Professor of orthopedic surgery at The university of Texas at Austin

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Health Austin (UTHA)

City

Austin

State/Province

Texas

ZIP/Postal Code

78701

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Ring, M.D

Phone

512-495-5067

David.Ring@austin.utexas.edu

Facility Name

University of Texas Health Austin

City

Austin

State/Province

Texas

ZIP/Postal Code

78701

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sina Ramtin

Phone

512-495-5067

sina.ramtin@austin.utexas.edu

First Name & Middle Initial & Last Name & Degree

David Ring, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Sleep Assessment: The Benefits of Identifying Sleep Disturbance Using a Sleep Questionnaire

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