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

Sponsor

University of Texas at Austin (Other)

Overall Status

Recruiting

CT.gov ID

NCT06074224

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disturbance	Other: Sleep assessment score Other: No Score	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clinician with Scores 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 The patients in the intervention group will include those for whom their clinician was given their sleep questionnaire result before the visit.
Active Comparator: Clinician without Scores The control group will include patients whose clinicians do not view the results, simulating usual care.	Other: No Score The patients in the control group will include those for whom their clinician was not given their sleep questionnaire result before the visit.

Arm

Intervention/Treatment

Experimental: Clinician with Scores

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

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

Active Comparator: Clinician without Scores

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

Other: No Score

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

Outcome Measures

Primary Outcome Measures

Jefferson Scale of Patient's Perceptions of Physician Empathy [through study completion, an average of 6 months]
The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five 7-point scale questions and higher scores indicated greater perceived clinician empathy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

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

Exclusion criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Austin (UTHA)	Austin	Texas	United States	78701
2	University of Texas Health Austin	Austin	Texas	United States	78701

Sponsors and Collaborators

University of Texas at Austin

Investigators

Principal Investigator: David Ring, MD, Professor of orthopedic surgery at The university of Texas at Austin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Ring, Professor of Surgery and Perioperative Care Department, University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT06074224

Other Study ID Numbers:

2020-05-0067

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dyssomnias

Parasomnias

Study Results

No Results Posted as of Oct 10, 2023