Improving Older Adults' Decision Making for OSAT

Obstructive Sleep Apnea Clinical Trial

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Official title:

Improving Older Adults' Decision Making for Obstructive Sleep Apnea Treatment (Phase 3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138993
• Other study ID #: 16001482
• Status: Completed
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: September 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the feasibility of conducting a randomized controlled trial that tests a patient decision aid for obstructive sleep apnea in older adults with newly-diagnosed obstructive sleep apnea treated in an outpatient sleep clinic. Half of the participants will use a patient decision aid, while the other half will receive general information about sleep.

Description:

Patient decision aids are one strategy for helping older adults make informed decisions about treatments. Patient decision aids improve patients' knowledge about therapies and encourage them to actively weigh the risks and benefits of each therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 30, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. age >= 60 years

2. diagnosed with obstructive sleep apnea on a sleep study

3. able to read English-language newspaper text (if needed, using contact lens/glasses)

4. able to write words in a paper booklet

5. scheduled for a sleep clinic appointment with a UCLA sleep provider

6. able to attend a sleep educational session prior to sleep clinic appointment

Exclusion Criteria:

1. unable to provide informed consent

2. dementia

3. mild cognitive impairment diagnosis or Mini-Cog score < 3

4. treated for obstructive sleep apnea for > 30 days prior to scheduled sleep education intervention

5. severe physical or mental illness (e.g., hospitalized within past 7 days prior to scheduled sleep education intervention, substance abuse within 90 days of sleep education intervention)

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Patient decision aid
Web-based patient decision aid plus a paper workbook.
• General sleep education
Web-based information about sleep plus a paper workbook

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rates	The investigators will measure recruitment rates for our recruitment strategies	Through study completion, an average of 1 year
Primary	Enrollment rates	The investigators will measure enrollment rates	Through study completion, an average of 1 year
Secondary	The length of time for completing the intervention session	The investigators will measure the length of time for completing the intervention session	Through study completion, an average of 1 year