Improving Older Adults' Decision Making for OSAT

NCT ID: NCT03138993

Last Updated: 2019-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Patient decision aid

Group Type ACTIVE_COMPARATOR

Patient decision aid

Intervention Type BEHAVIORAL

Web-based patient decision aid plus a paper workbook.

General sleep education

Group Type SHAM_COMPARATOR

General sleep education

Intervention Type BEHAVIORAL

Web-based information about sleep plus a paper workbook

Interventions

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Patient decision aid

Web-based patient decision aid plus a paper workbook.

Intervention Type BEHAVIORAL

General sleep education

Web-based information about sleep plus a paper workbook

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Constance Fung, MD, MSHS

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Fung CH, Martin JL, Liang LJ, Hays RD, Col N, Patterson ES, Josephson K, Mitchell MN, Sanchez MC, Aysola R, Song Y, Dzierzewski JM, Huang D, Zeidler M, Alessi C. Efficacy of a patient decision aid for improving person-centered decision-making by older adults with obstructive sleep apnea. J Clin Sleep Med. 2021 Feb 1;17(2):121-128. doi: 10.5664/jcsm.8798.

Reference Type DERIVED
PMID: 32955013 (View on PubMed)

Other Identifiers

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16001482

Identifier Type: -

Identifier Source: org_study_id

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