Back to resultsImproving Older Adults' Decision Making for OSAT (eDecide2Rest)
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient decision aid
General sleep education
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- age >= 60 years
- diagnosed with obstructive sleep apnea on a sleep study
- able to read English-language newspaper text (if needed, using contact lens/glasses)
- able to write words in a paper booklet
- scheduled for a sleep clinic appointment with a UCLA sleep provider
- able to attend a sleep educational session prior to sleep clinic appointment
Exclusion Criteria:
- unable to provide informed consent
- dementia
- mild cognitive impairment diagnosis or Mini-Cog score < 3
- treated for obstructive sleep apnea for > 30 days prior to scheduled sleep education intervention
- 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)
Sites / Locations
- University of California, Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Patient decision aid
General sleep education
Arm Description
Outcomes
Primary Outcome Measures
Recruitment rates
The investigators will measure recruitment rates for our recruitment strategies
Enrollment rates
The investigators will measure enrollment rates
Secondary Outcome Measures
The length of time for completing the intervention session
The investigators will measure the length of time for completing the intervention session
Full Information
NCT ID
NCT03138993
First Posted
February 14, 2017
Last Updated
September 24, 2019
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT03138993
Brief Title
Improving Older Adults' Decision Making for OSAT
Acronym
eDecide2Rest
Official Title
Improving Older Adults' Decision Making for Obstructive Sleep Apnea Treatment (Phase 3)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
May 29, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient decision aid
Arm Type
Active Comparator
Arm Title
General sleep education
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
Patient decision aid
Intervention Description
Web-based patient decision aid plus a paper workbook.
Intervention Type
Behavioral
Intervention Name(s)
General sleep education
Intervention Description
Web-based information about sleep plus a paper workbook
Primary Outcome Measure Information:
Title
Recruitment rates
Description
The investigators will measure recruitment rates for our recruitment strategies
Time Frame
Through study completion, an average of 1 year
Title
Enrollment rates
Description
The investigators will measure enrollment rates
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
The length of time for completing the intervention session
Description
The investigators will measure the length of time for completing the intervention session
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age >= 60 years
diagnosed with obstructive sleep apnea on a sleep study
able to read English-language newspaper text (if needed, using contact lens/glasses)
able to write words in a paper booklet
scheduled for a sleep clinic appointment with a UCLA sleep provider
able to attend a sleep educational session prior to sleep clinic appointment
Exclusion Criteria:
unable to provide informed consent
dementia
mild cognitive impairment diagnosis or Mini-Cog score < 3
treated for obstructive sleep apnea for > 30 days prior to scheduled sleep education intervention
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)
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32955013
Citation
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.
Results Reference
derived
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Improving Older Adults' Decision Making for OSAT
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