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A pilot study of information about sleep mailed directly to patients

Sleep EducatioN information sent Directly to patients: pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11530968
Enrollment
1900
Registered
2020-05-05
Start date
2019-11-27
Completion date
Unknown
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia Mental and Behavioural Disorders

Interventions

After the initial opt-out period, eligible participants are randomized to one of three groups: 1) Active program: mailed information about sleeping pill risks and a free, anonymous onl

Sponsors

Department of Veterans Affairs Greater Los Angeles Healthcare
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 65 years or older 2. Obtain care from VA medical centers in VISN 19 (Colorado, Oklahoma, Utah, Montana, Wyoming, Idaho) 3. Have been prescribed a benzodiazepine or z-drug from a VA pharmacy within the past 18 months

Exclusion criteria

Exclusion criteria: 1. History of seizures based on problem list in VA electronic health record 2. History of bipolar disorder based on problem list in VA electronic health record 3. Deceased

Design outcomes

Primary

MeasureTime frame
Active benzodiazepine and/or z-drug prescription listed in the electronic health record 6 months after randomization

Secondary

MeasureTime frame
1. Insomnia severity (measured using the Insomnia Severity Index) 6 months and 12 months after randomization 2. Active benzodiazepines and/or z-drug prescriptions listed in the electronic health record 12 months after randomization 3. Hip fracture rate at 6 and 12 months after randomization measured using the electronic health record 4. Mortality rate 6 and 12 months after randomization measured using the electronic health record 5. Usability of mailed program materials and websites measured using a mailed survey at the end of the program 6. Acceptability of mailed program materials and websites measured using a mailed survey at the end of the program

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026