Treating Sleep Problems in VA Adult Day Health Care (HERO-ADHC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01259401
First received: December 10, 2010
Last updated: January 6, 2015
Last verified: January 2015
Results First Received: December 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Insomnia
Sleep Disorders
Interventions: Behavioral: Sleep Intervention Program
Behavioral: Sleep Education control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Veterans enrolled in the ADHC program for at least one month were screened for study eligibility criteria (i.e., the ability to understand screening items and to communicate during the screening process. If the individual was interested, written informed consent was obtained.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 72 participants were enrolled into the study. After baseline assessment, 30 participants were not eligible for randomization: too cognitive impaired to participate (13); medical or behavioral issue (n=6); no longer met criteria for insomnia (n=3); discharged from ADHC (n=4); refused randomization (n=2); withdrew (n=2).

Reporting Groups
  Description
SIP Group

The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.

Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia.

Control Group

The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care

Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education.


Participant Flow for 2 periods

Period 1:   End of 4-week Intervention
    SIP Group     Control Group  
STARTED     21     21  
COMPLETED     21     21  
NOT COMPLETED     0     0  

Period 2:   4-month Follow-up
    SIP Group     Control Group  
STARTED     21     21  
COMPLETED     21     19  
NOT COMPLETED     0     2  
Death                 0                 1  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SIP Group

The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.

Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia.

Control Group

The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care

Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education.

Total Total of all reporting groups

Baseline Measures
    SIP Group     Control Group     Total  
Number of Participants  
[units: participants]
  21     21     42  
Age  
[units: years]
Mean ± Standard Deviation
  77.7  ± 10.2     76.4  ± 9.9     77.1  ± 9.9  
Gender  
[units: participants]
     
Female     3     0     3  
Male     18     21     39  
Race/Ethnicity, Customized  
[units: participants]
     
White     13     17     30  
Non-white     8     4     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sleep Efficiency   [ Time Frame: End of 4-week intervention ]

2.  Primary:   Sleep Efficiency   [ Time Frame: 4-month follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size; predominantly male study sample


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jennifer Martin
Organization: VA Greater Los Angeles Healthcare System
phone: 818 891-7711 ext 9173
e-mail: Jennifer.Martin@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01259401     History of Changes
Other Study ID Numbers: E7037-R
Study First Received: December 10, 2010
Results First Received: December 17, 2014
Last Updated: January 6, 2015
Health Authority: United States: Federal Government