Trial Outcomes & Findings for Treating Sleep Problems in VA Adult Day Health Care (NCT NCT01259401)

NCT ID: NCT01259401

Last Updated: 2025-02-25

Results Overview

Percentage of time asleep while in bed estimated by actigraphy

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: End of 4-week intervention
• Results posted on: 2025-02-25

Participant Flow

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.

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).

Participant milestones

Measure	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.
End of 4-week Intervention STARTED	21	21
End of 4-week Intervention COMPLETED	21	21
End of 4-week Intervention NOT COMPLETED	0	0
4-month Follow-up STARTED	21	21
4-month Follow-up COMPLETED	21	19
4-month Follow-up NOT COMPLETED	0	2

Reasons for withdrawal

Measure	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.
4-month Follow-up Death	0	1
4-month Follow-up Lost to Follow-up	0	1

Baseline Characteristics

Treating Sleep Problems in VA Adult Day Health Care

Baseline characteristics by cohort

Measure	SIP Group n=21 Participants 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 n=21 Participants 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 n=42 Participants Total of all reporting groups
Age, Continuous	77.7 years STANDARD_DEVIATION 10.2 • n=5 Participants	76.4 years STANDARD_DEVIATION 9.9 • n=7 Participants	77.1 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized White	13 participants n=5 Participants	17 participants n=7 Participants	30 participants n=5 Participants
Race/Ethnicity, Customized Non-white	8 participants n=5 Participants	4 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: End of 4-week intervention

Population: Two SIP subjects had missing data for this variable.

Percentage of time asleep while in bed estimated by actigraphy

Outcome measures

Measure	SIP Group n=19 Participants 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 n=21 Participants 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.
Sleep Efficiency	86.6 percentage of time in bed spent asleep Interval 84.3 to 88.8	83.3 percentage of time in bed spent asleep Interval 81.2 to 85.4

PRIMARY outcome

Timeframe: 4-month follow-up

Population: Two SIP subjects had missing data for this variable.

Percentage of time asleep while in bed estimated by actigraphy.

Outcome measures

Measure	SIP Group n=19 Participants 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 n=19 Participants 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.
Sleep Efficiency	85.3 percentage of time in bed asleep Interval 82.5 to 88.1	81.5 percentage of time in bed asleep Interval 78.7 to 84.3

Adverse Events

SIP Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SIP Group n=21 participants at risk 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 n=21 participants at risk 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.
Skin and subcutaneous tissue disorders Wrist abrasion from actigraph	4.8% 1/21 • Four months	4.8% 1/21 • Four months

Additional Information

Dr. Jennifer Martin

VA Greater Los Angeles Healthcare System

Phone: 818 891-7711

Email: Jennifer.Martin@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place