NCT00393627

Brief Summary

Sleep disturbances are widespread among demented residents of board and care homes and are a leading cause for transfer into nursing homes. This study is a randomized controlled clinical trial to evaluate the efficacy of a 4-week Sleep Education Program (SEP) for demented residents of board and care homes who are experiencing sleep disturbances. Residents of adult family homes (board and care homes with 2-6 residents) will be randomized into SEP or usual care control. Analysis of outcomes will determine whether the SEP is feasible and effective in adult family home settings, and whether the SEP delays transition into higher levels of institutional care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

3.2 years

First QC Date

October 26, 2006

Last Update Submit

June 12, 2012

Conditions

Dementia

Keywords

DementiaSleep disturbanceBehavioral strategiesAlzheimer's DiseaseAdult Family Homes

Outcome Measures

Primary Outcomes (1)

  • Actigraphy sleep estimates

    6 months

Study Arms (2)

1

EXPERIMENTAL

Sleep Education Program: The Sleep Education Program (SEP) is conducted by a licensed MS- or PhD-level mental health professional experienced in working with persons with dementia and their caregivers. The therapist meets with the AFH owner/operator and staff for four weekly sessions at the AFH. The SEP content includes information about the causes of sleep problems in dementia, and provides staff with assistance in developing customized resident behavioral sleep plans focused on environmental (light and noise), dietary (eliminating caffeine and excessive nighttime fluids), and sleep scheduling (reducing afternoon/ evening napping; consistent, appropriate bed and rising times) factors that are commonly associated with resident nighttime awakenings. A written manual is used.

Behavioral: Sleep Education Program

2

PLACEBO COMPARATOR

Routine medical care

Behavioral: Sleep Education Program

Interventions

Sleep Education ProgramBEHAVIORAL

The Sleep Education Program (SEP) is conducted by a licensed MS- or PhD-level mental health professional experienced in working with persons with dementia and their caregivers. The therapist meets with the AFH owner/operator and staff for four weekly sessions at the AFH. The SEP content includes information about the causes of sleep problems in dementia, and provides staff with assistance in developing customized resident behavioral sleep plans focused on environmental (light and noise), dietary (eliminating caffeine and excessive nighttime fluids), and sleep scheduling (reducing afternoon/ evening napping; consistent, appropriate bed and rising times) factors that are commonly associated with resident nighttime awakenings. A written manual is used.

12

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Probable or possible AD diagnosis
  • Two or more sleep problems on the Sleep Disorders inventory
  • Sleep problems occurring three or more times per week
  • Living in an Adult Family Home with owner/operator and staff willing to participate

You may not qualify if:

  • Previously diagnosed primary sleep disorder, e.g. sleep apnea or restless legs syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

DementiaParasomniasAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersSleep Wake DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Susan M McCurry, Ph.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 30, 2006

Study Start

June 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(1)