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Behavioral Sleep Intervention in Adult Family Homes

Primary Purpose

Dementia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sleep Education Program
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Dementia, Sleep disturbance, Behavioral strategies, Alzheimer's Disease, Adult Family Homes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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.

Routine medical care

Outcomes

Primary Outcome Measures

Actigraphy sleep estimates

Secondary Outcome Measures

Full Information

First Posted
October 26, 2006
Last Updated
June 12, 2012
Sponsor
University of Washington
Collaborators
Alzheimer's Association
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1. Study Identification

Unique Protocol Identification Number
NCT00393627
Brief Title
Behavioral Sleep Intervention in Adult Family Homes
Official Title
Efficacy of Behavioral Interventions to Improve Sleep in Adult Family Homes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Alzheimer's Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study addresses the clinical problem of sleep and nighttime behavioral disturbances in older adults with dementia living in board and care homes. Board and care facilities provide room and board, 24-hour supervision, and assistance with personal care tasks for two or more residents not related to the owner or operator. Many elderly persons who need residential care choose board and care facilities over the alternatives because of their small size and homelike environment. Adult family homes (AFHs) are small board and care homes with 2-6 residents. Sleep and nighttime behavioral disturbances such as wandering, getting out of bed repeatedly, and day/night confusion are widespread among demented residents of AFHs, and are a leading cause for transfer into nursing homes. However, little is known about how best to treat these problems. Adult family homes vary widely in their type of ownership, staffing schedules, physical environment, resident eligibility criteria, physician access, level of family involvement, and ratio of private/public pay clients. There have been no sleep intervention studies conducted in AFHs, and strategies that have been shown to improve sleep in community-dwelling or nursing home patients may not be feasible or effective in AFH settings. Residents of AFHs have higher rates of functional and health problems that can contribute to sleep disturbances than do community-dwelling patients, and paid caregivers have demanding on-the-job responsibilities and schedules not typically faced by family caregivers. In contrast to skilled nursing facilities, AFH employees often live 24-hours on-site, have limited training in dementia care, and have no licensed health care professionals supervising day-to-day activities. Identification of strategies that could be used as part of a staff educational program to manage sleep and nighttime behavioral disturbances in this unique environment is sorely needed. If successful, such strategies would help residents remain in a less restrictive environment for a longer time, and enhance resident quality of life. The goal of the project is test the efficacy of a 4-session behavioral intervention for improving sleep and reducing nighttime behavioral disturbances in dementia residents of adult family homes compared to AFH residents in a usual care control condition. This project builds upon previous research conducted by the Principal Investigator showing that brief behavioral interventions can improve sleep of persons with Alzheimer's disease who are living in the community with family caregivers. It applies rigorous methodology to determine whether these interventions are equally feasible and effective in adult family home settings, and whether they delay transition into higher levels of institutional care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia, Sleep disturbance, Behavioral strategies, Alzheimer's Disease, Adult Family Homes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Routine medical care
Intervention Type
Behavioral
Intervention Name(s)
Sleep Education Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Actigraphy sleep estimates
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Previously diagnosed primary sleep disorder, e.g. sleep apnea or restless legs syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan M McCurry, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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Behavioral Sleep Intervention in Adult Family Homes

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