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A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers

A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Care2Sleep improves sleep, health, and quality of life for people with Alzheimer's disease or related dementia and their caregivers. Pairs are assigned by chance to five sessions of Care2Sleep in person, Care2Sleep by video visit, or an in-person education program. The study also measures inflammation, the body's response to injury or illness, in caregivers.

This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). Eligible participants will be randomly assigned to in-person Care2Sleep, telehealth Care2Sleep, or to an in-person education control group. The Care2Sleep programs and the control education program will consist of five sessions. The intervention and control programs will begin after baseline assessment and randomization. Posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients must be older than 60 and have Alzheimer's disease or related dementia listed in their medical record.
  • Patients must live in the community, not a care facility, and have an eligible caregiver.
  • Patients must have more than one sleep problem more than three times a week on a nighttime behavior checklist.
  • Patients must have no untreated sleep disorders, such as breathing pauses during sleep or restless legs.
  • Caregivers must be older than 18, live with the patient, and be a family member, partner, or friend.
  • Caregivers must have regularly helped with more than one basic daily task or more than one household task for the past six months.
  • Caregivers must score above 5 on a sleep quality test and at least 23 on a memory and thinking test.
  • Caregivers must be able to communicate in English.

Who can't join

  • Patients who cannot get out of bed or walk, even with a walking aid.
  • Patients with a severe illness and an expected lifespan of less than six months.
  • Paid, professional caregivers.
  • Pairs in which either the patient or caregiver does not meet all study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria for Patients * Have a diagnosis of Alzheimer's disease (probable or possible) or other related dementia as documented in an electronic medical record * Community-dwelling * \>1 sleep problems \>3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale, - - Aged \>60 years * Have no untreated sleep disorders (e.g., sleep apnea, restless legs syndrome) * Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound) * Have no severe medical conditions with a life expectancy of less than 6 months * Have an eligible caregiver Inclusion Criteria for Caregivers * Live with an eligible patient * Aged \>18 years * Is related to the patient as a family member, a significant other, or a friend * Have regularly assisted patient with \>1 of 6 basic activities of daily living (ADLs; i.e., bathing, dressing, toileting, transferring, continence, feeding) or \>1 of 8 Instrumental ADL (IADLs; i.e., using the telephone, shopping, food preparation, housekeeping, laundry, transportation, taking medications, managing money) for the past 6 months * Pittsburgh Sleep Quality Index (PSQI) total score \>5 * Montreal Cognitive Assessment (MoCA) ≥23 * Can communicate in English Exclusion Criteria: * Patients will be excluded if they are bedbound or have severe medical conditions with a life expectancy of less than 6 months. * Paid, professional caregivers will also be excluded. * If the eligibility criteria for either a patient or a caregiver are not met, the dyads will be excluded for this study.

Study sites (3)

CA