Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT02057068
Eligibility Criteria:
Inclusion Criteria:
* Care recipient must be age 60 and over and require assistance from the identified caregiver with more than one Activity of Daily Living or three or more Instrumental Activities of Daily Living,
* have a life expectancy of greater than or equal to six (6) months,
* have no plans for transitioning out of home in the next six months,
* and have approval from the primary care provider to participate in the research.
* Caregivers must live with care recipient
* Caregivers must obtain a negative mini-cog assessment or negative TICS-m assessment. Caregivers can be any relation (spouse, child, sibling, friend, etc.) to the care recipient so long as the two are cohabitating.
* Caregiver can be any age.
* For Phase 2 and Phase 3 of the study, either the care recipient or the caregiver must have difficulty sleeping as indicated by scores on the Insomnia Severity Index.
Exclusion Criteria:
* Parkinson's with tremor or other movement disorder that would invalidate actigraphy
* Untreated diagnosis of sleep apnea or restless leg syndrome
* Inability to tolerate actigraphy
* CG and CR sleep efficiency \> 85% and/or both members of dyad report sleeping well
* Caregivers must have a negative screen with the Mini-Cog or the ModifiedTelephone Interview for Cognitive Status (TICS-M) to demonstrate cognitive capacity to provide informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02057068
Study Brief:
Protocol Section:
NCT02057068