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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT02420535
Eligibility Criteria:
Inclusion Criteria:
General
* Age 21 years or older
* Ability to read, speak and understand English
* Home location within 50 miles of the study site Caregivers (CG)
* Active primary caregiver of a Person with Dementia (PwD) for at least 6 months and planning to remain the primary caregiver for the next 2 months
* Currently living with the PwD
* CG plans to live in the area for the duration of the study
* Is familiar and comfortable utilizing technology (e.g. computers, tablets, the internet)
Persons with Dementia (PwD)
* CG reports that the PwD exhibits at least one or more behavioral symptoms (any behavior at any frequency)
* PwD receiving psychotropic medication or cognitive enhancers will not be excluded.
* If PwD is on any of four classes of psychotropic medications (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) or an anti-dementia medication (memantine or a cholinesterase inhibitor), we will require that he/she have been on a stable dose for 60 days prior to enrollment (typical time frame in clinical trials) to minimize possible confounding effects of concomitant medications.
* Clinical diagnosis of dementia (any type) or a score of less than 24 on the Mini-Mental State Examination (MMSE)
Exclusion Criteria:
General
* Inability to read, speak or understand English
* Home location greater than 50 miles from the study site
* Lack of regular access to a telephone Caregivers (CG)
* Reading literacy of less than 6th grade
* Visual impairment to the extent of prohibiting interaction with the tool
* Hearing impairment sufficient to prohibit telephone communication
* Other self-identified mental or physical health issues that would distinctly interfere with the ability to reasonably test the tool or complete behavioral interventions (e.g. substance use disorder, schizophrenia, severe mobility issues)
* Hospitalized more than 3 times in the past year
* Participating in another study to help caregivers care for the person with dementia.
Persons with Dementia (PwD)
* At a terminal phase of illness, unable to respond to the environment or with a life expectancy less than 6 months
* Active suicide risk
* Imminent placement to nursing home (within the next 60 days)
* Hospitalized more than 3 times in the past year
* Currently in another study testing a medication to control behavioral symptoms
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02420535
Study Brief:
Protocol Section:
NCT02420535