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 @ 12:30 PM
Ignite Modification Date:
2025-12-24 @ 12:30 PM
NCT ID:
NCT00119561
Eligibility Criteria:
Inclusion Criteria:
Caregiver
* Age: 21 years or older
* Family member of the care recipient
* Must live with care recipient or share cooking facilities
* Must have a telephone
* Must plan to remain in the area for the duration of the intervention and follow-up
* Caregiver role for more than 6 months
* Must provide an average of 4 hours of supervision or direct assistance per day for the care recipient
* Risk Screening Tool: must have a total score of at least 1 for question 36, and a total of at least 2 for questions 38-40 (on the Screening Form)
Care Recipient
* NINCDS (MD diagnosis) or cognitive impairment (raw score on MMSE of 23 or less)
* Must be a Veteran with dementia or being cared for by a Veteran who receives services at the Memphis VAMC
Exclusion Criteria:
Caregiver
* Active treatment (chemotherapy; radiation therapy) for cancer
* Imminent placement of care recipient into a nursing home (within 6 months)
* SPMSQ: \> 4 errors
Care Recipient
* History of Parkinson's Disease or a stroke with no reported decline in memory over the past year
* Active treatment (chemotherapy or radiation therapy) for cancer
* More than three acute medical hospitalizations in the past year (other than psychiatric or Alzheimer's Disease related admissions)
* Schizophrenia (onset of delusions before age 45) or other severe mental illness
* Dementia secondary to head trauma (probable)
* Blindness or deafness if either disability prohibits them from data collection or participation in the interventions
* MMSE = 0 and Bedbound (routinely confined to bed or chair for at least 22 hours a day, for at least 4 of the last 7 days)
* Planned nursing home admission in 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00119561
Study Brief:
Protocol Section:
NCT00119561