Eligibility Module

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: 2025-12-25 @ 12:35 AM
Ignite Modification Date: 2025-12-25 @ 12:35 AM
NCT ID: NCT00259467
Eligibility Criteria: Inclusion Criteria: * Care Recipient * English Speaking * NINCDS-ADRDA diagnosis\[physician generated of dementia or mini-mental state examination score of less than or equal to 23;3\] Able to feel self; and participates in at least 2 other activities of daily living\[ADLs-Bathing, Dressing, Grooming, Toileting, Transferring from bed to chair\] As reported by caregiver. * Caregiver * English Speaking * Family member 21 years of age or older \[male or female\] * Lives with Care Recipient * Has telephone in the home * Plans to live in area for 8 months * Indicated willingness to learn new approaches by which to engage care recipient in meaningful activities * Provides 4 or more hours a day directly caring or providing for care recipient Exclusion Criteria: * Care Recipient * Has Schizophrenia or Bi-Polar Disorder * Their Dementia is secondary to probable head trauma * Their MMSE score is equal to zero and they are bed bound, defined as confinement to bed or chair for at least 22 hours a day for at least 4 of 7 days * They are not responsive to their environment * Caregiver * Are currently involved in another clinical trial of psycho-social or educational interventions for caregivers * Are planning to place their family member in a nursing home within the next 8 months. Also, the care recipient/caregiver dyad will be excluded if either caregiver or care recipient: 1) has a terminal illness with life expectancy less than 8 months 2)is in active treatment for cancer or 3) has had greater than 3 acute medical hospitalizations within the past year.
Healthy Volunteers: False
Sex: ALL
Minimum Age: 21 Years
Study: NCT00259467
Study Brief:
Protocol Section: NCT00259467