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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT05567120
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18
* English speaking
* Informal caregiver of an individual with ADRD diagnosis
* Lives with or near the care recipient
* Provides at least 10 hours of care per week to a person with ADRD
* Has provided care to a person with ADRD for 6 months or more, prior to enrollment
* Cognitively intact (Score of ≥ 26 on adjusted MoCA-Blind)
* Score of ≥ 12 on the Negative Affect Scale of Positive and Negative Affect Schedule OR at least one significant negative emotion (score of ≥ 3)
Exclusion Criteria:
* Age ≤ 18
* Non-English speaking
* Paid caregiver
* Care recipient does not have ADRD diagnosis
* Provides care for less than 10 hours per week
* Has provided care for less than 6 months, prior to enrollment
* Care recipient is currently enrolled in hospice
* Meets criteria for severe Major Depression (Montgomery Asberg Depression Rating Scale ≥ 30) that may require hospitalization
* Significant Cognitive impairment (Score of \< 26 on adjusted MoCA-Blind)
* Score of \< 12 on the Negative Affect Scale of Positive and Negative Affect Schedule or no significant negative emotion
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05567120
Study Brief:
Protocol Section:
NCT05567120