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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT03606304
Eligibility Criteria:
Inclusion Criteria:
1. age ≥ 65;
2. having a primary diagnosis of HF (New York Heart Association \[NYHA\] Class I, II, III) of the index hospitalization;
3. having clinically significant depressive symptoms (PHQ-9 score≥10) at both hospital discharge and four weeks after hospital discharge;
4. inadequate HF self-care ability (any domain score in the Self-Care of Heart Failure Index \[SCHFI\]≤70/100); and
5. having normal or mildly impaired cognitive function (score of Montreal Cognitive Assessment \[MoCA\]: 23-30).
Exclusion Criteria:
1. being listed for an implanted ventricular assist device, heart transplant or currently receiving Milrinone infusion (indicating decompensated HF);
2. receiving hospice care or end-of-life care;
3. having diagnoses of the following, a) delirium or advanced Alzheimer's disease, b) malignant cancer, coronary artery disease requiring surgery or angioplasty, renal disease on dialysis in the present or within the past two years, c) severe psychotic disorder or suicidal ideation (or scored "0" in PHQ-9 item #9);
4. initiation or titration of antidepressants in the past 8 weeks; or
5. inability to give informed consent and/or to communicate verbally in English.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT03606304
Study Brief:
Protocol Section:
NCT03606304