An interventional study of Usual Care post-Intensive Care Unit (ICU) and Anticipating Decline and Providing Therapy (ADAPT) in Cognitive Impairment, Dementia and Post ICU Syndrome, sponsored by Wake Forest University Health Sciences. Active, not recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
This pilot feasibility study will be a randomized control trial of usual care following Intensive Care Unit (ICU) discharge compared to the Anticipating Decline and Providing Therapy (ADAPT) screening and support intervention. The trial aims to enroll 120 older adults (age 60 or older).
Anticipating Decline and Providing Therapy (ADAPT) is a program designed to support the implementation of a routine post-ICU cognitive impairment screening and support intervention. The program includes a routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge. Patients with a screening assessment that may be consistent with cognitive impairment or dementia will receive additional resources including a specialized care plan developed by the Sticht Center for Healthy Aging and Alzheimer's Prevention. The specialized care plan is adapted from a health system-based dementia care intervention and designed to support post-ICU cognitive concerns. It was adapted with input from geriatrics, intensive care, and outpatient primary care clinicians. Also conducted are semi-structured interviews with 22 older adult ICU survivors and 6 primary care physicians to elicit preferences and the intervention was further adapted based on these results.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 109 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
routine clinic visits
Behavioral: Usual Care post-Intensive Care Unit (ICU)
The program includes a routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge
Behavioral: Anticipating Decline and Providing Therapy (ADAPT)
routine clinic visits
Also known as: routine clinic visits
routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge
Also known as: Post-ICU cognitive screening
Number of participants in Cognitive Screening Intervention Arm
Number of participants in intervention arm who complete cognitive screening at 6 weeks
Time frame: Week 6
Change in Percentage of participants having mild cognitive impairment (MCI), probable dementia and the combination of either MCI or probable dementia
percentage of participants adjudicated as having mild cognitive impairment (MCI), probable dementia and the combination of either MCI or probable dementia
Time frame: Week 28
Change in number of Participants between those enrolled and those who were eligible but declined
compare pre-specified baseline characteristics (i.e., age, sex, race, ICU length of stay) between those enrolled and those who were eligible but declined
Time frame: Week 52
Number of eligible participants who complete specialized care plan development visit
Number of eligible participants who complete specialized care plan development visit
Time frame: up to week 28
Change in Modified Caregiver Strain Index (MCSI) Scores
the modified caregiver strain index will be assessed via telephone call to identified caregiver or care partner in both groups - a 13-question tool that measures strain related to care provision - Scoring is 2 points for each 'yes', and 1 point for each 'sometimes' response. The higher the score, the higher the level of caregiver strain - range of 13-26
Time frame: Week 28
Change in the number of hospitalizations and Emergency Department visits
healthcare utilization will be the number of hospitalizations and Emergency Department (ED) visits
Time frame: Month 12
Change in the Number of neuropsychiatric prescriptions medications
number of neuropsychiatric prescriptions medications will be measured using the electronic health record
Time frame: Month 12
Change in number of new diagnoses of dementia or mild cognitive impairment
new diagnosis of dementia or mild cognitive impairment will be measured using the electronic health record
Time frame: Month 12
Acceptability of Intervention Measure (AIM) Scores
The Acceptability of Intervention Measure (AIM) - Response Scale - 4 item scales. Each item will be measured on a 5 point Likert scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree - The score is calculated mean. Higher scores reflect higher measure of acceptability
Time frame: Week 28
Acceptability of Intervention Appropriateness Measure (IAM) Scores
Intervention Appropriateness Measure (IAM) - Response Scale - 4 item scales. Each item will be measured on a 5 point Likert scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree - The score is calculated mean. Higher scores reflect higher measure of appropriateness
Time frame: Week 28
Acceptability of Feasibility of Intervention measure (FIM) Scores
The Acceptability of Feasibility of Intervention Measure (FIM) - Response Scale - 4 item scales. Each item will be measured on a 5 point Likert scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree - The score is calculated mean. Higher scores reflect higher measure of feasibility
Time frame: Week 28
Qualitative Perception
semi-structured interviews with participants for feedback about the intervention - this will not be a numerical score
Time frame: Week 28
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences