Your session is about to expire
← Back to Search
Behavioral Intervention
ADAPT Program for Post Intensive Care Syndrome (ADAPT Trial)
N/A
Recruiting
Led By Jessica Palakshappa, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 60 and older at time of discharge from medical intensive care unit
Minimum 72 hour Intensive Care Unit stay in medical ICU at Atrium Health Wake Forest Baptist
Must not have
Continued residence in skilled nursing facility or rehab that prevents ability to complete study telephone call at time of first cognitive screen attempt
Life-expectancy < 6 months from pre-existing illness (defined as diagnosis of metastatic cancer, cirrhosis, advanced heart failure, prior palliative care referral)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the usual care given to older adults after they leave the ICU to a new screening and support program called ADAPT. The goal is to enroll 120 older adults in the study.
Who is the study for?
This trial is for older adults aged 60 or above who have been discharged from the ICU and may be at risk of post-intensive care syndrome, dementia, or other cognitive impairments. Specific eligibility details are not provided.
What is being tested?
The study compares usual post-ICU care with a new intervention called ADAPT which includes screening and support to prevent cognitive decline. It's a randomized control trial aiming to enroll 120 participants.
What are the potential side effects?
Since the interventions involve usual care practices and additional screening/support measures, side effects are not typical as with drug trials but could include emotional distress or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older and was recently in the ICU.
Select...
I stayed in the ICU at Atrium Health Wake Forest Baptist for at least 72 hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I live in a facility that makes it hard for me to take part in study calls.
Select...
My doctor expects I have more than 6 months to live despite my serious illness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants in Cognitive Screening Intervention Arm
Secondary study objectives
Acceptability of Feasibility of Intervention measure (FIM) Scores
Acceptability of Intervention Appropriateness Measure (IAM) Scores
Acceptability of Intervention Measure (AIM) Scores
+7 moreOther study objectives
Qualitative Perception
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Anticipating Decline and Providing Therapy (ADAPT) careExperimental Treatment1 Intervention
The program includes a routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge
Group II: Usual CareActive Control1 Intervention
routine clinic visits
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,804 Previous Clinical Trials
28,194,779 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,477,815 Total Patients Enrolled
Jessica Palakshappa, MDPrincipal InvestigatorWake Forest University Health Sciences