RECRUITING

Anticipating Decline and Providing Therapy

Conditions

Cognitive Impairment Dementia Post ICU Syndrome Critical Illness Cognitive Impairment, Mild Post ICU Post-ICU Screening older adults aging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Anticipating Decline and Providing Therapy (ADAPT): Post-ICU Cognitive Screening Pilot and Feasibility Randomized Controlled Trial

Quick Facts

Study Start:2024-03-08

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06182995

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 60 and older at time of discharge from intensive care unit * Minimum 72 hour Intensive Care Unit stay in an ICU at Atrium Health Wake Forest Baptist * Delirium during ICU stay as determined by positive Confusion Assessment Method (CAM)-ICU score, review of clinical - documentation, or discussion with clinical team * Primary care provider in the Atrium Health Wake Forest system or intention to follow with Primary Care Physician in Atrium Health system * English speaking	* Death during initial hospitalization and/or discharge to Hospice * Life-expectancy \< 6 months from pre-existing illness (defined as diagnosis of metastatic cancer, cirrhosis, advanced heart failure, prior palliative care referral) * Acute Traumatic Brain Injury * Continued residence in skilled nursing facility or rehab that prevents ability to complete study telephone call at time of first cognitive screen attempt * Prior history of dementia in electronic health record * Language or communication barrier that prohibits intervention participation * Participant cannot identify family or caregiver contact or family/caregiver unwilling to participate * Subject or legally authorized representative (LAR) decline consent * Unstable telephone service for contact after hospital discharge * Primary residence outside of North Carolina

Inclusion Criteria

Exclusion Criteria

* Age 60 and older at time of discharge from intensive care unit
* Minimum 72 hour Intensive Care Unit stay in an ICU at Atrium Health Wake Forest Baptist
* Delirium during ICU stay as determined by positive Confusion Assessment Method (CAM)-ICU score, review of clinical - documentation, or discussion with clinical team
* Primary care provider in the Atrium Health Wake Forest system or intention to follow with Primary Care Physician in Atrium Health system
* English speaking

* Death during initial hospitalization and/or discharge to Hospice
* Life-expectancy \< 6 months from pre-existing illness (defined as diagnosis of metastatic cancer, cirrhosis, advanced heart failure, prior palliative care referral)
* Acute Traumatic Brain Injury
* Continued residence in skilled nursing facility or rehab that prevents ability to complete study telephone call at time of first cognitive screen attempt
* Prior history of dementia in electronic health record
* Language or communication barrier that prohibits intervention participation
* Participant cannot identify family or caregiver contact or family/caregiver unwilling to participate
* Subject or legally authorized representative (LAR) decline consent
* Unstable telephone service for contact after hospital discharge
* Primary residence outside of North Carolina

Contacts and Locations

Study Contact

Taniya Wilson, MS

CONTACT

336-716-6591

tamwilso@wakhealth.edu

Jessica Palakshappa, MD

CONTACT

336-716-8465

jpalaksh@wakehealth.edu

Principal Investigator

Jessica Palakshappa, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Jessica Palakshappa, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-08

Study Completion Date2027-03

Study Record Updates

Study Start Date2024-03-08

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

Post ICU
Post-ICU Screening
older adults
aging

Additional Relevant MeSH Terms

Cognitive Impairment
Dementia
Post ICU Syndrome
Critical Illness
Cognitive Impairment, Mild