Cognitive ImpairmentADAPTNCT06182995
Anticipating Decline and Providing Therapy
A study testing Anticipating Decline and Providing Therapy (ADAPT) in people with Cognitive Impairment and Dementia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment, Dementia, Post ICU Syndrome
- What is being tested?
- Anticipating Decline and Providing Therapy (ADAPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: Anticipating Decline and Providing Therapy (ADAPT): Post-ICU Cognitive Screening Pilot and Feasibility Randomized Controlled Trial
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).
Read the detailed description
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.
- Conditions
- Cognitive Impairment, Dementia, Post ICU Syndrome, Critical Illness, Cognitive Impairment, Mild
- Being tested
- Usual Care post-Intensive Care Unit (ICU), Anticipating Decline and Providing Therapy (ADAPT)
- Keywords
- Post ICU, Post-ICU Screening, older adults, aging
- Medical subject headings
- Cognitive Dysfunction, Dementia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care post-Intensive Care Unit (ICU)Behavioural
Also called routine clinic visits
routine clinic visits
Anticipating Decline and Providing Therapy (ADAPT)Behavioural
Also called Post-ICU cognitive screening
routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | routine clinic visits Receives: Behavioral: Usual Care post-Intensive Care Unit (ICU) |
| Anticipating Decline and Providing Therapy (ADAPT) care | Experimental | The program includes a routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge Receives: Behavioral: Anticipating Decline and Providing Therapy (ADAPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in Cognitive Screening Intervention Arm
Number of participants in intervention arm who complete cognitive screening at 6 weeks
Measured: Week 6
Secondary outcomes (10)
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
Measured: 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
Measured: Week 52
Number of eligible participants who complete specialized care plan development visit
Number of eligible participants who complete specialized care plan development visit
Measured: 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
Measured: 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
Measured: Month 12
Change in the Number of neuropsychiatric prescriptions medications
number of neuropsychiatric prescriptions medications will be measured using the electronic health record
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start8 Mar 2024
- Primary completion1 Mar 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Target sample size is 120 participants, randomized 1:1 to usual care or Anticipating Decline and Providing Therapy (ADAPT) arm.
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jessica Palakshappa, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182995
- Sponsor's protocol ID
- IRB00102934
- Other IDs
- 1K23AG073529
- Acronym
- ADAPT
- Status last verified
- Aug 2026
- First submitted
- 30 Nov 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticipating Decline and Providing Therapy (ADAPT): Post-ICU Cognitive Screening Pilot and Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06182995
- Acronym / sponsor ID
- ADAPT / IRB00102934
- Conditions
- Cognitive Impairment, Dementia, Post ICU Syndrome, Critical Illness, Cognitive Impairment, Mild
- Keywords
- Post ICU, Post-ICU Screening, older adults, aging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Target sample size is 120 participants, randomized 1:1 to usual care or Anticipating Decline and Providing Therapy (ADAPT) arm.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual Care post-Intensive Care Unit (ICU)routine clinic visits |
| Anticipating Decline and Providing Therapy (ADAPT) care | Experimental | Behavioral: Anticipating Decline and Providing Therapy (ADAPT)The program includes a routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Care post-Intensive Care Unit (ICU)Also: routine clinic visitsroutine clinic visits | Behavioural | Usual Care |
| Anticipating Decline and Providing Therapy (ADAPT)Also: Post-ICU cognitive screeningroutine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge | Behavioural | Anticipating Decline and Providing Therapy (ADAPT) care |
Primary outcome
Number of participants in Cognitive Screening Intervention Arm
Time frame: Week 6
Number of participants in intervention arm who complete cognitive screening at 6 weeks
10 secondary outcomes
Change in Percentage of participants 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
Time frame: Week 52
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
Time frame: Week 28
Change in the number of hospitalizations and Emergency Department visits
Time frame: Month 12
Change in the Number of neuropsychiatric prescriptions medications
Time frame: Month 12
Change in number of new diagnoses of dementia or mild cognitive impairment
Time frame: Month 12
Acceptability of Intervention Measure (AIM) Scores
Time frame: Week 28
Acceptability of Intervention Appropriateness Measure (IAM) Scores
Time frame: Week 28
Acceptability of Feasibility of Intervention measure (FIM) Scores
Time frame: Week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Palakshappa, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticipating Decline and Providing Therapy (ADAPT) in people with Cognitive Impairment and Dementia, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants in Cognitive Screening Intervention Arm (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.