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Alzheimer DiseaseNCT05143255

Developing a Communication Intervention for People With Memory Challenges and Their Care Partners

A study testing KNOW in people with Alzheimer Disease and Dementia, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed research is consistent with broader public health goals focused on improving communication regarding end-of-life care and the Centers for Medicare and Medicaid Services' (CMS) call for increased patient engagement in advance care planning (ACP) as part of standard care. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease, Dementia
What is being tested?
KNOW
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
9 Dec 2024to 5 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Below we outline criteria for patient/care recipient (CR) (which includes patient/CR only or patient/CR enrolled as part of a dyad), care partner (CR) (which includes CR only or CR enrolled as part of a dyad), and dyad only relevant eligibility criteria:

Patient/care recipient (CR) eligibility criteria:

  1. Montreal Cognitive Assessment-Blind (MoCA-B) score of 9-18;
  2. decision-making capacity to consent to a low risk study as indicated by a score of ≥9 on the University of California-San Diego Brief Assessment of Capacity to Consent, a 10-item measure validated in patients with challenges in memory;
  3. capacity to execute a Health Care Proxy, as indicated by a score of ≥ 11 on the validated and reliable HCP Guidelines for ability to execute a HCP among nursing home residents;
  4. age ≥ 65;
  5. reports receiving care and/or support from an unpaid care partner; and
  6. reports that at least one of their ADs has not been completed (for CR's enrolled without a CP only).

A MoCA-B score of 9-18 is consistent with clinical guidelines for an average MoCA score for individuals with mild Alzheimer's disease and is within the threshold for having capacity to complete advance directives. Patients with this score are mobile, communicative, and generally involved in making medical care decisions. While patients must report having a care partner to be eligible, the patient can be enrolled in the study even if their care partner is not enrolled.

Care partner (CP) eligibility criteria:

  1. provides informal (unpaid) care for a person with memory challenges, per self-report;
  2. MoCA-B score of ≥19; and reports that at least one of the CR's ADs has not been completed (for CPs enrolled without a patient only).

While care partners must report caring for a person with memory challenges, the care partner can be enrolled in the study even if the patient is not enrolled.

Eligibility criteria for CRs and CPs enrolled as a dyad: In addition to the criteria above for CR and CP: (1) the CR and/or CP report that at least one of the CR's ADs has not been completed.

Patient and care partner exclusion criteria:

  1. not fluent in English;
  2. ≤17 years of age;
  3. too ill or weak to complete the interviews (per the interviewer);
  4. presence of significant sensory, language, or motor deficit (e.g., visual or hearing loss, paralysis, aphasia) (per self report, the interviewer or medical record); or
  5. patient is in the late stage of dementia (i.e., severe cognitive impairment), is bed-bound, or has a nursing home admission planned within 12 months per CP report or the medical record.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Cornell Medicine

    New York, New York, 10065

Other trials in United States

About this study

Official title: Developing a Communication Intervention to Help People With Memory Challenges and Their Care Partners Engage in Advance Care Planning

The proposed research is consistent with broader public health goals focused on improving communication regarding end-of-life care and the Centers for Medicare and Medicaid Services' (CMS) call for increased patient engagement in advance care planning (ACP) as part of standard care. The proposed study will address this public health issue by developing a communication-based intervention designed to improve Alzheimer's Disease and Related Dementias (ADRD) patients' and care partners' engagement in ACP, distress and care partner burden, and completion of advance directives and receipt of goal-concordant care at the end-of-life. Therefore, this study is aligned with the National Institute on Aging's long-term goal to improve the quality of care for ADRD patients and CMS's goal to increase engagement in ACP.

Read the detailed description

The goals of this study are to: (1) develop a communication-based intervention, called KNow the Optimal Way (KNOW) for Alzheimer's Disease and Related Dementias (ADRD) patients and care partners that includes theoretically grounded communication strategies (e.g., acknowledgment, validation of fears) and distress management techniques (e.g., deep breathing, muscle relaxation); (2) evaluate the feasibility and acceptability of the intervention; and (3) test the preliminary efficacy of the intervention on ADRD patients' and care partners' preparedness for and engagement in advance care planning (ACP), and completion of advance directives (primary outcomes) as well as patient-care partner concordance on the person with dementia (PWD)'s healthcare values, perceived need for ACP, psychological distress, communication quality, and care partner burden (secondary outcomes).

Being tested
KNOW
Keywords
caregiving, advance care planning, communication
Medical subject headings
Alzheimer Disease, Dementia, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KNOWBehavioural

    KNow the Optimal Way (KNOW) is a manualized ADRD patient-care partner intervention designed to increase engagement in advance care planning (ACP) and completion of advance directives among early stage ADRD patients and their care partners using theoretically grounded distress tolerance techniques (inhibitory learning theory) and communication skills (cognitive-social processing theory) consistent with recommended guidelines for discussions about ACP in ADRD care.

Study groups in NCT05143255
Study groupRoleWhat they receive
KNOW InterventionExperimentalNot described
Receives: Behavioral: KNOW

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in advance care planning preparedness, as measured by the Advance Care Planning Engagement Survey: Process Measures

    Change in advance care planning preparedness will be assessed in patients and care partners using the reliable and valid Advance Care Planning Engagement Survey: Process Measures (31-items). Response options range from 1=never to 5=a lot. Questions include those asking about knowledge of advance care planning, degree of contemplation about advance care planning, and self-efficacy and readiness to engage in advance care planning. Overall scores can range from 31 to 155, with higher scores indicating more engagement in advance care planning.

    Measured: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

  2. Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures

    Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options range from 1=never to 5= a lot. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Scores can range from 4 to 20, with higher scores indicating that more decisions have been made around advance care planning.

    Measured: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

  3. Change in care partners' engagement in advance care planning, as measured by the Van Scoy and Sudore measure which adapts the Decision Maker subscale of the Advance Care Planning Engagement Survey

    Change in care partner engagement in advance care planning will be assessed with a companion measure in the final phases of validation by Van Scoy and Sudore. This measure adapts the Advance Care Planning Engagement Survey to apply to care partners. Response options range from 1=never to 5=a lot. Scores can range from 4 to 20, with higher scores indicating more decisions have been made.

    Measured: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

  4. Change in discussion of advance directives

    Discussion of advance directives will be assessed with an 8-item measure that asks persons with ADRD and care partner whether the patient has discussed end-of-life care, living will, health care proxy, and DNR orders with family/patient and doctor/patient's doctor. Response options are yes or no. A total score is created by adding up the number of discussions, which can range from 0 to 8, with 0 meaning no discussions have occurred (low score) to 8, meaning all discussions have occurred (high score).

    Measured: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

  5. Change in the number of patients who have completed advance directives

    Completion of advance directives will be assessed by asking patients whether they have completed a do-not-resuscitate order, a living will, and/or or identified a health care proxy; data will be verified through the patient's electronic health record. Completion will be scored a 0 if the patient has completed none and 1 if they have completed one or more of the advance directives. Additional analyses will be done on each individual advance directive (e.g., 0 if no DNR order, 1 if yes to completing DNR order).

    Measured: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

Secondary outcomes (6)

  1. Change in concordance on healthcare values, as measured by the Health Care Values Rating Scale

    Change in concordance on healthcare values will be assessed by ADRD patients' and care partners' ratings of the ADRD patient's values on the Health Care Values Rating Scale, a 13-item measure of the degree to which various values influence medical treatment decisions developed in ADRD patients. Each item is rated on a three-point Likert scale (1=influence not at all to 3=influence a lot). Concordance will be defined as a difference of one or less per item between responses of ADRD patients and their care partners (rating the ADRD patient's values).

    Measured: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

  2. Change in perceived need for advanced care planning (ACP), as measured by the Decisional Balance scale

    Change in perceived need for advance care planning will be assessed with the reliable and validated Decisional Balance scale, a 12-item scale that assesses perceived pros and cons of engaging in ACP. Each item is rated on a five-point Likert scale (1=not important to 5=extremely important) indicating how important a certain feature of advance care planning is. Overall scores can range from 12 (low importance) to 60 (high importance).

    Measured: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

  3. Change in psychological distress/depression, as measured by the Center for Epidemiological Studies Depression Scale

    Change in psychological distress will be assessed with the 20-item Center for Epidemiological Studies Depression Scale which has demonstrated validity in ADRD patients and their care partners and the seven-item anxiety subscale of the Hospital Anxiety and Depression Scale. Each item rates the degree of occurrence of certain depressive features from rarely or none of the time (less than 1 day) to most or all of the time (5-7 days). Total scores can range from 20 to 80, with higher scores indicating higher frequency.

    Measured: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

  4. Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS)

    Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), a valid and reliable 14-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. The HADS contains two seven-item subscales: 1) anxiety and 2) depressive symptoms. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS total score. Total scores can range from 0 to 42, with higher numbers indicating higher levels of distress.

    Measured: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

  5. Change in communication quality, as measured by the Family Communication Subscale of the Cancer Communication Assessment Tool for Patients and Families (CCAT-PF)

    Communication quality will be assessed with the 5-item Family Communication subscale of the Cancer Communication Assessment Tool for Patients and Families, a valid measure in cancer patients and care partners. Response options are on a 5-point Likert-type scale (1 = strongly disagree to 5= strongly agree). Scores can range from 5 to 25, with higher scores indicating worse communication quality.

    Measured: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

  6. Change in care partner burden (care partner only), as measured by the Zarit Burden Interview

    Care partner burden will be assessed with the Zarit Burden Interview (ZBI), a reliable and valid 22-item measure of caregiver (care partner) burden used in intervention studies of cancer caregivers (care partners). Response options are on a 5-point Likert-type scale (0 = never to 4=nearly always). Scores can range from 0 to 88, with higher scores indicating higher levels of burden.

    Measured: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2021
  2. Study start9 Dec 2024
  3. Primary completion5 Feb 2026
  4. Study completion5 Feb 2026

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05143255
Sponsor's protocol ID
21-04023598
Other IDs
R21AG070501
Status last verified
Mar 2026
First submitted
18 Nov 2021
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing KNOW in people with Alzheimer Disease and Dementia, run by Weill Medical College of Cornell University 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?

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: finished, as of the sponsor's last update on 25 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in advance care planning preparedness, as measured by the Advance Care Planning Engagement Survey: Process Measures (time frame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05143255.

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 25 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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