Developing a Communication Intervention for People With Memory Changes and Their Caregivers

Alzheimer Disease Clinical Trial

Official title:

A Communication-based Intervention for Early Stage Dementia Patient-caregiver Dyads to Increase Engagement in Advance Care Planning and Reduce Caregiver Burden

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05143255
• Other study ID #: 21-04023598
• Secondary ID: R21AG070501
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Weill Medical College of Cornell University
• Contact: Samantha Lang, PhD
• Phone: 646-397-8178
• Email: sfl4001[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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' understanding of the disease trajectory, 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.

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), completion of advance directives, and understanding of disease trajectory (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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient Inclusion Criteria:

1. Montreal Cognitive Assessment (MoCA) score of =11-21

2. score of =9 on the University of California-San Diego Brief Assessment of Capacity to Consent,

3. capacity to execute a Health Care Proxy,

4. identification of an informal CP.

5. age = 65

6. impaired autonomy in memory function, ADLs, or IADLs per the care partner's report.

Care Partner Inclusion Criteria:

1. the person whom the patient indicates provides their informal (unpaid) care

2. MoCA score of =26

Exclusion Criteria for Patient or Care Partner:

• not fluent in English

• =17 years of age

• too ill or weak to complete the interviews (per the interviewer)

• presence of significant sensory, language, or motor deficit (e.g., visual or hearing loss, paralysis, aphasia)

• in active cancer treatment

• has a terminal illness with a life expectancy of six months or less

• 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

• has a diagnosis of Major Depressive Disorder, Bipolar Disorder, current psychotic disorder or substance abuse disorder per self-report or the medical record

• patient-care partner dyads who have completed advance directives, due to the lack of need for an intervention

• Corresponding patient or care partner does not consent to take part in the study

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Behavioral:
• KNOW
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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Primary	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.	Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Primary	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.	Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Primary	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).	Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Primary	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).	Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Primary	Change in knowledge about dementia trajectory, as measured by the Alzheimer's Disease Knowledge Scale	Change in knowledge about dementia trajectory will be assessed with the four-item subscale on disease course from the Alzheimer's Disease Knowledge Scale. These items have been used in prior work on advance care planning in the context of dementia. Items ask about facts related to Alzheimer's disease (e.g., "a person with Alzheimer's disease becomes increasingly likely to fall down as the disease gets worse"); item responses are true or false.	Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Secondary	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).	Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Secondary	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).	Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Secondary	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.	Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Secondary	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.	Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Secondary	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.	Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Secondary	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.	Baseline, Post-Intervention (within 2 weeks), 3-month follow up