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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-09

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Alzheimer Disease Dementia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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KNOW Intervention

Group Type EXPERIMENTAL

KNOW

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes