Improving communication for people with memory challenges and their caregivers
Developing a Communication Intervention to Help People With Memory Challenges and Their Care Partners Engage in Advance Care Planning
This study is testing a new communication program to help people with Alzheimer's and their caregivers talk better about end-of-life care and reduce stress.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05143255 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a communication-based intervention called KNow the Optimal Way (KNOW) for patients with Alzheimer's Disease and Related Dementias (ADRD) and their care partners. The intervention will incorporate communication strategies and distress management techniques to enhance engagement in advance care planning (ACP) and reduce caregiver burden. The study will evaluate the feasibility and acceptability of the intervention, as well as its preliminary efficacy on various outcomes related to ACP and patient-care partner concordance. The ultimate goal is to improve the quality of end-of-life care for ADRD patients.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 65 and older with mild to moderate cognitive impairment and their informal care partners.
Not a fit: Patients in the late stages of dementia or those with significant sensory or language deficits may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance communication and planning for end-of-life care among ADRD patients and their caregivers.
How similar studies have performed: Other studies have shown promise in improving communication and engagement in advance care planning for similar patient populations, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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. score of ≥11 on the capacity to execute a Health Care Proxy Guideline, 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) * 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
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sara Czaja, PhD — Weill Medical College of Cornell University
- Study coordinator: Sophie Park
- Email: sep4008@med.cornell.edu
- Phone: 646-962-7141
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.