Chelsea G Cox1, Mary M Ryan B A2, Daniel L Gillen3, Joshua D Grill4. 1. Institute for Memory Impairments and Neurological Disorders (CGC, DLG, JDG), University of California, Irvine, Irvine, CA. 2. the Department of Statistics (MMR, DLG), University of California, Irvine, Irvine, CA. 3. Institute for Memory Impairments and Neurological Disorders (CGC, DLG, JDG), University of California, Irvine, Irvine, CA; the Department of Statistics (MMR, DLG), University of California, Irvine, Irvine, CA. 4. Institute for Memory Impairments and Neurological Disorders (CGC, DLG, JDG), University of California, Irvine, Irvine, CA; the Department of Psychiatry and Human Behavior (JDG), University of California, Irvine, Irvine, CA; the Department of Neurobiology and Behavior (JDG), University of California, Irvine, Irvine, CA; Institute for Clinical and Translational Science (JDG), University of California, Irvine, Irvine, CA. Electronic address: jgrill@uci.edu.
Abstract
OBJECTIVE: All Alzheimer disease (AD) clinical trials, including those enrolling patients with mild cognitive impairment (MCI), require dyadic participation. The purpose of this study was to elucidate how people with MCI and their study partners decide whether to enroll in clinical trials. METHODS: This was a mixed methods interview study. We interviewed patient participants with a consensus research diagnosis of MCI and their study partners. Interviews examined how dyads decide whether to enroll in a clinical trial and whether AD biomarker testing affects willingness to enroll. RESULTS: Though most MCI patients and study partners would decide in partnership whether to enroll in a clinical trial, agreement was lower among nonspousal, compared with spousal, dyads. Deterrents to enrollment included concerns about patient safety and inconvenience, especially for study partners. Motivators to enrollment included altruism, the desire to contribute to research, hope for patient benefit, and the desire to learn more about the patient's condition. When asked open-ended questions about motivators to enroll in trials, few patients cited access to biomarker testing specifically, though most expressed a desire to undergo biomarker testing when asked directly. CONCLUSION: Spousal and nonspousal MCI dyads may approach clinical trial decisions differently. Future research should investigate how AD biomarker testing affects participants' willingness to enroll in trials.
OBJECTIVE: All Alzheimer disease (AD) clinical trials, including those enrolling patients with mild cognitive impairment (MCI), require dyadic participation. The purpose of this study was to elucidate how people with MCI and their study partners decide whether to enroll in clinical trials. METHODS: This was a mixed methods interview study. We interviewed patientparticipants with a consensus research diagnosis of MCI and their study partners. Interviews examined how dyads decide whether to enroll in a clinical trial and whether AD biomarker testing affects willingness to enroll. RESULTS: Though most MCI patients and study partners would decide in partnership whether to enroll in a clinical trial, agreement was lower among nonspousal, compared with spousal, dyads. Deterrents to enrollment included concerns about patient safety and inconvenience, especially for study partners. Motivators to enrollment included altruism, the desire to contribute to research, hope for patient benefit, and the desire to learn more about the patient's condition. When asked open-ended questions about motivators to enroll in trials, few patients cited access to biomarker testing specifically, though most expressed a desire to undergo biomarker testing when asked directly. CONCLUSION: Spousal and nonspousal MCI dyads may approach clinical trial decisions differently. Future research should investigate how AD biomarker testing affects participants' willingness to enroll in trials.
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