Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2023-09-01
2024-06-17
Brief Summary
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Detailed Description
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Aim 1: Employ a caregiver (user)-centered design approach to modify and tailor a negotiations and dispute resolution (NDR) training intervention to support communication skills of family caregivers of adults with AD.
Aim 2: Utilizing Multiphase Optimization Strategy (MOST), conduct a randomized controlled trial of the NDR intervention that targets better communication between caregivers and health teams to determine the feasibility of delivering the intervention, and derive estimates of the effect of 3 intervention components on changes in patient-centered outcomes at post-intervention and follow-up.
Exploratory Aim 3: Explore if intervention components (lectures/exercises) interact to change communication between caregivers and health care teams at post-intervention and follow-up.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
Individuals will be randomized to 1 of 8 experimental conditions. Participants can be assigned to intervention ("Yes") or control ("No") conditions for each component. All participants will receive a "caregiver-patient" negotiation exercise so that no participant gets an inactive placebo.
OTHER
NONE
Study Groups
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Condition 1
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Caregiver vs. Patient [Beginner]
Participants will be assigned a 'Caregiver vs. Patient' \[Beginner\] online negotiation exercise. All participants will complete this exercise, so it will serve as the constant.
Condition 2
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Caregiver vs. Patient [Beginner]
Participants will be assigned a 'Caregiver vs. Patient' \[Beginner\] online negotiation exercise. All participants will complete this exercise, so it will serve as the constant.
Caregiver vs. Patient [Advanced]
Participants will be assigned a 'Caregiver vs. Patient \[Difficult\]' online negotiation exercise. This exercise is "advanced" compared to the constant since it involves negotiating more than one conflict.
Condition 3
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Caregiver vs. Patient [Beginner]
Participants will be assigned a 'Caregiver vs. Patient' \[Beginner\] online negotiation exercise. All participants will complete this exercise, so it will serve as the constant.
Caregiver vs. Physician
Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.
Condition 4
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Caregiver vs. Patient [Beginner]
Participants will be assigned a 'Caregiver vs. Patient' \[Beginner\] online negotiation exercise. All participants will complete this exercise, so it will serve as the constant.
Caregiver vs. Physician
Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.
Caregiver vs. Patient [Advanced]
Participants will be assigned a 'Caregiver vs. Patient \[Difficult\]' online negotiation exercise. This exercise is "advanced" compared to the constant since it involves negotiating more than one conflict.
Condition 5
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Caregiver vs. Patient [Beginner]
Participants will be assigned a 'Caregiver vs. Patient' \[Beginner\] online negotiation exercise. All participants will complete this exercise, so it will serve as the constant.
Caregiver vs. Caregiver
Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.
Condition 6
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Caregiver vs. Patient [Beginner]
Participants will be assigned a 'Caregiver vs. Patient' \[Beginner\] online negotiation exercise. All participants will complete this exercise, so it will serve as the constant.
Caregiver vs. Caregiver
Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.
Caregiver vs. Patient [Advanced]
Participants will be assigned a 'Caregiver vs. Patient \[Difficult\]' online negotiation exercise. This exercise is "advanced" compared to the constant since it involves negotiating more than one conflict.
Condition 7
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Caregiver vs. Patient [Beginner]
Participants will be assigned a 'Caregiver vs. Patient' \[Beginner\] online negotiation exercise. All participants will complete this exercise, so it will serve as the constant.
Caregiver vs. Caregiver
Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.
Caregiver vs. Physician
Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.
Condition 8
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Caregiver vs. Patient [Beginner]
Participants will be assigned a 'Caregiver vs. Patient' \[Beginner\] online negotiation exercise. All participants will complete this exercise, so it will serve as the constant.
Caregiver vs. Caregiver
Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.
Caregiver vs. Physician
Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.
Caregiver vs. Patient [Advanced]
Participants will be assigned a 'Caregiver vs. Patient \[Difficult\]' online negotiation exercise. This exercise is "advanced" compared to the constant since it involves negotiating more than one conflict.
Interventions
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Caregiver vs. Patient [Beginner]
Participants will be assigned a 'Caregiver vs. Patient' \[Beginner\] online negotiation exercise. All participants will complete this exercise, so it will serve as the constant.
Caregiver vs. Caregiver
Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.
Caregiver vs. Physician
Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.
Caregiver vs. Patient [Advanced]
Participants will be assigned a 'Caregiver vs. Patient \[Difficult\]' online negotiation exercise. This exercise is "advanced" compared to the constant since it involves negotiating more than one conflict.
Eligibility Criteria
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Inclusion Criteria
* Currently provide care-giving support (e.g. emotional, social, physical, task-related) to an adult over the age of 65;
* Currently provide care-giving support at least 1 hour per week (e.g. may include grocery shopping, scheduling appointments, and transportation);
* Currently involved in any decision-making related to the healthcare and support of this adult over the age of 65;
* Score \>2 on the 8-item Informant Interview to Differentiate Aging and Dementia (AD8);
* Access to and the ability to use the internet to complete a series of online activities; and
* Have a valid email address or the willingness to create one to access during the study
Exclusion Criteria
* Unable to speak and read English
21 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Northwestern University
OTHER
Responsible Party
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Lee Lindquist
Associate Professor of Medicine, Chief - Geriatrics
Locations
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Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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