Negotiation Training for Caregiver Communication in AD

Study Overview
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Brief Summary
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The purpose of this study is to design a Negotiation and Dispute Resolution (NDR) training intervention to improve communication and address resolution of conflicts that family caregivers of patients with cognitive impairment and/or Alzheimer's Disease (AD) frequently experience.

Detailed Description
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The goal of this study is to design a Negotiation and Dispute Resolution (NDR) training intervention to improve communication and address resolution of conflicts that family caregivers of patients with cognitive impairment and/or Alzheimer's Disease (AD) frequently experience. Specifically this study will: 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.

Official Title
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Negotiation Training to Optimize Caregiver Communication in Alzheimer's Disease

Conditions
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Alzheimer Disease, Cognitive Impairment

Intervention / Treatment
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* Behavioral: Caregiver vs. Patient [Beginner]
* Behavioral: Caregiver vs. Caregiver
* Behavioral: Caregiver vs. Physician
* Behavioral: Caregiver vs. Patient [Advanced]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Speak/read English; 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: Less than 21 years old Unable to speak and read English

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The randomized controlled clinical trial has a full factorial testing 3 components at 2 levels each (on and off). 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition 1<br>(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant. | Behavioral: Caregiver vs. Patient [Beginner]<br>* 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.<br>|
| Experimental: Condition 2<br>(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient [Advanced]' ' conflict negotiation/dispute resolution exercise | Behavioral: Caregiver vs. Patient [Beginner]<br>* 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.<br>Behavioral: Caregiver vs. Patient [Advanced]<br>* 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.<br>|
| Experimental: Condition 3<br>(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise | Behavioral: Caregiver vs. Patient [Beginner]<br>* 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.<br>Behavioral: Caregiver vs. Physician<br>* Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.<br>|
| Experimental: Condition 4<br>(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 | Behavioral: Caregiver vs. Patient [Beginner]<br>* 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.<br>Behavioral: Caregiver vs. Physician<br>* Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.<br>Behavioral: Caregiver vs. Patient [Advanced]<br>* 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.<br>|
| Experimental: Condition 5<br>(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise | Behavioral: Caregiver vs. Patient [Beginner]<br>* 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.<br>Behavioral: Caregiver vs. Caregiver<br>* Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.<br>|
| Experimental: Condition 6<br>(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 | Behavioral: Caregiver vs. Patient [Beginner]<br>* 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.<br>Behavioral: Caregiver vs. Caregiver<br>* Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.<br>Behavioral: Caregiver vs. Patient [Advanced]<br>* 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.<br>|
| Experimental: Condition 7<br>(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 | Behavioral: Caregiver vs. Patient [Beginner]<br>* 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.<br>Behavioral: Caregiver vs. Caregiver<br>* Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.<br>Behavioral: Caregiver vs. Physician<br>* Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.<br>|
| Experimental: Condition 8<br>(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 | Behavioral: Caregiver vs. Patient [Beginner]<br>* 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.<br>Behavioral: Caregiver vs. Caregiver<br>* Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.<br>Behavioral: Caregiver vs. Physician<br>* Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.<br>Behavioral: Caregiver vs. Patient [Advanced]<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being | Caregiver well-being as measured by the Positive Affect and Well-being scale for the Neurology Quality of Life (Neuro-QOL) | 1 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | PROMIS Ca Adult Item Bank Emotional distress-Anxiety. The PROMIS Anxiety instruments measure self-reported fear (fearfulness, panic), anxious misery (worry, dread), and hyper-arousal (tension, nervousness, restlessness). | 3 months post-baseline | 
| Caregiver strain | Caregiver Strain Index The Modified Caregiver Strain Index (MCSI) is a 13-question validated tool that measures strain related to care provision. It measures the following major domains: Financial, Physical, Psychological, Social and Personal. This instrument can be used to assess individuals of any age who have assumed the caregiving role for an older adult. | 3 months post-baseline | 
| Caregiver burden | Burden Scale for Family Caregivers (BSFC-s): a 10-item short version of the Burden Scale for Family Caregivers that detects the amount of burden perceived by the family caregiver. | 3 months post-baseline | 
| Fatigue | PROMIS Fatigue The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. | 3 months post-baseline | 
| General self-efficacy | PROMIS General Self-Efficacy - Short Form | 3 months post-baseline | 
| Caregiving self-efficacy | PROMIS Care-giving Self Efficacy | 3 months post-baseline | 
| Emotional support | PROMIS Emotional Support - Short Form. The PROMIS Emotional Support item bank assesses perceived feelings of being cared for and valued as a person; having confidant relationships. | 3 months post-baseline | 
| Informational support | PROMIS Informational Support - Short Form. The PROMIS Informational Support item bank assesses perceived availability of helpful information or advice. | 3 months post-baseline | 
| Satisfaction with Social Roles/Activities | PROMIS Satisfaction with Social Roles/Activities | 3 months post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family caregiver, Negotiation, Dispute resolution, Conflict communication