Negotiation Training for Caregiver Communication in AD
- Conditions
- Alzheimer DiseaseCognitive Impairment
- Interventions
- Behavioral: Caregiver vs. Patient [Beginner]Behavioral: Caregiver vs. PhysicianBehavioral: Caregiver vs. CaregiverBehavioral: Caregiver vs. Patient [Advanced]
- Registration Number
- NCT04837937
- Lead Sponsor
- Northwestern University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 132
- 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
- Less than 21 years old
- Unable to speak and read English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Condition 4 Caregiver vs. Physician (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 Condition 5 Caregiver vs. Caregiver (1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise Condition 7 Caregiver vs. Caregiver (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 Condition 8 Caregiver vs. Physician (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 Condition 1 Caregiver vs. Patient [Beginner] (1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant. Condition 2 Caregiver vs. Patient [Beginner] (1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise Condition 4 Caregiver vs. Patient [Beginner] (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 Condition 5 Caregiver vs. Patient [Beginner] (1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise Condition 6 Caregiver vs. Patient [Advanced] (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 Condition 8 Caregiver vs. Patient [Beginner] (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 Condition 3 Caregiver vs. Physician (1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise Condition 7 Caregiver vs. Patient [Beginner] (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 Condition 3 Caregiver vs. Patient [Beginner] (1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise Condition 7 Caregiver vs. Physician (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 Condition 8 Caregiver vs. Caregiver (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 Condition 2 Caregiver vs. Patient [Advanced] (1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise Condition 4 Caregiver vs. Patient [Advanced] (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 Condition 6 Caregiver vs. Patient [Beginner] (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 Condition 6 Caregiver vs. Caregiver (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 Condition 8 Caregiver vs. Patient [Advanced] (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
- Primary Outcome Measures
Name Time Method Well-being 1 months post-baseline Caregiver well-being as measured by the Positive Affect and Well-being scale for the Neurology Quality of Life (Neuro-QOL)
- Secondary Outcome Measures
Name Time Method Informational support 3 months post-baseline PROMIS Informational Support - Short Form.
The PROMIS Informational Support item bank assesses perceived availability of helpful information or advice.Caregiver strain 3 months post-baseline 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.Caregiver burden 3 months post-baseline 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.
Caregiving self-efficacy 3 months post-baseline PROMIS Care-giving Self Efficacy
Emotional support 3 months post-baseline 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.Satisfaction with Social Roles/Activities 3 months post-baseline PROMIS Satisfaction with Social Roles/Activities
Anxiety 3 months post-baseline 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).General self-efficacy 3 months post-baseline PROMIS General Self-Efficacy - Short Form
Fatigue 3 months post-baseline 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.
Trial Locations
- Locations (1)
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States