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Negotiation Training for Caregiver Communication in AD

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Northwestern University

Status

Completed

Conditions

Alzheimer Disease
Cognitive Impairment

Treatments

Behavioral: Caregiver vs. Patient [Beginner]
Behavioral: Caregiver vs. Physician
Behavioral: Caregiver vs. Patient [Advanced]
Behavioral: Caregiver vs. Caregiver

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04837937
1R01AG068421-01 (U.S. NIH Grant/Contract)
R01AG068421-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

132 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

132 participants in 8 patient groups

Condition 1
Experimental group
Description:
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Treatment:
Behavioral: Caregiver vs. Patient [Beginner]
Condition 2
Experimental group
Description:
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Treatment:
Behavioral: Caregiver vs. Patient [Advanced]
Behavioral: Caregiver vs. Patient [Beginner]
Condition 3
Experimental group
Description:
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Treatment:
Behavioral: Caregiver vs. Physician
Behavioral: Caregiver vs. Patient [Beginner]
Condition 4
Experimental group
Description:
(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
Treatment:
Behavioral: Caregiver vs. Patient [Advanced]
Behavioral: Caregiver vs. Physician
Behavioral: Caregiver vs. Patient [Beginner]
Condition 5
Experimental group
Description:
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Treatment:
Behavioral: Caregiver vs. Caregiver
Behavioral: Caregiver vs. Patient [Beginner]
Condition 6
Experimental group
Description:
(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
Treatment:
Behavioral: Caregiver vs. Caregiver
Behavioral: Caregiver vs. Patient [Advanced]
Behavioral: Caregiver vs. Patient [Beginner]
Condition 7
Experimental group
Description:
(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
Treatment:
Behavioral: Caregiver vs. Caregiver
Behavioral: Caregiver vs. Physician
Behavioral: Caregiver vs. Patient [Beginner]
Condition 8
Experimental group
Description:
(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
Treatment:
Behavioral: Caregiver vs. Caregiver
Behavioral: Caregiver vs. Patient [Advanced]
Behavioral: Caregiver vs. Physician
Behavioral: Caregiver vs. Patient [Beginner]

Trial documents
3

Trial contacts and locations

1

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Central trial contact

Lee A Lindquist, MD MPH MBA; Vanessa Ramirez-Zohfeld, MPH

Data sourced from clinicaltrials.gov

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