Negotiation Training for Caregiver Communication in AD

NCT04837937 | Completed Results DMC

• 2 other identifiers: R01AG068421-011R01AG068421-01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Cognitive Impairment

Keywords

Family caregiver; Negotiation; Dispute resolution; Conflict communication

Outcome Measures

Primary Outcomes (1)

• Change in Neuro-QoL Positive Affect and Well-Being Score

  Caregiver well-being as measured by the Positive Affect and Well-being scale for the Neurology Quality of Life (Neuro-QOL). The measure is a 9-item panel rating how caregivers experience feelings of positive affect and well-being. Responses are Likert scales, scored 1-5, Never (1), Rarely (2), Sometimes (3), Often (4), Always (5). Responses are summed for a final score and converted to a t-score per Neuro-QoL manual scoring conventions. Population mean T-Score is 50 and SD is 10. Higher scores indicate higher levels of Positive Affect and Well-Being. Positive change represents an increase in positive affect/well-being, and negative change represents a decrease.

  Baseline (pre-intervention) and 1 Month Post-intervention

Secondary Outcomes (7)

• Change in PROMIS Anxiety Score

  1 months post-baseline

• Change in Zarit Caregiver Burden Score

  1 month post-baseline

• Change in PROMIS Fatigue Score

  1 month post-baseline

• Change in PROMIS Short Form General Self Efficacy T Score

  1 months post-baseline

• PROMIS Short Form Emotional Support T Score at Baseline

  Baseline Measure

Other Outcomes (8)

• Participant Retention Rate at 3 Months Post-baseline

  3 months post-baseline

• System Usability Scale Score

  2 weeks post-intervention

• USE Acceptability Score

  2 weeks post-intervention

Study Arms (8)

Condition 1

EXPERIMENTAL

(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]

Condition 2

EXPERIMENTAL

(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]; Behavioral: Caregiver vs. Patient [Advanced]

Condition 3

EXPERIMENTAL

(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise

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

Condition 4

EXPERIMENTAL

(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]; Behavioral: Caregiver vs. Physician; Behavioral: Caregiver vs. Patient [Advanced]

Condition 5

EXPERIMENTAL

(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise

Behavioral: Caregiver vs. Patient [Beginner]; Behavioral: Caregiver vs. Caregiver

Condition 6

EXPERIMENTAL

(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]; Behavioral: Caregiver vs. Caregiver; Behavioral: Caregiver vs. Patient [Advanced]

Condition 7

EXPERIMENTAL

(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]; Behavioral: Caregiver vs. Caregiver; Behavioral: Caregiver vs. Physician

Condition 8

EXPERIMENTAL

(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]; Behavioral: Caregiver vs. Caregiver; Behavioral: Caregiver vs. Physician; Behavioral: Caregiver vs. Patient [Advanced]

Interventions

Caregiver vs. Patient [Beginner] BEHAVIORAL

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 1; Condition 2; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8

Caregiver vs. Caregiver BEHAVIORAL

Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.

Condition 5; Condition 6; Condition 7; Condition 8

Caregiver vs. Physician BEHAVIORAL

Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.

Condition 3; Condition 4; Condition 7; Condition 8

Caregiver vs. Patient [Advanced] BEHAVIORAL

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 2; Condition 4; Condition 6; Condition 8

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Less than 21 years old
• Unable to speak and read English

Sponsors & Collaborators

• Northwestern University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Olvera C, Ramirez-Zohfeld V, Murawski A, Pfammatter AF, Lindquist LA. Evaluating a negotiation training program for family caregivers of older people using a Multiphase Optimization Strategy (MOST) design and protocol. Contemp Clin Trials Commun. 2026 Jan 12;49:101596. doi: 10.1016/j.conctc.2026.101596. eCollection 2026 Feb.

  PMID: 41607873 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Negotiating

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Communication; Behavior

Results Point of Contact

• Title: Vanessa Ramirez-Zohfeld
• Organization: Northwestern University- Feinberg School of Medicine- Division of Geriatrics

vanessa-ramirez-0@northwestern.edu

+1 312 503 3916

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Chief - Geriatrics

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: September 1, 2023
• Primary Completion: April 20, 2024
• Study Completion: June 17, 2024
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)