Negotiation Training for Caregiver Communication in AD

Negotiation Training to Optimize Caregiver Communication in Alzheimer's Disease

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Alzheimer Disease
• Intervention / Treatment: Behavioral: Caregiver vs. Patient [Beginner]; Behavioral: Caregiver vs. Patient [Advanced]; Behavioral: Caregiver vs. Physician; Behavioral: Caregiver vs. Caregiver

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Condition 1; (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]; 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.
Experimental: Condition 2; (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]; 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.; Behavioral: 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.
Experimental: Condition 3; (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise	Behavioral: 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.; Behavioral: Caregiver vs. Physician; Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.
Experimental: 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	Behavioral: 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.; Behavioral: 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.; Behavioral: Caregiver vs. Physician; Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.
Experimental: Condition 5; (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise	Behavioral: 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.; Behavioral: Caregiver vs. Caregiver; Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.
Experimental: 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	Behavioral: 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.; Behavioral: 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.; Behavioral: Caregiver vs. Caregiver; Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.
Experimental: 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	Behavioral: 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.; Behavioral: Caregiver vs. Physician; Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.; Behavioral: Caregiver vs. Caregiver; Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.
Experimental: 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	Behavioral: 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.; Behavioral: 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.; Behavioral: Caregiver vs. Physician; Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.; Behavioral: Caregiver vs. Caregiver; Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PROMIS Anxiety Score	The PROMIS Adult Emotional Distress-Anxiety scale measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), and hyper-arousal (tension, nervousness, restlessness) in respondents during the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always). We deployed the four item short form, with scores ranging from 4-20, with higher scores indicating greater severity of anxiety. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. We calculate change in T-Score from baseline to one month per participant and take the mean of those observations to produce mean change in T-score by condition.	1 months post-baseline
Change in Zarit Caregiver Burden Score	The Zarit Burden Interview, a popular caregiver self-report measure used by many aging agencies, originated as a 29-item questionnaire (Zarit, Reever & Bach-Peterson, 1980). The revised version contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). The total score range is 0 to 88. Increasing scores indicate increasing burden. Scores were measured at baseline and at 1 month post-intervention and a change score was computed for each participant. These change scores are averaged to produce the by-condition mean change in burden score. Positive results indicate an increase in burden, and negative results indicate a decrease in burden.	1 month post-baseline
Change in PROMIS Fatigue Score	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. We deployed PROMIS Fatigue Form 7a, a seven item likert scale panel ranging from 1=never to 5=always. Scores range from 7-35. Higher scores indicate more fatigue. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. We calculate change in T-Score from baseline to one month per participant and take the mean of those observations to produce mean change in T-score by condition.	1 month post-baseline
Change in PROMIS Short Form General Self Efficacy T Score	the PROMIS General Self-Efficacy - Short Form is a four item panel which measures confidence in one's ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations. The four items are 1-5 Likert scales, 1=never, 5=always. Minimum score is a 4 and maximum is a 20. Raw Scores are converted to T scores with mean 50 and SD 10 per the PROMIS scoring manual. Higher score=greater self efficacy.	1 months post-baseline
PROMIS Short Form Emotional Support T Score at 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 confident relationships. The short form 6a deployed here is a 6 item likert scale panel, which assesses responses as 1=never and 5=always in response to item statements. Minimum score is a 6 and maximum is a 30. Higher scores indicate greater feelings of emotional support. The raw score is rescaled per the PROMIS scoring manual into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.	Baseline Measure
Change in PROMIS Satisfaction With Social Roles/Activities Score	The PROMIS adult Satisfaction with Social Roles and Activities item bank assesses satisfaction with performing one's usual social roles and activities (e.g., "I am satisfied with my ability to participate in family activities"). Short form 8a is deployed here. This is an 8 item likert scale panel, with responses rated 1=never and 5=always. Scores range from 8 to 40. Higher scores indicate greater satisfaction with social roles and activities. The raw score is rescaled per the PROMIS scoring manual into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.	1 months post-baseline
Change in Neuro-QoL Caregiver Specific Anxiety Score	TBI-CareQOL is a set of self-report measures within the Neuro-QoL™ measurement system that assesses the health-related quality of life (HRQOL) of caregivers of adults with traumatic brain injury (TBI). Among these is the Caregiver specific anxiety measure. This is a six item likert panel with responses rated 1=never and 5=always, for a combined score range of 6-30. Higher scores indicate greater levels of anxiety. Raw scores were rescaled per the Neuro-QoL scoring manual into T-Scores with a mean of 50 and an SD of 10. Difference between T-score at baseline and 1-month was computed for each participant to produce a change score, and these change scores are averaged to produce per condition means.	1 month post-baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Retention Rate at 3 Months Post-baseline	Percentage- numerator=# of participants who completed 3 month post-baseline assessment, denominator=# of participants randomized to a condition.	3 months post-baseline
System Usability Scale Score	Measuring the feasibility of the intervention by measuring the usability of the intervention as measured by the System Usability Scale (SUS), a 10-item measure of usability. SUS is a 10-item likert panel, with scores ranging from 1-5. Scores are tabulated by converting raw scores by subtracting 1 from each raw score and then summing per the scoring manual: summed score=2.5*(20+(sum of odd numbered questions)-(sum of even number questions)). The minimum and maximum values are thus 50 and 100. Higher scores indicate greater usability.	2 weeks post-intervention
USE Acceptability Score	The USE Acceptability score measures the acceptability of the intervention, employing an 8-item panel of 1-7 Likert scale questions, with a 0 option for "not applicable". Raw score is converted to 0-100 score as follows: 2.040163*(summed raw scores - 8). Higher scores indicate greater acceptability.	2 weeks post-intervention
Exercise Completion Rate	Measuring the feasibility of the intervention by assessing completion of negotiation training exercises.	2 weeks post-baseline
Change in DUTCH Conflict Handling Scores	The Dutch Test for Conflict Handling measures aspects of conflict resolution pertaining to the negotiator. The DUTCH measures conflict handling in five domains: avoiding, forcing, yielding, problem solving, and compromising. Each domain is measured independently using panels of four 1-5 likert scale questions each. Domain scores thus range from 5-20, converted to 0-100 with the following formula: 6.25*(domain score-1). Intra-participant change is measured for each subdomain between baseline and 1 month and generalized to produce mean change per domain. Higher scores per domain indicate more intense conflict handling behavior in the given domain- lower scores indicate less intensity.	1 month post-baseline
Change in Negotiation Knowledge Scores	We deployed a panel of 15 questions measuring participant knowledge of negotiation techniques. The panel measures knowledge in three subdomains (identification of interests, rights, and power statements) and can also be measured in aggregate to assess knowledge across the three subdomains. Participants receive 1 point for each correct answer. All Scores, including subdomain scores, are converted to a 0/100 measure. Intraparticipant change is assessed between baseline and 1 month post-intervention. Dependent Sample T-Tests were performed on the change scores from baseline-1 month.	1 months post-baseline
Utilization Rates	We deployed a survey panel of 5 yes/no questions to participants asking them about utilization of negotiation techniques in the month following the intervention. Result rates are out of 100%.	1 month post-baseline
Change In Positive and Negative Affect Schedule Scores	The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point verbal frequency scale of 1 (not at all) to 5 (very much). Scores are evaluated out of 50. The ten item scales thus have score ranges from 10-50. Higher scores in a single domain indicate greater perception of that type of affect. So, higher positive affect scores=greater positive affect, and higher negative affect scores=higher negative affect. Positive change on either scale indicates an increase in that domain, and negative change on either scale indicates a decrease in that domain.	1 month post-baseline

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): April 20, 2024
• Study Completion (Actual): June 17, 2024

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Family caregiver; Negotiation; Dispute resolution; Conflict communication
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: R01AG068421-01 (U.S. NIH Grant/Contract); 1R01AG068421-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No