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Alzheimer DiseaseNCT04837937

Negotiation Training for Caregiver Communication in AD

A study testing Caregiver vs. Patient [Beginner], Caregiver vs. Caregiver and Caregiver vs. Physician in people with Alzheimer Disease and Cognitive Impairment, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease, Cognitive Impairment
What is being tested?
Caregiver vs. Patient [Beginner], Caregiver vs. Caregiver and Caregiver vs. Physician
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteUnited States
Study dates
1 Sep 2023to 17 Jun 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Caregiver vs. Patient [Beginner], Caregiver vs. Caregiver, Caregiver vs. Physician, Caregiver vs. Patient [Advanced]
Keywords
Family caregiver, Negotiation, Dispute resolution, Conflict communication
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Negotiating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caregiver vs. Patient [Beginner]Behavioural

    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.

  • Caregiver vs. CaregiverBehavioural

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

  • Caregiver vs. PhysicianBehavioural

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

  • Caregiver vs. Patient [Advanced]Behavioural

    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.

Study groups in NCT04837937
Study groupRoleWhat they receive
Condition 1Experimental(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Receives: Behavioral: Caregiver vs. Patient [Beginner]
Condition 2Experimental(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient [Advanced]' ' conflict negotiation/dispute resolution exercise
Receives: Behavioral: Caregiver vs. Patient [Beginner]; Behavioral: Caregiver vs. Patient [Advanced]
Condition 3Experimental(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Receives: Behavioral: Caregiver vs. Patient [Beginner]; Behavioral: Caregiver vs. Physician
Condition 4Experimental(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
Receives: Behavioral: Caregiver vs. Patient [Beginner]; Behavioral: Caregiver vs. Physician; Behavioral: Caregiver vs. Patient [Advanced]
Condition 5Experimental(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Receives: Behavioral: Caregiver vs. Patient [Beginner]; Behavioral: Caregiver vs. Caregiver
Condition 6Experimental(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
Receives: Behavioral: Caregiver vs. Patient [Beginner]; Behavioral: Caregiver vs. Caregiver; Behavioral: Caregiver vs. Patient [Advanced]
Condition 7Experimental(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
Receives: Behavioral: Caregiver vs. Patient [Beginner]; Behavioral: Caregiver vs. Caregiver; Behavioral: Caregiver vs. Physician
Condition 8Experimental(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
Receives: Behavioral: Caregiver vs. Patient [Beginner]; Behavioral: Caregiver vs. Caregiver; Behavioral: Caregiver vs. Physician; Behavioral: Caregiver vs. Patient [Advanced]

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)
  1. 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.

    Measured: 1 months post-baseline

  2. 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.

    Measured: 1 month post-baseline

  3. 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.

    Measured: 1 month post-baseline

  4. 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.

    Measured: 1 months post-baseline

  5. 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.

    Measured: Baseline Measure

  6. 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.

    Measured: 1 months post-baseline

  7. 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.

    Measured: 1 month post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start1 Sep 2023
  3. Primary completion20 Apr 2024
  4. Study completion17 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
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)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04837937
Sponsor's protocol ID
R01AG068421-01
Other IDs
1R01AG068421-01
Status last verified
Jul 2025
First submitted
6 Apr 2021
Last updated
1 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ramirez-Zohfeld V, Murawski A, Jobin C, Olvera C, Mell J, Brett J, Gratch J, Tschoe M, Pfammatter AF, Lindquist LA. NegotiAge-An AI-Based Caregiver Negotiation Training: Results From the Multiphase Optimization Strategy (MOST) Trial. J Am Geriatr Soc. 2026 Jul;74(7):2032-2040. doi: 10.1111/jgs.70546. Epub 2026 Jun 17.

    PubMed 42308028
  • 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.

    PubMed 41607873

Questions about this trial

What is this clinical trial studying?

A study testing Caregiver vs. Patient [Beginner], Caregiver vs. Caregiver and Caregiver vs. Physician in people with Alzheimer Disease and Cognitive Impairment, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Neuro-QoL Positive Affect and Well-Being Score (time frame: Baseline (pre-intervention) and 1 Month Post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04837937, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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