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Alzheimer's Disease (AD)NCT07859540

Negotiation Training for Family Caregivers of People With Alzheimer's Disease

A study testing NegotiAge and PlanYourLifespan in people with Alzheimer's Disease (AD) and Dementia, run by Northwestern University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

Family caregivers of people living with Alzheimer's disease and related dementias often experience conflicts and communication challenges when coordinating care, making decisions, and interacting with family members and healthcare providers. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
What is being tested?
NegotiAge and PlanYourLifespan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
Nov 2026to 31 Aug 2028
Phase
Interventional

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

  • Age 21 years or older
  • Self-identify as a family caregiver or unpaid care partner of a person with Alzheimer's disease, a related dementia, cognitive impairment, or memory loss.
  • Provide at least 2 hours per week of assistance, support, advocacy, healthcare coordination, or decision-making for the care recipient.
  • Able to read, understand, and communicate in English.
  • Able and willing to provide informed consent.
  • Have regular access to an internet-connected computer, tablet, or smartphone and be comfortable using web-based programs and surveys.
  • Willing to be randomized to either the NegotiAge intervention group or the attention-control group and complete all study assessments.

Who cannot join

  • Prior participation in PlanYourLifespan studies (STU00209195 or STU00225351).
  • Prior participation in any NegotiAge study (STU00212921).
  • Younger than 21 years of age.
  • Not currently serving as a family caregiver or unpaid care partner for a person with Alzheimer's disease, a related dementia, cognitive impairment, or memory loss.
  • Unable to provide informed consent.
  • Unable to read, understand, or communicate in English sufficiently to complete study activities.
  • Significant cognitive impairment or another condition that would prevent meaningful participation in study activities.
  • Lack of access to the technology required for participation in the online intervention and study assessments.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

    Lee A Lindquist, MD, MPH, MBA

Other trials in United States

About this study

Official title: Negotiation Training to Optimize Caregiver Communication in Alzheimer's Disease

Family caregivers of people living with Alzheimer's disease and related dementias often experience conflicts and communication challenges when coordinating care, making decisions, and interacting with family members and healthcare providers. These challenges can contribute to caregiver burden, stress, anxiety, and reduced well-being.

The purpose of this study is to evaluate the effectiveness of NegotiAge, an online negotiation and communication training program designed for family caregivers. NegotiAge provides education and interactive practice exercises to help caregivers develop negotiation, problem-solving, conflict-resolution, and communication skills that can be applied to real-world caregiving situations.

Approximately 200 family caregivers will be randomly assigned to either the NegotiAge intervention or an attention-control educational website. Participants will complete online surveys before the intervention, immediately after the intervention, and at 1-month and 3-month follow-up time-points. The study will examine whether NegotiAge reduces caregiver burden and improves communication, conflict-management behaviors, self-efficacy, stress, anxiety, fatigue, and well-being. Findings from this research may help improve support programs for family caregivers of people living with Alzheimer's disease and related dementias.

Read the detailed description

Family caregivers of persons living with Alzheimer's disease and related dementias (ADRD) frequently encounter communication challenges and interpersonal conflicts while coordinating care, making healthcare decisions, advocating for care recipients, and interacting with family members and healthcare professionals. These challenges contribute to caregiver burden, stress, anxiety, and reduced quality of life. Effective communication and conflict-management skills may improve caregivers' ability to navigate complex caregiving situations and support better caregiver outcomes.

NegotiAge is a web-based negotiation and conflict-resolution training intervention developed to improve communication, problem-solving, and conflict-management skills among family caregivers of persons living with ADRD. The intervention includes online educational content and interactive scenario-based exercises that allow participants to practice negotiation and communication strategies in simulated caregiving situations. Scenarios address common caregiving conflicts involving persons living with dementia, family members, healthcare providers, and healthcare systems. Some training activities incorporate automated conversational technology to provide standardized practice opportunities.

This study is a Stage 2 randomized controlled efficacy trial designed to evaluate the effectiveness of NegotiAge. Approximately 200 family caregivers will be randomized in a 1:1 ratio to either the NegotiAge intervention or an attention-control condition consisting of access to an educational website. Participants will complete assessments at baseline, immediately following intervention completion, and at 1-month and 3-month follow-up.

The primary objective is to determine the efficacy of NegotiAge for reducing caregiver burden. Secondary objectives are to evaluate intervention effects on caregiver conflict-management behaviors, stress, anxiety, fatigue, self-efficacy, social well-being, and related psychosocial outcomes. Findings from this study will provide evidence regarding the efficacy of NegotiAge and inform future effectiveness and implementation research aimed at supporting family caregivers of persons living with Alzheimer's disease and related dementias.

This is a fully remote study. Eligible participants may enroll from anywhere within the United States.

Being tested
NegotiAge, PlanYourLifespan
Keywords
Alzheimer's Disease, Dementia, Family caregiver, Caregiver burden, Negotiation training, Caregiver communication, Behavioral intervention, Online intervention
Medical subject headings
Alzheimer Disease, Dementia, Cognitive Dysfunction, Caregiver Burden

What participants receive

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

  • NegotiAgeBehavioural

    NegotiAge is a self-paced, web-based negotiation and conflict-resolution training program designed for family caregivers of persons living with Alzheimer's disease and related dementias. The intervention consists of educational modules and interactive scenario-based practice exercises that teach communication, negotiation, problem-solving, and conflict-management skills. Training content addresses common caregiving situations, including communication with persons living with dementia, disagreements among family members, healthcare decision-making, and interactions with healthcare providers and health systems. Participants access the intervention through a secure online platform and complete the training independently using a computer, tablet, or smartphone. Some practice exercises utilize automated conversational technology to provide standardized opportunities to practice negotiation and communication skills in simulated caregiving scenarios.

  • PlanYourLifespanBehavioural

    PlanYourLifespan (PYL) is a web-based educational planning resource that provides information and tools related to future healthcare needs, caregiving, memory loss, family communication, hospitalizations, and financial planning.

Study groups in NCT07859540
Study groupRoleWhat they receive
NegotiAge InterventionExperimentalParticipants assigned to this arm will receive access to NegotiAge, a self-paced, web-based negotiation and conflict-resolution training program for family caregivers of persons living with Alzheimer's disease and related dementias. The intervention includes educational modules and interactive scenario-based practice exercises designed to improve communication, negotiation, problem-solving, and conflict-management skills. Participants complete the intervention online using a computer, tablet, or smartphone.
Receives: Behavioral: NegotiAge
PlanYourLifespan Attention-ControlActive comparatorParticipants assigned to this arm will receive access to PlanYourLifespan (PYL), a web-based educational resource that provides information and planning tools related to future healthcare needs, caregiving, hospitalizations, memory loss, communication with family members, and financial planning. Participants may review website content during the study period.
Receives: Behavioral: PlanYourLifespan

What is being measured

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

  1. 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-intervention

Secondary outcomes (6)
  1. 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.

    Measured: 1 month post-intervention

  2. Change in PROMIS Anxiety T-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 month post-intervention

  3. Change in NIH Toolbox Adult Perceived Stress T-Score

    The NIH Toolbox Adult Percieved Stress scale measures self-reported stress experienced by the subject in the past month. Each item on the measure is rated on a 5-point scale (1=never; 2=almost never; 3=sometimes; 4=fairly often; and 5=very often). We deployed the ten item fixed form for adults (18+). Raw scores ranging from 10-50, with higher scores indicating greater perception of stress. 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-intervention

  4. Change in PROMIS Fatigue T-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-intervention

  5. Change in PROMIS 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 month post-intervention

  6. Change in Neuro-QoL Positive Affect and Well-being T-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: 1 month post-intervention

Timeline

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

  1. First posted5 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionApr 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07859540
Sponsor's protocol ID
STU00226821
Other IDs
2R56AG068421-06
Status last verified
Sep 2026
First submitted
29 Sep 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data collected during the study, including demographic characteristics, caregiving experiences, caregiver burden, conflict-management behaviors, stress, anxiety, fatigue, self-efficacy, social well-being, intervention engagement measures, and other study outcomes assessed at baseline, post-intervention, 1-month follow-up, and 3-month follow-up. Direct identifiers will not be included in shared datasets.

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