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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Alzheimer Disease, Cognitive Impairment
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 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.
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)
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
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
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
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
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
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
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.
- First posted8 Apr 2021
- Study start1 Sep 2023
- Primary completion20 Apr 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lee Lindquist, Northwestern University
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 42308028Olvera 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negotiation Training to Optimize Caregiver Communication in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04837937
- Acronym / sponsor ID
- R01AG068421-01
- Conditions
- Alzheimer Disease, Cognitive Impairment
- Keywords
- Family caregiver, Negotiation, Dispute resolution, Conflict communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Posted 1 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- 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.
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Behavioral: Caregiver vs. Patient [Beginner](1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant. |
| Condition 2 | Experimental | Behavioral: Caregiver vs. Patient [Beginner], Behavioral: Caregiver vs. Patient [Advanced](1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient [Advanced]' ' conflict negotiation/dispute resolution exercise |
| Condition 3 | Experimental | Behavioral: Caregiver vs. Patient [Beginner], Behavioral: Caregiver vs. Physician(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise |
| Condition 4 | Experimental | Behavioral: Caregiver vs. Patient [Beginner], Behavioral: Caregiver vs. Physician, Behavioral: Caregiver vs. Patient [Advanced](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 |
| Condition 5 | Experimental | Behavioral: Caregiver vs. Patient [Beginner], Behavioral: Caregiver vs. Caregiver(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise |
| Condition 6 | Experimental | Behavioral: Caregiver vs. Patient [Beginner], Behavioral: Caregiver vs. Caregiver, Behavioral: Caregiver vs. Patient [Advanced](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 |
| Condition 7 | Experimental | Behavioral: Caregiver vs. Patient [Beginner], Behavioral: Caregiver vs. Caregiver, Behavioral: Caregiver vs. Physician(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 |
| Condition 8 | Experimental | Behavioral: Caregiver vs. Patient [Beginner], Behavioral: Caregiver vs. Caregiver, Behavioral: Caregiver vs. Physician, Behavioral: Caregiver vs. Patient [Advanced](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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (2 listed)
- Less than 21 years old
- Unable to speak and read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Condition 1, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8 |
| Caregiver vs. CaregiverParticipants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise. | Behavioural | Condition 5, Condition 6, Condition 7, Condition 8 |
| Caregiver vs. PhysicianParticipants will be assigned a 'Caregiver vs. Physician' online negotiation exercise. | Behavioural | Condition 3, Condition 4, Condition 7, Condition 8 |
| 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. | Behavioural | Condition 2, Condition 4, Condition 6, Condition 8 |
Primary outcome
Change in Neuro-QoL Positive Affect and Well-Being Score
Time frame: Baseline (pre-intervention) and 1 Month Post-intervention
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.
7 secondary outcomes
Change in PROMIS Anxiety Score
Time frame: 1 months post-baseline
Change in Zarit Caregiver Burden Score
Time frame: 1 month post-baseline
Change in PROMIS Fatigue Score
Time frame: 1 month post-baseline
Change in PROMIS Short Form General Self Efficacy T Score
Time frame: 1 months post-baseline
PROMIS Short Form Emotional Support T Score at Baseline
Time frame: Baseline Measure
Change in PROMIS Satisfaction With Social Roles/Activities Score
Time frame: 1 months post-baseline
Change in Neuro-QoL Caregiver Specific Anxiety Score
Time frame: 1 month post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42308028Ramirez-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.
- Derived from this study: PubMed 41607873Olvera 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.