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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG068421-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Condition 2 | Experimental | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient [Advanced]' ' conflict negotiation/dispute resolution exercise |
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| Condition 3 | Experimental | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42308028 | Derived | 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 Jun 17. doi: 10.1111/jgs.70546. Online ahead of print. | |
| 41607873 | Derived | 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. |
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Two participants consented but were not randomized to a condition. One of these participants did not complete baseline intake and was not randomized to a treatment. The other participant did complete baseline intake but did not complete the study phase which assigns participants to a condition (a unique hyperlink which assigns condition and treatment materials when opened- this participant did not open their link).
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| ID | Title | Description |
|---|---|---|
| FG000 | Universal | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant. |
| FG001 | Older Adult | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient [Advanced]' ' conflict negotiation/dispute resolution exercise |
| FG002 | Physician | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise |
| FG003 | Physician/OA | (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 |
| FG004 | Sister | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise |
| FG005 | Sister/OA | (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 |
| FG006 | Sister/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 |
| FG007 | Sister/Physician/OA | (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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Universal Only | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant. |
| BG001 | Older Adult |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants with available data at baseline and 1 month post-intervention assessments were analyzed. | Posted | Mean | Standard Deviation | T-Score | Baseline (pre-intervention) and 1 Month Post-intervention |
|
From Baseline enrollment (pre-intervention) until end of study (3 months post-intervention)
Adverse event (AE):Any unfavorable and unintended sign or symptom temporally associated with the NDR training, regardless of whether it is considered related to intervention. Serious Adverse Event (SAE):Any AE that results in: a life-threatening situation (places the subject at immediate risk of death from the event as it occurred); death; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Condition 1 | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanessa Ramirez-Zohfeld | Northwestern University- Feinberg School of Medicine- Division of Geriatrics | +1 312 503 3916 | vanessa-ramirez-0@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 12, 2024 | May 6, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2024 | Jul 11, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2023 | May 6, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D017008 | Negotiating |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| Condition 5 |
| Experimental |
(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise |
|
| 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 |
|
| 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 |
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| 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 |
|
| Caregiver vs. Caregiver | Behavioral | Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise. |
|
| Caregiver vs. Physician | Behavioral | Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise. |
|
| 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. |
|
| 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 |
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 |
(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient [Advanced]' ' conflict negotiation/dispute resolution exercise
| BG002 | Physician | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise |
| BG003 | Physician/OA | (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 |
| BG004 | Sister | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise |
| BG005 | Sister/OA | (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 |
| BG006 | Sister/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 |
| BG007 | Sister/Physician/OA | (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 |
| BG008 | Total | Total of all reporting groups |
| Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Positive Affect and Well-Being | Positive Affect and Well-Being as measured at baseline by Neuro-QoL Positive Affect and Well Being scale. Population mean T-Score is 50 with an SD of 10. Higher scores on the scale represent better self-reported health (i.e. higher score=more positive affect and well being). | Mean | Standard Deviation | T-Score |
|
(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant. |
| OG001 | Older Adult | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient [Advanced]' ' conflict negotiation/dispute resolution exercise |
| OG002 | Physician | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise |
| OG003 | Physician/OA | (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 |
| OG004 | Sister | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise |
| OG005 | Sister/OA | (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 |
| OG006 | Sister/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 |
| OG007 | Sister/Physician/OA | (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 |
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| Secondary | 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. | All participants who were randomized and completed the 1 month post-intervention assessment are included in the change analysis (n=125). | Posted | Mean | Standard Deviation | Change in T-Score | 1 months post-baseline |
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| Secondary | 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. | All participants with data available at 1 months post baseline were included in the analysis. | Posted | Mean | Standard Deviation | Change in Burden Score | 1 month post-baseline |
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| Secondary | 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. | All participants with data available at 1 months post baseline were included in the analysis. | Posted | Mean | Standard Error | Change in T-Score | 1 month post-baseline |
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| Secondary | 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. | All participants with data available at 1 months post baseline were included in the analysis. | Posted | Mean | Standard Deviation | change in T-Score | 1 months post-baseline |
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| Secondary | 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. | All individuals who received and completed the baseline assessment are included in the analysis population (N=131). | Posted | Mean | Standard Deviation | T-Score | Baseline Measure |
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| Secondary | 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. | All participants with data available at 1 months post baseline were included in the analysis. | Posted | Mean | Standard Deviation | Change in T Score | 1 months post-baseline |
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| Secondary | 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. | All participants with data available at 1 months post baseline were included in the analysis. | Posted | Mean | Standard Deviation | change in T-Score | 1 month post-baseline |
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| Other Pre-specified | 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. | 131 participants were randomized from a total 133 consented- 2 did not complete pre-randomization activities. Here we were interested in the raw number of recruited participants retained regardless of intervention received, thus all participants were considered in the analysis and group segmentation would be inappropriate for the calculation. | Posted | Count of Participants | Participants | 3 months post-baseline |
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| Other Pre-specified | 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. | 128 participants of 131 randomized completed the 2 weeks post-intervention assessment. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks post-intervention |
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| Other Pre-specified | 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. | 128 of 131 randomized participants completed the post-intervention assessment. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks post-intervention |
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| Other Pre-specified | Exercise Completion Rate | Measuring the feasibility of the intervention by assessing completion of negotiation training exercises. | Posted | Count of Participants | Participants | 2 weeks post-baseline |
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| Other Pre-specified | 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. | All 125 participants who completed both the baseline and 1-month post-intervention assessments are included in the analysis. | Posted | Mean | Standard Deviation | Change in Domain Score (out of 100) | 1 month post-baseline |
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| Other Pre-specified | 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. | All Participants who completed the 1 month post-intervention assessment are included. | Posted | Mean | Standard Deviation | Change in Score Baseline-1 Month | 1 months post-baseline |
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| Other Pre-specified | 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%. | 125 participants out of 131 randomized had data available at one month post-intervention. Of those, only 85 were deployed the website utilization question. | Posted | Count of Participants | Participants | 1 month post-baseline |
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| Other Pre-specified | 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. | All participants with data available at 1 month post-intervention were included in the analysis. | Posted | Mean | Standard Deviation | Change in Score | 1 month post-baseline |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Condition 2 | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient [Advanced]' ' conflict negotiation/dispute resolution exercise | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Condition 3 | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | 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 | 0 | 16 | 0 | 16 | 0 | 16 |
| EG004 | Condition 5 | (1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise | 0 | 17 | 0 | 17 | 0 | 17 |
| EG005 | 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 | 0 | 16 | 0 | 16 | 0 | 16 |
| EG006 | 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 | 0 | 17 | 0 | 17 | 0 | 17 |
| EG007 | 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 | 0 | 17 | 0 | 17 | 0 | 17 |
Not provided
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D003142 | Communication |
| D001519 | Behavior |
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| Change in Forcing Score |
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| Change in Problem Solving Score |
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| Change in Yielding Score |
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| Change in Avoiding Score |
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Univariate ANOVA on change in Compromising Score (out of 100) between Baseline and 1 Month Post-Intervention. |
| ANOVA |
| .13 |
Alpha for significance=0.05 |
| Mean Difference (Final Values) |
| 2.25 |
| Standard Deviation |
| 16.33 |
| Superiority |
| Univariate ANOVA on change in Forcing Score (out of 100) between Baseline and 1 Month Post-Intervention. | ANOVA | <.0001 | Alpha for significance=0.05 | Mean Difference (Final Values) | -6.85 | Standard Deviation | 18.76 | Superiority |
| Univariate ANOVA on change in Problem Solving Score (out of 100) between Baseline and 1 Month Post-Intervention. | ANOVA | .86 | Alpha for Significance=0.05 | Mean Difference (Final Values) | -.25 | Standard Deviation | 15.62 | Superiority |
| Univariate ANOVA on change in Yielding Score (out of 100) between Baseline and 1 Month Post-Intervention. | ANOVA | .32 | Alpha for significance=0.05 | Mean Difference (Final Values) | -1.1 | Standard Deviation | 12.30 | Superiority |
| Change in Interests score |
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| Change in Power Score |
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| Change in Rights Score |
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Univariate ANOVA on change in Negotiation Knowledge Interests score, Baseline 1-month. Threshold for significance was alpha=0.05. |
| ANOVA |
| .0018 |
alpha=0.05 |
| Mean Difference (Final Values) |
| 4.933 |
| Standard Deviation |
| 17.33 |
| Superiority |
| Univariate ANOVA on change in Negotiation Knowledge Power score, Baseline 1-month. | ANOVA | .91 | Threshold for significance was alpha=0.05. | Mean Difference (Final Values) | .2 | Standard Deviation | 19.69 | Superiority |
| Univariate ANOVA on change in Negotiation Knowledge Rights score, Baseline 1-month. | ANOVA | .11 | Threshold for significance was alpha=0.05. | Mean Difference (Final Values) | 3.2 | Standard Deviation | 22.35 | Superiority |
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| In the past month, have you experienced any conflicts related to the care of your older adult? |
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| In the past month, have you used anything you learned from the negotiation training activities? |
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| Are there other parts of your life where you used negotiation skills gained during this study? |
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| In the past month, have you negotiated anything related to the care of your older adult? |
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| Negative Affect Score |
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| Univariate ANOVA of change in positive affect score between baseline-1 month post-intervention. Test is a 2-sided dependent sample t-test. | 2-sided dependent sample t-test | .4305 | Mean Difference (Final Values) | .3440 | Standard Deviation | 4.86 | 95 | -.52 | 1.21 | Superiority |
| Yes |
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| Yes |
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| Yes |
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| Yes |
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