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Negotiation Training for Caregiver Communication in AD

Primary Purpose

Alzheimer Disease, Cognitive Impairment

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Caregiver vs. Patient [Beginner]

Caregiver vs. Caregiver

Caregiver vs. Physician

Caregiver vs. Patient [Advanced]

About this trial

This is an interventional other trial for Alzheimer Disease focused on measuring Family caregiver, Negotiation, Dispute resolution, Conflict communication

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Speak/read English;
Currently provide care-giving support (e.g. emotional, social, physical, task-related) to an adult over the age of 65;
Currently provide care-giving support at least 2 hours 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); and
Access to and the ability to use the internet to complete a series of online activities

Exclusion Criteria:

Less than 21 years old
Unable to speak and read English

Sites / Locations

Northwestern University Feinberg School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Condition 1

Condition 2

Condition 3

Condition 4

Condition 5

Condition 6

Condition 7

Condition 8

Arm Description

(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.

(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient [Advanced]' ' conflict negotiation/dispute resolution exercise

(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise

(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

(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise

(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

(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

(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

Outcomes

Primary Outcome Measures

Well-being

Caregiver well-being as measured by the Positive Affect and Well-being scale for the Neurology Quality of Life (Neuro-QOL)

Secondary Outcome Measures

Anxiety

PROMIS Ca Adult Item Bank Emotional distress-Anxiety. The PROMIS Anxiety instruments measure self-reported fear (fearfulness, panic), anxious misery (worry, dread), and hyper-arousal (tension, nervousness, restlessness).

Caregiver strain

Caregiver Strain Index The Modified Caregiver Strain Index (MCSI) is a 13-question validated tool that measures strain related to care provision. It measures the following major domains: Financial, Physical, Psychological, Social and Personal. This instrument can be used to assess individuals of any age who have assumed the caregiving role for an older adult.

Caregiver burden

Burden Scale for Family Caregivers (BSFC-s): a 10-item short version of the Burden Scale for Family Caregivers that detects the amount of burden perceived by the family caregiver.

Fatigue

PROMIS Fatigue 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.

General self-efficacy

PROMIS General Self-Efficacy - Short Form

Caregiving self-efficacy

PROMIS Care-giving Self Efficacy

Emotional support

PROMIS Emotional Support - Short Form. The PROMIS Emotional Support item bank assesses perceived feelings of being cared for and valued as a person; having confidant relationships.

Informational support

PROMIS Informational Support - Short Form. The PROMIS Informational Support item bank assesses perceived availability of helpful information or advice.

Satisfaction with Social Roles/Activities

PROMIS Satisfaction with Social Roles/Activities

Full Information

NCT ID

NCT04837937

First Posted

April 6, 2021

Last Updated

September 5, 2023

Sponsor

Northwestern University

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04837937

Brief Title

Negotiation Training for Caregiver Communication in AD

Official Title

Negotiation Training to Optimize Caregiver Communication in Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2023 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, Cognitive Impairment

Keywords

Family caregiver, Negotiation, Dispute resolution, Conflict communication

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

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)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Condition 1

Arm Type

Experimental

Arm Description

(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.

Arm Title

Condition 2

Arm Type

Experimental

Arm Description

(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient [Advanced]' ' conflict negotiation/dispute resolution exercise

Arm Title

Condition 3

Arm Type

Experimental

Arm Description

(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise

Arm Title

Condition 4

Arm Type

Experimental

Arm Description

Arm Title

Condition 5

Arm Type

Experimental

Arm Description

(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise

Arm Title

Condition 6

Arm Type

Experimental

Arm Description

Arm Title

Condition 7

Arm Type

Experimental

Arm Description

Arm Title

Condition 8

Arm Type

Experimental

Arm Description

(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

Intervention Type

Behavioral

Intervention Name(s)

Caregiver vs. Patient [Beginner]

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Caregiver vs. Caregiver

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Caregiver vs. Physician

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Caregiver vs. Patient [Advanced]

Intervention Description

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.

Primary Outcome Measure Information:

Title

Well-being

Description

Caregiver well-being as measured by the Positive Affect and Well-being scale for the Neurology Quality of Life (Neuro-QOL)

Time Frame

1 months post-baseline

Secondary Outcome Measure Information:

Title

Anxiety

Description

Time Frame

3 months post-baseline

Title

Caregiver strain

Description

Time Frame

3 months post-baseline

Title

Caregiver burden

Description

Burden Scale for Family Caregivers (BSFC-s): a 10-item short version of the Burden Scale for Family Caregivers that detects the amount of burden perceived by the family caregiver.

Time Frame

3 months post-baseline

Title

Fatigue

Description

Time Frame

3 months post-baseline

Title

General self-efficacy

Description

PROMIS General Self-Efficacy - Short Form

Time Frame

3 months post-baseline

Title

Caregiving self-efficacy

Description

PROMIS Care-giving Self Efficacy

Time Frame

3 months post-baseline

Title

Emotional support

Description

PROMIS Emotional Support - Short Form. The PROMIS Emotional Support item bank assesses perceived feelings of being cared for and valued as a person; having confidant relationships.

Time Frame

3 months post-baseline

Title

Informational support

Description

PROMIS Informational Support - Short Form. The PROMIS Informational Support item bank assesses perceived availability of helpful information or advice.

Time Frame

3 months post-baseline

Title

Satisfaction with Social Roles/Activities

Description

PROMIS Satisfaction with Social Roles/Activities

Time Frame

3 months post-baseline

Other Pre-specified Outcome Measures:

Title

Intervention Feasibility: Recruitment

Description

Measuring the feasibility of the intervention by collecting study recruitment rates (# of people)

Time Frame

3 months post-baseline

Title

Intervention Feasibility: Retention

Description

Measuring the feasibility of the intervention by collecting study participant retention rates (# of people)

Time Frame

3 months post-baseline

Title

Intervention Feasibility: Usability

Description

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.

Time Frame

3 months post-baseline

Title

Intervention Feasibility: Acceptability

Description

Measuring the feasibility and acceptability of the intervention using the USE Scale, a 30-item measure of usefulness, satisfaction, ease of use, and ease of learning.

Time Frame

3 months post-baseline

Title

Intervention Feasibility: Completion

Description

Measuring the feasibility of the intervention by assessing completion of negotiation training exercises.

Time Frame

3 months post-baseline

Title

Negotiation and Conflict

Description

Caregiver negotiation processes and communication will be assessed using the Dutch Test for Conflict Handling (DUTCH), a widely used tool that measures aspects of conflict resolution pertaining to the negotiator.

Time Frame

3 months post-baseline

Title

Negotiation Knowledge

Description

Survey measuring caregiver knowledge of negotiation strategies

Time Frame

3 months post-baseline

Title

Negotiation Utilization

Description

Survey measuring caregiver utilization of negotiation strategies

Time Frame

3 months post-baseline

Title

Program Assessment

Description

Survey measuring the perception of the assigned intervention program, satisfaction, progress. Likert scale. Open-ended questions to obtain qualitative data on subjects' perception.

Time Frame

3 months post-baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Speak/read English; Currently provide care-giving support (e.g. emotional, social, physical, task-related) to an adult over the age of 65; Currently provide care-giving support at least 1 hour per week (e.g. may include grocery shopping, scheduling appointments, and transportation); Currently involved in any decision-making related to the healthcare and support of this adult over the age of 65; Score >2 on the 8-item Informant Interview to Differentiate Aging and Dementia (AD8); Access to and the ability to use the internet to complete a series of online activities; and Have a valid email address or the willingness to create one to access during the study Exclusion Criteria: Less than 21 years old Unable to speak and read English

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vanessa Ramirez-Zohfeld, MPH

Phone

312-503-3916

vanessa-ramirez-0@northwestern.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Lee A Lindquist, MD MPH MBA

lal425@northwestern.edu

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alaine Murawski, AM

alaine.murawski@northwestern.edu

12. IPD Sharing Statement

Plan to Share IPD

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