Negotiation Training for Caregiver Communication in AD

Alzheimer Disease Clinical Trial

Official title:

Negotiation Training to Optimize Caregiver Communication in Alzheimer's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04837937
• Other study ID #: R01AG068421-01
• Secondary ID: 1R01AG068421-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: March 31, 2025
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention Feasibility: Recruitment	Measuring the feasibility of the intervention by collecting study recruitment rates (# of people)	3 months post-baseline
Other	Intervention Feasibility: Retention	Measuring the feasibility of the intervention by collecting study participant retention rates (# of people)	3 months post-baseline
Other	Intervention Feasibility: Usability	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.	3 months post-baseline
Other	Intervention Feasibility: Acceptability	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.	3 months post-baseline
Other	Intervention Feasibility: Completion	Measuring the feasibility of the intervention by assessing completion of negotiation training exercises.	3 months post-baseline
Other	Negotiation and Conflict	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.	3 months post-baseline
Other	Negotiation Knowledge	Survey measuring caregiver knowledge of negotiation strategies	3 months post-baseline
Other	Negotiation Utilization	Survey measuring caregiver utilization of negotiation strategies	3 months post-baseline
Other	Program Assessment	Survey measuring the perception of the assigned intervention program, satisfaction, progress. Likert scale. Open-ended questions to obtain qualitative data on subjects' perception.	3 months post-baseline
Primary	Well-being	Caregiver well-being as measured by the Positive Affect and Well-being scale for the Neurology Quality of Life (Neuro-QOL)	1 months post-baseline
Secondary	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).	3 months post-baseline
Secondary	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.	3 months post-baseline
Secondary	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.	3 months post-baseline
Secondary	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.	3 months post-baseline
Secondary	General self-efficacy	PROMIS General Self-Efficacy - Short Form	3 months post-baseline
Secondary	Caregiving self-efficacy	PROMIS Care-giving Self Efficacy	3 months post-baseline
Secondary	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.	3 months post-baseline
Secondary	Informational support	PROMIS Informational Support - Short Form.; The PROMIS Informational Support item bank assesses perceived availability of helpful information or advice.	3 months post-baseline
Secondary	Satisfaction with Social Roles/Activities	PROMIS Satisfaction with Social Roles/Activities	3 months post-baseline