Clinical trial NCT04837937: Negotiation Training for Caregiver Communication in AD
Official title: Negotiation Training to Optimize Caregiver Communication in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Cognitive Impairment
Keywords: Family caregiver
Negotiation
Dispute resolution
Conflict communication
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-04-08
Enrollment: 132
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Well-being
timeFrame: 1 months post-baseline
Secondary outcomes:
measure: Anxiety
timeFrame: 3 months post-baseline
measure: Caregiver strain
timeFrame: 3 months post-baseline
measure: Caregiver burden
timeFrame: 3 months post-baseline
measure: Fatigue
timeFrame: 3 months post-baseline
measure: General self-efficacy
timeFrame: 3 months post-baseline
measure: Caregiving self-efficacy
timeFrame: 3 months post-baseline
measure: Emotional support
timeFrame: 3 months post-baseline
measure: Informational support
timeFrame: 3 months post-baseline
measure: Satisfaction with Social Roles/Activities
timeFrame: 3 months post-baseline
Other outcomes:
measure: Intervention Feasibility: Recruitment
timeFrame: 3 months post-baseline
measure: Intervention Feasibility: Retention
timeFrame: 3 months post-baseline
measure: Intervention Feasibility: Usability
timeFrame: 3 months post-baseline
measure: Intervention Feasibility: Acceptability
timeFrame: 3 months post-baseline
measure: Intervention Feasibility: Completion
timeFrame: 3 months post-baseline
measure: Negotiation and Conflict
timeFrame: 3 months post-baseline
measure: Negotiation Knowledge
timeFrame: 3 months post-baseline
measure: Negotiation Utilization
timeFrame: 3 months post-baseline
measure: Program Assessment
timeFrame: 3 months post-baseline
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
References: