Negotiation Training to Optimize Caregiver Communication in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Change in Neuro-QoL Positive Affect and Well-Being Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Less than 21 years old
- •Unable to speak and read English
研究组 & 干预措施
Condition 1
(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
干预措施: Caregiver vs. Patient [Beginner] (Behavioral)
Condition 2
(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient [Advanced]' ' conflict negotiation/dispute resolution exercise
干预措施: Caregiver vs. Patient [Beginner] (Behavioral)
Condition 2
(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient [Advanced]' ' conflict negotiation/dispute resolution exercise
干预措施: Caregiver vs. Patient [Advanced] (Behavioral)
Condition 3
(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
干预措施: Caregiver vs. Patient [Beginner] (Behavioral)
Condition 3
(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
干预措施: Caregiver vs. Physician (Behavioral)
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
干预措施: Caregiver vs. Patient [Beginner] (Behavioral)
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
干预措施: Caregiver vs. Patient [Beginner] (Behavioral)
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
干预措施: Caregiver vs. Physician (Behavioral)
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
干预措施: Caregiver vs. Patient [Advanced] (Behavioral)
Condition 5
(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
干预措施: Caregiver vs. Patient [Beginner] (Behavioral)
Condition 5
(1) 'Caregiver vs. Patient [Beginner]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
干预措施: Caregiver vs. Caregiver (Behavioral)
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
干预措施: Caregiver vs. Patient [Beginner] (Behavioral)
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
干预措施: Caregiver vs. Caregiver (Behavioral)
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
干预措施: Caregiver vs. Patient [Advanced] (Behavioral)
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
干预措施: Caregiver vs. Caregiver (Behavioral)
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
干预措施: Caregiver vs. Physician (Behavioral)
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
干预措施: Caregiver vs. Patient [Beginner] (Behavioral)
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
干预措施: Caregiver vs. Caregiver (Behavioral)
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
干预措施: Caregiver vs. Physician (Behavioral)
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
干预措施: Caregiver vs. Patient [Advanced] (Behavioral)
结局指标
主要结局
Change in Neuro-QoL Positive Affect and Well-Being Score
时间窗: 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.
次要结局
- Change in PROMIS Anxiety Score(1 months post-baseline)
- Change in Zarit Caregiver Burden Score(1 month post-baseline)
- Change in PROMIS Fatigue Score(1 month post-baseline)
- Change in PROMIS Short Form General Self Efficacy T Score(1 months post-baseline)
- PROMIS Short Form Emotional Support T Score at Baseline(Baseline Measure)
- Change in PROMIS Satisfaction With Social Roles/Activities Score(1 months post-baseline)
- Change in Neuro-QoL Caregiver Specific Anxiety Score(1 month post-baseline)
- Change in PROMIS Anxiety Score(1 months post-baseline)
- Change in Zarit Caregiver Burden Score(1 month post-baseline)
- Change in PROMIS Fatigue Score(1 month post-baseline)
- Change in PROMIS Short Form General Self Efficacy T Score(1 months post-baseline)
- PROMIS Short Form Emotional Support T Score at Baseline(Baseline Measure)
- Change in PROMIS Satisfaction With Social Roles/Activities Score(1 months post-baseline)
- Change in Neuro-QoL Caregiver Specific Anxiety Score(1 month post-baseline)
研究者
Lee Lindquist
Associate Professor of Medicine, Chief - Geriatrics
Northwestern University