Efficacy of the WeCareAdvisor: An Online Tool to Help Caregivers Manage Behavioral and Psychological Symptoms in Persons Living With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- Long-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia
研究概览
简要总结
The WeCareAdvisor is an online tool to help caregivers manage behavioral and psychological symptoms of people living with dementia. The trial will evaluate its efficacy to reduce caregiver distress, improve confidence managing behaviors, as well as reduce occurrences and severity of behavioral and psychological symptoms.
Visit https://wecareadvisorstudy.com/ for more information.
详细描述
Caregivers enrolled in the study will use the web-based WeCareAdvisor tool for either three or six months, depending upon group allocation (immediate treatment vs. 3-month waitlist). Caregivers will be interviewed at baseline, 1, 3 and 6 months by telephone to evaluate their health and wellbeing. Also, utilization data of the tool will be captured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single blind allocation. Study interviewers will be masked to group allocation. Other research personnel (investigator, project manager, interventionist), may become aware of group allocation. Caregivers will be asked not to disclose to interviewers the group to which they are assigned.
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
- •self-identify as the primary caregiver to the person living with memory loss or dementia;
- •has been a primary caregiver for at least 6 months;
- •report managing >1 behavioral symptom(s) in the past month;
- •has an email account or smartphone (to receive daily tips and reminder messages);
- •English speaking;
- •has own smartphone, tablet, laptop, or desktop computer and access to Internet;
- •If person living with dementia is on an anti-dementia or psychotropic medication, they must be on a stable dose for at least 60 days prior to enrollment.
- •If caregiver is on an anti-depression or other psychotropic medication, they must be on a stable does for at least 60 days prior to enrollment
- •Lives in the United States or US territory
排除标准
- •Caregiver currently involved in another clinical trial of psychosocial or educational interventions for dementia;
- •Caregiver has a visual impairment that prohibits interaction with the tool, and/or have a hearing impairment sufficient to prohibit telephone communication;
- •Caregiver reports person living with dementia is not responsive to his/her environment (e.g., unable to understand short commands or recognize a person coming in/out of the room);
- •Caregiver reports person living with dementia is an active suicide risk
- •Caregiver reports person living with dementia is likely to have an imminent placement in a long-term care facility (within 6 months).
- •Either caregiver/person living with dementia has a terminal disease with life expectancy < 6 months, is in active treatment for cancer, or has had more than 3 acute medical hospitalizations over the past year.
结局指标
主要结局
Long-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia
时间窗: 3 months
Caregivers will rate their level of confidence in dementia signs and symptom management using the 25-item Caregiver Confidence in Medical Sign/Symptom Management scale. For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version, caregivers rate confidence managing behaviors (0 (low-confidence - 10- high-confidence))
Short-Term Change in Person Living with Dementia- Frequency of Behaviors by Severity
时间窗: 1 Month
Neuropsychiatric Inventory-Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) and severity (0=none to 3=marked)
Long-Term Change in Person Living with Dementia- Frequency of Behaviors by Severity
时间窗: 3 Months
Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) and severity (0=none to 3=marked)
Short-term Change in Caregiver Distress with Behaviors
时间窗: 1 Month
For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version (NPI-C), caregivers rate level of distress with behavior (0=not distressing to 5=extremely upset)
Long-term Change in Caregiver Distress with Behaviors (3-Months)
时间窗: 3 months
For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version (NPI-C), caregivers rate level of distress with behavior (0=not distressing to 5=extremely upset)
Short-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia
时间窗: 1 month
Caregivers will rate their level of confidence in dementia signs and symptom management using the 25-item Caregiver Confidence in Medical Sign/Symptom Management scale. For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version, caregivers rate confidence managing behaviors (0 = low confidence - 10= high confidence)
Short-term Change in Caregiver Distress with Behaviors
时间窗: 1 Month
For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version (NPI-C), caregivers rate level of distress with behavior (0=not distressing to 5=extremely upset)
Long-term Change in Caregiver Distress with Behaviors (3-Months)
时间窗: 3 months
For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version (NPI-C), caregivers rate level of distress with behavior (0=not distressing to 5=extremely upset)
Short-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia
时间窗: 1 month
Caregivers will rate their level of confidence in dementia signs and symptom management using the 25-item Caregiver Confidence in Medical Sign/Symptom Management scale. For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version, caregivers rate confidence managing behaviors (0 = low confidence - 10= high confidence)
Long-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia
时间窗: 3 months
Caregivers will rate their level of confidence in dementia signs and symptom management using the 25-item Caregiver Confidence in Medical Sign/Symptom Management scale. For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version, caregivers rate confidence managing behaviors (0 (low-confidence - 10- high-confidence))
Short-Term Change in Person Living with Dementia- Frequency of Behaviors by Severity
时间窗: 1 Month
Neuropsychiatric Inventory-Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) and severity (0=none to 3=marked)
Long-Term Change in Person Living with Dementia- Frequency of Behaviors by Severity
时间窗: 3 Months
Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) and severity (0=none to 3=marked)
次要结局
- Short Term Change in Caregiver- Negative Communications(1 Month)
- Long Term Change in Caregiver- Negative Communications(3 Month)
- Utilization of tool use(Through study completion, up to 6 months.)
- Short-Term Change in Person Living with Dementia- Frequency of Behaviors(1 months)
- Long-Term Change in Person Living with Dementia- Frequency of Behaviors(3 months)
- Short-Term Change in Person Living with Dementia- Severity of Behaviors(1 months)
- Long-Term Change in Person Living with Dementia- Severity of Behaviors(3 months)
- Short-Term Change in Person Living with Dementia- Number of Behaviors(1 months)
- Long-Term Change in Person Living with Dementia- Number of Behaviors(3 months)
- Short-Term Change in Person with Dementia- Level of Functioning(1 months)
- Long-Term Change in Person with Dementia- Level of Functioning(3 months)
- Short-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia(1 months)
- Long-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia(3 months)
- Change in Person with Dementia's Medications(6 months)
- Short Term Change in Caregiver Wellbeing(1 Month)
- Long Term Change in Caregiver Wellbeing(3 Months)
- Short-Term Change in Person with Dementia- Level of Functioning(1 months)
- Long-Term Change in Person with Dementia- Level of Functioning(3 months)
- Short-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia(1 months)
- Long-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia(3 months)
- Change in Person with Dementia's Medications(6 months)
- Short Term Change in Caregiver Wellbeing(1 Month)
- Long Term Change in Caregiver Wellbeing(3 Months)
- Short Term Change in Caregiver- Negative Communications(1 Month)
- Long Term Change in Caregiver- Negative Communications(3 Month)
- Utilization of tool use(Through study completion, up to 6 months.)
- Short-Term Change in Person Living with Dementia- Frequency of Behaviors(1 months)
- Long-Term Change in Person Living with Dementia- Frequency of Behaviors(3 months)
- Short-Term Change in Person Living with Dementia- Severity of Behaviors(1 months)
- Long-Term Change in Person Living with Dementia- Severity of Behaviors(3 months)
- Short-Term Change in Person Living with Dementia- Number of Behaviors(1 months)
- Long-Term Change in Person Living with Dementia- Number of Behaviors(3 months)