Development and Piloting of a Family-Centered, mHealth-Enhanced Intervention to Promote Caregiving Mastery in Detection, Prevention, and Management of Delirium Superimposed on Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Number of Participants Who Complete the Study
研究概览
简要总结
Delirium superimposed on dementia (DSD) is an acute and serious condition that is common in persons living with dementia (PLWD). Involvement of family caregivers may aid prevention, early detection, and management of DSD. The purpose of the proposed study is two-fold. First, the investigators will develop a family-centered, mHealth-enhanced DSD caregiving mastery program ("Aliviado DSD Caregiving Mastery Program") through a 5-week co-design workshop with 8 family caregivers (Aim 1). The investigators will adapt/refine the existing clinician-centered DSD contents and an mHealth app from the evidence-based "Aliviado Dementia Care" program for use by family caregivers to support their day-to-day implementation of DSD detection, prevention, and management tasks in the community. Second, the investigators will pilot test the full Aliviado DSD Caregiving Mastery Program with family caregivers of PLWD at high risk for delirium, assessing feasibility, acceptability, app usability, and preliminary program impact (Aim 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be eligible as a "dementia caregiver" in the co-design workshop, an individual must:
- •be at least 18 years old,
- •be English-speaking,
- •provide at least 8 hours of unpaid care weekly or live with a community-dwelling PLWD,
- •self-identify as unfamiliar with DSD,
- •have the capacity to consent, and
- •have Internet access
- •To be eligible as a "DSD caregiver" in the co-design workshop, an individual must:
- •be at least 18 years old,
- •be English-speaking,
- •be a current or past dementia caregiver with experience caring for a relative or friend during his/her DSD episode within the past 12 months,
- •have the capacity to consent, and
- •have Internet access.
- •To be eligible to participate in the feasibility trial, an individual must meet all of the following criteria:
- •Being 18 years old or older,
- •English-speaking,
- •Providing at least 8 hours of unpaid care per week to, or living with, a community dwelling PLWD whose Delirium Risk Assessment Score >=5,
- •Having the capacity to give informed consent, and
- •Having a smartphone with Internet access.
排除标准
- •Individuals who are blind or deaf will be excluded.
研究组 & 干预措施
Family Caregivers of PLWD at High Risk for Delirium
Participants will complete the Aliviado DSD Caregiving Mastery Program. This involves a caregiver education/training period from Week 0 to Week 2, and an implementation period from Week 3 to Week 6.
干预措施: Aliviado DSD Caregiving Mastery Program (Behavioral)
结局指标
主要结局
Number of Participants Who Complete the Study
时间窗: Week 6
Measure of feasibility. Feasibility indicated by retention rate of 85%.
Program Satisfaction Questionnaire Score: Satisfaction
时间窗: Week 6
Measure of acceptability. Acceptability was indicated by at least 80% of caregivers reporting high satisfaction. The questionnaire comprised 16 items, including 12 Likert-type questions assessing program satisfaction, one Yes/No question assessing caregivers' intention to make changes in how they provide care for PLWD based on what they learned from the program, and three open-ended questions for additional feedback. Each Likert-type item was rated on a 4-point scale (1 = strongly disagree; 2 = disagree; 3 = agree; 4 = strongly agree). The total satisfaction score was calculated as the sum of the 12 Likert-type items, yielding a possible range of 12-48, with higher scores indicating greater satisfaction (high satisfaction defined as a score \> 36). This outcome is measured as the number of participants with a high satisfaction score.
Program Satisfaction Questionnaire Score: Intention to Change
时间窗: Week 6
Measure of acceptability. Acceptability was indicated by at least 80% of caregivers responding "Yes" to the Yes/No question on the Program Satisfaction Questionnaire: "Will you make any changes in how you care for your relative or friend with dementia based on what you learned in this program?" This outcome is measured as the number of participants who answer "Yes" to the intention-to-change question.
Number of Participants Who Complete All Training Videos by Week 2
时间窗: Up to Week 2
Measure of acceptability.
Number of Participants Who Complete Weekly Delirium Screening at Least Twice by Week 6
时间窗: Up to Week 6
Measure of acceptability.
Modified IBM Computer Usability Satisfaction Questionnaire Score
时间窗: Up to Week 6
Modified by the Aliviado team to assess the usability of mobile apps, it consists of (1) 22 Likert-type questions rated on a scale from 1 to 5 (1="Strongly Disagree"; 2 ="Disagree"; 3="Neither agree or disagree"; 4="Agree" 5="Strongly Agree") assessing app usability, content, and interface; (2) one 4-point item on readiness to launch; (3) three Yes/No questions assessing frequency of app use and internet connectivity; and (4) three open-ended questions to provide additional feedback. The total usability satisfaction score is calculated by averaging responses to the twenty-two 5-point Likert-type items related to app usability, content, and interface. A score of 4 or higher indicates high user satisfaction and good usability.
次要结局
- Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 2(Baseline, Week 2)
- Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 6(Baseline, Week 6)
- Change From Baseline in Modified Caregiver Strain Index Score at Week 6(Baseline, Week 6)
- Change From Baseline in Center for Epidemiological Studies Depression Scale (CES-D) Score at Week 6(Baseline, Week 6)
- Change From Baseline in Short Form Zarit Burden Interview Score at Week 6(Baseline, Week 6)
- Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 2(Baseline, Week 2)
- Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 6(Baseline, Week 6)
- Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 2(Baseline, Week 2)
- Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 6(Baseline, Week 6)