The Living Memory Home: Reducing Grief and Improving Relationships Between Home-Based Patients With ADRD and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- The Feasibility of the LMH-4-DCP application as measured by the number of website logins per participant out of total required (minimum= 6).
研究概览
简要总结
The purpose of this study is to evaluate an online platform -- the Living Memory Home for Dementia Care Pairs (LMH-4-DCP) for persons with dementia and their family caregivers to engage in reminiscence activities together and record meaningful memories.
The main aims of this study are:
- To evaluate the feasibility and acceptability of the LMH-4-DCP platform.
- To explore the potential for LMH-4-DCP to reduce feelings of pre-loss grief and enhancing relationship quality in dementia family caregivers and their care-recipients ('Care-Pairs')
Care pair participants will be asked to log-in to LMH-4-DCP and complete study activities three times per week for two weeks. Researchers will compare the intervention group to an attention control condition to see if LMH-4-DCP's use is associated with reduced feelings of caregiver pre-loss grief and improved care pair relationship quality at follow-up.
详细描述
The goal of this randomized controlled trial is to evaluate the Living Memory Home for Dementia Care Pairs (LMH-4-DCP) web application, a dyadic online psychosocial reminiscence platform, to reduce feelings of pre-loss grief and improve relationship quality in individuals with dementia and their family caregivers ('Care Pairs').
The main aims of this study are:
- To evaluate the feasibility and acceptability of the LMH-4-DCP platform.
- To explore the influence of the LMH-4-DCP intervention on reducing feelings of pre-loss grief and enhancing relationship quality in the care pair
Caregiver participants randomized to the intervention condition will be asked to log-in to LMH-4-DCP and complete reminiscence activities three times per week for two weeks. Researchers will compare the intervention group to an attention control condition, which includes LMH-4-DCP use without reminiscence-specific features, to see if LMH-4-DCP's use is associated with reduced feelings of caregiver pre-loss grief and improved care pair relationship quality at follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Family Caregivers:
- •be a primary source of care for a family member in the early to moderate stages of dementia
- •18 years of age or older
- •English-speaking
- •able to use the internet and has internet access
- •residing in the United States
排除标准
- •Caregiver exclusion criteria:
- •is not the primary family caregiver of the PwD
- •under the age of 18-years-old
- •exhibits cognitive impairment (by scoring 3 or more on the SPMSQ)
- •does not speak English as a primary language.
- •PwD exclusion criteria:
- •severe cognitive impairment detected by the clinical or study staff using validated, brief screening tools (e.g., a score of 8 errors or more on the SPMSQ)
- •does not demonstrate capacity to consent (e.g., a score of 9 or fewer errors on the University of California-San Diego Brief Assessment of Capacity to consent
- •PwD is living in a long-term care facility
- •does not speak English as a primary language
- •is under the age of 18 years old.
研究组 & 干预措施
Attention Control Arm
干预措施: LMH-4-DCP access without reminiscence activities (Behavioral)
LMH-4-DCP Intervention
干预措施: LMH-4-DCP (Behavioral)
结局指标
主要结局
The Feasibility of the LMH-4-DCP application as measured by the number of website logins per participant out of total required (minimum= 6).
时间窗: 2 Weeks
The feasibility of the application will be measured by the number of times the participant logs in to the LMH-4-DCP web application. The minimum number of logins recommended to the participants is 6.
The Feasibility of the LMH-4-DCP study as measured by participant retention, as indicated by the number of participants lost to follow-up.
时间窗: 2 Weeks
Participant retention, as an aspect of feasibility, will be measured by the recorded number of participants number lost to follow-up. A number of the enrolled participants who the study team contacted three times, but did not answer or continue participation, will be recorded.
The Feasibility of the LMH-4-DCP study as measured by participant retention, as indicated by the number of recorded dropouts.
时间窗: 2 Weeks
Participant retention, as an aspect of feasibility, will be measured by the recorded number of dropouts. A number of the participants who asked to withdraw/drop-out from the study after being enrolled will be recorded.
The Feasibility of the LMH-4-DCP application as measured by the time spent in each activity within the web application.
时间窗: 2 Weeks
The feasibility of the application will be measured by the time spent in each activity. The time will be measured in minutes and seconds. For example, 5 minutes and 30 seconds.
The Feasibility of the LMH-4-DCP study as measured by the proportion of family caregivers who (1) consent to participate.
时间窗: 2 Weeks
The feasibility of the LMH-4-DCP study will be measured by the proportion of family caregivers who consent to participate among those who were invited and screened into the study.
The Feasibility of the LMH-4-DCP study as measured by recruitment rates and the proportion of family caregivers (2) decline participation.
时间窗: 2 Weeks
The feasibility of the LMH-4-DCP study will be measured by the proportion of family caregivers who decline to participate among those who were invited and screened into the study.
The Feasibility of the LMH-4-DCP study as measured by recruitment rates and the proportion of (3) are deemed ineligible based on screening criteria.
时间窗: 2 Weeks
The feasibility of the LMH-4-DCP study will be measured by the proportion of family caregivers who are deemed ineligible based on screening criteria among those who were invited to participate in the study.
The Usability of the LMH-4-DCP application as measured by the System Usability Scale (SUS).
时间窗: 2 Weeks
The usability of the web application will be measured by the SUS. This scale is a 10-item assessment of the usability of a system, helping identify areas for improvement. Response options range from 1=Strongly Disagree to 5-Strongly Agree. Scores range from 0-100, with higher scores indicative of greater usability.
The Acceptability of the LMH-4-DCP application as measured by a survey that measures the participants satisfaction and acceptability of the application.
时间窗: 2 Weeks
The acceptability of the web application will be measured by the use of surveys assessing usability, engagement, acceptability, suggestions for improvement. Participants will be asked to rate their agreement with statements including "I enjoyed my experience using the LMH-4-DCP application". Response options are rated on a five-point scale from 1-Strongly Disagree to 5-Strongly Agree. Because the surveys differ slightly by group, the intervention groups scores range from 8-40 and the control groups' scores range from 7-35, with higher scores indicating greater satisfaction and acceptability.
The Acceptability of the LMH-4-DCP application as measured by a qualitative survey that measures the participants satisfaction and acceptability of the application.
时间窗: 2 Weeks
The acceptability of the web application will be measured by the use of open-ended items assessing usability, engagement, acceptability, suggestions for improvement. The intervention group participants will also be administered five open-ended qualitative items asking for feedback on LMH-4-DCP. Sample items include: "Which LMH-4-DCP features were most valuable and why?"
The Feasibility of the LMH-4-DCP Application as Measured by the Number of Website Logins Per Participant Out of Total Required (Minimum = 6).
时间窗: 2 Weeks
The feasibility of the application will be measured by the number of times the participant logs in to the LMH-4-DCP web application. The minimum number of logins recommended to the participants is 6.
The Feasibility of the LMH-4-DCP Study as Measured by Participant Retention, as Indicated by the Number of Participants Lost to Follow-Up.
时间窗: 2 Weeks
Participant retention, as an aspect of feasibility, will be measured by the recorded number of participants lost to follow-up. A number of the enrolled participants who the study team contacted three times, but did not answer or continue participation, will be recorded.
The Feasibility of the LMH-4-DCP Study as Measured by Participant Retention, as Indicated by the Number of Recorded Dropouts.
时间窗: 2 Weeks
Participant retention, as an aspect of feasibility, will be measured by the recorded number of dropouts. A number of the participants who asked to withdraw/drop-out from the study after being enrolled will be recorded.
The Feasibility of the LMH-4-DCP Application as Measured by the Time Spent in Each Activity Within the Web Application.
时间窗: 2 Weeks
The feasibility of the application will be measured by the time spent in each activity. The time will be measured in minutes and seconds. For example, 5 minutes and 30 seconds.
The Feasibility of the LMH-4-DCP Study as Measured by Recruitment Rates and the Proportion of Family Caregivers Who (1) Consent to Participate.
时间窗: 2 Weeks
The feasibility of the LMH-4-DCP study will be measured by the proportion of family caregivers who consent to participate among those who were invited and screened into the study.
The Feasibility of the LMH-4-DCP Study as Measured by Recruitment Rates and the Proportion of Family Caregivers (2) Decline Participation.
时间窗: 2 Weeks
The feasibility of the LMH-4-DCP study will be measured by the proportion of family caregivers who decline to participate among those who were invited and screened into the study.
The Feasibility of the LMH-4-DCP Study as Measured by Recruitment Rates and the Proportion of (3) Are Deemed Ineligible Based on Screening Criteria.
时间窗: 2 Weeks
The feasibility of the LMH-4-DCP study will be measured by the proportion of family caregivers who are deemed ineligible based on screening criteria among those who were invited to participate in the study.
The Usability of the LMH-4-DCP Application as Measured by the System Usability Scale (SUS).
时间窗: 2 Weeks
The usability of the web application will be measured by the System Usability Scale (SUS). This scale is a 10-item assessment of the usability of a system, helping identify areas for improvement. Response options range from 1 - Strongly Disagree to 5 - Strongly Agree. Scores range from 0-100, with higher scores indicative of greater usability.
The Acceptability of the LMH-4-DCP Application as Measured by a Survey That Measures the Participants Satisfaction and Acceptability of the Application.
时间窗: 2 Weeks
The acceptability of the LMH-4-DCP application was assessed among caregiver participants assigned to the intervention arm using a study-specific survey evaluating usability, engagement, acceptability, and suggestions for improvement. Participants rated their agreement with statements such as "I enjoyed my experience using the LMH-4-DCP application" on a five-point Likert scale ranging from 1 - Strongly Disagree to 5 - Strongly Agree. Total scores range from 8 to 40, with higher scores indicating greater satisfaction and acceptability of the intervention.
The Acceptability of the LMH-4-DCP Application as Measured by a Qualitative Survey That Measures the Participants Satisfaction and Acceptability of the Application.
时间窗: 2 Weeks
The acceptability of the web application will be measured by the use of open-ended items assessing usability, engagement, acceptability, suggestions for improvement. The intervention group participants will also be administered five open-ended qualitative items asking for feedback on LMH-4-DCP, including: "How was your overall experience using LMH-4-DCP?" and "Which LMH-4-DCP features did you find most valuable? Why?"
次要结局
- Change in Grief Severity as measured by the Pre-Loss Grief-12 (PG-12)(Baseline, 2 Weeks)
- Change in Relationship Quality as measured by the Relational Deprivation Scale.(Baseline, 2 Weeks)
- Change in Relationship Quality as measured by the Mutuality Scale.(Baseline, 2 Weeks)
- Change in Relationship Quality as measured by the Relationship Rewards Scale (RSS) Scale.(Baseline, 2 Weeks)
- Change in Grief Severity as Measured by the Pre-Loss Prolonged Grief Revised (PG-12-R) Instrument.(Baseline, 2 Weeks)
- Change in Relationship Quality as Measured by the Relational Deprivation Scale.(Baseline, 2 Weeks)
- Change in Relationship Quality as Measured by the Mutuality Scale.(Baseline, 2 Weeks)
- Change in Relationship Quality as Measured by the Relationship Rewards Scale.(Baseline, 2 Weeks)