READyR: A Remote Assessment and Dynamic Response Intervention to Support Couples in Planning for Changing Dementia Care Needs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean difference effect sizes for pre-post change in the care dyad's relationship quality
研究概览
简要总结
The purpose of the READyR study (originally called SHARE-sense) is to redevelop and test an intervention program to remotely assess for changing dementia-related care needs.
详细描述
Unmet dementia-related care needs are highly prevalent, and are detrimental to the care dyad's (person with dementia and their family care partner) health, safety, mortality, and likelihood of nursing home placement. The first phase of this study involves redevelopment of the intervention program into a 3-session values-based needs assessment intervention (delivered over 6 weeks) designed for early-stage persons with dementia and their primary family caregiver (i.e. spouse or partner). A secondary data analysis and focus groups will be conducted in order to complete the redevelopment phase. Objective digital data on behavioral patterns (from sensors and wearables) will be incorporated into a needs assessment that will allow for dynamic tailoring of the READyR program to new and unforeseen care needs.
People who voluntarily decide to participate in this study will be asked to participate in three sessions: Session 1 for baseline assessments gathered from all participants (including remote in-home monitoring), Session 2 for discussing the participant's care values and their alignment with current patterns of activities (assessed by remote monitoring) in the home, and Session 3 for addressing current dementia related care needs and setting goals for the future.
Participants who complete this study will be offered participation in a follow-up monitoring period to further study the possibilities for dynamic tailoring of their dementia-related needs assessment.
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
- None
入排标准
- 年龄范围
- 62 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with Dementia
- •62 years or older;
- •Able to identify a family care partner over age 20 who is living with you and will also consent to fully participate in the study;
- •Probable or confirmed diagnosis of mild cognitive impairment or early-stage dementia
- •Age and education adjusted MOCA score > 15 (at most recent measurement by parent study) corresponding to early to moderate stage dementia
排除标准
- •Inability to speak English or read printed materials in English
- •Conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the intervention materials);
- •Any uncontrolled medical condition that is expected to preclude completion of the study, such as late stage cancers.
- •Family Care Partners
- •21 years or older;
- •Self-identifying as a family member and care partner residing with the PwD participant;
- •Inability to speak English or read printed materials in English
- •Conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the intervention materials);
- •Any uncontrolled medical condition that is expected to preclude completion of the study, such as late stage cancers.
研究组 & 干预措施
READyR A
Group A will start the READyR intervention immediately after the baseline Session 1. The READyR program consists of a 3-session, values-based needs assessment intervention designed to match objectively-assessed in-home activity patterns with subjective reports of participants' care values. The goal of the intervention is to address unmet dementia-related care needs and help couples prepare for the future, and reduce strain on their relationship, and help maintain their health and well-being. Session 2 will occur approximately 3 weeks after Session 1, and Session 3 will occur approximately 3 weeks after Session 2. Session 3 also includes follow-up assessments.
干预措施: READyR A (Behavioral)
READyR B (wait list comparison)
Group B - the wait list comparison group - will have a 60-minute support session (comparator intervention) about 3 weeks after the baseline Session 1. The support session will include general information about dementia-related care needs that does not take into account the individual participant's care values or objective in-home activity patterns. They will also receive a check-in call approximately 3 weeks later, with follow-up assessments. Group B will begin the READyR intervention sessions following completion of follow-up assessments.
干预措施: READyR B (Behavioral)
结局指标
主要结局
Mean difference effect sizes for pre-post change in the care dyad's relationship quality
时间窗: Baseline, 6 weeks, 12 weeks
The Dyadic Relationship Scale assesses the positive dyadic interactions and negative dyadic strain experienced by caregivers (11 items) and care recipients (10 items). Items are averaged for a summary score that ranges from 0 to 3, with higher scores indicating more positive interactions in the relationship, or more relationship strain, respectively. Sebern, M.D. \& Whitlatch, C.J. (2007). Dyadic Relationship Scale: A measure of the impact of the provision and receipt of family care. The Gerontologist, 47(6), 741-751.
Mean difference effect sizes for pre-post change the care dyad's preparation for future care needs
时间窗: Baseline, 6 weeks, 12 weeks
The Preparation for Future Care Needs Scale (Short Form) assesses the degree to which an individual has engaged in planning for future care needs in late life using 15 items and 5 subscales representing distinct planning processes (awareness, gathering information, decision making, concrete planning, avoidance). Items are scored on a 5 point Likert scale with higher scores indicating greater preparation for future care needs. Sorensen, S., Chapman, B. P., Duberstein, P. R., Pinquart, M., \& Lyness, J. M. (2017). Assessing future care preparation in late life: Two short measures. Psychol Assess, 29(12), 1480-1495.
次要结局
- Mean difference effect sizes for pre-post change in care-related strain(Baseline and weekly for 12 weeks)
- Mean difference effect sizes for pre-post change in concealment of emotions.(Baseline, 6 weeks, and 12 weeks)
- Mean difference effect sizes for pre-post change in quality of life(Baseline, 6 weeks, and 12 weeks)
研究者
Lyndsey Miller
Principal Investigator
Oregon Health and Science University