Alzheimer Disease, Caregiver Stress Syndrome, Dementia, Relationship, Marital
Conditions
Keywords
Needs Assessment, Family Caregiver, Technology, Remote Monitoring, Care Values, Aging-in-place
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALREADyR A
Two active sessions to conduct an individually-tailored dementia-related needs assessment, incorporating the participant's care values and objective data from remote in-home monitoring.
BEHAVIORALREADyR B
Active comparator. Two sessions to deliver general information about dementia-related care needs.
Sponsors
National Institute on Aging (NIA)
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Dyads will be randomized (assigned by chance) to one of two groups: 1) READyR A or 2) READyR B (Wait List Control).
Eligibility
Sex/Gender
ALL
Age
62 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Persons with Dementia Inclusion: 1. 62 years or older; 2. 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; 3. Probable or confirmed diagnosis of mild cognitive impairment or early-stage dementia 4. Age and education adjusted MOCA score \> 15 (at most recent measurement by parent study) corresponding to early to moderate stage dementia Exclusion: 1. Inability to speak English or read printed materials in English 2. Conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the intervention materials); 3. Any uncontrolled medical condition that is expected to preclude completion of the study, such as late stage cancers. Family Care Partners Inclusion: 1. 21 years or older; 2. Self-identifying as a family member and care partner residing with the PwD participant; Exclusion: 1. Inability to speak English or read printed materials in English 2. Conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the intervention materials); 3. Any uncontrolled medical condition that is expected to preclude completion of the study, such as late stage cancers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference effect sizes for pre-post change the care dyad's preparation for future care needs | 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. |
| Mean difference effect sizes for pre-post change in the care dyad's relationship quality | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference effect sizes for pre-post change in care-related strain | Baseline and weekly for 12 weeks | Subjective strain from caregiving will be assessed among family care partners at baseline and follow-up assessments using the Zarit Burden Interview (ZBI), short-form (12 items). Scores range from 0-48 with higher scores indicating a greater degree of strain from providing care. |
| Mean difference effect sizes for pre-post change in quality of life | Baseline, 6 weeks, and 12 weeks | The Quality of Life: Alzheimer's Disease Scale assesses individual perceptions of quality of life (from poor to excellent) across 13 items. Items are averaged for a summary score of 1 to 4, higher scores indicating greater degree of quality of life. Logsdon, R. G., Gibbons, L. E., McCurry, S. M., & Teri, L. (1999). Quality of Life in Alzheimer's Disease: Patient and Caregiver Reports. Journal of Mental Health and Aging, 5(1), 21-32. |
| Mean difference effect sizes for pre-post change in concealment of emotions. | Baseline, 6 weeks, and 12 weeks | The Emotional Intimacy Disruptive Behavior Scale (8 items) assesses the frequency of engagement in behaviors to conceal emotions about an illness from one's partner. Druley, J. A., Stephens, M. A. P., & Coyne, J. C. (1997). Emotional and physical intimacy in coping with Lupus: Women's dilemmas of disclosure and approach. . Health Psychology, 16, 506-514. |
Countries
United States
Outcome results
None listed