Clinical trial NCT04542109: REmote Assessment and Dynamic Response Intervention
Official title: READyR: A Remote Assessment and Dynamic Response Intervention to Support Couples in Planning for Changing Dementia Care Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Relationship, Marital
Caregiver Stress Syndrome
Keywords: Needs Assessment
Family Caregiver
Technology
Remote Monitoring
Care Values
Aging-in-place
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 62
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Mean difference effect sizes for pre-post change the care dyad's preparation for future care needs
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Mean difference effect sizes for pre-post change in the care dyad's relationship quality
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Mean difference effect sizes for pre-post change in care-related strain
timeFrame: Baseline and weekly for 12 weeks
measure: Mean difference effect sizes for pre-post change in quality of life
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Mean difference effect sizes for pre-post change in concealment of emotions.
timeFrame: Baseline, 6 weeks, and 12 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Lyndsey M Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller LM, Solomon DN, Whitlatch CJ, Hiatt SO, Wu CY, Reynolds C, Au-Yeung WM, Kaye J, Steele JS. The Remote Assessment and Dynamic Response Program: Development of an In-Home Dementia-Related Care Needs Assessment to Improve Well-Being. Innov Aging. 2022 Feb 7;6(2):igac006. doi: 10.1093/geroni/igac006. eCollection 2022.