Clinical trial NCT04686838: REmote Assessment and Dynamic Response Intervention II
Official title: READyR-II: Dynamic Tailoring Phase for 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
Remote Monitoring
Technology
Care Values
Aging-in-Place
Family Caregiver
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 21
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
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the READyR II Study is to test a dynamic tailoring phase of a remote assessment 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. READyR II tests a dynamic tailoring phase of an intervention program that was previously developed to remotely assess dementia-related care needs using digital data on behavioral patterns (from sensors and wearables) in the home. READyR II follows participants who have completed READyR for a total of six months in order to detect anomalies in activity patterns that may indicate new and unforeseen care needs.

People who voluntarily decide to participate in this follow-up intervention study will be asked to continue participating with the in-home monitoring sensor platform, complete weekly questionnaires, and receive regular follow-up telephone calls from the study team.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Inclusion:

* 21 years or older;
* Self-identifying as a family member and care partner residing with the PwD participant;

Exclusion:

* 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.

Primary outcomes:
measure: Mean difference effect sizes for pre-post change the care dyad's preparation for future care needs
timeFrame: Baseline compared with 18 weeks
measure: Mean difference effect sizes for pre-post change in the care dyad's relationship quality
timeFrame: Baseline compared with 18 weeks
measure: Mean difference effect sizes for pre-post change in the amount of incongruence between the care partner's understanding of the care values of the person with dementia
timeFrame: Baseline compared with 18 weeks
Secondary outcomes:
measure: Mean difference effect sizes for pre-post change in the amount of care-related strain reported
timeFrame: Baseline compared with 12 weeks
measure: Mean difference effect sizes for pre-post change in the care dyad's quality of life
timeFrame: Baseline compared with 18 weeks
measure: Mean difference effect sizes for pre-post change in the care dyad's concealment of emotions
timeFrame: Baseline compared with 18 weeks
Other outcomes:
measure: Time spent out of the home
timeFrame: Continuously over 18 weeks
measure: Physical activity / sedentary behavior
timeFrame: Continuously over 18 weeks
measure: Time spent together / separate
timeFrame: Continuously over 18 weeks
measure: Sleep patterns
timeFrame: Continuously over 18 weeks
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: