REmote Assessment and Dynamic Response Intervention II (READyR-II)

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Relationship, Marital; Alzheimer Disease; Caregiver Stress Syndrome; Dementia

Treatments: Behavioral: READyR II: B; Behavioral: READyR II: A

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04686838

17-2

P30AG024978-17 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of the READyR II Study is to test a dynamic tailoring phase of a remote assessment for changing dementia-related care needs.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

READyR II A

Experimental group

Description:

Continuous monitoring will be conducted and analyzed for anomaly detection. Participants in this arm will receive contact phone call when a potential change in care needs is indicated by an anomaly.

Treatment:

Behavioral: READyR II: A

READyR II B (comparison)

Active Comparator group

Description:

Sensors will remain in the home but anomaly detection analysis will not be performed and contact phone calls will be at regular intervals without dynamic tailoring content. Standard educational content will instead be shared over the phone.

Treatment:

Behavioral: READyR II: B