REmote Assessment and Dynamic Response Intervention II

NCT ID: NCT04686838

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-11-25

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

READyR II A

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.

Group Type: EXPERIMENTAL

READyR II: A

Intervention Type: BEHAVIORAL

Continuous monitoring for anomaly detection and contact phone call when a potential change in care needs is indicated by an anomaly.

READyR II B (comparison)

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.

Group Type: ACTIVE_COMPARATOR

READyR II: B

Intervention Type: BEHAVIORAL

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.

Interventions

READyR II: A

Continuous monitoring for anomaly detection and contact phone call when a potential change in care needs is indicated by an anomaly.

Intervention Type: BEHAVIORAL

READyR II: B

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Lyndsey Miller

Co-Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lyndsey M Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

P30AG024978-17

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-2

Identifier Type: -

Identifier Source: org_study_id