REmote Assessment and Dynamic Response Intervention II

NCT04686838 | Completed

• 2 other identifiers: 17-2P30AG024978-17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Needs Assessment; Remote Monitoring; Technology; Care Values; Aging-in-Place; Family Caregiver

Outcome Measures

Primary Outcomes (3)

• Mean difference effect sizes for pre-post change the care dyad's preparation for future care needs

  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.

  Baseline compared with 18 weeks

• Mean difference effect sizes for pre-post change in the care dyad's relationship quality

  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.

  Baseline compared with 18 weeks

• 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

  The Care Values Scale assesses the importance of four care-related values to the person with dementia from the perspectives of the person with dementia and their care partner. Items for each of the four subscales are averaged for a summary score that ranges from 1 to 3, with higher scores indicating greater importance of the care value to the person with dementia. Miller LM, Whitlatch CJ, Lee CS, Caserta MS. Care Values in Dementia: Patterns of Perception and Incongruence Among Family Care Dyads. The Gerontologist. 2018.

  Baseline compared with 18 weeks

Secondary Outcomes (3)

• Mean difference effect sizes for pre-post change in the amount of care-related strain reported

  Baseline compared with 12 weeks

• Mean difference effect sizes for pre-post change in the care dyad's quality of life

  Baseline compared with 18 weeks

• Mean difference effect sizes for pre-post change in the care dyad's concealment of emotions

  Baseline compared with 18 weeks

Other Outcomes (4)

• Time spent out of the home

  Continuously over 18 weeks

• Physical activity / sedentary behavior

  Continuously over 18 weeks

• Time spent together / separate

  Continuously over 18 weeks

Study Arms (2)

READyR II A

EXPERIMENTAL

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.

Behavioral: READyR II: A

READyR II B (comparison)

ACTIVE COMPARATOR

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.

Behavioral: READyR II: B

Interventions

READyR II: A BEHAVIORAL

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

READyR II A

READyR II: B 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.

READyR II B (comparison)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Lyndsey M Miller, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will all agree to the dynamic tailoring phase with remote monitoring and surveys, and will not know whether the phone calls are related to anomaly detection or are a control condition phone call.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: Dyads will be randomized (assigned by chance) to one of two groups: 1) READyR A or 2) READyR B

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 29, 2020
• Study Start: July 1, 2021
• Primary Completion: November 17, 2022
• Study Completion: November 25, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

US (1)