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

Primary Purpose

Dementia, Alzheimer Disease, Relationship, Marital

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
READyR II: A
READyR II: B
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Needs Assessment, Remote Monitoring, Technology, Care Values, Aging-in-Place, Family Caregiver

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

READyR II A

READyR II B (comparison)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Mean difference effect sizes for pre-post change in the amount of care-related strain reported
Subjective strain from caregiving will be assessed among family care partners at baseline and follow-up assessments using the Zarit Burden Interview (ZBI), short-form (12 items). Scores range from 0-48 with higher scores indicating a greater degree of strain from providing care.
Mean difference effect sizes for pre-post change in the care dyad's quality of life
The Quality of Life: Alzheimer's Disease Scale assesses individual perceptions of quality of life (from poor to excellent) across 13 items. Items are averaged for a summary score of 1 to 4, higher scores indicating greater degree of quality of life. Logsdon, R. G., Gibbons, L. E., McCurry, S. M., & Teri, L. (1999). Quality of Life in Alzheimer's Disease: Patient and Caregiver Reports. Journal of Mental Health and Aging, 5(1), 21-32.
Mean difference effect sizes for pre-post change in the care dyad's concealment of emotions
The Emotional Intimacy Disruptive Behavior Scale (8 items) assesses the frequency of engagement in behaviors to conceal emotions about an illness from one's partner. Druley, J. A., Stephens, M. A. P., & Coyne, J. C. (1997). Emotional and physical intimacy in coping with Lupus: Women's dilemmas of disclosure and approach. Health Psychology, 16, 506-514.

Full Information

First Posted
December 16, 2020
Last Updated
January 15, 2023
Sponsor
Oregon Health and Science University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04686838
Brief Title
REmote Assessment and Dynamic Response Intervention II
Acronym
READyR-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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
November 17, 2022 (Actual)
Study Completion Date
November 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease, Relationship, Marital, Caregiver Stress Syndrome
Keywords
Needs Assessment, Remote Monitoring, Technology, Care Values, Aging-in-Place, Family Caregiver

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Dyads will be randomized (assigned by chance) to one of two groups: 1) READyR A or 2) READyR B
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
READyR II A
Arm Type
Experimental
Arm 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.
Arm Title
READyR II B (comparison)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
READyR II: A
Intervention Description
Continuous monitoring for anomaly detection and contact phone call when a potential change in care needs is indicated by an anomaly.
Intervention Type
Behavioral
Intervention Name(s)
READyR II: B
Intervention 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.
Primary Outcome Measure Information:
Title
Mean difference effect sizes for pre-post change the care dyad's preparation for future care needs
Description
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.
Time Frame
Baseline compared with 18 weeks
Title
Mean difference effect sizes for pre-post change in the care dyad's relationship quality
Description
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.
Time Frame
Baseline compared with 18 weeks
Title
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
Description
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.
Time Frame
Baseline compared with 18 weeks
Secondary Outcome Measure Information:
Title
Mean difference effect sizes for pre-post change in the amount of care-related strain reported
Description
Subjective strain from caregiving will be assessed among family care partners at baseline and follow-up assessments using the Zarit Burden Interview (ZBI), short-form (12 items). Scores range from 0-48 with higher scores indicating a greater degree of strain from providing care.
Time Frame
Baseline compared with 12 weeks
Title
Mean difference effect sizes for pre-post change in the care dyad's quality of life
Description
The Quality of Life: Alzheimer's Disease Scale assesses individual perceptions of quality of life (from poor to excellent) across 13 items. Items are averaged for a summary score of 1 to 4, higher scores indicating greater degree of quality of life. Logsdon, R. G., Gibbons, L. E., McCurry, S. M., & Teri, L. (1999). Quality of Life in Alzheimer's Disease: Patient and Caregiver Reports. Journal of Mental Health and Aging, 5(1), 21-32.
Time Frame
Baseline compared with 18 weeks
Title
Mean difference effect sizes for pre-post change in the care dyad's concealment of emotions
Description
The Emotional Intimacy Disruptive Behavior Scale (8 items) assesses the frequency of engagement in behaviors to conceal emotions about an illness from one's partner. Druley, J. A., Stephens, M. A. P., & Coyne, J. C. (1997). Emotional and physical intimacy in coping with Lupus: Women's dilemmas of disclosure and approach. Health Psychology, 16, 506-514.
Time Frame
Baseline compared with 18 weeks
Other Pre-specified Outcome Measures:
Title
Time spent out of the home
Description
Time spent out of home will be robustly and accurately measured through an algorithm using sensor (motion/contact) and actigraphy data. Petersen J, Austin D, Mattek N, Kaye J. Time Out-of-Home and Cognitive, Physical, and Emotional Wellbeing of Older Adults: A Longitudinal Mixed Effects Model. PloS one. 2015;10(10):e0139643.
Time Frame
Continuously over 18 weeks
Title
Physical activity / sedentary behavior
Description
Physical activity and sedentary bouts will be measured using actigraphy data.
Time Frame
Continuously over 18 weeks
Title
Time spent together / separate
Description
Time spent together/separate as a dyad will be observed through previously-developed algorithms using data from PIR motion/contact sensors and actigraphy. We will consider times when the informal care dyad is together in the same room, separate within/outside of the home, and time in bathroom together (indicating ADL dependency).
Time Frame
Continuously over 18 weeks
Title
Sleep patterns
Description
Sleep patterns be measured using actigraphy, motion sensors, and a bed mat sensor.
Time Frame
Continuously over 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndsey M Miller, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified IPD will be available upon request to our Alzheimer's Disease Research Center Supporting Information: Time Frame: Data will become available after completion of study and after publication of primary study aims. Access Criteria: Requests need to made to the PI at the Oregon Alzheimer's Disease Research Center (OARDC). A short data request form will need to be submitted to the OADRC.

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REmote Assessment and Dynamic Response Intervention II

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