READyR-II: REmote Assessment and Dynamic Response Intervention II

Sponsor

Oregon Health and Science University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04686838

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arms

16.8

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Alzheimer Disease Relationship, Marital Caregiver Stress Syndrome	Behavioral: READyR II: A Behavioral: READyR II: B	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (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.

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Nov 17, 2022

Anticipated Study Completion Date :

Nov 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: READyR II: A Continuous monitoring for anomaly detection and contact phone call when a potential change in care needs is indicated by an anomaly.
Active Comparator: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: READyR II: A

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

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

Mean difference effect sizes for pre-post change the care dyad's preparation for future care needs [Baseline compared with 18 weeks]
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 [Baseline compared with 18 weeks]
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 [Baseline compared with 18 weeks]
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 [Baseline compared with 12 weeks]
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 [Baseline compared with 18 weeks]
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 [Baseline compared with 18 weeks]
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.

Other Outcome Measures

Time spent out of the home [Continuously over 18 weeks]
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.
Physical activity / sedentary behavior [Continuously over 18 weeks]
Physical activity and sedentary bouts will be measured using actigraphy data.
Time spent together / separate [Continuously over 18 weeks]
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).
Sleep patterns [Continuously over 18 weeks]
Sleep patterns be measured using actigraphy, motion sensors, and a bed mat sensor.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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.