REmote Assessment and Dynamic Response Intervention II

Browse trials for

• Dementia 2,230
• Alzheimer Disease 3,765

Keywords

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

Dementia

2,230 studies on the registry are indexed under Dementia; 549 are open to participants now.

This study's enrollment of 30 is below the median of 83 across 1,669 interventional studies indexed under Dementia.

Lead sponsor

Oregon Health and Science University is the lead sponsor of 694 studies on the registry; 133 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 39 (76%) have results posted.

Eligibility criteria

Study arms

• 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

• 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

Interventions

• BehavioralREADyR II: A

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

• BehavioralREADyR 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.

Primary outcomes

1. 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.

   Time frame: Baseline compared with 18 weeks

2. 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.

   Time frame: Baseline compared with 18 weeks

3. 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.

   Time frame: Baseline compared with 18 weeks

Secondary outcomes

1. 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.

   Time frame: Baseline compared with 12 weeks

2. 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.

   Time frame: Baseline compared with 18 weeks

3. 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.

   Time frame: Baseline compared with 18 weeks

Other outcomes

1. Time spent out of the home

   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

2. Physical activity / sedentary behavior

   Physical activity and sedentary bouts will be measured using actigraphy data.

   Time frame: Continuously over 18 weeks

3. Time spent together / separate

   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

4. Sleep patterns

   Sleep patterns be measured using actigraphy, motion sensors, and a bed mat sensor.

   Time frame: Continuously over 18 weeks

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code