REmote Assessment and Dynamic Response Intervention

NCT04542109 | Completed

• 2 other identifiers: Interventional 16-2P30AG024978-16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the READyR study (originally called SHARE-sense) is to redevelop and test an intervention program to remotely assess for changing dementia-related care needs.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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, 6 weeks, 12 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, 6 weeks, 12 weeks

Secondary Outcomes (3)

• Mean difference effect sizes for pre-post change in care-related strain

  Baseline and weekly for 12 weeks

• Mean difference effect sizes for pre-post change in quality of life

  Baseline, 6 weeks, and 12 weeks

• Mean difference effect sizes for pre-post change in concealment of emotions.

  Baseline, 6 weeks, and 12 weeks

Study Arms (2)

READyR A

EXPERIMENTAL

Group A will start the READyR intervention immediately after the baseline Session 1. The READyR program consists of a 3-session, values-based needs assessment intervention designed to match objectively-assessed in-home activity patterns with subjective reports of participants' care values. The goal of the intervention is to address unmet dementia-related care needs and help couples prepare for the future, and reduce strain on their relationship, and help maintain their health and well-being. Session 2 will occur approximately 3 weeks after Session 1, and Session 3 will occur approximately 3 weeks after Session 2. Session 3 also includes follow-up assessments.

Behavioral: READyR A

READyR B (wait list comparison)

ACTIVE COMPARATOR

Group B - the wait list comparison group - will have a 60-minute support session (comparator intervention) about 3 weeks after the baseline Session 1. The support session will include general information about dementia-related care needs that does not take into account the individual participant's care values or objective in-home activity patterns. They will also receive a check-in call approximately 3 weeks later, with follow-up assessments. Group B will begin the READyR intervention sessions following completion of follow-up assessments.

Behavioral: READyR B

Interventions

READyR A BEHAVIORAL

Two active sessions to conduct an individually-tailored dementia-related needs assessment, incorporating the participant's care values and objective data from remote in-home monitoring.

Also known as: SHARE-sense

READyR A

READyR B BEHAVIORAL

Active comparator. Two sessions to deliver general information about dementia-related care needs.

READyR B (wait list comparison)

Eligibility Criteria

• Age: 62 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

Related Publications (1)

• Miller LM, Solomon DN, Whitlatch CJ, Hiatt SO, Wu CY, Reynolds C, Au-Yeung WM, Kaye J, Steele JS. The Remote Assessment and Dynamic Response Program: Development of an In-Home Dementia-Related Care Needs Assessment to Improve Well-Being. Innov Aging. 2022 Feb 7;6(2):igac006. doi: 10.1093/geroni/igac006. eCollection 2022.

  PMID: 35402736 DERIVED

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: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 9, 2020
• Study Start: April 27, 2021
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• 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

Locations

US (1)