REmote Assessment and Dynamic Response Intervention

NCT ID: NCT04542109

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-27
• Study Completion Date: 2022-06-17

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.

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. The first phase of this study involves redevelopment of the intervention program into a 3-session values-based needs assessment intervention (delivered over 6 weeks) designed for early-stage persons with dementia and their primary family caregiver (i.e. spouse or partner). A secondary data analysis and focus groups will be conducted in order to complete the redevelopment phase. Objective digital data on behavioral patterns (from sensors and wearables) will be incorporated into a needs assessment that will allow for dynamic tailoring of the READyR program to new and unforeseen care needs.

People who voluntarily decide to participate in this study will be asked to participate in three sessions: Session 1 for baseline assessments gathered from all participants (including remote in-home monitoring), Session 2 for discussing the participant's care values and their alignment with current patterns of activities (assessed by remote monitoring) in the home, and Session 3 for addressing current dementia related care needs and setting goals for the future.

Participants who complete this study will be offered participation in a follow-up monitoring period to further study the possibilities for dynamic tailoring of their dementia-related needs assessment.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

READyR A

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.

Group Type: EXPERIMENTAL

READyR A

Intervention Type: 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.

READyR B (wait list comparison)

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.

Group Type: ACTIVE_COMPARATOR

READyR B

Intervention Type: BEHAVIORAL

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

Interventions

READyR A

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.

Intervention Type: BEHAVIORAL

READyR B

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

Intervention Type: BEHAVIORAL

Other Intervention Names

SHARE-sense

Eligibility Criteria

Inclusion Criteria

1. 62 years or older;

2. 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;

3. Probable or confirmed diagnosis of mild cognitive impairment or early-stage dementia

4. Age and education adjusted MOCA score > 15 (at most recent measurement by parent study) corresponding to early to moderate stage dementia

Exclusion:

1. Inability to speak English or read printed materials in English

2. Conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the intervention materials);

3. Any uncontrolled medical condition that is expected to preclude completion of the study, such as late stage cancers.

Family Care Partners

Inclusion:

1. 21 years or older;

2. Self-identifying as a family member and care partner residing with the PwD participant;

Exclusion:

1. Inability to speak English or read printed materials in English

2. Conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the intervention materials);

3. Any uncontrolled medical condition that is expected to preclude completion of the study, such as late stage cancers.

• Minimum Eligible Age: 62 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Lyndsey Miller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lyndsey M Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35402736 (View on PubMed)

Other Identifiers

P30AG024978-16

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Interventional 16-2

Identifier Type: -

Identifier Source: org_study_id