REmote Assessment and Dynamic Response Intervention (READyR)

Oregon Health & Science University (OHSU)

Status: Completed

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

Treatments: Behavioral: READyR B; Behavioral: READyR A

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04542109

P30AG024978-16 (U.S. NIH Grant/Contract)

Interventional 16-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 62+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Persons with Dementia

Inclusion:

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

READyR A

Experimental group

Description:

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.

Treatment:

Behavioral: READyR A

READyR B (wait list comparison)

Active Comparator group

Description:

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.

Treatment:

Behavioral: READyR B