DementiaREADyR-IINCT04686838
REmote Assessment and Dynamic Response Intervention II
A study testing READyR II: A and READyR II: B in people with Dementia and Alzheimer Disease, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease, Relationship, Marital
- What is being tested?
- READyR II: A and READyR II: B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 25 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 21 years or older;
- Self-identifying as a family member and care partner residing with the PwD participant;
Who cannot join
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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
The purpose of the READyR II Study is to test a dynamic tailoring phase of a remote assessment for changing dementia-related care needs.
Read the 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.
- Being tested
- READyR II: A, READyR II: B
- Keywords
- Needs Assessment, Remote Monitoring, Technology, Care Values, Aging-in-Place, Family Caregiver
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
READyR II: ABehavioural
Continuous monitoring for anomaly detection and contact phone call when a potential change in care needs is indicated by an anomaly.
READyR II: BBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| READyR II A | Experimental | 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. Receives: Behavioral: READyR II: A |
| READyR II B (comparison) | Active comparator | 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. Receives: Behavioral: READyR II: B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline compared with 18 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.
Measured: Baseline compared with 18 weeks
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.
Measured: Baseline compared with 18 weeks
Secondary outcomes (3)
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.
Measured: Baseline compared with 12 weeks
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.
Measured: Baseline compared with 18 weeks
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.
Measured: Baseline compared with 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jul 2021
- Primary completion17 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dyads will be randomized (assigned by chance) to one of two groups: 1) READyR A or 2) READyR B
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lyndsey Miller, Oregon Health and Science University
- Investigators
- Lyndsey M Miller, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686838
- Sponsor's protocol ID
- 17-2
- Other IDs
- P30AG024978-17
- Acronym
- READyR-II
- Status last verified
- Jan 2023
- First submitted
- 16 Dec 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04686838
- Acronym / sponsor ID
- READyR-II / 17-2
- Keywords
- Needs Assessment, Remote Monitoring, Technology, Care Values, Aging-in-Place, Family Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the READyR II Study is to test a dynamic tailoring phase of a remote assessment 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. 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Dyads will be randomized (assigned by chance) to one of two groups: 1) READyR A or 2) READyR B
| Arm | Type | Receives |
|---|---|---|
| READyR II A | Experimental | Behavioral: READyR II: AContinuous 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. |
| READyR II B (comparison) | Active comparator | Behavioral: READyR II: BSensors 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 21 years or older;
Key exclusion criteria (7 listed)
- 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
- Inability to speak English or read printed materials in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| READyR II: AContinuous monitoring for anomaly detection and contact phone call when a potential change in care needs is indicated by an anomaly. | Behavioural | READyR II A |
| READyR II: BSensors 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. | Behavioural | READyR II B (comparison) |
Primary outcome
Mean difference effect sizes for pre-post change the care dyad's preparation for future care needs
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Mean difference effect sizes for pre-post change in the amount of care-related strain reported
Time frame: Baseline compared with 12 weeks
Mean difference effect sizes for pre-post change in the care dyad's quality of life
Time frame: Baseline compared with 18 weeks
Mean difference effect sizes for pre-post change in the care dyad's concealment of emotions
Time frame: Baseline compared with 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndsey M Miller, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing READyR II: A and READyR II: B in people with Dementia and Alzheimer Disease, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference effect sizes for pre-post change the care dyad's preparation for future care needs (time frame: Baseline compared with 18 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.