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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG057714 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The proposed study will adapt and pilot test an efficacious advance care planning interventions, Sharing Patient's Illness Representations to Increase Trust (SPIRIT), with patients with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible. Patient and surrogate decision maker dyads will participate in a single SPIRIT session and will then have a follow up phone call 2-3 days later. One year after the SPIRIT session some surrogates will be contacted to provide additional feedback about the intervention.
Progressive memory loss and impairment of reasoning and judgment are the main symptoms of dementia (including Alzheimer's Disease). For this reason, people in the early stages of dementia are encouraged to engage in advance care planning (ACP) while they are still competent to appoint a surrogate decision maker and meaningfully participate in ACP discussions with the surrogate.
The most common type of ACP is completing a medical power of attorney or living will, which does not require the patient and/or the family to understand the complexity of the medical decision-making process faced by the surrogate as the patient progresses to advanced disease. The failure to engage in ACP before the window of opportunity closes (i.e., before loss of decision making capacity) has serious adverse consequences with the greatest impact on the surrogate. As a matter of course in dementia, family members are left to make decisions regarding care transition, tube feeding, and other life-sustaining treatment without input from the patient and in the absence of a full understanding of the wishes, values and preferences of the patient.
To make an impact on the state of ACP for patients with dementia and their surrogates, the researchers will adapt and pilot test an efficacious ACP intervention, Sharing Patient's Illness Representations to Increase Trust (SPIRIT), with patients with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible. SPIRIT is a brief, scalable patient- and family-centered ACP intervention based on the Representational Approach to Patient Education with a goal to promote cognitive and emotional preparation for end-of-life decision making for patients with a serious or life-threatening illness and their surrogates. SPIRIT focuses on having both the patient and the surrogate fully understand end-of-life decision making in anticipation of a loss of decision-making capacity.
A panel of seven experts will provide feedback on adapting SPIRIT to persons with dementia and their surrogates, followed by pilot testing among the target population to refine the intervention. SPIRIT will also be adapted to a video conference format so that patients and surrogates can receive the intervention in their home. In this study, the SPIRIT intervention will be examined with a randomized clinical trial with three groups: SPIRIT-in person, SPIRIT-remote, and usual care. The researchers will recruit 120 dyads of patients with mild dementia and their surrogates, and the groups will be stratified by race (white vs non-white). The primary outcomes are patient and surrogate self-reported preparedness for end-of-life decision making which will be measured at baseline and shortly after the intervention (by phone in the next 2-3 days). Additionally, the researchers will compare the completion rates of advance directives among the three groups and the impact of the three treatment conditions perceived by surrogates at 1-year post intervention.
As of July 2020, recruitment of participants into the SPIRIT-in person study arm ceased in consideration of social distancing guidelines due to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Participants enrolled after this date will be randomized to either the SPIRIT-remote or usual care study arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPIRIT-in person | Experimental | Patients and surrogates who participate in the SPIRIT intervention in person. |
|
| SPIRIT-remote | Experimental | Patients and surrogates who participate in the SPIRIT intervention remotely, via teleconference. |
|
| Usual care | Active Comparator | Patients and surrogates who receive the standard information about advance directives that is provided at the time of diagnosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPIRIT-in person | Behavioral | The SPIRIT-in person intervention adapted for dementia will include one session and will be conducted in a private room at the clinic. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention is expected to last 45-60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Dyad Congruence With Goals-of-Care Tool | Dyad congruence was assessed using the Goals-of-Care Tool which has been modified to include two scenarios relevant to the context of dementia. There are three response options: "The goals of care should focus on delaying my death no matter what, and thus I want to continue life-sustaining treatment", "The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment", and "I am not sure". Persons with dementia and surrogates complete this tool independently and their responses are then compared to determine dyad congruence (either congruent in both scenarios or incongruent). If both members of the dyad endorse "I am not sure", they are considered incongruent. | Baseline, follow up phone call at 2-3 days post-intervention |
| Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants | Surrogate decision-making confidence is measured using the 5-item Decision Making Confidence (DMC) scale. DMC assesses a surrogate's confidence in knowing the patient's wishes, ability to make treatment decisions even in a highly stressful situation, ability to seek information about risks and benefits of medical choices, ability to handle unwanted pressure from others, and ability to communicate with providers about the patient's wishes. Surrogates indicate how confident they are about making medical decisions, if the patient becomes unable to make their own decisions, by their level of agreement with statements along a scale of (0) "not confident at all" to (4) "Very confident". Total scores range from 0 - 20, with higher scores indicating greater confidence. | Baseline, follow up phone call at 2-3 days post-intervention |
| Surrogate's Overall Preparedness Scale | The Overall Preparedness Scale for end-of-life decision making for surrogates is a 23-item investigator-developed measure. The measure assesses the level of preparedness for end-of-life decision making in the cognitive, emotional, and behavioral dimensions on a 4-point scale (1=strongly disagree to 4=strongly agree). Total scores range from 23 to 92, with higher scores indicating higher levels of preparedness. | Baseline, follow up phone call at 2-3 days post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Advance Directives Among Phase II Participants | At the Baseline visit, participants were asked if they had already completed an advance directive. Medical records were reviewed to determine if the patient completed an advance directive (a medical power of attorney or living will) by 12 months post-intervention. If there was no documentation in the medical record, the surrogate was contacted to get confirmation on the status of the Advance Directive. |
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Inclusion Criteria for Patients with Mild to Moderate Dementia:
Exclusion Criteria for Patients with Mild to Moderate dementia:
Inclusion Criteria for Surrogates:
Exclusion Criteria for Surrogates:
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| Name | Affiliation | Role |
|---|---|---|
| Mi-Kyung Song, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assisted Living Facilities in the Metro Atlanta Area | Atlanta | Georgia | 30030 | United States | ||
| Grady Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31373868 | Background | Song MK, Ward SE, Hepburn K, Paul S, Kim H, Shah RC, Morhardt DJ, Medders L, Lah JJ, Clevenger CC. Can Persons with Dementia Meaningfully Participate in Advance Care Planning Discussions? A Mixed-Methods Study of SPIRIT. J Palliat Med. 2019 Nov;22(11):1410-1416. doi: 10.1089/jpm.2019.0088. Epub 2019 Aug 2. | |
| 29870867 | Derived | Song MK, Ward SE, Hepburn K, Paul S, Shah RC, Morhardt DJ. SPIRIT advance care planning intervention in early stage dementias: An NIH stage I behavioral intervention development trial. Contemp Clin Trials. 2018 Aug;71:55-62. doi: 10.1016/j.cct.2018.06.005. Epub 2018 Jun 2. |
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In July 2020 the protocol was modified, eliminating the SPIRIT-in person intervention due to the coronavirus disease 2019 (COVID-19) pandemic which prohibited in person research visits. The study design changed to SPIRIT-remote versus usual care and a new randomization method was initiated for the two arm design. Due to the change in randomization method mid-study, participants enrolled before and after the randomization change are analyzed separately (as original or modified randomization).
Participants were recruited from healthcare clinics in Georgia and Illinois, USA. Participant enrollment began May 4, 2018. Follow-up for the 2-3 day post-intervention assessment was completed by February 3, 2022 and follow up for the 12 months post-intervention time point was completed by December 7, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | SPIRIT-in Person - Persons With Dementia, Original Randomization | Persons with dementia participating in the SPIRIT intervention in person, during the original randomization design. SPIRIT-in person: The SPIRIT-in person intervention adapted for dementia includes one session and is conducted in a private room at the clinic. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes. |
| FG001 | SPIRIT-in Person - Surrogates, Original Randomization | Surrogates participating in the SPIRIT intervention in person, during the original randomization design. SPIRIT-in person: The SPIRIT-in person intervention adapted for dementia includes one session and is conducted in a private room at the clinic. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes. |
| FG002 | SPIRIT-remote - Persons With Dementia, Original Randomization | Persons with dementia participating in the SPIRIT intervention remotely, via teleconference, during the original randomization design. SPIRIT-remote: The SPIRIT-remote intervention adapted for dementia includes one session and is conducted through teleconference. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes. |
| FG003 | SPIRIT-remote - Surrogates, Original Randomization | Surrogates participating in the SPIRIT intervention remotely, via teleconference, during the original randomization design. SPIRIT-remote: The SPIRIT-remote intervention adapted for dementia includes one session and is conducted through teleconference. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes. |
| FG004 | Usual Care - Persons With Dementia, Original Randomization | Persons with dementia receiving the standard information about advance directives that is provided at the time of diagnosis, during the original randomization design. Usual care: Participants receive the usual care that is provided through the clinic they receive care through. This may include completing advanced directives, referral to a support group, or referral to a social worker for further discussion about end of life issues. |
| FG005 | Usual Care - Surrogates, Original Randomization | Surrogates receiving the standard information about advance directives that is provided at the time of diagnosis, during the original randomization design. Usual care: Participants receive the usual care that is provided through the clinic they receive care through. This may include completing advanced directives, referral to a support group, or referral to a social worker for further discussion about end of life issues. |
| FG006 | SPIRIT-remote - Persons With Dementia, Modified Randomization | Persons with dementia participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design. SPIRIT-remote: The SPIRIT-remote intervention adapted for dementia includes one session and is conducted through teleconference. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes. |
| FG007 | SPIRIT-remote - Surrogates, Modified Randomization | Surrogates participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design. SPIRIT-remote: The SPIRIT-remote intervention adapted for dementia includes one session and is conducted through teleconference. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes. |
| FG008 | Usual Care - Persons With Dementia, Modified Randomization | Persons with dementia receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design. Usual care: Participants receive the usual care that is provided through the clinic they receive care through. This may include completing advanced directives, referral to a support group, or referral to a social worker for further discussion about end of life issues. |
| FG009 | Usual Care - Surrogates, Modified Randomization | Surrogates receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design. Usual care: Participants receive the usual care that is provided through the clinic they receive care through. This may include completing advanced directives, referral to a support group, or referral to a social worker for further discussion about end of life issues. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SPIRIT-in Person - Persons With Dementia, Original Randomization | Persons with dementia participating in the SPIRIT intervention in person, during the original randomization design. |
| BG001 | SPIRIT-in Person - Surrogates, Original Randomization |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dyad Congruence With Goals-of-Care Tool | Dyad congruence was assessed using the Goals-of-Care Tool which has been modified to include two scenarios relevant to the context of dementia. There are three response options: "The goals of care should focus on delaying my death no matter what, and thus I want to continue life-sustaining treatment", "The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment", and "I am not sure". Persons with dementia and surrogates complete this tool independently and their responses are then compared to determine dyad congruence (either congruent in both scenarios or incongruent). If both members of the dyad endorse "I am not sure", they are considered incongruent. | The number of participants analyzed reflects the number of person with dementia and surrogate dyads (two persons per dyad). This analysis includes dyads who completed the indicated study visit. Three dyads from the SPIRIT-in person original randomization, and 3 dyads from the SPIRIT-remote modified randomization did not complete the 2-3 day post-intervention follow up visit. | Posted | Count of Participants | Participants | Baseline, follow up phone call at 2-3 days post-intervention |
Adverse events were documented during the intervention session (Day 1). Known deaths that occurred up to the 12 month assessment were documented.
Only adverse events related to the intervention, such as emotional distress, were documented during the intervention session. Due to the population being examined and the nature of this study, deaths are not considered as an adverse event in this population, however, known deaths occurring up to the 12 month assessment were documented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPIRIT-in Person - Persons With Dementia, Original Randomization | Persons with dementia participating in the SPIRIT intervention in person, during the original randomization design. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mi-Kyung Song, PhD | Emory University | 404-727-3134 | mi-kyung.song@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2020 | Feb 1, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 18, 2021 | Sep 22, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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|
| SPIRIT-remote | Behavioral | The SPIRIT-remote intervention adapted for dementia will include one session and will be conducted through teleconference. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention is expected to last 45-60 minutes. |
|
| Usual care | Behavioral | Participants will receive the usual care that is provided through the clinic they receive care through. This may include completing advanced directives, referral to a support group, or referral to a social worker for further discussion about end of life issues. |
|
|
| Baseline, up to 12 months post-intervention |
| Patient's Overall Preparedness Scale | The Overall Preparedness Scale for end-of-life decision making for patients is a 22 item investigator-developed measure. The measure assesses the level of preparedness for end-of-life decision making in the cognitive, emotional, and behavioral dimensions on a 4-point scale (1=strongly disagree to 4=strongly agree). Total scores range from 22 to 88, with higher scores indicating higher levels of preparedness. | Baseline, follow up phone call at 2-3 days post-intervention |
| Atlanta |
| Georgia |
| 30303 |
| United States |
| Emory Clinic Geriatrics | Atlanta | Georgia | 30329 | United States |
| Rush Alzheimer's Disease Center | Chicago | Illinois | 60612 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| Death of dyad partner |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
Surrogates participating in the SPIRIT intervention in person, during the original randomization design. |
| BG002 | SPIRIT-remote - Persons With Dementia, Original Randomization | Persons with dementia participating in the SPIRIT intervention remotely, via teleconference, during the original randomization design. |
| BG003 | SPIRIT-remote - Surrogates, Original Randomization | Surrogates participating in the SPIRIT intervention remotely, via teleconference, during the original randomization design. |
| BG004 | Usual Care - Persons With Dementia, Original Randomization | Persons with dementia receiving the standard information about advance directives that is provided at the time of diagnosis, during the original randomization design. |
| BG005 | Usual Care - Surrogates, Original Randomization | Surrogates receiving the standard information about advance directives that is provided at the time of diagnosis, during the original randomization design. |
| BG006 | SPIRIT-remote - Persons With Dementia, Modified Randomization | Persons with dementia participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design. |
| BG007 | SPIRIT-remote - Surrogates, Modified Randomization | Surrogates participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design. |
| BG008 | Usual Care - Persons With Dementia, Modified Randomization | Persons with dementia receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design. |
| BG009 | Usual Care - Surrogates, Modified Randomization | Surrogates receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design. |
| BG010 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | SPIRIT-in Person, Original Randomization | Person with dementia and surrogate dyads participating in the SPIRIT intervention in person, during the original randomization design. |
| OG001 | SPIRIT-remote, Original Randomization | Person with dementia and surrogate dyads participating in the SPIRIT remotely, during the original randomization design. |
| OG002 | Usual Care, Original Randomization | Person with dementia and surrogate dyads receiving usual care, during the original randomization design. |
| OG003 | SPIRIT-remote, Modified Randomization | Person with dementia and surrogate dyads participating in the SPIRIT remotely, during the modified randomization design. |
| OG004 | Usual Care, Modified Randomization | Person with dementia and surrogate dyads receiving usual care, during the modified randomization design. |
|
|
| Primary | Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants | Surrogate decision-making confidence is measured using the 5-item Decision Making Confidence (DMC) scale. DMC assesses a surrogate's confidence in knowing the patient's wishes, ability to make treatment decisions even in a highly stressful situation, ability to seek information about risks and benefits of medical choices, ability to handle unwanted pressure from others, and ability to communicate with providers about the patient's wishes. Surrogates indicate how confident they are about making medical decisions, if the patient becomes unable to make their own decisions, by their level of agreement with statements along a scale of (0) "not confident at all" to (4) "Very confident". Total scores range from 0 - 20, with higher scores indicating greater confidence. | This analysis includes participants who completed the indicated study visit. Three dyads from the SPIRIT-in person original randomization, and 3 dyads from the SPIRIT-remote modified randomization did not complete the 2-3 day post-intervention follow up visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline, follow up phone call at 2-3 days post-intervention |
|
|
|
| Primary | Surrogate's Overall Preparedness Scale | The Overall Preparedness Scale for end-of-life decision making for surrogates is a 23-item investigator-developed measure. The measure assesses the level of preparedness for end-of-life decision making in the cognitive, emotional, and behavioral dimensions on a 4-point scale (1=strongly disagree to 4=strongly agree). Total scores range from 23 to 92, with higher scores indicating higher levels of preparedness. | This analysis includes participants who completed the indicated study visit. Three dyads from the SPIRIT-in person original randomization, and 3 dyads from the SPIRIT-remote modified randomization did not complete the 2-3 day post-intervention follow up visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline, follow up phone call at 2-3 days post-intervention |
|
|
|
| Secondary | Completion of Advance Directives Among Phase II Participants | At the Baseline visit, participants were asked if they had already completed an advance directive. Medical records were reviewed to determine if the patient completed an advance directive (a medical power of attorney or living will) by 12 months post-intervention. If there was no documentation in the medical record, the surrogate was contacted to get confirmation on the status of the Advance Directive. | Posted | Count of Participants | Participants | Baseline, up to 12 months post-intervention |
|
|
|
| Secondary | Patient's Overall Preparedness Scale | The Overall Preparedness Scale for end-of-life decision making for patients is a 22 item investigator-developed measure. The measure assesses the level of preparedness for end-of-life decision making in the cognitive, emotional, and behavioral dimensions on a 4-point scale (1=strongly disagree to 4=strongly agree). Total scores range from 22 to 88, with higher scores indicating higher levels of preparedness. | This analysis includes participants who completed the indicated study visit. Three dyads from the SPIRIT-in person original randomization, and 3 dyads from the SPIRIT-remote modified randomization did not complete the 2-3 day post-intervention follow up visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline, follow up phone call at 2-3 days post-intervention |
|
|
|
| 1 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | SPIRIT-in Person - Surrogates, Original Randomization | Surrogates participating in the SPIRIT intervention in person, during the original randomization design. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | SPIRIT-remote - Persons With Dementia, Original Randomization | Persons with dementia participating in the SPIRIT intervention remotely, via teleconference, during the original randomization design. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | SPIRIT-remote - Surrogates, Original Randomization | Surrogates participating in the SPIRIT intervention remotely, via teleconference, during the original randomization design. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG004 | Usual Care - Persons With Dementia, Original Randomization | Persons with dementia receiving the standard information about advance directives that is provided at the time of diagnosis, during the original randomization design. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG005 | Usual Care - Surrogates, Original Randomization | Surrogates receiving the standard information about advance directives that is provided at the time of diagnosis, during the original randomization design. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG006 | SPIRIT-remote - Persons With Dementia, Modified Randomization | Persons with dementia participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design. | 1 | 40 | 0 | 40 | 0 | 40 |
| EG007 | SPIRIT-remote - Surrogates, Modified Randomization | Surrogates participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG008 | Usual Care - Persons With Dementia, Modified Randomization | Persons with dementia receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design. | 1 | 39 | 0 | 39 | 0 | 39 |
| EG009 | Usual Care - Surrogates, Modified Randomization | Surrogates receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design. | 0 | 39 | 0 | 39 | 0 | 39 |
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| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
|
|
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| 2-3 Days Post-intervention |
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|
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| 2-3 Days Post-intervention |
|
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| Baseline - Incomplete |
|
| 12-month cumulative - Complete |
|
| 12-month cumulative - Incomplete |
|
|
| 2-3 Days Post-intervention |
|
|