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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR001452 | U.S. NIH Grant/Contract | View source | |
| UL1TR001450 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The purpose of this research is pilot test a nurse led intervention previously used in patients with pulmonary fibrosis and their caregivers in a new population (persons living with Mild Cognitive Impairment or Alzheimer's disease and their caregivers. The researchers hypothesize improving advanced care planning in this population will result in enhanced quality of life over illness trajectory and improve safety for community dwelling PWD/CG dyads. Findings from this study will inform additional necessary adaptations required prior to conducting larger scale powered randomized control trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUPPORT-D Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A Program of SUPPORT-D (dementia) | Behavioral | The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alzheimer's Disease Knowledge Scale (ADKS) Score | 30 items (T/F) summed total of correct items higher score indicates higher knowledge (scores range from 0-30) | baseline, at study completion, an average of 8 weeks |
| Acceptability of Intervention Measure (AIM) Score | 4 items (5 point Likert scale) average score across items higher score indicates more acceptability of intervention (raw score ranges from 4-20) | at study completion, an average of 8 weeks |
| Feasibility Score | 4 items (5 point Likert scale) average score across items higher score indicates greater feasibility of intervention (raw scores range from 4-20) | at study completion, an average of 8 weeks |
| Change Zarit Caregiver Burden Score | 12 items (5 point Likert scale (0-4)) summed score with higher scores indicating greater caregiver distress (raw scores range from 0-48) | baseline, at study completion, an average of 8 weeks |
| Change in Perceived Stress Scale Score | 10 items (4 point Likert scale ranging from 0-4) summed score across items with higher scores indicate greater levels of stress (scores range from 0-40) | baseline and at study completion, an average of 8 weeks |
| Change in Quality of Life-Alzheimer's Disease (QoL-AD) Score | 13 items (4 point Likert scale ranging from 1-4) summed score across items with higher scores indicating better quality of life (scores range from 13-52) | baseline and at study completion, an average of 8 weeks |
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Inclusion Criteria:
The participants in this study include persons with Alzheimer's disease (PWD) and their caregivers (CG.
Caregivers (CG)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana M Layne, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Number of dyads or individual caregivers who received SUPPORT-D Intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caregiver Group | A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Alzheimer's Disease Knowledge Scale (ADKS) Score | 30 items (T/F) summed total of correct items higher score indicates higher knowledge (scores range from 0-30) | Posted | Mean | Standard Deviation | score on a scale | baseline, at study completion, an average of 8 weeks |
|
8 weeks
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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 | SUPPORT-D Caregiver Group | A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks). |
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Many care recipients did not believe PROMIS measures applied to them so they did not complete those measures. Some participants chose to not complete all survey items.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Diana Layne | Medical University of South Carolina | (843) 792-8515 | layne@musc.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 | Oct 2, 2023 | Mar 3, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 30, 2023 | Feb 14, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Change in Self-efficacy for Caregiving Score | 8 items rated from 1-10 mean score across items with higher scores indicating higher self-efficacy (raw scores range from 8-80) | baseline and at study completion, an average of 8 weeks |
| Change in Safety Assessment Scale Score | 16 items with response options ranging from 0 to 4. The minimum score is 0, indicating no safety concerns, while the maximum score is 64, indicating significant safety risks. | baseline and at study completion, an average of 8 weeks |
| Appropriateness of Intervention Score | 4 items (5 point Likert scale) average score across items higher score indicates greater appropriateness of intervention (scores range from 4-20) | at study completion, an average of 8 weeks |
| BG001 | Care Recipient Group | A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks). |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Alzheimer's Disease Knowledge Scale | 30 items (T/F) summed total of correct items higher score indicates higher knowledge (scores range from 0-30) | Mean | Standard Deviation | units on a scale |
|
| Perceived Stress Scale | 10 items (4 point Likert scale from 0-4) summed score across items with higher scores indicate greater levels of stress (scores range from 0-40) | Row population differs from overall due to participants not completing all survey items. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life in Alzheimer's Disease Scale | 13 items (4 point Likert scale ranging from 1-4) summed score across items with higher scores indicating better quality of life (scores range from 13-52) | Row population differs from overall sample due to participants not completing all survey items. | Mean | Standard Deviation | units on a scale |
|
| Caregiver Self-efficacy Scale | 8 items rated from 1-10 mean score across items with higher scores indicating higher self-efficacy (raw scores range from 8-80) | This is a caregiver only measure care recipients not assessed for this measure. Row total may differ from overall population due to participants not completing all survey items. | Mean | Standard Deviation | units on a scale |
|
| Safety Assessment Scale | 16 items on 4 point likert scale ranging from 0-4 summed score across items with higher scores indicating higher risk for accidents (scores range from 0-64) | This is a caregiver measure only, care recipients not assessed. Row total may differ from overall sample due to participants not completing all survey items. | Mean | Standard Deviation | units on a scale |
|
| Zarit Burden Interview | 12 items (5 point Likert scale from 0-4) summed score with higher scores indicating greater caregiver distress (raw scores range from 0-48) | This is a caregiver only measure, care recipient not assessed. Row total may differ from overall sample due to participants not completing all survey items. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Care Recipient Group | A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks). |
|
|
| Primary | Acceptability of Intervention Measure (AIM) Score | 4 items (5 point Likert scale) average score across items higher score indicates more acceptability of intervention (raw score ranges from 4-20) | Posted | Mean | Standard Deviation | score on a scale | at study completion, an average of 8 weeks |
|
|
|
| Primary | Feasibility Score | 4 items (5 point Likert scale) average score across items higher score indicates greater feasibility of intervention (raw scores range from 4-20) | Posted | Mean | Standard Deviation | score on a scale | at study completion, an average of 8 weeks |
|
|
|
| Primary | Change Zarit Caregiver Burden Score | 12 items (5 point Likert scale (0-4)) summed score with higher scores indicating greater caregiver distress (raw scores range from 0-48) | Posted | Mean | Standard Deviation | score on a scale | baseline, at study completion, an average of 8 weeks |
|
|
|
| Primary | Change in Perceived Stress Scale Score | 10 items (4 point Likert scale ranging from 0-4) summed score across items with higher scores indicate greater levels of stress (scores range from 0-40) | Posted | Mean | Standard Deviation | score on a scale | baseline and at study completion, an average of 8 weeks |
|
|
|
| Primary | Change in Quality of Life-Alzheimer's Disease (QoL-AD) Score | 13 items (4 point Likert scale ranging from 1-4) summed score across items with higher scores indicating better quality of life (scores range from 13-52) | Posted | Mean | Standard Error | score on a scale | baseline and at study completion, an average of 8 weeks |
|
|
|
| Primary | Change in Self-efficacy for Caregiving Score | 8 items rated from 1-10 mean score across items with higher scores indicating higher self-efficacy (raw scores range from 8-80) | Posted | Mean | Standard Deviation | score on a scale | baseline and at study completion, an average of 8 weeks |
|
|
|
| Primary | Change in Safety Assessment Scale Score | 16 items with response options ranging from 0 to 4. The minimum score is 0, indicating no safety concerns, while the maximum score is 64, indicating significant safety risks. | Posted | Mean | Standard Deviation | score on a scale | baseline and at study completion, an average of 8 weeks |
|
|
|
| Primary | Appropriateness of Intervention Score | 4 items (5 point Likert scale) average score across items higher score indicates greater appropriateness of intervention (scores range from 4-20) | Posted | Mean | Standard Deviation | units on a scale | at study completion, an average of 8 weeks |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | SUPPORT-D Care Recipient Group | A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks). | 0 | 22 | 0 | 22 | 0 | 22 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|