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| ID | Type | Description | Link |
|---|---|---|---|
| 3P30AG064200-02S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study will test a prototype pandemic caregiver training and education course designed for caregivers of persons living with dementia (PLWD). Participants will be randomized to take the course immediately or to take the course after completion of an 8-week waiting period.
Family caregivers, the backbone of care for the upwards of 7 million community-dwelling individuals living with Alzheimer's disease in the U.S., provide at least 85% of the care these individuals receive, at some risk to their own well-being, and are instrumental in navigating healthcare systems. Without their care, it is almost certain that persons living with dementia (PLWD) would have much higher rates of acute and emergency care use than their age-matched peers, perilous venues for them in the best of times, potentially deadly during this pandemic. With coronavirus disease 2019 (COVID-19) restrictions, the amount of care they provide and the expertise needed to provide the care will increase. Typically, caregivers are strangers in healthcare and pandemic landscapes, but they are now called on to enact home care and safety measures and navigate an intricate, complex, and opaque system without the benefit of a compass or a translator, and largely without understanding their role in or having the skills for navigating the system. A variety of interventions have demonstrated benefit in enhancing caregivers' caregiving capacities, with resulting positive outcomes for both caregivers and care recipients. Only a few of these useful interventions, Tele-Savvy among them, have employed distance delivery means, thus enabling rural caregivers and others precluded by circumstance from attending in-person programs to take part in the intervention programs.
The study will assess a psychoeducational intervention for dementia caregivers. Participating caregivers will be randomized to immediately enroll in the study intervention or to be in a waitlist group that will begin the intervention 8 weeks later. Participants will complete interviews at baseline and after the 8-week study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychoeducational Intervention | Experimental | Caregivers receiving the psychoeducational intervention immediately. |
|
| Waitlist | No Intervention | Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychoeducational Intervention | Behavioral | The intervention is an online course providing education and training to caregivers over an 8 week period. The self-paced course provides information on caregiving for a PLWD during a pandemic, navigating the health care system for a PLWD, and managing daily life (including self-care). |
| Measure | Description | Time Frame |
|---|---|---|
| Center for Epidemiologic Studies - Depression (CES-D) Scale Score | The CES-D is a 20-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 0 to 3 where rarely is scored as 0 and most of the time is scored as 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression. | Baseline, Week 8 |
| State-Trait Anxiety Inventory (STAI) Score | The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety. | Baseline, Week 8 |
| Perceived Stress Scale (PSS-14) Score | The Perceived Stress Scale includes 14 items assessing self-reported caregiving stress. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and higher values indicate greater perceived stress. | Baseline, Week 8 |
| Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score | The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the person living with dementia (PLWD). | Baseline, Week 8 |
| Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score | The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Clevenger, DNP, APRN | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
All of the individual participant data collected during the trial will be made available for sharing, after deidentification.
Individual participant data will be available for sharing beginning 3 months and ending 5 years following article publication.
Individual participant data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal. Proposals should be directed to carolyn.clevenger@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website.
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| ID | Title | Description |
|---|---|---|
| FG000 | Psychoeducational Intervention Immediately | Caregivers receiving the psychoeducational intervention immediately. |
| FG001 | Psychoeducational Intervention After Waiting Period | Caregivers receiving the psychoeducational intervention after a waiting period of 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Psychoeducational Intervention Immediately | Caregivers receiving the psychoeducational intervention immediately. |
| BG001 | Psychoeducational Intervention After Waiting Period | Caregivers receiving the psychoeducational intervention after a waiting period of 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is missing for one caregiver |
| 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 | Center for Epidemiologic Studies - Depression (CES-D) Scale Score | The CES-D is a 20-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 0 to 3 where rarely is scored as 0 and most of the time is scored as 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression. | This analysis includes participants who attended the indicated study visits. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 16.
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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 | Psychoeducational Intervention Immediately | Caregivers receiving the psychoeducational intervention immediately. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Clevenger, DMP, APRN | Emory University | 404-712-2394 | carolyn.clevenger@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 29, 2021 | Jul 14, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 15, 2020 | Jul 14, 2023 | ICF_001.pdf |
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|
| Baseline, Week 8 |
| Zarit Burden Interview Score | The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care. | Baseline, Week 8 |
| Caregiver Mastery Scales - Competency Score | The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The Caregiving Competence section includes 4 items are responded to on a 4-point scale where 1 = not at all and 4 = completely. Total scores range from 4 to 16 where higher scores indicate greater feelings of mastery of caregiving. | Baseline, Week 8 |
| Caregiver Assessment of Behavioral Skill - Self-report Score | The Caregiver Assessment of Behavioral Skill - Self-report instrument is a 17-item caregiver self-assessment of perceived capacity to manage care situations. Responses are given on a 3-point scale where 0 = seldom true and 3 = true most of the time, for behaviors exhibited by or relevant to the PLWD. Total scores range from 0 to 51 where higher scores indicate perceived ability to manage providing care. | Baseline, Week 8 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Highest Education Level | Count of Participants | Participants |
|
| Employed Outside of the Home | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| Geographic Area of Residence | Count of Participants | Participants |
|
| Care Provided for Spouse | Count of Participants | Participants |
|
| Age of Person Cared For | Age is missing for one person receiving care | Mean | Standard Deviation | years |
|
| Reside in Same House as Person Receiving Care | Count of Participants | Participants |
|
| Person Cared for Diagnosed with Dementia | Count of Participants | Participants |
|
| Stage of Dementia of Person Cared For | Count of Participants | Participants |
|
| Amount of Help From Friends and Family | Count of Participants | Participants |
|
| Amount of Strife | Participants were asked "Thinking about your family and friends and about your caregiving and support responsibilities, how much strife and disagreement have family and friends added to the difficulties you may face in your overall caregiving experience?" | Count of Participants | Participants |
|
| Also Provide Care to Others | Participants were asked "Are there others in your family or among your friends and neighbors for whom you also feel responsible to provide care or other kinds of support (e.g. financial, legal, emotional, logistical, etc.)?" | Count of Participants | Participants |
|
Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks. |
|
|
| Primary | State-Trait Anxiety Inventory (STAI) Score | The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety. | This analysis includes participants who attended the indicated study visits and who provided complete information for the survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
|
|
| Primary | Perceived Stress Scale (PSS-14) Score | The Perceived Stress Scale includes 14 items assessing self-reported caregiving stress. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and higher values indicate greater perceived stress. | This analysis includes participants who attended the indicated study visits. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
|
|
| Primary | Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score | The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the person living with dementia (PLWD). | This analysis includes participants who attended the indicated study visits and who provided complete information for the survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
|
|
| Primary | Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score | The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD. | This analysis includes participants who attended the indicated study visits and who provided complete information for the survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
|
|
| Primary | Zarit Burden Interview Score | The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care. | This analysis includes participants who attended the indicated study visits. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
|
|
| Primary | Caregiver Mastery Scales - Competency Score | The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The Caregiving Competence section includes 4 items are responded to on a 4-point scale where 1 = not at all and 4 = completely. Total scores range from 4 to 16 where higher scores indicate greater feelings of mastery of caregiving. | This analysis includes participants who attended the indicated study visits. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
|
|
| Primary | Caregiver Assessment of Behavioral Skill - Self-report Score | The Caregiver Assessment of Behavioral Skill - Self-report instrument is a 17-item caregiver self-assessment of perceived capacity to manage care situations. Responses are given on a 3-point scale where 0 = seldom true and 3 = true most of the time, for behaviors exhibited by or relevant to the PLWD. Total scores range from 0 to 51 where higher scores indicate perceived ability to manage providing care. | This analysis includes participants who attended the indicated study visits. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Psychoeducational Intervention After Waiting Period | Caregivers receiving the psychoeducational intervention after a waiting period of 8 weeks. | 0 | 50 | 0 | 50 | 0 | 50 |
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| Missing response |
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| Unknown or Not Reported |
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| Asian |
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| Other |
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| Missing response/did not wish to answer |
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| College graduate |
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| Graduate degree |
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| Missing response |
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| Missing response |
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| Lesbian |
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| Heterosexual |
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| Missing response |
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| Rural |
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| Missing response |
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| Missing response |
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| Missing response |
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| Late Stage - loses ability to respond with environment/needs extensive help with daily activities |
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| No known diagnosis of dementia |
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| A little help |
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| Not much help |
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| Almost no help |
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| Missing response |
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| Occasional Strife |
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| Some serious difficulties |
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| A main source of difficulties |
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| Missing response |
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| Missing response |
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