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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG064103 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of North Carolina, Charlotte | OTHER |
| National Institute on Aging (NIA) | NIH |
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This study will test the feasibility and influence of a behavioral intervention called "Cuidando Juntos" in Latino caregivers of people with dementia. The study will examine if the intervention is well received by Latino caregivers and if the caregivers' social connectedness and loneliness is associated with their levels of stress, burden, and depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cuidando juntos | Behavioral | Caregiver TLC program will be culturally tailored by including a focus on addressing cultural values to promote social connectedness and translated into Spanish (Cuidando Juntos). Cuidando Juntos consists of 8 modules: stress management; behavioral activation; building resilience; building self-care skills; managing difficult emotions; reducing isolation; and two on understanding and responding to difficult behaviors of the PLWD. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in PHQ-9 to Assess Depressive Symptoms | The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).The scale ranges from 0-27, with higher scores indicating higher depression. | Baseline to six weeks |
| Mean Change in Perceived Stress Scale | The perceived stress scale is a 4-item questionnaire, with a score range of 0 to 16. Higher scores are correlated with more stress. | Baseline to six weeks |
| Mean Change in Zarit Caregiver Burden 6-item Version | The Zarit caregiver burden 6-item version is a self-administered instrument that ranges from 0-88. Higher scores indicate more burden. | Baseline to six weeks |
| Mean Change in Caregiver Self-Efficacy Scale (CSES-8) | The caregiver self-efficacy scale is an 8-item scale developed to reflect components of typical caregiver support interventions that range from 0 to 8. Higher scores indicate being more confident. | Baseline to six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Social Network Scale | The Social network scale is a self-report measure of social engagement that includes engagement with family and friends.The Short version, a 6-item scale, is used. The scale ranges from 0 to 35; higher scores indicate better outcome. | Baseline to six weeks |
| Mean Change in UCLA Loneliness Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina, Charlotte | Charlotte | North Carolina | 28223 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41849439 | Derived | Montoro-Rodriguez J, Reeve CL, Gallagher-Thompson D, Ramsey J, Choryan Bilbrey A, Kajiyama B, Quinones MM. Supporting Hispanic caregiver subjective health and well-being: a test of user-reactions and preliminary efficacy of a psychoeducational program for Hispanic dementia caregivers. Gerontologist. 2026 May 11;66(6):gnag029. doi: 10.1093/geront/gnag029. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Cuidando juntos: Caregiver TLC program will be culturally tailored by including a focus on addressing cultural values to promote social connectedness and translated into Spanish (Cuidando Juntos). Cuidando Juntos consists of 6 modules: stress management; behavioral activation; building resilience; building self-care skills; managing difficult emotions; reducing isolation; and two on understanding and responding to difficult behaviors of the PLWD. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Cuidando juntos: Caregiver TLC program will be culturally tailored by including a focus on addressing cultural values to promote social connectedness and translated into Spanish (Cuidando Juntos). Cuidando Juntos consists of 6 modules: stress management; behavioral activation; building resilience; building self-care skills; managing difficult emotions; reducing isolation; and two on understanding and responding to difficult behaviors of the PLWD. |
| Units | Counts |
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| Participants |
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| 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 | Mean Change in PHQ-9 to Assess Depressive Symptoms | The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).The scale ranges from 0-27, with higher scores indicating higher depression. | We have 6 pre trial participants that were not included in the analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline to six weeks |
|
From enrollment through completion of all study activities, including intervention sessions and follow-up assessments, up to approximately 10 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 | All Participants | Cuidando juntos: Caregiver TLC program will be culturally tailored by including a focus on addressing cultural values to promote social connectedness and translated into Spanish (Cuidando Juntos). Cuidando Juntos consists of 6 modules: stress management; behavioral activation; building resilience; building self-care skills; managing difficult emotions; reducing isolation; and two on understanding and responding to difficult behaviors of the PLWD. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julian Montoro-Rodriguez, PI | University of North Carolina at Charlotte | 9092049061 | jmontoro@uncc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 12, 2023 | Apr 7, 2026 | Prot_SAP_ICF_000.pdf |
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The UCLA loneliness scale is a 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. The scale measures from 0 to 60; higher scores indicate more loneliness. |
| Baseline to six weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Income | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| Work status | Count of Participants | Participants |
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| Years providing care | Count of Participants | Participants |
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| Primary | Mean Change in Perceived Stress Scale | The perceived stress scale is a 4-item questionnaire, with a score range of 0 to 16. Higher scores are correlated with more stress. | We have 6 pre trial participants that were not included in the analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline to six weeks |
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| Primary | Mean Change in Zarit Caregiver Burden 6-item Version | The Zarit caregiver burden 6-item version is a self-administered instrument that ranges from 0-88. Higher scores indicate more burden. | We have 6 pre trial participants that were not included in the analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline to six weeks |
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| Primary | Mean Change in Caregiver Self-Efficacy Scale (CSES-8) | The caregiver self-efficacy scale is an 8-item scale developed to reflect components of typical caregiver support interventions that range from 0 to 8. Higher scores indicate being more confident. | We have 6 pre trial participants that were not included in the analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline to six weeks |
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| Secondary | Mean Change in Social Network Scale | The Social network scale is a self-report measure of social engagement that includes engagement with family and friends.The Short version, a 6-item scale, is used. The scale ranges from 0 to 35; higher scores indicate better outcome. | We have 6 pre trial participants that were not included in the analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline to six weeks |
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| Secondary | Mean Change in UCLA Loneliness Scale | The UCLA loneliness scale is a 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. The scale measures from 0 to 60; higher scores indicate more loneliness. | We have 6 pre trial participants that were not included in the analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline to six weeks |
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| 31 |
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