The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207, United States
NCT Number: NCT02844478
The purpose of this study is to explore the differences in quality of life , inflammation, stress, telomere length, and mucosal immune function of Hispanic and non-Hispanic caregivers of persons with Alzheimer's disease and related dementias (ADRD). The caregivers will complete the Stress-Busting Program for Family Caregivers in the language of their choice (English or Spanish).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
San Antonio, Texas, 78207, United States
The overarching goal of this project is to (1) explore the differences in quality of life (QoL), inflammation, stress, telomere length, and mucosal immune function of Hispanic caregivers of persons with ADRD and (2) determine whether a caregiver intervention can effectively improve the QoL, inflammation, stress, telomere length, and mucosal immune function biomarkers of Hispanic caregivers.
The proposed study is a non-randomized trial design with three groups of ADRD caregivers that vary based on Hispanic ethnicity and English/Spanish language preference. The project's specific aims are:
Specific Aim 1: To compare the quality of life (QoL) (stress, depression, and burden), mucosal immunity function (sIgA), stress (sCortisol and sAmylase), inflammation(CRP), and telomere length in Spanish-speaking Hispanic, English-speaking Hispanic, and English-speaking non-Hispanic caregivers who participate in an evidence-based Stress-Busting Program (SBP) for family caregivers of family members living with ADRD. Working hypothesis: At baseline, Spanish-speaking Hispanic caregivers have lower QoL and immune function, higher levels of inflammation and stress, and shorter telomeres as compared to Hispanic and non-Hispanic English-speaking caregivers.
Specific Aim 2: To compare the impact of the SBP on QoL and biomarkers for stress, aging, inflammation and mucosal immunity among those caregivers completing the SBP (Hispanic caregivers completing the culturally adapted translated version to Spanish of SBP and Hispanic and non-Hispanic caregivers completing the English-SBP). Working Hypothesis: Spanish-speaking Hispanic caregivers completing the Spanish-SBP show more improvement in their QoL and biomarkers of stress, mucosal immunity, aging and inflammation post-intervention as compared to Hispanic and Non-Hispanic caregivers completing the English-SBP. To achieve these aims, the investigators propose to deliver the 9-week English SBP and the translated and culturally adapted Spanish-SBP. Saliva and blood samples and self- report measures of QoL will be collected at baseline and 9 weeks (end of intervention)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In addition to Alzheimer's disease, other causes of dementia include multiple sclerosis, Parkinson's, post-traumatic stress disorder (PTSD), and/or traumatic brain injury (TBI),
Exclusion criteria
The SBP caregiver intervention has been successfully delivered and disseminated in the US. It is currently offered in 9 states and 16 Texas counties . The SBP is designed to a) improve the QoL of family caregivers who provide care for people with ADRD and b) help caregivers manage their stress and cope better with their lives. The SBP is implemented using a Master Trainer/Group Facilitator (lay leader) model. The SBP is a multi-component intervention that meets for 90 minutes once a week for 9 consecutive weeks.
Other names: SBP-E
The SBP caregiver intervention has been successfully delivered and disseminated in the US. It is currently offered in 9 states and 16 Texas counties . The SBP is designed to a) improve the QoL of family caregivers who provide care for people with ADRD and b) help caregivers manage their stress and cope better with their lives. The SBP is implemented using a Master Trainer/Group Facilitator (lay leader) model. The SBP is a multi-component intervention that meets for 90 minutes once a week for 9 consecutive weeks. The Spanish translation and cultural adaptation of the SBP has been completed under the direction of the PI.
Other names: SBP-S
Time frame: Baseline and end of intervention (Week 9)
Time frame: Baseline and end of intervention (Week 9)
Time frame: Baseline and end of intervention (Week 9)
Time frame: Baseline and end of intervention (Week 9)
Time frame: Baseline and end of intervention (Week 9)
Time frame: Baseline and end of intervention (Week 9)
Time frame: Baseline and end of intervention (Week 9)
Time frame: Baseline and end of intervention (Week 9)
Time frame: Baseline and end of intervention (Week 9)
Time frame: Baseline and end of intervention (Week 9)
The University of Texas Health Science Center at San Antonio
Other
Effect of Stress-Busting Program on Caregivers' Quality of Life, Stress/Immunity Bio-markers, and Cellular Aging
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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