Stress, Psychological Clinical Trial
Official title:
Effect of Stress-Busting Program on Caregivers' Quality of Life, Stress/Immunity Bio-markers, and Cellular Aging
NCT number | NCT02844478 |
Other study ID # | HSC20160309H |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | June 2018 |
Verified date | October 2018 |
Source | The University of Texas Health Science Center at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 37 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. self-identified caregiver for a person living with ADRD. Family caregivers of people with ADRD include spouses, adult children, grandchildren, siblings, partners, and significant others. 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), 2. over the age of 18, 3. those wishing to participate in the Spanish SBP must speak and read Spanish. Exclusion Criteria: - Speaking a language other than English or Spanish - Caring for an individual not diagnosed with a cognitive impairment as delineated in inclusion criteria. |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio | Alzheimer's Association, Caring Companions, San Antonio Claude D. Pepper Older Americans Independence Center, San Antonio Geriatrics Research Education and Clinical Center- GRECC, The Sam and Ann Barshop Institute for Longevity and Aging Studies, WellMed Charitable Foundation |
United States,
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Arévalo-Flechas LC. Factors influencing Latino/Hispanic caregivers' perception of the experience of caring for a relative with Alzheimer's disease. Dissertation Abstracts International. DAI-B 69/066
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Lucke KT, Martinez H, Mendez TB, Arévalo-Flechas LC. Resolving to go forward: the experience of Latino/Hispanic family caregivers. Qual Health Res. 2013 Feb;23(2):218-30. doi: 10.1177/1049732312468062. — View Citation
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Telomere length | Baseline and end of intervention (Week 9) | ||
Secondary | Salivary flow rate | Baseline and end of intervention (Week 9) | ||
Secondary | Saliva potential hydrogen (pH) | Baseline and end of intervention (Week 9) | ||
Secondary | Salivary protein | Baseline and end of intervention (Week 9) | ||
Secondary | Perceived Stress Scale | Baseline and end of intervention (Week 9) | ||
Secondary | Center for Epidemiologic Depression (CES-D) | Baseline and end of intervention (Week 9) | ||
Secondary | Screen for Caregiver Burden | Baseline and end of intervention (Week 9) | ||
Secondary | Salivary alpha Amylase (sAA) | Baseline and end of intervention (Week 9) | ||
Secondary | Secretory immunoglobulin A (SIgA) | Baseline and end of intervention (Week 9) | ||
Secondary | C Reactive Protein (CRP) | Baseline and end of intervention (Week 9) |
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