Clinical trial NCT02844478: Stress-Busting Program and QoL, Bio-markers of Immunity/Stress and Cellular Aging
Official title: Effect of Stress-Busting Program on Caregivers' Quality of Life, Stress/Immunity Bio-markers, and Cellular Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Telomere Shortening
Stress, Physiological
Keywords: Caregiving
Family caregiving
Stress
dementia caregiving
Hispanics
Spanish
Telomere
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: WellMed Charitable Foundation
name: The Claude D. Pepper Older Americans Independence Centers
name: The Sam and Ann Barshop Institute for Longevity and Aging Studies
name: San Antonio Geriatrics Research Education and Clinical Center- GRECC
name: Caring Companions
name: Alzheimer's Association
First posted: 2016-07-26
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Telomere length
timeFrame: Baseline and end of intervention (Week 9)
Secondary outcomes:
measure: Salivary flow rate
timeFrame: Baseline and end of intervention (Week 9)
measure: Saliva potential hydrogen (pH)
timeFrame: Baseline and end of intervention (Week 9)
measure: Salivary protein
timeFrame: Baseline and end of intervention (Week 9)
measure: Perceived Stress Scale
timeFrame: Baseline and end of intervention (Week 9)
measure: Center for Epidemiologic Depression (CES-D)
timeFrame: Baseline and end of intervention (Week 9)
measure: Screen for Caregiver Burden
timeFrame: Baseline and end of intervention (Week 9)
measure: Salivary alpha Amylase (sAA)
timeFrame: Baseline and end of intervention (Week 9)
measure: Secretory immunoglobulin A (SIgA)
timeFrame: Baseline and end of intervention (Week 9)
measure: C Reactive Protein (CRP)
timeFrame: Baseline and end of intervention (Week 9)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Audie L. Murphy VA Hospital, STVHCS
name: Lyda C Arevalo-Flechas, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Audie L. Murphy VA Hospital, STVHCS
name: Chih-Ko Yeh, BDS, PhD
role: PRINCIPAL_INVESTIGATOR
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