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Stress-Busting Program and QoL, Bio-markers of Immunity/Stress and Cellular Aging

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ClinicalTrials.gov Identifier: NCT02844478
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
WellMed Charitable Foundation
The Claude D. Pepper Older Americans Independence Centers
The Sam and Ann Barshop Institute for Longevity and Aging Studies
San Antonio Geriatrics Research Education and Clinical Center- GRECC
Caring Companions
Alzheimer's Association
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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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).

Condition or disease Intervention/treatment Phase
Stress, Psychological Telomere Shortening Stress, Physiological Behavioral: SBP English Behavioral: SBP SPANISH Not Applicable

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Stress-Busting Program on Caregivers' Quality of Life, Stress/Immunity Bio-markers, and Cellular Aging
Actual Study Start Date : September 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: SBP ENGLISH
Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in English
 Behavioral: SBP English
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 Name: SBP-E
Experimental: SBP SPANISH
Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in Spanish
 Behavioral: SBP SPANISH
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 Name: SBP-S


Outcome Measures
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Primary Outcome Measures :
  1. Telomere length [ Time Frame: Baseline and end of intervention (Week 9) ]

Secondary Outcome Measures :
  1. Salivary flow rate [ Time Frame: Baseline and end of intervention (Week 9) ]
  2. Saliva potential hydrogen (pH) [ Time Frame: Baseline and end of intervention (Week 9) ]
  3. Salivary protein [ Time Frame: Baseline and end of intervention (Week 9) ]
  4. Perceived Stress Scale [ Time Frame: Baseline and end of intervention (Week 9) ]
  5. Center for Epidemiologic Depression (CES-D) [ Time Frame: Baseline and end of intervention (Week 9) ]
  6. Screen for Caregiver Burden [ Time Frame: Baseline and end of intervention (Week 9) ]
  7. Salivary alpha Amylase (sAA) [ Time Frame: Baseline and end of intervention (Week 9) ]
  8. Secretory immunoglobulin A (SIgA) [ Time Frame: Baseline and end of intervention (Week 9) ]
  9. C Reactive Protein (CRP) [ Time Frame: Baseline and end of intervention (Week 9) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844478


Locations
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United States, Texas
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
WellMed Charitable Foundation
The Claude D. Pepper Older Americans Independence Centers
The Sam and Ann Barshop Institute for Longevity and Aging Studies
San Antonio Geriatrics Research Education and Clinical Center- GRECC
Caring Companions
Alzheimer's Association
Investigators
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Principal Investigator: Lyda C Arevalo-Flechas, PhD, RN Audie L. Murphy VA Hospital, STVHCS
Principal Investigator: Chih-Ko Yeh, BDS, PhD Audie L. Murphy VA Hospital, STVHCS
More Information
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Additional Information:

Publications:
Arevalo-Flechas LC, Acton G, Escamilla M, Bonner P, Lewis SL. Latino Alzheimer's caregivers: What is important to them?. Journal of Managerial Psychology. 2014; 6(29):661-684
Arevalo-Flechas LC. Beyond translated consents: Culturally competent research. Perioperative Nursing Clinics. 2009; 4(3):287 - 296.
Medrano MA, DeVoe PH, Padilla A, Arévalo-Flechas LC. A targeted review to examine reporting of translation methodology in Hispanic health studies. Hispanic health care international : the official journal of the National Association of Hispanic Nurses. 2010; 8(3):145 - 153
Arévalo-Flechas LC, Lewis SL. Lost in translation: What does burden mean to Latino caregivers? [Abstract]. Journal of the American Geriatrics Society. 2006;54(4):S177
Radloff LS.The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385-408.
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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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02844478    
Other Study ID Numbers: HSC20160309H
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by The University of Texas Health Science Center at San Antonio:
Caregiving
Family caregiving
Stress
dementia caregiving
 Hispanics
Spanish
Telomere
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms