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

Primary Purpose

Stress, Psychological, Telomere Shortening, Stress, Physiological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SBP English
SBP SPANISH
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress, Psychological focused on measuring Caregiving, Family caregiving, Stress, dementia caregiving, Hispanics, Spanish, Telomere

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SBP ENGLISH

SBP SPANISH

Arm Description

Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in English

Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in Spanish

Outcomes

Primary Outcome Measures

Telomere length

Secondary Outcome Measures

Salivary flow rate
Saliva potential hydrogen (pH)
Salivary protein
Perceived Stress Scale
Center for Epidemiologic Depression (CES-D)
Screen for Caregiver Burden
Salivary alpha Amylase (sAA)
Secretory immunoglobulin A (SIgA)
C Reactive Protein (CRP)

Full Information

First Posted
July 20, 2016
Last Updated
October 15, 2018
Sponsor
The University of Texas Health Science Center at San Antonio
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
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1. Study Identification

Unique Protocol Identification Number
NCT02844478
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Telomere Shortening, Stress, Physiological
Keywords
Caregiving, Family caregiving, Stress, dementia caregiving, Hispanics, Spanish, Telomere

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBP ENGLISH
Arm Type
Active Comparator
Arm Description
Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in English
Arm Title
SBP SPANISH
Arm Type
Experimental
Arm Description
Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in Spanish
Intervention Type
Behavioral
Intervention Name(s)
SBP English
Other Intervention Name(s)
SBP-E
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SBP SPANISH
Other Intervention Name(s)
SBP-S
Intervention Description
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.
Primary Outcome Measure Information:
Title
Telomere length
Time Frame
Baseline and end of intervention (Week 9)
Secondary Outcome Measure Information:
Title
Salivary flow rate
Time Frame
Baseline and end of intervention (Week 9)
Title
Saliva potential hydrogen (pH)
Time Frame
Baseline and end of intervention (Week 9)
Title
Salivary protein
Time Frame
Baseline and end of intervention (Week 9)
Title
Perceived Stress Scale
Time Frame
Baseline and end of intervention (Week 9)
Title
Center for Epidemiologic Depression (CES-D)
Time Frame
Baseline and end of intervention (Week 9)
Title
Screen for Caregiver Burden
Time Frame
Baseline and end of intervention (Week 9)
Title
Salivary alpha Amylase (sAA)
Time Frame
Baseline and end of intervention (Week 9)
Title
Secretory immunoglobulin A (SIgA)
Time Frame
Baseline and end of intervention (Week 9)
Title
C Reactive Protein (CRP)
Time Frame
Baseline and end of intervention (Week 9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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), over the age of 18, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyda C Arevalo-Flechas, PhD, RN
Organizational Affiliation
Audie L. Murphy VA Hospital, STVHCS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chih-Ko Yeh, BDS, PhD
Organizational Affiliation
Audie L. Murphy VA Hospital, STVHCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19583056
Citation
Lewis SL, Miner-Williams D, Novian A, Escamilla MI, Blackwell PH, Kretzschmar JH, Arevalo-Flechas LC, Bonner PN. A stress-busting program for family caregivers. Rehabil Nurs. 2009 Jul-Aug;34(4):151-9. doi: 10.1002/j.2048-7940.2009.tb00271.x.
Results Reference
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23258419
Citation
Lucke KT, Martinez H, Mendez TB, Arevalo-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.
Results Reference
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Citation
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
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Citation
Arevalo-Flechas LC. Beyond translated consents: Culturally competent research. Perioperative Nursing Clinics. 2009; 4(3):287 - 296.
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Citation
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
Results Reference
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Citation
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
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25601209
Citation
Turner RM, Hinton L, Gallagher-Thompson D, Tzuang M, Tran C, Valle R. Using an Emic lens to understand how Latino families cope with dementia behavioral problems. Am J Alzheimers Dis Other Demen. 2015 Aug;30(5):454-62. doi: 10.1177/1533317514566115. Epub 2015 Jan 19.
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Results Reference
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Links:
URL
http://www.pewresearch.org/fact-tank/2014/12/16/with-fewer-new-arrivals-census-lowers-hispanic-
Description
Pew Research Center statistics on Hispanics.
URL
https://youtu.be/2QYdXGZNp5A
Description
Technology Engineering and Design (TEDx) presentation: All Alzheimer's Caregivers are not Created Equal.
URL
http://pqdtopen.proquest.com/pubnum/3311328.html
Description
Factors influencing Hispanic caregivers' perception of the experience of caring for a relative with Alzheimer's disease

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

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