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

Stress, Psychological Clinical Trial

Official title:

Effect of Stress-Busting Program on Caregivers' Quality of Life, Stress/Immunity Bio-markers, and Cellular Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844478
• Other study ID #: HSC20160309H
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 2018

Study information

• Verified date: October 2018
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Stress, Physiological
• Stress, Psychological
• Telomere Shortening

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

References & Publications (17)

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

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

Arevalo-Flechas LC. Beyond translated consents: Culturally competent research. Perioperative Nursing Clinics. 2009; 4(3):287 - 296.

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

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

Gallagher-Thompson D, Coon DW, Solano N, Ambler C, Rabinowitz Y, Thompson LW. Change in indices of distress among Latino and Anglo female caregivers of elderly relatives with dementia: site-specific results from the REACH national collaborative study. Gerontologist. 2003 Aug;43(4):580-91. — View Citation

Granger DA, Kivlighan KT, el-Sheikh M, Gordis EB, Stroud LR. Salivary alpha-amylase in biobehavioral research: recent developments and applications. Ann N Y Acad Sci. 2007 Mar;1098:122-44. Epub 2007 Mar 1. Review. — View Citation

Hinton L, Haan M, Geller S, Mungas D. Neuropsychiatric symptoms in Latino elders with dementia or cognitive impairment without dementia and factors that modify their association with caregiver depression. Gerontologist. 2003 Oct;43(5):669-77. — View Citation

Lewis SL, Miner-Williams D, Novian A, Escamilla MI, Blackwell PH, Kretzschmar JH, Arévalo-Flechas LC, Bonner PN. A stress-busting program for family caregivers. Rehabil Nurs. 2009 Jul-Aug;34(4):151-9. — View Citation

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

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

Ortiz F, Fitten LJ, Cummings JL, Hwang S, Fonseca M. Neuropsychiatric and behavioral symptoms in a community sample of Hispanics with Alzheimer's disease. Am J Alzheimers Dis Other Demen. 2006 Aug-Sep;21(4):263-73. — View Citation

Piazza JR, Almeida DM, Dmitrieva NO, Klein LC. Frontiers in the use of biomarkers of health in research on stress and aging. J Gerontol B Psychol Sci Soc Sci. 2010 Sep;65(5):513-25. doi: 10.1093/geronb/gbq049. Epub 2010 Jul 20. Review. — View Citation

Radloff LS.The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385-408.

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. — View Citation

Vitaliano PP, Russo J, Young HM, Becker J, Maiuro RD. The screen for caregiver burden. Gerontologist. 1991 Feb;31(1):76-83. — View Citation

Yeh CK, Johnson DA, Dodds MW. Impact of aging on human salivary gland function: a community-based study. Aging (Milano). 1998 Oct;10(5):421-8. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

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)

External Links

•   Factors influencing Hispanic caregivers' perception of the experience of caring for a relative with Alzheimer's disease
•   National Alliance for Caregiving. Hispanic family caregiving in the U.S. (Evercare Publication). Minnetonka,
•   Pew Research Center statistics on Hispanics.
•   Technology Engineering and Design (TEDx) presentation: All Alzheimer's Caregivers are not Created Equal.