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

NCT02844478 | Completed DMC

• 1 other identifier: HSC20160309H
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress, Psychological; Telomere Shortening; Stress, Physiological

Keywords

Caregiving; Family caregiving; Stress; dementia caregiving; Hispanics; Spanish; Telomere

Outcome Measures

Primary Outcomes (1)

• Telomere length

  Baseline and end of intervention (Week 9)

Secondary Outcomes (9)

• Salivary flow rate

  Baseline and end of intervention (Week 9)

• Saliva potential hydrogen (pH)

  Baseline and end of intervention (Week 9)

• Salivary protein

  Baseline and end of intervention (Week 9)

• Perceived Stress Scale

  Baseline and end of intervention (Week 9)

• Center for Epidemiologic Depression (CES-D)

  Baseline and end of intervention (Week 9)

Study Arms (2)

SBP ENGLISH

ACTIVE COMPARATOR

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

Behavioral: SBP English

SBP SPANISH

EXPERIMENTAL

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

Behavioral: SBP SPANISH

Interventions

SBP English BEHAVIORAL

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.

Also known as: SBP-E

SBP ENGLISH

SBP SPANISH BEHAVIORAL

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.

Also known as: SBP-S

SBP SPANISH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Speaking a language other than English or Spanish

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• WellMed Charitable Foundation: collaborator
• The Claude D. Pepper Older Americans Independence Centers: collaborator
• The Sam and Ann Barshop Institute for Longevity and Aging Studies: collaborator
• San Antonio Geriatrics Research Education and Clinical Center- GRECC: collaborator
• Caring Companions: collaborator
• Alzheimer's Association: collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78207, United States

Location

Related Publications (17)

• 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.

  PMID: 19583056 BACKGROUND

• 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.

  PMID: 23258419 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25601209 BACKGROUND

• 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. doi: 10.1093/geront/43.5.669.

  PMID: 14570963 BACKGROUND

• 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. doi: 10.1177/1533317506289350.

  PMID: 16948291 BACKGROUND

• 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. doi: 10.1093/geront/43.4.580.

  PMID: 12937336 BACKGROUND

• Vitaliano PP, Russo J, Young HM, Becker J, Maiuro RD. The screen for caregiver burden. Gerontologist. 1991 Feb;31(1):76-83. doi: 10.1093/geront/31.1.76.

  PMID: 2007478 BACKGROUND

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

  BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 20647348 BACKGROUND

• 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. doi: 10.1196/annals.1384.008. Epub 2007 Mar 1.

  PMID: 17332070 BACKGROUND

• 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. doi: 10.1007/BF03339889.

  PMID: 9932146 BACKGROUND

• 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

  BACKGROUND

Related Links

• Pew Research Center statistics on Hispanics.
• Technology Engineering and Design (TEDx) presentation: All Alzheimer's Caregivers are not Created Equal.
• Factors influencing Hispanic caregivers' perception of the experience of caring for a relative with Alzheimer's disease

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 26, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

US (1)