Stress-Busting Program and QoL, Bio-markers of Immunity/Stress and Cellular Aging
NCT ID: NCT02844478
Last Updated: 2018-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
37 participants
INTERVENTIONAL
2016-09-30
2018-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Alzheimer's Caregiver Coping: Mental and Physical Health
NCT02317523
Hypnosis for Sleep Quality in Caregivers of Individuals With Alzheimer's Disease
NCT04779866
Self- Care TALK Study - Promoting Alzheimer's Disease (AD) Spousal Caregiver Health
NCT00646074
Dementia Family Caregiver Study
NCT04894006
Self-Care Training for Family Caregivers of Persons With Neurodegeneration
NCT06200909
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SBP ENGLISH
Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in English
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
Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in Spanish
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
WellMed Charitable Foundation
UNKNOWN
The Claude D. Pepper Older Americans Independence Centers
OTHER
The Sam and Ann Barshop Institute for Longevity and Aging Studies
UNKNOWN
San Antonio Geriatrics Research Education and Clinical Center- GRECC
UNKNOWN
Caring Companions
UNKNOWN
Alzheimer's Association
OTHER
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lyda C Arevalo-Flechas, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Audie L. Murphy VA Hospital, STVHCS
Chih-Ko Yeh, BDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Audie L. Murphy VA Hospital, STVHCS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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
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.
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.
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.
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.
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.
Radloff LS.The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385-408.
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.
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.
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.
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.
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
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HSC20160309H
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.