Stress, PsychologicalNCT02844478
Stress-Busting Program and QoL, Bio-markers of Immunity/Stress and Cellular Aging
A study testing SBP English and SBP SPANISH in people with Stress, Psychological and Telomere Shortening, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Telomere Shortening, Stress, Physiological
- What is being tested?
- SBP English and SBP SPANISH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Speaking a language other than English or Spanish
- Caring for an individual not diagnosed with a cognitive impairment as delineated in inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207
About this study
Official title: Effect of Stress-Busting Program on Caregivers' Quality of Life, Stress/Immunity Bio-markers, and Cellular Aging
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).
Read the 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)
- Being tested
- SBP English, SBP SPANISH
- Keywords
- Caregiving, Family caregiving, Stress, dementia caregiving, Hispanics, Spanish, Telomere
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBP EnglishBehavioural
Also called SBP-E
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 SPANISHBehavioural
Also called SBP-S
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.
| Study group | Role | What they receive |
|---|---|---|
| SBP ENGLISH | Active comparator | Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in English Receives: Behavioral: SBP English |
| SBP SPANISH | Experimental | Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in Spanish Receives: Behavioral: SBP SPANISH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomere length
Measured: Baseline and end of intervention (Week 9)
Secondary outcomes (9)
Salivary flow rate
Measured: Baseline and end of intervention (Week 9)
Saliva potential hydrogen (pH)
Measured: Baseline and end of intervention (Week 9)
Salivary protein
Measured: Baseline and end of intervention (Week 9)
Perceived Stress Scale
Measured: Baseline and end of intervention (Week 9)
Center for Epidemiologic Depression (CES-D)
Measured: Baseline and end of intervention (Week 9)
Screen for Caregiver Burden
Measured: Baseline and end of intervention (Week 9)
Salivary alpha Amylase (sAA)
Measured: Baseline and end of intervention (Week 9)
Secretory immunoglobulin A (SIgA)
Measured: Baseline and end of intervention (Week 9)
C Reactive Protein (CRP)
Measured: Baseline and end of intervention (Week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Lyda C Arevalo-Flechas, PhD, RN, Principal investigator, Audie L. Murphy VA Hospital, STVHCSChih-Ko Yeh, BDS, PhD, Principal investigator, Audie L. Murphy VA Hospital, STVHCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844478
- Sponsor's protocol ID
- HSC20160309H
- Status last verified
- Oct 2018
- First submitted
- 20 Jul 2016
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 19583056Lucke 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.
PubMed 23258419Arevalo-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.
PubMed 25601209Hinton 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.
PubMed 14570963Ortiz 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.
PubMed 16948291Gallagher-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.
PubMed 12937336Vitaliano 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.
PubMed 2007478Radloff 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.
PubMed 6668417Piazza 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.
PubMed 20647348Granger 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.
PubMed 17332070
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stress-Busting Program on Caregivers' Quality of Life, Stress/Immunity Bio-markers, and Cellular Aging
- ClinicalTrials.gov ID
- NCT02844478
- Acronym / sponsor ID
- HSC20160309H
- Keywords
- Caregiving, Family caregiving, Stress, dementia caregiving, Hispanics, Spanish, Telomere
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- 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
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBP ENGLISH | Active comparator | Behavioral: SBP EnglishCaregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in English |
| SBP SPANISH | Experimental | Behavioral: SBP SPANISHCaregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in Spanish |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Speaking a language other than English or Spanish
- Caring for an individual not diagnosed with a cognitive impairment as delineated in inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBP EnglishAlso: SBP-EThe 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. | Behavioural | SBP ENGLISH |
| SBP SPANISHAlso: SBP-SThe 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. | Behavioural | SBP SPANISH |
Primary outcome
Telomere length
Time frame: Baseline and end of intervention (Week 9)
9 secondary outcomes
Salivary flow rate
Time frame: Baseline and end of intervention (Week 9)
Saliva potential hydrogen (pH)
Time frame: Baseline and end of intervention (Week 9)
Salivary protein
Time frame: Baseline and end of intervention (Week 9)
Perceived Stress Scale
Time frame: Baseline and end of intervention (Week 9)
Center for Epidemiologic Depression (CES-D)
Time frame: Baseline and end of intervention (Week 9)
Screen for Caregiver Burden
Time frame: Baseline and end of intervention (Week 9)
Salivary alpha Amylase (sAA)
Time frame: Baseline and end of intervention (Week 9)
Secretory immunoglobulin A (SIgA)
Time frame: Baseline and end of intervention (Week 9)
C Reactive Protein (CRP)
Time frame: Baseline and end of intervention (Week 9)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Background: PubMed 19583056Lewis 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.
- Background: PubMed 23258419Lucke 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.
- BackgroundArevalo-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
- BackgroundArevalo-Flechas LC. Beyond translated consents: Culturally competent research. Perioperative Nursing Clinics. 2009; 4(3):287 - 296.
- BackgroundMedrano 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
- BackgroundArévalo-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: PubMed 25601209Turner 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.
- Background: PubMed 14570963Hinton 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.
- Background: PubMed 16948291Ortiz 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.
- Background: PubMed 12937336Gallagher-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.
- Background: PubMed 2007478Vitaliano 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.
- BackgroundRadloff LS.The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385-408.
- Pew Research Center statistics on Hispanics.Link provided by the sponsor.
- Technology Engineering and Design (TEDx) presentation: All Alzheimer's Caregivers are not Created Equal.Link provided by the sponsor.
- Factors influencing Hispanic caregivers' perception of the experience of caring for a relative with Alzheimer's diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyda C Arevalo-Flechas, PhD, RN principal investigator
Audie L. Murphy VA Hospital, STVHCS
Chih-Ko Yeh, BDS, PhD principal investigator
Audie L. Murphy VA Hospital, STVHCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBP English and SBP SPANISH in people with Stress, Psychological and Telomere Shortening, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere length (time frame: Baseline and end of intervention (Week 9)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02844478, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.