Diabetes MellitusENDSTIGMANCT02828995
Evaluating the Influence of Diabetes Stigma on Medication Adherence
An observational study of Diabetes Mellitus, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The "Evaluating the iNfluence of Diabetes STIGma on Medication Adherence: The ENDSTIGMA Study" was designed to develop a comprehensive diabetes stigma survey measure. The draft measure will be piloted with approximately 50 patients visiting the Vanderbilt University Medical Center (VUMC) Diabetes Clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Comprehensive Diabetes Stigma Survey
- How many people
- 508 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2016to Dec 2017
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be adult patients with an established diagnosis of diabetes and who are taking at least 1 medication to manage their diabetes.
Who may be able to join
- 18 years of age or older
- Type I or II DM for at least 1 year
- Taking at least 1 medication to manage diabetes
Who cannot join
- Under 18 years of age
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2372
About this study
The "Evaluating the iNfluence of Diabetes STIGma on Medication Adherence: The ENDSTIGMA Study" was designed to develop a comprehensive diabetes stigma survey measure. The draft measure will be piloted with approximately 50 patients visiting the Vanderbilt University Medical Center (VUMC) Diabetes Clinic. This pilot data will be used to validate the new survey measure and to determine if any questions in the diabetes stigma measure are predictive of diabetes medication adherence.
Read the detailed description
Diabetes mellitus (DM) is a chronic condition affecting an estimated 422 million adults worldwide and 28.9 million adults in the US. DM can lead to increased risk of mortality and significant complications including amputation, blindness, cardiovascular disease, and kidney damage. The risk of developing these outcomes can be mediated by early diagnosis and treatment, such as by patient self-management by lifestyle changes and/or taking medication. However, outcome improvement depends on control of blood glucose levels, which in turn depend on adherence to treatment. Several psychosocial factors are known to affect treatment adherence for chronic conditions, one of which is stigma.
Stigma arises when social norms result in the marginalization of people with a certain identity or trait. Negative stereotypes of people in the stigmatized group result in their systematic exclusion and/or discrimination. Chronic disease diagnosis itself can lead to the development of disease-specific identity-based stigma, in that a person's identity is disrupted by a new label (e.g. "diabetic") applied to them, until they incorporate this new label into a positive sense of self. Minority stress theory describes the impact of identity-based marginalization on health outcomes. According to minority stress theory, discrimination and stigma may lead to heightened stress levels, which can translate over time into heightened mental and physical health disparities for the stigmatized group. Categories of stigma experienced by patients include enacted stigma, perceived stigma, self-stigma, and concealment. Enacted stigma refers to acts of discrimination against people in a stigmatized group. Perceived stigma refers both to the fear of experiencing enacted stigma, as well as to the shame resulting from belonging to or being associated with a stigmatized group. Self-stigma refers to the internalization of negative group stereotypes by members of the stigmatized group. Concealment, also called non-disclosure, refers to the hiding of a stigmatized identity or condition.
Stigma has been shown to negatively affect access to care as well as quality of life in people living with chronic diseases. Disease-specific stigma scales have been developed for various conditions, including mental illness, HIV/AIDS, epilepsy, and obesity. These scales have been used to facilitate interventions to minimize negative effects of stigma on health behaviors and outcomes. In comparison to other health conditions, diabetes stigma has only recently emerged as a research topic of interest.
DM has been reported to be a health condition that is relatively less stigmatized in comparison to other conditions. One publication suggested in its introduction that "diabetes does not appear to have associated stigma." As such, there have been publications comparing the degree of stigma experienced by DM patients with those with conditions such as schizophrenia, dementia, HIV, depression, and hypertension. However, numerous qualitative studies interviewing people with diabetes have revealed that DM patients do experience significant disease-related stigma.
In the literature, DM-related enacted stigma examples include workplace discrimination (decreased chance of being hired and increased chance of job loss); threatened or actual termination of romantic relationships; and judgmental behavior from healthcare professionals. Likewise, examples of perceived stigma include fear of being characterized as an illicit drug user when injecting insulin in public; and feelings of isolation when choosing to eat different foods, particularly in family and cultural situations. Self-stigma and concealment examples include avoidance of social events; timing self-management so it can be done in isolation; and altering blood glucose recordings, so as to appear "healthy."
Despite ample evidence of the existence of DM-specific stigma, limited attempts have been made to measure it. The Diabetes Distress Scale (DDS) was designed to measure "emotional burden, physician-related distress, regimen-related distress, and…interpersonal distress" associated with DM. However, the DDS does not comprehensively measure all the types of stigma minority stress theory has shown to contribute to chronic disease health disparities. The Barriers to Diabetes Adherence measure includes six questions about stigma, but the scope of these questions was limited and targeted towards an adolescent population with Type 1 DM. A limited number of previous publications have adapted disease-specific stigma scales from other conditions or developed their own questionnaires for said conditions for their diabetes stigma research needs. To date, only one publication has developed and validated a stigma scale specifically for DM patients, and this measure only addressed self-stigma. Therefore, to our knowledge, there is currently no scale that measures multiple facets of DM-specific stigma that may be contributing to sub-optimal patient diabetes self-management. Given the relationship between stigma, treatment adherence, and adverse health outcomes for chronic disease patients, development of a comprehensive DM stigma scale may lead to improvements in DM patient centered care, which will be addressed by the following Specific Aims:
Specific Aims
- Develop a novel quantitative measure that comprehensively measures enacted stigma, perceived stigma, and self-stigma and concealment specific to adult DM patients
- Pilot the measure with 30-50 DM patients
- Validate the measure and determine if DM stigma is associated with obesity, diabetes type, insulin use, and/or is predictive of medication adherence
- Conditions
- Diabetes Mellitus
- Being tested
- Comprehensive Diabetes Stigma Survey
- Keywords
- Diabetes Mellitus, Stigma, Social Determinants of Health
- Medical subject headings
- Diabetes Mellitus, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Diabetes Stigma SurveyOther
The surveys to be administered in the ENDSTIGMA study are as follows:
- The Adherence to Refills and Medications for Diabetes survey is a validated, diabetes-specific survey measure utilizing patient self-report to assess diabetes medication adherence.
- The Demographics survey will be used to assess participant baseline characteristics, including body mass index (BMI). The questions contained in this survey have been validated by Dr. Kerri Cavanaugh's research group.
- Comprehensive Diabetes Stigma Survey is a novel survey being developed and validated in the ENDSTIGMA study. The ENDSTIGMA study will also compare the results from this survey with the medication adherence results, to determine if there is an association between diabetes stigma and medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Diabetes Stigma Survey | Participants in the END STIGMA study will be adult patients who have been receiving diabetes-related medical care for a minimum of 12 months in the Vanderbilt University Medical Center Diabetes Clinic and who take at least 1 medication to manage their diabetes. Receives: Other: Comprehensive Diabetes Stigma Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Stigma
The composite stigma score from the Comprehensive Diabetes Stigma Survey measure will be calculated from patient survey responses.
Measured: Baseline
Diabetes Medication Adherence
The composite diabetes medication adherence score will be calculated from patient responses to the Adherence to Refills and Medications Scale - Diabetes (ARMS-D) survey.
Measured: Baseline
Secondary outcomes (2)
Diabetes Patient Height (in Inches)
Self-Report of Diabetes Patient Height
Measured: Baseline
Diabetes Patient Weight (in Pounds)
Self-Report of Diabetes Patient Weight
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start8 Jul 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerri Cavanaugh, Vanderbilt University Medical Center
- Investigators
- Kerri Cavanaugh, MD/MHS, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828995
- Sponsor's protocol ID
- 160986
- Acronym
- ENDSTIGMA
- Status last verified
- Jan 2018
- First submitted
- 20 Jun 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
World Health Organization. Global report on diabetes. Geneva: World Health Organization, 2016.
Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta: U.S. Department of Health and Human Services, 2014.
Stolar M. Glycemic control and complications in type 2 diabetes mellitus. Am J Med. 2010 Mar;123(3 Suppl):S3-11. doi: 10.1016/j.amjmed.2009.12.004.
PubMed 20206730Egede LE, Gebregziabher M, Echols C, Lynch CP. Longitudinal effects of medication nonadherence on glycemic control. Ann Pharmacother. 2014 May;48(5):562-70. doi: 10.1177/1060028014526362. Epub 2014 Feb 28.
PubMed 24586059Kato A, Fujimaki Y, Fujimori S, Isogawa A, Onishi Y, Suzuki R, Yamauchi T, Ueki K, Kadowaki T, Hashimoto H. Association between self-stigma and self-care behaviors in patients with type 2 diabetes: a cross-sectional study. BMJ Open Diabetes Res Care. 2016 Jan 5;4(1):e000156. doi: 10.1136/bmjdrc-2015-000156. eCollection 2016.
PubMed 26835138Link BG, Phelan JC. Conceptualizing stigma. Annu Rev Sociol. 2001;27:363-85.
Laws MB. Explanatory Models and Illness Experience of People Living with HIV. AIDS Behav. 2016 Sep;20(9):2119-29. doi: 10.1007/s10461-016-1358-1.
PubMed 26971285Goldman JB, Maclean HM. The significance of identity in the adjustment to diabetes among insulin users. Diabetes Educ. 1998 Nov-Dec;24(6):741-8. doi: 10.1177/014572179802400610.
PubMed 10025297Abdoli S, Ashktorab T, Ahmadi F, Parvizy S, Dunning T. Seeking new identity through the empowerment process. Iran J Nurs Midwifery Res. 2014 Mar;19(2):145-51.
PubMed 24834083Mirowsky J, Ross CE. Social Causes of Psychological Distress. NY: Aldine de Gruyter; 1989.
Meyer IH. Prejudice, social stress, and mental health in lesbian, gay, and bisexual populations: conceptual issues and research evidence. Psychol Bull. 2003 Sep;129(5):674-697. doi: 10.1037/0033-2909.129.5.674.
PubMed 12956539Pearlin LI. The sociological study of stress. J Health Soc Behav. 1989 Sep;30(3):241-56.
PubMed 2674272Lick DJ, Durso LE, Johnson KL. Minority Stress and Physical Health Among Sexual Minorities. Perspect Psychol Sci. 2013 Sep;8(5):521-48. doi: 10.1177/1745691613497965.
PubMed 26173210Scambler G, Hopkins A. Being epileptic: Coming to terms with stigma. Sociol Health Illn. 1986;8:26-43.
Corrigan PW, Watson AC. The paradox of self-stigma and mental illness. Clin Psychol. 2002;9:35-53
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Influence of Diabetes Stigma on Medication Adherence
- ClinicalTrials.gov ID
- NCT02828995
- Acronym / sponsor ID
- ENDSTIGMA / 160986
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Stigma, Social Determinants of Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 8 Jul 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 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 "Evaluating the iNfluence of Diabetes STIGma on Medication Adherence: The ENDSTIGMA Study" was designed to develop a comprehensive diabetes stigma survey measure. The draft measure will be piloted with approximately 50 patients visiting the Vanderbilt University Medical Center (VUMC) Diabetes Clinic. This pilot data will be used to validate the new survey measure and to determine if any questions in the diabetes stigma measure are predictive of diabetes medication adherence.
Detailed description
Diabetes mellitus (DM) is a chronic condition affecting an estimated 422 million adults worldwide and 28.9 million adults in the US. DM can lead to increased risk of mortality and significant complications including amputation, blindness, cardiovascular disease, and kidney damage. The risk of developing these outcomes can be mediated by early diagnosis and treatment, such as by patient self-management by lifestyle changes and/or taking medication. However, outcome improvement depends on control of blood glucose levels, which in turn depend on adherence to treatment. Several psychosocial factors are known to affect treatment adherence for chronic conditions, one of which is stigma.
Stigma arises when social norms result in the marginalization of people with a certain identity or trait. Negative stereotypes of people in the stigmatized group result in their systematic exclusion and/or discrimination. Chronic disease diagnosis itself can lead to the development of disease-specific identity-based stigma, in that a person's identity is disrupted by a new label (e.g. "diabetic") applied to them, until they incorporate this new label into a positive sense of self. Minority stress theory describes the impact of identity-based marginalization on health outcomes. According to minority stress theory, discrimination and stigma may lead to heightened stress levels, which can translate over time into heightened mental and physical health disparities for the stigmatized group. Categories of stigma experienced by patients include enacted stigma, perceived stigma, self-stigma, and concealment. Enacted stigma refers to acts of discrimination against people in a stigmatized group. Perceived stigma refers both to the fear of experiencing enacted stigma, as well as to the shame resulting from belonging to or being associated with a stigmatized group. Self-stigma refers to the internalization of negative group stereotypes by members of the stigmatized group. Concealment, also called non-disclosure, refers to the hiding of a stigmatized identity or condition.
Stigma has been shown to negatively affect access to care as well as quality of life in people living with chronic diseases. Disease-specific stigma scales have been developed for various conditions, including mental illness, HIV/AIDS, epilepsy, and obesity. These scales have been used to facilitate interventions to minimize negative effects of stigma on health behaviors and outcomes. In comparison to other health conditions, diabetes stigma has only recently emerged as a research topic of interest.
DM has been reported to be a health condition that is relatively less stigmatized in comparison to other conditions. One publication suggested in its introduction that "diabetes does not appear to have associated stigma." As such, there have been publications comparing the degree of stigma experienced by DM patients with those with conditions such as schizophrenia, dementia, HIV, depression, and hypertension. However, numerous qualitative studies interviewing people with diabetes have revealed that DM patients do experience significant disease-related stigma.
In the literature, DM-related enacted stigma examples include workplace discrimination (decreased chance of being hired and increased chance of job loss); threatened or actual termination of romantic relationships; and judgmental behavior from healthcare professionals. Likewise, examples of perceived stigma include fear of being characterized as an illicit drug user when injecting insulin in public; and feelings of isolation when choosing to eat different foods, particularly in family and cultural situations. Self-stigma and concealment examples include avoidance of social events; timing self-management so it can be done in isolation; and altering blood glucose recordings, so as to appear "healthy."
Despite ample evidence of the existence of DM-specific stigma, limited attempts have been made to measure it. The Diabetes Distress Scale (DDS) was designed to measure "emotional burden, physician-related distress, regimen-related distress, and…interpersonal distress" associated with DM. However, the DDS does not comprehensively measure all the types of stigma minority stress theory has shown to contribute to chronic disease health disparities. The Barriers to Diabetes Adherence measure includes six questions about stigma, but the scope of these questions was limited and targeted towards an adolescent population with Type 1 DM. A limited number of previous publications have adapted disease-specific stigma scales from other conditions or developed their own questionnaires for said conditions for their diabetes stigma research needs. To date, only one publication has developed and validated a stigma scale specifically for DM patients, and this measure only addressed self-stigma. Therefore, to our knowledge, there is currently no scale that measures multiple facets of DM-specific stigma that may be contributing to sub-optimal patient diabetes self-management. Given the relationship between stigma, treatment adherence, and adverse health outcomes for chronic disease patients, development of a comprehensive DM stigma scale may lead to improvements in DM patient centered care, which will be addressed by the following Specific Aims:
Specific Aims
- Develop a novel quantitative measure that comprehensively measures enacted stigma, perceived stigma, and self-stigma and concealment specific to adult DM patients
- Pilot the measure with 30-50 DM patients
- Validate the measure and determine if DM stigma is associated with obesity, diabetes type, insulin use, and/or is predictive of medication adherence
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Diabetes Stigma Survey | – | Other: Comprehensive Diabetes Stigma SurveyParticipants in the END STIGMA study will be adult patients who have been receiving diabetes-related medical care for a minimum of 12 months in the Vanderbilt University Medical Center Diabetes Clinic and who take at least 1 medication to manage their diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be adult patients with an established diagnosis of diabetes and who are taking at least 1 medication to manage their diabetes.
Key inclusion criteria (3 listed)
- 18 years of age or older
- Type I or II DM for at least 1 year
- Taking at least 1 medication to manage diabetes
Key exclusion criteria (2 listed)
- Under 18 years of age
- Non-English speaking
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 |
|---|---|---|
| Comprehensive Diabetes Stigma SurveyThe surveys to be administered in the ENDSTIGMA study are as follows: 1. The Adherence to Refills and Medications for Diabetes survey is a validated, diabetes-specific survey measure utilizing patient self-report to assess diabetes medication adherence. 2. The Demographics survey will be used to assess participant baseline characteristics, including body mass index (BMI). The questions contained in this survey have been validated by Dr. Kerri Cavanaugh's research group. 3. Comprehensive Diabetes Stigma Survey is a novel survey being developed and validated in the ENDSTIGMA study. The ENDSTIGMA study will also compare the results from this survey with the medication adherence results, to determine if there is an association between diabetes stigma and medication adherence. | Other | Comprehensive Diabetes Stigma Survey |
Primary outcome
Diabetes Stigma
Time frame: Baseline
The composite stigma score from the Comprehensive Diabetes Stigma Survey measure will be calculated from patient survey responses.
Diabetes Medication Adherence
Time frame: Baseline
The composite diabetes medication adherence score will be calculated from patient responses to the Adherence to Refills and Medications Scale - Diabetes (ARMS-D) survey.
2 secondary outcomes
Diabetes Patient Height (in Inches)
Time frame: Baseline
Diabetes Patient Weight (in Pounds)
Time frame: Baseline
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 25 Jan 2018.
- BackgroundWorld Health Organization. Global report on diabetes. Geneva: World Health Organization, 2016.
- BackgroundCenters for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta: U.S. Department of Health and Human Services, 2014.
- Background: PubMed 20206730Stolar M. Glycemic control and complications in type 2 diabetes mellitus. Am J Med. 2010 Mar;123(3 Suppl):S3-11. doi: 10.1016/j.amjmed.2009.12.004.
- Background: PubMed 24586059Egede LE, Gebregziabher M, Echols C, Lynch CP. Longitudinal effects of medication nonadherence on glycemic control. Ann Pharmacother. 2014 May;48(5):562-70. doi: 10.1177/1060028014526362. Epub 2014 Feb 28.
- Background: PubMed 26835138Kato A, Fujimaki Y, Fujimori S, Isogawa A, Onishi Y, Suzuki R, Yamauchi T, Ueki K, Kadowaki T, Hashimoto H. Association between self-stigma and self-care behaviors in patients with type 2 diabetes: a cross-sectional study. BMJ Open Diabetes Res Care. 2016 Jan 5;4(1):e000156. doi: 10.1136/bmjdrc-2015-000156. eCollection 2016.
- BackgroundLink BG, Phelan JC. Conceptualizing stigma. Annu Rev Sociol. 2001;27:363-85.
- Background: PubMed 26971285Laws MB. Explanatory Models and Illness Experience of People Living with HIV. AIDS Behav. 2016 Sep;20(9):2119-29. doi: 10.1007/s10461-016-1358-1.
- Background: PubMed 10025297Goldman JB, Maclean HM. The significance of identity in the adjustment to diabetes among insulin users. Diabetes Educ. 1998 Nov-Dec;24(6):741-8. doi: 10.1177/014572179802400610.
- Background: PubMed 24834083Abdoli S, Ashktorab T, Ahmadi F, Parvizy S, Dunning T. Seeking new identity through the empowerment process. Iran J Nurs Midwifery Res. 2014 Mar;19(2):145-51.
- BackgroundMirowsky J, Ross CE. Social Causes of Psychological Distress. NY: Aldine de Gruyter; 1989.
- Background: PubMed 12956539Meyer IH. Prejudice, social stress, and mental health in lesbian, gay, and bisexual populations: conceptual issues and research evidence. Psychol Bull. 2003 Sep;129(5):674-697. doi: 10.1037/0033-2909.129.5.674.
- Background: PubMed 2674272Pearlin LI. The sociological study of stress. J Health Soc Behav. 1989 Sep;30(3):241-56.
- Individual participant dataSharing planned: No
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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.
Kerri Cavanaugh, MD/MHS principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Vanderbilt University Medical Center 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 3 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 25 Jan 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?
Diabetes Stigma (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT02828995, which also lists 39 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 25 Jan 2018.