Sickle Cell DiseaseSSQNCT03488264
Stigma, Self-management, & Quality of Life in SCD
An observational study of Sickle Cell Disease and Quality of Life, run by Duke University at 2 sites in 2 countries.
Trial summary
Many individuals with sickle cell disease experience both a poor quality of life and stigma. Individuals with SCD often experience high levels of stigma which can be a barrier to good self-management and hinder quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease, Quality of Life, Stigma, Social
- How many people
- 102 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Feb 2018to 27 Oct 2018
- 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: Adults with sickle cell disease in the United States and Jamaica
Who may be able to join
- at least 18 years of age,
- ability to understand English,
- diagnosis of SCD based on one of the following genotypes (ICD-10-CM code): HbSS (D57.0-D57.02), HbSC (D57.2-57.21), Hb SS/Bthalassemia+ or Hb SS/a-thalassemia- (D57.1, D57.4-D57.41, D57.8-D57.819).
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Jamaica1 site
Sickle Cell Unit, The University of the West Indies
Mona, Kingston 7
About this study
Official title: Understanding the Intersection of Stigma and Self-Management of Sickle Cell Disease
Many individuals with sickle cell disease experience both a poor quality of life and stigma. Individuals with SCD often experience high levels of stigma which can be a barrier to good self-management and hinder quality of life. The purpose of this research is to improve understanding of the relationships between stigma, self-management, and quality of life in SCD in the United States and Jamaica. The findings from this project will contribute to the development of a tool to measure self-management strategies and will also guide the development of interventions to improve SCD self-management.
Read the detailed description
The goal of the proposed study is to explore the complex relationships between perceived stigma, demographic and clinical characteristics, sickle cell disease (SCD) self-management strategies, and quality of life (QoL) in adults with SCD in the United States (US) and Jamaica, countries with important differences relevant to this study. Proposed is a cross sectional study that will use a convergent parallel mixed methods design (individual interviews and self-report surveys). Participants will be interviewed about SCD self-management strategies and how sources of stigma influence these strategies. Quantitative measures will be used to assess perceived stigma [SCD Health-Related Stigma Scale (SCD-HRSS)] and QoL [Adult Sickle Cell Quality of Life Measures (ASCQ-Me): emotional impact, pain episodes, pain impact, sleep impact, social functioning impact, and stiffness impact; disease severity]. The primary outcome of the study is stigma and the secondary outcome is QoL(emotional impact, pain episodes, pain impact, sleep impact, social functioning impact, and stiffness impact; disease severity).
The specific aims of this study are to:
Aim 1: Determine the influences of perceived stigma and demographic and clinical characteristics on SCD self-management and QoL in adults with SCD in the US and Jamaica.
Question 1: What are the influences of perceived stigma and demographic and clinical characteristics on SCD self-management? Question 2: What are the influences of perceived stigma and demographic and clinical characteristics on QoL? Aim 2: Describe the relationship between SCD self-management strategies and QoL.
- Medical subject headings
- Anemia, Sickle Cell, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| United States | 50 participants will be recruited from the United States. | |
| Jamaica | 50 participants will be recruited from Jamaica. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Stigma
The Sickle Cell Disease Health-Related Stigma Scale (SCD-HRSS) will assess stigma. SCD-HRSS has 4 subscales that measure stigma from the public, doctors, nurses, and family; and consists of 40 items on a 6 point Likert scale. It is scored by obtaining the sum of the mean score of the four subscales (subscales: 10-60; total scale: 40-240). Higher scores indicate higher perceived stigma.
Measured: 10 minutes
Disease-related Stigma
The Measure of Sickle Cell Stigma (MoSCS) will assess stigma. MoSCS consists of 11-items with 4 subscales assessing social exclusion, internalized stigma, disclosure concerns, and expected discrimination. It is measured on a 6 point Likert scale; scores range from 6-36 and are obtained by summing and averaging the total scale. Higher scores indicate higher perceived stigma.
Measured: 5 minutes
Secondary outcomes (8)
Quality of life
Quality of life will be measured using Adult Sickle Cell Quality of life Measures (ASCQ-Me) subscales for emotional impact, pain episodes, pain impact, sleep impact, social functioning impact, and stiffness impact. For pain episodes separate composite scores are calculated for pain frequency (0-11) and severity (0-22). Higher scores indicate worse health status. Raw scores for the remaining scales range 5-25 and are developed by using T-Score transformation to standardize raw scores to have a mean of 50 (indicates an average health score on the scale) and standard deviation of 10 (represents one SD). Higher scores indicate healthier status.
Measured: 14-21 minutes
Emotional impact
Score on the ASCQ-Me Emotional Impact - Raw scores for this scale ranges 5-25 and are developed by using T-Score transformation to standardize raw scores to have a mean of 50 (indicates an average health score on the scale) and standard deviation of 10 (represents one SD). Higher scores indicate healthier status.
Measured: 2-3 minutes
Pain episodes
Score on ASCQ-Me Pain episodes - For pain episodes separate composite scores are calculated for pain frequency (0-11) and severity (0-22). Higher scores indicate worse health status.
Measured: 2-3 minutes
Pain impact
Score on ASCQ-Me Pain impact - Raw scores for this scale ranges 5-25 and are developed by using T-Score transformation to standardize raw scores to have a mean of 50 (indicates an average health score on the scale) and standard deviation of 10 (represents one SD). Higher scores indicate healthier status.
Measured: 2-3 minutes
Sleep impact
Score on ASCQ-Me Sleep impact - Raw scores for this scale ranges 5-25 and are developed by using T-Score transformation to standardize raw scores to have a mean of 50 (indicates an average health score on the scale) and standard deviation of 10 (represents one SD). Higher scores indicate healthier status.
Measured: 2-3 minutes
Social functioning impact
Score on ASCQ-Me Social functioning impact - Raw scores for this scale ranges 5-25 and are developed by using T-Score transformation to standardize raw scores to have a mean of 50 (indicates an average health score on the scale) and standard deviation of 10 (represents one SD). Higher scores indicate healthier status.
Measured: 2-3 minutes
Stiffness impact
Score on the ASCQ-Me stiffness impact - Raw scores for this scale ranges 5-25 and are developed by using T-Score transformation to standardize raw scores to have a mean of 50 (indicates an average health score on the scale) and standard deviation of 10 (represents one SD). Higher scores indicate healthier status.
Measured: 2-3 minutes
Disease Severity
The ASCQ-Me Medical History Checklist (SCD-MHC) contains 9 items that list treatments and conditions associated with SCD (leg ulcers, avascular necrosis) that are scored dichotomously (0-9) with higher scores indicating higher disease severity.
Measured: 2-3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start13 Feb 2018
- Primary completion27 Oct 2018
- Study completion27 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Tanabe, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488264
- Sponsor's protocol ID
- Pro00084001
- Acronym
- SSQ
- Status last verified
- Mar 2019
- First submitted
- 29 Mar 2018
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Intersection of Stigma and Self-Management of Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT03488264
- Acronym / sponsor ID
- SSQ / Pro00084001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 27 Oct 2018 (actual)
- Study completion
- 27 Oct 2018 (actual)
- First posted
- 4 Apr 2018 (actual)
- 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.
Many individuals with sickle cell disease experience both a poor quality of life and stigma. Individuals with SCD often experience high levels of stigma which can be a barrier to good self-management and hinder quality of life. The purpose of this research is to improve understanding of the relationships between stigma, self-management, and quality of life in SCD in the United States and Jamaica. The findings from this project will contribute to the development of a tool to measure self-management strategies and will also guide the development of interventions to improve SCD self-management.
Detailed description
The goal of the proposed study is to explore the complex relationships between perceived stigma, demographic and clinical characteristics, sickle cell disease (SCD) self-management strategies, and quality of life (QoL) in adults with SCD in the United States (US) and Jamaica, countries with important differences relevant to this study. Proposed is a cross sectional study that will use a convergent parallel mixed methods design (individual interviews and self-report surveys). Participants will be interviewed about SCD self-management strategies and how sources of stigma influence these strategies. Quantitative measures will be used to assess perceived stigma [SCD Health-Related Stigma Scale (SCD-HRSS)] and QoL [Adult Sickle Cell Quality of Life Measures (ASCQ-Me): emotional impact, pain episodes, pain impact, sleep impact, social functioning impact, and stiffness impact; disease severity]. The primary outcome of the study is stigma and the secondary outcome is QoL(emotional impact, pain episodes, pain impact, sleep impact, social functioning impact, and stiffness impact; disease severity).
The specific aims of this study are to:
Aim 1: Determine the influences of perceived stigma and demographic and clinical characteristics on SCD self-management and QoL in adults with SCD in the US and Jamaica.
Question 1: What are the influences of perceived stigma and demographic and clinical characteristics on SCD self-management? Question 2: What are the influences of perceived stigma and demographic and clinical characteristics on QoL? Aim 2: Describe the relationship between SCD self-management strategies and QoL.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| United States | – | –50 participants will be recruited from the United States. |
| Jamaica | – | –50 participants will be recruited from Jamaica. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with sickle cell disease in the United States and Jamaica
Key inclusion criteria (3 listed)
- at least 18 years of age,
- ability to understand English,
- diagnosis of SCD based on one of the following genotypes (ICD-10-CM code): HbSS (D57.0-D57.02), HbSC (D57.2-57.21), Hb SS/Bthalassemia+ or Hb SS/a-thalassemia- (D57.1, D57.4-D57.41, D57.8-D57.819).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-Related Stigma
Time frame: 10 minutes
The Sickle Cell Disease Health-Related Stigma Scale (SCD-HRSS) will assess stigma. SCD-HRSS has 4 subscales that measure stigma from the public, doctors, nurses, and family; and consists of 40 items on a 6 point Likert scale. It is scored by obtaining the sum of the mean score of the four subscales (subscales: 10-60; total scale: 40-240). Higher scores indicate higher perceived stigma.
Disease-related Stigma
Time frame: 5 minutes
The Measure of Sickle Cell Stigma (MoSCS) will assess stigma. MoSCS consists of 11-items with 4 subscales assessing social exclusion, internalized stigma, disclosure concerns, and expected discrimination. It is measured on a 6 point Likert scale; scores range from 6-36 and are obtained by summing and averaging the total scale. Higher scores indicate higher perceived stigma.
8 secondary outcomes
Quality of life
Time frame: 14-21 minutes
Emotional impact
Time frame: 2-3 minutes
Pain episodes
Time frame: 2-3 minutes
Pain impact
Time frame: 2-3 minutes
Sleep impact
Time frame: 2-3 minutes
Social functioning impact
Time frame: 2-3 minutes
Stiffness impact
Time frame: 2-3 minutes
Disease Severity
Time frame: 2-3 minutes
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 11 Apr 2019.
- 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.
Paula Tanabe, PhD principal investigator
Duke University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Quality of Life, run by Duke University at 2 sites in 2 countries.
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 0 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 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Jamaica. 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?
Health-Related Stigma (time frame: 10 minutes). 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?
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 11 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.