Stigma, Self-management, & Quality of Life in SCD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Understanding the Intersection of Stigma and Self-Management of Sickle Cell Disease

Conditions
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Sickle Cell Disease, Quality of Life, Stigma, Social, Disease Self-Management

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| United States<br>50 participants will be recruited from the United States. | |
| Jamaica<br>50 participants will be recruited from Jamaica. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 2-3 minutes |