Stigma, Self-management, & Quality of Life in SCD (SSQ)

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Sickle Cell Disease; Stigma, Social; Disease 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 Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Jamaica
  • Kingston 7
    • Mona, Kingston 7, Jamaica
      • Sickle Cell Unit, The University of the West Indies
• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Dominique Bulgin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with sickle cell disease in the United States and Jamaica

Description

Inclusion Criteria:

1. at least 18 years of age,
2. ability to understand English,
3. 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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
United States; 50 participants will be recruited from the United States.
Jamaica; 50 participants will be recruited from Jamaica.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Paula Tanabe, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Actual): October 27, 2018
• Study Completion (Actual): October 27, 2018

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 4, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: Pro00084001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No