Clinical trial NCT03488264: Stigma, Self-management, & Quality of Life in SCD
Official title: Understanding the Intersection of Stigma and Self-Management of Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Quality of Life
Stigma, Social
Disease Self-Management
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with sickle cell disease in the United States and Jamaica

Brief 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. 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Health-Related Stigma
timeFrame: 10 minutes
measure: Disease-related Stigma
timeFrame: 5 minutes
Secondary outcomes:
measure: Quality of life
timeFrame: 14-21 minutes
measure: Emotional impact
timeFrame: 2-3 minutes
measure: Pain episodes
timeFrame: 2-3 minutes
measure: Pain impact
timeFrame: 2-3 minutes
measure: Sleep impact
timeFrame: 2-3 minutes
measure: Social functioning impact
timeFrame: 2-3 minutes
measure: Stiffness impact
timeFrame: 2-3 minutes
measure: Disease Severity
timeFrame: 2-3 minutes
Other outcomes:
Locations:
city: Durham
country: United States
facility: Dominique Bulgin
state: North Carolina
city: Mona
country: Jamaica
facility: Sickle Cell Unit, The University of the West Indies
state: Kingston 7
Study officials:
affiliation: Duke University
name: Paula Tanabe, PhD
role: PRINCIPAL_INVESTIGATOR
References: