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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03488264
Other study ID # Pro00084001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 13, 2018
Est. completion date October 27, 2018

Study information

Verified date March 2019
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date October 27, 2018
Est. primary completion date October 27, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Jamaica Sickle Cell Unit, The University of the West Indies Mona Kingston 7
United States Dominique Bulgin Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Countries where clinical trial is conducted

United States,  Jamaica, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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