Study Stopped
Poor enrollment
Efficacy of a Decision Aid for Hydroxyurea in Sickle Cell Disease
1 other identifier
interventional
2
1 country
3
Brief Summary
The trial is a prospective, randomized study to determine the efficacy of training for use of a web based Decision Aid for Hydroxyurea(HU) usage among subjects with Sickle Cell Disease(SCD). Subjects are randomized primarily either to using a web based decision aid with training versus without training. Subjects in each group will be further randomized to 1) subjects receiving pretest surveys; and 2) subjects that do not receive pretest surveys.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2018
CompletedFirst Posted
Study publicly available on registry
July 5, 2018
CompletedStudy Start
First participant enrolled
August 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2019
CompletedJuly 23, 2019
July 1, 2019
11 months
June 28, 2018
July 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Knowledge Survey score to estimate the impact of use of the Decision Aid with training versus without training in improving knowledge regarding HydroxyUrea for Sickle Cell Disease
Subjects knowledge will be tested by using a knowledge Survey that was given at baseline and at 4 weeks follow up phone call. It is a 27 True, False or Unsure questionnaire that tests subjects knowledge of understanding risk for severe lung disease (pulmonary hypertension). This test is administered to both groups that are in turn randomized to to receive the pretest AND posttest or just the posttest surveys.
Baseline and 4 week follow up
Secondary Outcomes (3)
Change in decisional conflict scale to estimate the impact of use of the Decision Aid with training versus without training aid on decisional conflict
Baseline and 4 week follow up
Change in decision self efficacy scale to estimate the impact of use of the Decision Aid with training versus without training aid on decisional conflict
Baseline and 4 week follow up
Change in Preparation for Decision Making Scale to estimate the impact of use of the Decision Aid with training versus without training aid on decisional conflict
Baseline and 4 week follow up
Study Arms (2)
Training for use of web based Decision Aid
EXPERIMENTALSubjects will be provided access to the decision aid website and will receive a log-in identification, user password and url at time of consent and will be guided during a 30 minutes training session to use the website. They will ben be asked to continue to peruse the website at home to learn more about hydroxyurea. Participants in each group will be further randomized to 1) pretest surveys and posttest surveys; and 2)only posttest surveys
No training for use of web based Decision Aid
PLACEBO COMPARATORSubjects will receive a log-in identification, user password and url at time of scheduled appointment for web access. They will not receive training but will be instructed to maneuver through the website and access the information pertaining to hydroxyurea and access the videos for the purposes of learning. Participants will be asked to peruse the website for 30 minutes at time of consent then to continue to access the website at home to learn about hydroxyurea treatment. Participants in each group will be further randomized to 1) pretest surveys and posttest surveys; and 2)only posttest surveys
Interventions
Subjects will be guided during a 30 minutes training session to use the website
Subjects will not be guided during a 30 minutes training session to use the website
Subjects will be randomized to one of two groups initially: Those who do not receive training for the decision aid and those who are trained to navigate the decision aid. subjects in each group will be randomized to complete pre test and posttest surveys or only posttest surveys that will take 15 mts of time
Subjects will be randomized to one of two groups initially: Those who do not receive training for the decision aid and those who are trained to navigate the decision aid. subjects in each group will be randomized to complete pretest and posttest surveys or only posttest surveys.
Eligibility Criteria
You may qualify if:
- Individuals with sickle cell disease ages 18 to 80 years, inclusive Or parents of children (ages 9 months to \<18 years) whose child has not started Hydroxyurea
- Patients who have made a past decision to not obtain treatment with Hydroxyurea or who have not obtained treatment with Hydroxyurea in past 12 months. Or parents of children who have made a past decision to not obtain treatment with Hydroxyurea or who have not obtained treatment with Hydroxyurea in the past 12 months.
- Patients or parents of children who's doctor identifies the patient/child as someone who should be on Hydroxyurea
- All participants will be able to comprehend English
- Subjects will have access to the internet from iPad, smart phone, or personal computer
- For the cognitive interviews participants will not be eligible to consider hydroxyurea as a treatment option
You may not qualify if:
- Patient who has already made a decision to begin and has started Hydroxyurea. Or parent who has already made a decision for their child to begin and the child has started Hydroxyurea.
- Participated in prior Decision Aid study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (3)
Grady Health System
Atlanta, Georgia, 30303, United States
Hughes Spalding Children's Hospital
Atlanta, Georgia, 30303, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lakshmanan Krishnamurti, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 28, 2018
First Posted
July 5, 2018
Study Start
August 3, 2018
Primary Completion
July 3, 2019
Study Completion
July 3, 2019
Last Updated
July 23, 2019
Record last verified: 2019-07