NCT02785848

Brief Summary

The investigators will explore barriers to improving self-efficacy, or the ability to feel in control of their disease, and medication adherence with text messaging through surveys and interviews with adolescents and adults with SCD cared for at the Vanderbilt Meharry Center of Excellence (VMCE) in Sickle Cell Disease (SCD). The investigators will identify preferences to improve and sustain adherence to daily medication through selection of investigator-proposed or patient-generated text messaging strategies. Finally, the investigators will fill in the literature gaps by describing barriers to self-efficacy and medication adherence among adults with SCD as well as adolescents with SCD who are transitioning to adult care.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
26mo left

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
May 2016Jul 2028

Study Start

First participant enrolled

May 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Expected
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

6 years

First QC Date

May 25, 2016

Last Update Submit

September 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients with barriers to medication adherence

    High cost, forgetting, side effects, access to medications

    1 year

Secondary Outcomes (1)

  • Number of patients that prefer a tailored text messaging technological solution

    1 year

Study Arms (1)

Asthma and/or Sickle Cell Anemia

The investigators will examine patients with sickle cell disease, asthma, or both who are aged 12-70 years who take daily medications.

Other: Interviews and Surveys

Interventions

The investigators will perform semi-structured interviews and surveys on this cohort

Asthma and/or Sickle Cell Anemia

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigators will assess barriers to self-efficacy and medication adherence in the adolescents and adults with sickle cell disease (SCD), asthma, or both, who take daily medications such as hydroxyurea, asthma, or both, have access to mobile phones and/or computers and receive care at the VUMC/Matthew Walker clinic.

You may qualify if:

  • Receiving care at the VUMC/Matthew Walker clinic
  • Diagnosed with SCD, asthma, or both
  • Currently taking daily medications for SCD, such as hydroxyurea, asthma, or both
  • Having access to a mobile telephone and/or computer
  • Age 12-70 years

You may not qualify if:

  • \. Unable to perform interviews or surveys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Robert Cronin, MD, MS

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 25, 2016

First Posted

May 30, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2022

Study Completion (Estimated)

July 1, 2028

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations