NCT04877054

Pilot Evaluation of a Motivational Interviewing Intervention Targeting Adherence Behaviors in Youth With Sickle Cell Disease

Completed NA Last updated 10 August 2022

What this trial tests

NA trial testing Adherence Treatment Program in Sickle Cell Disease in 16 participants. Completed in 1 August 2022.

Timeline

30 December 2021

Primary endpoint
30 June 2022

1 August 2022

Quick facts

Lead sponsor	Johns Hopkins All Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	30 December 2021
Primary completion	30 June 2022
Estimated completion	1 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Adherence Treatment Program
• Education only

Conditions studied

• Sickle Cell Disease — all drugs for Sickle Cell Disease →

Sponsor

Johns Hopkins All Children's Hospital

Who can join

13 and older, any sex, with Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sickle cell disease (SCD) is a group of inherited blood disorders affecting 100,000 individuals in the United States. SCD often leads to complications, including pain crises and organ damage. Many individuals with SCD require medications (e.g., Hydroxyurea or Endari) that research has demonstrated reduce risk of complications and improve quality of life. Despite the need for strong medication adherence, adolescents and young adults (AYAs; 13-25 years) have the lowest adherence rates compared to other age groups. Efforts to reduce AYA non-adherence risk should include youth in earlier childhood and persist throughout the AYA developmental period, with the goal of maintaining adherence throughout childhood and young adulthood. Motivational Interviewing (MI) has been effective in increasing pediatric and adult medication adherence via in-person or telehealth delivery; however, researchers have yet to empirically evaluate MI for feasibility, acceptability, and/or efficacy in improving pediatric/AYA SCD medication adherence. The proposed feasibility trial will provide preliminary feasibility data for a newly developed MI+education intervention targeting medication adherence for pediatric and adolescents and young adults (AYA) patients who have sickle cell disease. This trial will also evaluate study design feasibility to inform a future randomized controlled trial (RCT). The investigators are interested in delivering the intervention to AYA patients and to parents of younger children who have sickle cell disease because the investigators anticipate that establishing strong adherence in younger childhood could prevent future non-adherence during the AYA developmental period. Participants will include 13-22 year-old patients with sickle cell disease as well as parents of 0-22 year-old patients with sickle cell disease. The investigators will randomize ten families to a 4-session telehealth MI+education intervention and five families to a one-session education-only control condition. All participants will complete assessments at three times. Intervention participants will complete the T2 assessment at their last intervention session (week 4-8), and the T3 assessment 16-20 weeks after study enrollment. Education arm participants will complete T2 assessments 4-8 weeks after study enrollment and will complete T3 assessments 16-20 weeks after study enrollment. Primary outcomes include intervention feasibility and acceptability and study design feasibility.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions for improving adherence to iron chelation therapy in people with sickle cell disease or thalassaemia.
   Geneen LJ, Dorée C, Estcourt LJ. · · 2023 · cited 4× · PMID 36877640 · DOI 10.1002/14651858.cd012349.pub3