Clinical trial NCT04877054: Pilot Evaluation of a Motivational Interviewing Intervention Targeting Adherence Behaviors in Youth With Sickle Cell Disease
Official title: Pilot Evaluation of a Telehealth Motivational Interviewing Intervention Targeting Adherence Behaviors in Youth With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: pediatric
sickle cell disease
adherence
telehealth
motivational interviewing
Hydroxyurea
Lead sponsor: Johns Hopkins All Children's Hospital
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 16
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 2:1 to the intervention versus an education-only control condition
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Participants will include 13-22 year-old patients with sickle cell disease as well as primary caregivers of 0-22 year-old sickle cell disease patients ("parents"). The lower age limit for patients' participation in their own intervention sessions was selected based on previous studies documenting MI effectiveness with adolescents as young as 13 years of age. The upper limit was selected based on the recruitment site's (JHACH) patient population.
* Participants must be able to speak and understand spoken English because MI is language-dependent.
* The patient's SCD regimen must include at least one of the following medications: Hydroxyurea, Endari, Adakveo, or Oxbryta.
* Patients who meet inclusion criteria may participate even if their parent chooses not to do so, although 13-17 year old patients may only participate with parent consent. Likewise, parents of patients may participate even if the AYA declines their own participation, as long as the AYA assents/consents to medical chart review. Adult patients (18-22 years of age) will not require parent consent and may choose to participate with or without a parent.

Exclusion Criteria:

* Potential participants who appear to have cognitive, motor, or language delays, as observed by research personnel or documented in the medical record, will be excluded from this study if delays preclude informed consent and/or study completion. Participants may request that research personnel read all assessment, education, and intervention materials aloud in a structured interview format, in which case participants could respond to items verbally and/or by pointing to visual aids. Because of this option, participants' ability to read and write are not requirements for participation.
* Because the MI component of the intervention is language-dependent and requires significant time and training for certification in another language, non-English speaking patients will only be included in this study if the psychology postdoctoral fellow hired in this study is a native Spanish speaker and can demonstrate MI proficiency in Spanish.
* Participants who score in the clinically significant range (t-scores 2 standard deviations above the mean) on any of the PROMIS measures assessing depression and anxiety will be removed from the study and provided mental health resources.

Primary outcomes:
measure: Change in sickle cell disease medication adherence
timeFrame: Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
measure: Intervention feasibility as assessed by the fidelity rating
timeFrame: Post intervention (weeks 4-8 after study enrollment)
measure: Intervention acceptability as assessed by the Abbreviated Acceptability Rating Profile
timeFrame: Post intervention (weeks 4-8 after study enrollment)
Secondary outcomes:
measure: Change in sickle cell disease knowledge as assessed by the Sickle-Cell Disease Knowledge Questionnaire
timeFrame: Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
measure: Change in healthy lifestyle self-efficacy as assessed by the Adolescent Lifestyle Profile II
timeFrame: Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
measure: Change in illness perception as assessed by the Brief Illness Perception Questionnaire
timeFrame: Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
measure: Change in self-esteem as assessed by the Rosenberg Self-Esteem Scale
timeFrame: Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
measure: Change in depression as assessed by the PROMIS Pediatric Depressive Symptoms-Short Form or PROMIS Adult Depressive Symptoms-Short Form
timeFrame: Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
measure: Change in anxiety as assessed by the PROMIS Anxiety Symptoms- Short Form or PROMIS Adult Anxiety Symptoms Short Form
timeFrame: Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
measure: Change in health literacy as assessed by the Health Literacy Skills Instrument- Short Form for adults or the Health Literacy Assessment Scale for Adolescents (HAS-A)
timeFrame: Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
Study officials:
affiliation: Johns Hopkins All Children's Hospital
name: Melissa Faith
role: PRINCIPAL_INVESTIGATOR
References: