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

NCT04877054 | Completed

• 1 other identifier: IRB00285183
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

pediatric; sickle cell disease; adherence; telehealth; motivational interviewing; Hydroxyurea

Outcome Measures

Primary Outcomes (3)

• Change in sickle cell disease medication adherence

  This questionnaire assesses participants' adherence to their sickle cell disease medication. The questionnaire is titled Sickle Cell Antibiotic Adherence Level Evaluation (SCAALE). Question items are scored in different directions depending on whether their wording reflects adherence or non-adherence. For each item, participants will rate each item on a Likert scale, such that the response indicating the 'best' adherence is scored one point and the response indicating the 'worst' adherence is scored five points. Possible subscale scores range from four points (most adherent) to 20 points (least adherent),and possible total scores range from 24 (most adherent) to 120 (least adherent).

  Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment

• Intervention feasibility as assessed by the fidelity rating

  Feasibility of conducting the intervention with high clinician fidelity, as evidenced by fidelity ratings for each session (fidelity represented as a percentage based on the extent to which the clinician covered all planned information for each session). Average intervention fidelity ratings should meet or exceed 80 percent fidelity.

  Post intervention (weeks 4-8 after study enrollment)

• Intervention acceptability as assessed by the Abbreviated Acceptability Rating Profile

  Patient and caregiver acceptability of the newly developed intervention, as evidenced by the Abbreviated Acceptability Rating Profile. Scores range from 8-48, with higher scores indicating greater acceptability. Scores equal to or greater than 30 indicate good acceptability per published standards.

  Post intervention (weeks 4-8 after study enrollment)

Secondary Outcomes (7)

• Change in sickle cell disease knowledge as assessed by the Sickle-Cell Disease Knowledge Questionnaire

  Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment

• Change in healthy lifestyle self-efficacy as assessed by the Adolescent Lifestyle Profile II

  Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment

• Change in illness perception as assessed by the Brief Illness Perception Questionnaire

  Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment

• Change in self-esteem as assessed by the Rosenberg Self-Esteem Scale

  Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment

• Change in depression as assessed by the PROMIS Pediatric Depressive Symptoms-Short Form or PROMIS Adult Depressive Symptoms-Short Form

  Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Intervention sessions will occur \~once per week, with all 4 sessions being completed within 4-8 weeks. Each session will include an education and motivational interviewing (MI) component.

Behavioral: Adherence Treatment Program

Education only Arm

ACTIVE COMPARATOR

Participants in the education-only control arm will receive one education session. The education session will occur via telephone or telehealth. Education will include medication purpose and adherence strategy recommendations delivered in a single telehealth session.

Behavioral: Education only

Interventions

Adherence Treatment Program BEHAVIORAL

4 telehealth sessions including a combination of psycho/medical education plus a motivational interviewing component.

Intervention Arm

Education only BEHAVIORAL

The control group will receive an education-only session. Education will include medication purpose and adherence strategy recommendations delivered in a single telehealth session.

Education only Arm

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Melissa Faith

  Johns Hopkins All Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 2:1 to the intervention versus an education-only control condition

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 7, 2021
• Study Start: December 30, 2021
• Primary Completion: June 30, 2022
• Study Completion: August 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)