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NCT Number: NCT04877054

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

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adherence Treatment Program

Behavioral

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

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.

Primary outcomes

  1. Change in sickle cell disease medication adherence

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

    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).

  2. Intervention feasibility as assessed by the fidelity rating

    Time frame: Post intervention (weeks 4-8 after study enrollment)

    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.

  3. Intervention acceptability as assessed by the Abbreviated Acceptability Rating Profile

    Time frame: Post intervention (weeks 4-8 after study enrollment)

    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.

Secondary outcomes

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

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

    Knowledge of sickle cell disease recommendations, as evidenced by scores on the Sickle Cell Disease Knowledge Questionnaire. Scores range from 0-28, with higher scores indicate greater knowledge.

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

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

    Self-efficacy maintaining healthy lifestyle behaviors, as evidenced by scores on the Lifestyle Profile II. Total mean scores range from 1-4 with greater scores indicating greater self-efficacy.

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

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

    Perception of illness, as evidenced by scores on the Brief Illness Perception.Questionnaire, Total scores range from 8-10 with greater scores indicating stronger illness perception.

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

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

    Self-esteem, as evidenced by scores on the Rosenberg Self-Esteem Scale. Total scores range from 10-40, with greater scores indicating greater self-esteem.

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

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

    Depressive symptoms, as evidenced by scores on the PROMIS Pediatric Depressive Symptoms-Short Form or PROMIS Adult Depressive Symptoms-Short Form. Scores range from 1-40 with greater scores indicate greater depressive symptoms.

  6. Change in anxiety as assessed by the PROMIS Anxiety Symptoms- Short Form or PROMIS Adult Anxiety Symptoms Short Form

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

    PROMIS Pediatric Anxiety Symptoms- Short Form or PROMIS Adult Anxiety Symptoms Short Form. The adult anxiety scores range from 1-35 and the pediatric anxiety score range from 1-40 with greater scores indicate greater anxiety symptoms.

  7. 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)

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

    Health literacy scores, as evidenced by scores on the Health Literacy Skills Instrument- Short Form for adults (HLSI-10) or the Health Literacy Assessment Scale for Adolescents (HAS-A). The HLSI-10 scores range from 0-10 with higher scores indicating higher levels of health literacy. The HAS-A has 3 scales. Scores on the Communication subscale range from 0-20 with higher scores representing better interpersonal communication. Scores on the Confusion subscale range from 0-16 with higher scores representing more confusion. Scores on the functional health literacy scale range from 0-20 with higher scores indicating a lower ability to read health information and understand numbers.

Sponsors and collaborators

Lead sponsor

Johns Hopkins All Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 7, 2021
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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