Back to resultsPilot Evaluation of a Motivational Interviewing Intervention Targeting Adherence Behaviors in Youth With Sickle Cell Disease
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adherence Treatment Program
Education only
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring pediatric, sickle cell disease, adherence, telehealth, motivational interviewing, Hydroxyurea
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.
Sites / Locations
- Johns Hopkins All Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Arm
Education only Arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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.
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.
Secondary Outcome Measures
Change in sickle cell disease knowledge as assessed by the Sickle-Cell Disease Knowledge Questionnaire
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.
Change in healthy lifestyle self-efficacy as assessed by the Adolescent Lifestyle Profile II
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.
Change in illness perception as assessed by the Brief Illness Perception Questionnaire
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.
Change in self-esteem as assessed by the Rosenberg Self-Esteem Scale
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.
Change in depression as assessed by the PROMIS Pediatric Depressive Symptoms-Short Form or PROMIS Adult Depressive Symptoms-Short Form
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.
Change in anxiety as assessed by the PROMIS Anxiety Symptoms- Short Form or PROMIS Adult Anxiety Symptoms Short Form
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.
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)
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.
Full Information
NCT ID
NCT04877054
First Posted
April 23, 2021
Last Updated
August 9, 2022
Sponsor
Johns Hopkins All Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04877054
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 30, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins All Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
pediatric, sickle cell disease, adherence, telehealth, motivational interviewing, Hydroxyurea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized 2:1 to the intervention versus an education-only control condition
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Education only Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Adherence Treatment Program
Intervention Description
4 telehealth sessions including a combination of psycho/medical education plus a motivational interviewing component.
Intervention Type
Behavioral
Intervention Name(s)
Education only
Intervention Description
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 Outcome Measure Information:
Title
Change in sickle cell disease medication adherence
Description
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).
Time Frame
Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
Title
Intervention feasibility as assessed by the fidelity rating
Description
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.
Time Frame
Post intervention (weeks 4-8 after study enrollment)
Title
Intervention acceptability as assessed by the Abbreviated Acceptability Rating Profile
Description
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.
Time Frame
Post intervention (weeks 4-8 after study enrollment)
Secondary Outcome Measure Information:
Title
Change in sickle cell disease knowledge as assessed by the Sickle-Cell Disease Knowledge Questionnaire
Description
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.
Time Frame
Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
Title
Change in healthy lifestyle self-efficacy as assessed by the Adolescent Lifestyle Profile II
Description
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.
Time Frame
Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
Title
Change in illness perception as assessed by the Brief Illness Perception Questionnaire
Description
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.
Time Frame
Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
Title
Change in self-esteem as assessed by the Rosenberg Self-Esteem Scale
Description
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.
Time Frame
Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
Title
Change in depression as assessed by the PROMIS Pediatric Depressive Symptoms-Short Form or PROMIS Adult Depressive Symptoms-Short Form
Description
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.
Time Frame
Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
Title
Change in anxiety as assessed by the PROMIS Anxiety Symptoms- Short Form or PROMIS Adult Anxiety Symptoms Short Form
Description
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.
Time Frame
Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
Title
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)
Description
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.
Time Frame
Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Faith
Organizational Affiliation
Johns Hopkins All Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Evaluation of a Motivational Interviewing Intervention Targeting Adherence Behaviors in Youth With Sickle Cell Disease
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