Sickle Cell DiseaseNCT04877054
Pilot Evaluation of a Motivational Interviewing Intervention Targeting Adherence Behaviors in Youth With Sickle Cell Disease
A study testing Adherence Treatment Program and Education only in people with Sickle Cell Disease, run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Adherence Treatment Program and Education only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: Pilot Evaluation of a Telehealth 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Adherence Treatment Program, Education only
- Keywords
- pediatric, sickle cell disease, adherence, telehealth, motivational interviewing, Hydroxyurea
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence Treatment ProgramBehavioural
4 telehealth sessions including a combination of psycho/medical education plus a motivational interviewing component.
Education onlyBehavioural
The control group will receive an education-only session. Education will include medication purpose and adherence strategy recommendations delivered in a single telehealth session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Education only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
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.
Measured: Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
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.
Measured: Baseline, post intervention (weeks 4-8 after study enrollment), and 16-20 weeks after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start30 Dec 2021
- Primary completion30 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 2:1 to the intervention versus an education-only control condition
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Faith, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877054
- Sponsor's protocol ID
- IRB00285183
- Status last verified
- Aug 2022
- First submitted
- 23 Apr 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of a Telehealth Motivational Interviewing Intervention Targeting Adherence Behaviors in Youth With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT04877054
- Acronym / sponsor ID
- IRB00285183
- Conditions
- Sickle Cell Disease
- Keywords
- pediatric, sickle cell disease, adherence, telehealth, motivational interviewing, Hydroxyurea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 2:1 to the intervention versus an education-only control condition
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Adherence Treatment ProgramIntervention 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. |
| Education only Arm | Active comparator | Behavioral: Education onlyParticipants 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adherence Treatment Program4 telehealth sessions including a combination of psycho/medical education plus a motivational interviewing component. | Behavioural | Intervention Arm |
| Education onlyThe control group will receive an education-only session. Education will include medication purpose and adherence strategy recommendations delivered in a single telehealth session. | Behavioural | Education only Arm |
Primary outcome
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).
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.
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.
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Faith principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence Treatment Program and Education only in people with Sickle Cell Disease, run by Johns Hopkins All Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.