Adolescent Behavior, Health Knowledge, Attitudes, Practice, Hypertension
Conditions
Brief summary
The proposed study will develop, test, and collect implementation data on a youth-led hypertension (HTN) education intervention, which will act as an electronic tool to guide youth through learning and then teaching adults on how to achieve better HTN control. Adults with HTN and youth will be recruited for user-centered design sessions to provide input in the development of a youth-led HTN education digital badge. The investigators will then recruit adult emergency department (ED) patients with uncontrolled HTN (blood pressure (BP) ≥130/80 mm Hg) who know (friend or family member) a youth (14-24 years old) and the youth themselves for a RCT. The adult plus youth dyad will be randomized to either: 1) intervention arm- 6-week youth-led HTN education digital badge at home- or 2) control arm- 6-week youth job readiness digital badge at home. In addition to the primary study outcome of adult BP change 2-months post-intervention, the investigator will collect secondary outcomes of HTN knowledge and youth self-efficacy, as well as implementation metrics of intervention acceptability, feasibility, and fidelity. Due to challenges recruiting youth through adults in the ED, we will be adding a cohort to the study where we will recruit interested youth from New Brunswick Health Sciences Technology High School (NBHSTHS). Specific aims are: Aim 1: Create a youth-led HTN education digital badge by means of user-centered design methods and community engagement with adults with HTN and youth to obtain input on the contents of the digital badge prior to implementation. Aim 1a: The hypertension knowledge assessment being used in the study has not been used before on youth or Spanish-speaking populations, so the investigators will obtain feedback on the assessment from these groups. Aim 2: Evaluate the effectiveness of a youth-led HTN education digital badge intervention on the primary outcome of mean systolic BP and diastolic BP change in adults with uncontrolled HTN at 2-months post-intervention compared to the control group (for participants recruited from the ED). Additionally, evaluate change in HTN knowledge and youth self-efficacy. Aim 3: Evaluate the implementation process of the youth-led HTN education digital badge by collecting qualitative and quantitative data on acceptability, feasibility, and fidelity of the intervention by participants.
Detailed description
The proposed study will integrate user-centered design, community engagement, and implementation science, with a randomized controlled trial (RCT), to develop, test, and collect implementation data on a youth-led hypertension (HTN) education digital badge. The badge will act as an electronic tool to guide youth through learning and then teaching adults on how to achieve better HTN control. Adults with HTN and youth will be recruited for user-centered design sessions to provide input in the development of a youth-led HTN education digital badge. The investigators will then recruit adult emergency department (ED) patients with uncontrolled HTN (blood pressure (BP) ≥130/80 mm Hg) who know (friend or family member) a youth (14-24 years old) and the youth themselves for a RCT. The adult plus youth dyad will be randomized to either: 1) intervention arm- 6-week youth-led HTN education digital badge at home- or 2) control arm- 6-week youth job readiness digital badge at home. In addition to the primary study outcome of adult BP change 2-months post-intervention, the investigator will collect secondary outcomes of HTN knowledge and youth self-efficacy, as well as implementation metrics of intervention acceptability, feasibility, and fidelity. Due to challenges recruiting youth through adults in the ED, we will be adding a cohort to the study. For this new cohort of the study, we will recruit interested youth from New Brunswick Health Sciences Technology High School (NBHSTHS). Students will be asked to pair themselves with an adult (18+) (preference for adult who has been diagnosed with hypertension, but not mandatory) with an existing relationship with the student where it would be feasible to complete an online module together 1 hour per week for 6 weeks. The adult must be fluent in English or Spanish and the student must be able to speak the fluent language of the adult. We will evaluate the youth-led digital hypertension (HTN) education intervention- an electronic tool to guide youth through learning and then teaching and supporting adults on how to control hypertension (for adults with hypertension) and how to avoid it (for adults without hypertension). Outcomes of interest are HTN knowledge, confidence in HTN management, and health behavior changes in participants, which will be obtained through pre- and post- intervention assessments. We will also be exploring outcomes of participant acceptability, feasibility, and fidelity of the intervention. Specific aims are: Aim 1: Create a youth-led HTN education digital badge by means of user-centered design methods and community engagement with adults with HTN and youth to obtain input on the contents of the digital badge prior to implementation. Aim 1a: The hypertension knowledge assessment being used in the study has not been used before on youth or Spanish-speaking populations, so the investigators will obtain feedback on the assessment from these groups. Aim 2: Evaluate the effectiveness of a youth-led HTN education digital badge intervention on the primary outcome of mean systolic BP and diastolic BP change in adults with uncontrolled HTN at 2-months post-intervention compared to the control group (for participants recruited from the ED). Additionally, evaluate change in HTN knowledge and youth self-efficacy. Aim 3: Evaluate the implementation process of the youth-led HTN education digital badge by collecting qualitative and quantitative data on acceptability, feasibility, and fidelity of the intervention by participants.
Interventions
The intervention is a youth-led HTN education digital intervention, which will be comprised of a 6-week playlist of one module per week comprising the playlist. Youth will learn from the module and will teach the adult in their dyad about hypertension education in each week's themed module.
Sponsors
Study design
Intervention model description
Study transitioned from a randomized controlled trial to a single group study. The total participants enrolled in the trial include all aspects of the study (including qualitative focus groups and interviews).
Eligibility
Inclusion criteria
* Aim 1: Participants will be youth (15-18 years) and adults (18+ years old) with self-reported HTN diagnosis. * Aim 1a: Participants will be youth (15-18 years) and Spanish-speaking adults (18+ years old) with self-reported HTN diagnosis. * Aim 2: ED cohort: Eligible adult participants will be 18+ year old ED patients with a history of HTN and two high BP (≥ 130/80 mmHg) readings during their ED visit who know a 14-24 year old. The eligible youth participants (14-24- year-old) must have access to the internet or data plan and a smart phone or computer. School cohort: Youth Eligibility: Any interested student at New Brunswick Health Sciences Technology High School. Adult Eligibility: Adult (18+) (preference for adult who has been diagnosed with hypertension) with an existing relationship with the youth where it would be feasible to complete an online module together 1 hour per week for 6 weeks. Fluency in English or Spanish (youth must be able to speak fluent language). * Aim 3: Everyone who consented to the RCT will be asked to complete a questionnaire, regardless of whether they completed the digital badge. Interested participants from the intervention arm will be recruited for the in-depth interviews.
Exclusion criteria
* Aim 1: Age \<15 years, inability to speak fluently in English or Spanish * Aim 1a: Age \<15 years, inability to speak fluently in English or Spanish * Aims 2 and 3: ED cohort: Age \<14 years, inability to speak fluently in English or Spanish, no access to the internet or a data plan and a smart phone or computer. School cohort: People who cannot take part in the study are people who are not able to speak fluently in English or Spanish (youth and adult must be able to speak the same language), and youth with no access to the internet or a data plan and a smart phone or computer. * Aim 3 (interviews): Participants from the control arm will not be eligible for the in-depth interviews.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| School Cohort: Hypertension Knowledge (Youth and Adult) | At end of 6-week intervention, and 1 month post-6-week intervention | Using 21-question assessment adapted from Williams et al.'s 1998 hypertension knowledge tool. Results reported are the mean number of questions correct out of 21. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ED Cohort: Hypertension Knowledge (Youth and Adult) | Baseline and 1 week and 2 months post-intervention completion | Using assessment adapted from Williams et al.'s 1998 hypertension knowledge tool |
| ED Cohort: Youth Self-efficacy | Baseline and 1 week and 2 months post-intervention completion | Using a 3-item investigator-created assessment tool on confidence in managing high blood pressure |
| School Cohort: Youth Self-efficacy | At end of 6-week intervention and 1 month post-6-week intervention | To measure youth confidence helping an adult manage hypertension, investigators created a 3-item assessment from 1 (not at all confident) to 10 (totally confident), on confidence to 1) teach, 2) encourage, and 3) help an adult lower their BP. The outcome measure represents the mean for each of the three items. |
| School Cohort: Adult Blood Pressure Self-care | At end of 6-week intervention and 1 month post-6-week intervention | Mean using the 10-question Adult Blood Pressure Self-Care Scale (Peters & Templin, 2010), which states: In general, how often are the following statements true about you? on a scale of 1-Never to 7-Always for self-reported frequency of behaviors (e.g. diet, exercise) that control BP. (e.g.: I am eating a low-salt diet each day.) |
| ED Cohort: Adult Self-efficacy to Manage HTN | Baseline and 1 week and 2 months post-intervention completion | Using Adult Self-Efficacy to Manage Hypertension Scale (Warren-Findlow et al.) |
| School Cohort: Adult Self-efficacy to Manage HTN | At end of 6-week intervention and 1 month post-6-week intervention | Mean using the 5-question Adult Self-Efficacy to Manage Hypertension Scale (Warren-Findlow et al.) which asks about confidence in managing BP control behaviors on a scale of 1-not at all confident to 10-totally confident. |
| ED Cohort: Adult Blood Pressure Self-care | Baseline and 1 week and 2 months post-intervention completion | Using the Adult Blood Pressure Self-Care Scale (Warren-Findlow et al.) |
Other
| Measure | Time frame | Description |
|---|---|---|
| For ED Cohort: Blood Pressure Change | Baseline to 1 week and 2 months post-intervention completion | Change in systolic and diastolic adult blood pressure (in mm Hg) |
Countries
United States
Participant flow
Pre-assignment details
Due to recruitment challenges for the ED cohort, Aim 2 of the study was changed from recruitment in the ED to recruitment in a school. Hence, we only have data for the school cohort. Additionally, the number of participants represents both members of each dyad (adults and youth) combined.
Participants by arm
| Arm | Count |
|---|---|
| Aim 2: School Cohort The intervention is a youth-led HTN education digital intervention, which will be comprised of a 6-week playlist of one module per week comprising the playlist. Youth will learn from the module and will teach the adult in their dyad about hypertension education in each week's themed module.
Youth-Led Hypertension Education Digital Intervention: The intervention is a youth-led HTN education digital intervention, which will be comprised of a 6-week playlist of one module per week comprising the playlist. Youth will learn from the module and will teach the adult in their dyad about hypertension education in each week's themed module. | 34 |
| Aim 1 Participants To develop the youth-led HTN digital intervention, we conducted a formative study to determine acceptable and easily comprehensible ways to present hypertension information to adults with hypertension and optimal ways to engage youth to support adults on how to achieve better hypertension control. After creating an intervention prototype with 6 weekly self-guided hypertension online modules, we recruited 12 youth (adolescents, aged 15-18 years) for 3 focus groups and 10 adult ED patients with hypertension for individual online interviews to garner feedback on the prototype. After completing a brief questionnaire, participants were asked about experiences with hypertension, preferences for a hypertension education intervention, and acceptability, feasibility, obstacles, and solutions for intervention implementation with youth and adults. | 22 |
| Aim 2: ED Cohort We found little success recruiting participants through the emergency department. No participants completed the study and we shifted to recruitment through a local high school (see Aim 2: School Cohort). | 4 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 2 |
Baseline characteristics
| Characteristic | Aim 2: School Cohort | Total | Aim 2: ED Cohort | Aim 1 Participants |
|---|---|---|---|---|
| Adult- Blood Pressure Self-Care Scale | 3.8 units on a scale STANDARD_DEVIATION 1 | 3.9 units on a scale STANDARD_DEVIATION 0.9 | 4.6 units on a scale STANDARD_DEVIATION 0.4 | — |
| Adult Self-Efficacy to Manage Hypertension Scale | 6.2 units on a scale STANDARD_DEVIATION 3.1 | 6.1 units on a scale STANDARD_DEVIATION 3.4 | 5.8 units on a scale STANDARD_DEVIATION 4 | — |
| Age, Continuous Adults | 43.3 years STANDARD_DEVIATION 4.7 | 47.2 years STANDARD_DEVIATION 12.5 | 61.5 years STANDARD_DEVIATION 20.5 | 49.8 years STANDARD_DEVIATION 17 |
| Age, Continuous Youth | 15.5 years STANDARD_DEVIATION 1.1 | 15.9 years STANDARD_DEVIATION 1.6 | 20.0 years STANDARD_DEVIATION 4.2 | 15.9 years STANDARD_DEVIATION 0.8 |
| HTN Knowledge Adults | 12.3 questions correct out of 21 total STANDARD_DEVIATION 4 | 12.5 questions correct out of 21 total STANDARD_DEVIATION 4.3 | 14 questions correct out of 21 total STANDARD_DEVIATION 7.1 | — |
| HTN Knowledge Youth | 13.0 questions correct out of 21 total STANDARD_DEVIATION 3.2 | 13.2 questions correct out of 21 total STANDARD_DEVIATION 3.2 | 15 questions correct out of 21 total STANDARD_DEVIATION 2.8 | — |
| Race (NIH/OMB) Adults American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adults Asian | 1 Participants | 6 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Adults Black or African American | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Adults More than one race | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Adults Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adults Unknown or Not Reported | 11 Participants | 11 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adults White | 4 Participants | 8 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Youth American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Youth Asian | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Youth Black or African American | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Youth More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Youth Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Youth Unknown or Not Reported | 3 Participants | 9 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Youth White | 8 Participants | 12 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Adults Female | 13 Participants | 19 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Adults Male | 4 Participants | 10 Participants | 0 Participants | 6 Participants |
| Sex: Female, Male Youth Female | 17 Participants | 25 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Youth Male | 0 Participants | 6 Participants | 1 Participants | 5 Participants |
| Youth- Confidence in Managing High Blood Pressure Encourage an adult to lower their high BP. | 6.9 units on a scale STANDARD_DEVIATION 2.9 | 7.0 units on a scale STANDARD_DEVIATION 2.9 | 8 units on a scale STANDARD_DEVIATION 2.8 | — |
| Youth- Confidence in Managing High Blood Pressure Help an adult lower their BP. | 6.2 units on a scale STANDARD_DEVIATION 3.4 | 6.4 units on a scale STANDARD_DEVIATION 3.3 | 8 units on a scale STANDARD_DEVIATION 2.8 | — |
| Youth- Confidence in Managing High Blood Pressure Teach an adult how to lower their high BP. | 5.6 units on a scale STANDARD_DEVIATION 3.2 | 5.9 units on a scale STANDARD_DEVIATION 3.2 | 8 units on a scale STANDARD_DEVIATION 2.8 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
School Cohort: Hypertension Knowledge (Youth and Adult)
Using 21-question assessment adapted from Williams et al.'s 1998 hypertension knowledge tool. Results reported are the mean number of questions correct out of 21.
Time frame: At end of 6-week intervention, and 1 month post-6-week intervention
Population: High Blood Pressure Knowledge (# correct responses), Mean (SD), \[95% CI\]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Youth | School Cohort: Hypertension Knowledge (Youth and Adult) | At end of 6-week intervention | 17.5 number of questions correct out of 21 | Standard Deviation 1.5 |
| Youth | School Cohort: Hypertension Knowledge (Youth and Adult) | 1 month post-6-week intervention | 17.9 number of questions correct out of 21 | Standard Deviation 2.7 |
| Adults | School Cohort: Hypertension Knowledge (Youth and Adult) | At end of 6-week intervention | 17.6 number of questions correct out of 21 | Standard Deviation 1.7 |
| Adults | School Cohort: Hypertension Knowledge (Youth and Adult) | 1 month post-6-week intervention | 17.8 number of questions correct out of 21 | Standard Deviation 2.4 |
ED Cohort: Adult Blood Pressure Self-care
Using the Adult Blood Pressure Self-Care Scale (Warren-Findlow et al.)
Time frame: Baseline and 1 week and 2 months post-intervention completion
Population: Due to recruitment challenges for the ED cohort, the study was changed from recruitment in the ED to recruitment in a school. Hence, we only have data for the school cohort.~No participants enrolled in the ED cohort completed the study (1 dyad- 1 adult and 1 youth were lost to follow-up and 1 dyad- 1 adult and 1 youth discontinued the intervention). No outcome data were collected from the ED cohort.
ED Cohort: Adult Self-efficacy to Manage HTN
Using Adult Self-Efficacy to Manage Hypertension Scale (Warren-Findlow et al.)
Time frame: Baseline and 1 week and 2 months post-intervention completion
Population: Due to recruitment challenges for the ED cohort, the study was changed from recruitment in the ED to recruitment in a school. Hence, we only have data for the school cohort.~No participants enrolled in the ED cohort completed the study (1 dyad- 1 adult and 1 youth were lost to follow-up and 1 dyad- 1 adult and 1 youth discontinued the intervention). No outcome data were collected from the ED cohort.
ED Cohort: Hypertension Knowledge (Youth and Adult)
Using assessment adapted from Williams et al.'s 1998 hypertension knowledge tool
Time frame: Baseline and 1 week and 2 months post-intervention completion
Population: Due to recruitment challenges for the ED cohort, the study was changed from recruitment in the ED to recruitment in a school. Hence, we only have data for the school cohort.~No participants enrolled in the ED cohort completed the study (1 dyad- 1 adult and 1 youth were lost to follow-up and 1 dyad- 1 adult and 1 youth discontinued the intervention). No outcome data were collected from the ED cohort.
ED Cohort: Youth Self-efficacy
Using a 3-item investigator-created assessment tool on confidence in managing high blood pressure
Time frame: Baseline and 1 week and 2 months post-intervention completion
Population: Due to recruitment challenges for the ED cohort, the study was changed from recruitment in the ED to recruitment in a school. Hence, we only have data for the school cohort.~No participants enrolled in the ED cohort completed the study (1 dyad- 1 adult and 1 youth were lost to follow-up and 1 dyad- 1 adult and 1 youth discontinued the intervention). No outcome data were collected from the ED cohort.
School Cohort: Adult Blood Pressure Self-care
Mean using the 10-question Adult Blood Pressure Self-Care Scale (Peters & Templin, 2010), which states: In general, how often are the following statements true about you? on a scale of 1-Never to 7-Always for self-reported frequency of behaviors (e.g. diet, exercise) that control BP. (e.g.: I am eating a low-salt diet each day.)
Time frame: At end of 6-week intervention and 1 month post-6-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Youth | School Cohort: Adult Blood Pressure Self-care | 4.9 score on a scale | Standard Deviation 1.2 |
| Adults | School Cohort: Adult Blood Pressure Self-care | 5.2 score on a scale | Standard Deviation 0.9 |
School Cohort: Adult Self-efficacy to Manage HTN
Mean using the 5-question Adult Self-Efficacy to Manage Hypertension Scale (Warren-Findlow et al.) which asks about confidence in managing BP control behaviors on a scale of 1-not at all confident to 10-totally confident.
Time frame: At end of 6-week intervention and 1 month post-6-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Youth | School Cohort: Adult Self-efficacy to Manage HTN | 8.1 score on a scale | Standard Deviation 1.7 |
| Adults | School Cohort: Adult Self-efficacy to Manage HTN | 8.5 score on a scale | Standard Deviation 1.4 |
School Cohort: Youth Self-efficacy
To measure youth confidence helping an adult manage hypertension, investigators created a 3-item assessment from 1 (not at all confident) to 10 (totally confident), on confidence to 1) teach, 2) encourage, and 3) help an adult lower their BP. The outcome measure represents the mean for each of the three items.
Time frame: At end of 6-week intervention and 1 month post-6-week intervention
Population: Participants completed the assessment at post-intervention and 1-month post-intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Youth | School Cohort: Youth Self-efficacy | Teach an adult how to lower their BP. | 8.2 score on a scale | Standard Deviation 1.3 |
| Youth | School Cohort: Youth Self-efficacy | Encourage an adult to lower their high BP. | 8.9 score on a scale | Standard Deviation 1 |
| Youth | School Cohort: Youth Self-efficacy | Help an adult lower their BP. | 8.8 score on a scale | Standard Deviation 1.6 |
| Adults | School Cohort: Youth Self-efficacy | Teach an adult how to lower their BP. | 8.7 score on a scale | Standard Deviation 1.4 |
| Adults | School Cohort: Youth Self-efficacy | Encourage an adult to lower their high BP. | 9.0 score on a scale | Standard Deviation 1.2 |
| Adults | School Cohort: Youth Self-efficacy | Help an adult lower their BP. | 9.0 score on a scale | Standard Deviation 1.3 |
For ED Cohort: Blood Pressure Change
Change in systolic and diastolic adult blood pressure (in mm Hg)
Time frame: Baseline to 1 week and 2 months post-intervention completion
Population: Due to recruitment challenges for the ED cohort, the study was changed from recruitment in the ED to recruitment in a school. Hence, we only have data for the school cohort. No outcome data were collected from the ED cohort.