Chronic DiseaseNCT03531866
Evaluation Study of Web-based Resource for Youth
A study testing DigiKnowIt News in people with Chronic Disease and Healthy, run by Innovation Research & Training at 1 site in United States.
Trial summary
This study will evaluate DigiKnowIt News, a web-based resource to educate youth about pediatric clinical research. Youth will be randomly assigned to one of three groups (1. Intervention Version A; 2) Intervention Version B; 3) Wait-list control). Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Healthy
- What is being tested?
- DigiKnowIt News
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2018to 17 Aug 2018
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Within the ages of 8 and 14 years of age
Who cannot join
- Does not speak English fluently, does not have access to a computer or tablet with internet connection, and or has participated in a clinical trial after kindergarten.
Trial locations and contacts
1 site in 1 country.
United States1 site
innovation Research & Training
Durham, North Carolina, 27713
About this study
Official title: Web-based Resource for Youth About Clinical Research
This study will evaluate DigiKnowIt News, a web-based resource to educate youth about pediatric clinical research. Youth will be randomly assigned to one of three groups (1. Intervention Version A; 2) Intervention Version B; 3) Wait-list control).
Read the detailed description
Compared to the high numbers of clinical trials with adults, there are far fewer clinical trials with children and adolescents; highlighting the need for more clinical trials with pediatric populations. Lacking in the area of pediatric clinical research are resources to educate children and adolescents about clinical research in fun, interactive, and developmentally appropriate ways. Thus, a web-based resource, DigiKnowIt News, was developed for youth aged 8 to 14 years to educate youth about participating in pediatric clinical trials. The web-based resource includes video spotlights, investigations, and electronic comic books. The purpose of this study is to conduct a randomized controlled trial to determine the effectiveness of the web-based resource and examine its impact on youths' knowledge about pediatric clinical trials, self-efficacy about making decisions about participation in clinical research, and positive attitudes towards participation.
- Conditions
- Chronic Disease, Healthy
- Being tested
- DigiKnowIt News
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigiKnowIt NewsBehavioural
DigiKnowIt News is an online, interactive, multimedia web-based resource designed to educate youth about participating in clinical trials. Youth will learn general information about clinical trials, their rights in a clinical trial, the good and not so good of participating in clinical trials, communication with others during a clinical trial, and specific types of procedures used in clinical trials (i.e., needles, scans). DigiKnowIt News is web-based and youth can complete it at home, on their own time.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Version A | Experimental | Youth will be asked to complete a version of DigiKnowIt News that includes investigations, comics, and spotlight videos that focus on four topic areas related to participating in clincial trials. Version A will include an additional topic area. Receives: Behavioral: DigiKnowIt News |
| Intervention Version B | Experimental | Youth will be asked to complete a version of DigiKnowIt News that includes investigations, comics, and spotlight videos that focus on four topic areas related to participating in clincial trials. Version B will include an additional topic area (different than in Version A). Receives: Behavioral: DigiKnowIt News |
| Wait-List Control | No intervention | Youth will not have access to DigiKnowIt News until after the post-test timepoint. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knowledge about Clinical Research
Questions will assess youth's factual knowledge about clinical research using a multiple choice format.
Measured: 2 weeks
Change in Attitudes toward Clinical Research
Questions will assess youth's attitudes toward pediatric clinical research on a 3-point Likert rating scale.
Measured: 2 weeks
Change in Self-Efficacy for Making Decisions
Questions will assess youth's self-efficacy for making decisions using a 5-point Likert scale.
Measured: 2 weeks
Secondary outcomes (4)
Changes in Initiative-Taking
Questions will assess youth's initiative-taking using a 5-point Likert scale.
Measured: 2 weeks
Changes in Hope
Questions will assess youth's perceptions of hope using a 6-point Likert scale.
Measured: 2 weeks
Changes in Parent-Child Communication
Questions will assess youth's perceptions about the quality of communication in their parent-child relationship using a 5-point Likert scale.
Measured: 2 weeks
Consumer Satisfaction
Questions will ask youth to reflect on their experiences with the web-based resource using 5-point Likert scales.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start24 May 2018
- Primary completion17 Aug 2018
- Study completion17 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovation Research & Training
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alison Parker, Innovation Research & Training
- Investigators
- Alison Parker, PhD, Principal investigator, Innovation Research & TrainingTracy Scull, PhD, Principal investigator, Innovation Research & Training
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531866
- Sponsor's protocol ID
- HHSN268201700010C
- Status last verified
- Apr 2019
- First submitted
- 7 May 2018
- Last updated
- 1 May 2019
- 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 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Resource for Youth About Clinical Research
- ClinicalTrials.gov ID
- NCT03531866
- Acronym / sponsor ID
- HHSN268201700010C
- Conditions
- Chronic Disease, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Innovation Research & TrainingUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 24 May 2018 (actual)
- Primary completion
- 17 Aug 2018 (actual)
- Study completion
- 17 Aug 2018 (actual)
- First posted
- 22 May 2018 (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.
This study will evaluate DigiKnowIt News, a web-based resource to educate youth about pediatric clinical research. Youth will be randomly assigned to one of three groups (1. Intervention Version A; 2) Intervention Version B; 3) Wait-list control).
Detailed description
Compared to the high numbers of clinical trials with adults, there are far fewer clinical trials with children and adolescents; highlighting the need for more clinical trials with pediatric populations. Lacking in the area of pediatric clinical research are resources to educate children and adolescents about clinical research in fun, interactive, and developmentally appropriate ways. Thus, a web-based resource, DigiKnowIt News, was developed for youth aged 8 to 14 years to educate youth about participating in pediatric clinical trials. The web-based resource includes video spotlights, investigations, and electronic comic books. The purpose of this study is to conduct a randomized controlled trial to determine the effectiveness of the web-based resource and examine its impact on youths' knowledge about pediatric clinical trials, self-efficacy about making decisions about participation in clinical research, and positive attitudes towards participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Version A | Experimental | Behavioral: DigiKnowIt NewsYouth will be asked to complete a version of DigiKnowIt News that includes investigations, comics, and spotlight videos that focus on four topic areas related to participating in clincial trials. Version A will include an additional topic area. |
| Intervention Version B | Experimental | Behavioral: DigiKnowIt NewsYouth will be asked to complete a version of DigiKnowIt News that includes investigations, comics, and spotlight videos that focus on four topic areas related to participating in clincial trials. Version B will include an additional topic area (different than in Version A). |
| Wait-List Control | No intervention | –Youth will not have access to DigiKnowIt News until after the post-test timepoint. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Within the ages of 8 and 14 years of age
Key exclusion criteria (1 listed)
- Does not speak English fluently, does not have access to a computer or tablet with internet connection, and or has participated in a clinical trial after kindergarten.
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 |
|---|---|---|
| DigiKnowIt NewsDigiKnowIt News is an online, interactive, multimedia web-based resource designed to educate youth about participating in clinical trials. Youth will learn general information about clinical trials, their rights in a clinical trial, the good and not so good of participating in clinical trials, communication with others during a clinical trial, and specific types of procedures used in clinical trials (i.e., needles, scans). DigiKnowIt News is web-based and youth can complete it at home, on their own time. | Behavioural | Intervention Version A, Intervention Version B |
Primary outcome
Change in Knowledge about Clinical Research
Time frame: 2 weeks
Questions will assess youth's factual knowledge about clinical research using a multiple choice format.
Change in Attitudes toward Clinical Research
Time frame: 2 weeks
Questions will assess youth's attitudes toward pediatric clinical research on a 3-point Likert rating scale.
Change in Self-Efficacy for Making Decisions
Time frame: 2 weeks
Questions will assess youth's self-efficacy for making decisions using a 5-point Likert scale.
4 secondary outcomes
Changes in Initiative-Taking
Time frame: 2 weeks
Changes in Hope
Time frame: 2 weeks
Changes in Parent-Child Communication
Time frame: 2 weeks
Consumer Satisfaction
Time frame: 1 day
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 1 May 2019.
- 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.
Alison Parker, PhD principal investigator
Innovation Research & Training
Tracy Scull, PhD principal investigator
Innovation Research & Training
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DigiKnowIt News in people with Chronic Disease and Healthy, run by Innovation Research & Training 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 1 inclusion and 1 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 1 May 2019. 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 Knowledge about Clinical Research (time frame: 2 weeks). 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 1 May 2019; AzTrials last refreshed its copy on 3 Nov 2026.