Diabetes Mellitus, Type 1Phase 2OMMSNCT02861157
Mobile Technology & Online Tools to Track Adherence in Chronic Illness Patients
A Phase 2 study testing Planet T1D in people with Diabetes Mellitus, Type 1, run by 3-C Institute for Social Development at 1 site in United States.
Trial summary
The purpose of this project is to test the efficacy of Planet T1D, a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Planet T1D
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2015to 12 Sep 2016
- Phase
- Phase 2
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 1 Diabetes diagnosis
- Between Ages of 12-17 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
3-C Institute for Social Development
Durham, North Carolina, 27713
About this study
The purpose of this project is to test the efficacy of Planet T1D, a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops. Investigators will examine the effectiveness of the Planet T1D mobile app and website in improving treatment adherence, disease-related knowledge, transition readiness, condition management, and the psychological correlates of these variables in youth with type 1 diabetes.
Read the detailed description
Advances in medical treatment options over the past several decades have translated into substantially higher survival rates for those who suffer with chronic illness. Consequently, the prevalence of chronic illness has risen significantly in recent years, such that one out of every four youth in the United States currently lives with a chronic illness. The health and well-being of these youth is directly impacted by the degree to which they adhere to their treatment regimen. However, treatment regimens for chronic illness can be highly complex, making adherence problematic, particularly when combined with deficits in memory and executive functioning concomitant with many chronic illnesses. Adherence also tends to deteriorate over time; the youth's motivation or commitment to treatment may decline as symptoms improve or negative side effects occur. With low adherence comes worsening symptoms and significantly greater risk for serious medical complications and mortality in young adulthood. The costs associated with low adherence, such as the need for additional care, are also substantial both for the patient and society.
While a number of factors have been found to impact treatment adherence, risk for non-adherence-across varied forms of chronic illness-is markedly elevated when the youth lacks disease- and treatment-related knowledge and when parents provide little supervision for carrying out regimen tasks. With nearly 90% of youth with chronic illness expected to survive and therefore transition from pediatric care into adult-focused healthcare systems, it is critically important to empower youth to take ownership of their own healthcare. To do so, we need to provide accessible, affordable tools that can effectively increase patients' skills and knowledge for managing their illness and support on-going adherence to their treatment regimen.
The purpose of this project is to test the efficacy of Planet T1D, a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops. Investigators will examine the effectiveness of the Planet T1D mobile app and website in improving treatment adherence, disease-related knowledge, transition readiness, condition management, and the psychological correlates of these variables in youth with type 1 diabetes.
All participants will complete study measures at pre- and post-assessment time points. In total, participants will take part in this study for approximately 2 months from pre- to post-assessment. Families will be recruited to participate in either the treatment condition or the control group. Families in the treatment condition will receive the Planet T1D app and access to the associated website for the full duration of the study (2 months) between pre-test and post-test. Families in the control group will not receive access to the app and website, but instead will be asked to complete a series of online questionnaires at each of the two data collection time points (pre-test, post-test).
Investigators hypothesize that greater use (i.e., dosage) and prolonged use of Planet T1D and access to the associated website will: increase disease-related knowledge, treatment adherence, self-efficacy for management of type 1 diabetes, current type 1 diabetes self-management behaviors, readiness to transition to independent self-care, and perceived benefits of type 1 diabetes treatment, while also decreasing perceived barriers to type 1 diabetes treatment. Moreover, investigators believe that improvement of these outcomes through use of Planet T1D will result in more positive mental health outcomes for patients, including higher reported quality of life. Investigators expect that those in the treatment condition will have better outcomes than those in the control group on all of these measures at both midpoint and post-assessment time points. Finally, investigators expect all participants to report high usability, quality, and value of the Planet T1D mobile app and website and to positively rate their experience with Planet T1D.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Planet T1D
- Keywords
- Type 1 Diabetes, Adolescents, T1D
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planet T1DBehavioural
Planet T1D is a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops.
| Study group | Role | What they receive |
|---|---|---|
| TX Condition: Planet T1D Intervention | Experimental | Families participating in the TX condition will be asked to attend a one-hour orientation session, during which study expectations and tasks will be explained. Families will be asked to watch a short 2-minute study overview video that summarizes study requirements and expectations. Parents and their children will then have the opportunity to provide informed consent/assent prior to their participation in the study. Youth participants will then receive a mobile phone preloaded with the Planet T1D app and a brief orientation to the app and associated website. Participants in the TX condition will receive immediate access to the Planet T1D application and website following the orientation session and will have four months to freely use the application. The TX group will be provided with a mobile phone for the full 2-months of the study. Receives: Behavioral: Planet T1D |
| CO Condition: Treatment-As-Usual | No intervention | A national sample of type 1 diabetes participants will be recruited through a partnership with Medikidz Ltd. Because of the inability to meet with remotely located participants for orientation and distribution of phones, these participants will be assigned to the treatment-as-usual, online control (CO) condition. For recruitment of the online control group, youth and parents interested in participating will be asked to complete a brief eligibility survey. Participants in the treatment-as-usual CO condition will not receive access to the Planet T1D app and website but will receive email reminders to complete surveys online at each time point. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Type 1 Diabetes Disease
Both parent and adolescent participants will complete a consultant-created 25 item questionnaire to assess their knowledge of type 1 diabetes.
Measured: Collected at two time points: pre-test and 2 months later at study completion to measure change
Diabetes Management Questionnaire (DMQ)
Both adolescent and parent participants will complete a modified version of the Diabetes Management Questionnaire (DMQ; Mehta, Nansel, Volkening, Butler, Haynie and Laffel, 2015). This 20-item measure assesses treatment adherence behaviors to help regulate blood sugar.
Measured: Collected at two time points: pre-test and 2 months later at study completion to measure change
Perceived Treatment Benefits
Both adolescents and their parents will report on their perceptions of the benefits and barriers of adherence to the condition treatment regimen. This measure was adapted from the Beliefs about Dietary Compliance scale (BDCS; Bennett et al, 2001) and contains 9 items on both the parent and youth versions.
Measured: Collected at two time points: pre-test and 2 months later at study completion to measure change
STARx Transition Readiness Questionnaire
Adolescents will complete the STARx Transition Readiness Questionnaire. This 18-item measure assesses the extent to which youth are ready to transition to independent care and manage their health-related needs independently. Items assess adolescents' independence in scheduling doctor's appointments, remembering to take medication, finding answers to health-related questions, knowledge of their condition, and how easy/difficult these tasks are for the youth.
Measured: Collected at two time points: pre-test and 2 months later at study completion to measure change
Secondary outcomes (4)
Diabetes Self-Efficacy scale
Adolescents will complete the 8-item Diabetes Self-Efficacy scale (Lorig K, Ritter PL, Villa FJ, 2009). This measure assesses patients' self-confidence in managing their condition, including self-confidence in (a) managing the disease autonomously, (b) knowing how to handle diabetes-related problems, and (c) practicing dietary behaviors necessary for blood sugar control.
Measured: Collected at two time points: pre-test and 2 months later at study completion to measure changetest
Self-Management: Self-Efficacy for Managing Chronic Disease Scale
The measure is composed of the 6-item Self-Efficacy for Managing Chronic Disease scale (Ritter \& Lorig, 2015), assessing confidence in self-management ability.
Measured: Collected at two time points: pre-test and 2 months later at study completion to measure change
Self-Management: Partners in Health Scale
Partners in Health scale (Cordova et al. 2013), a 11 item measure assessing ability to observe and manage symptoms.
Measured: Collected at two time points: pre-test and 2 months later at study completion to measure change
Quality of Life
Adolescents will complete a subset of 19 items from the Kidney Disease and Quality of Life-Short Form (KDQOL-SF; Hays et al., 1997). Items were modified to be more general and applicable to any medical condition. These items comprise subscales that assess patients' symptoms, burden of condition in interfering with life, cognitive functioning, social support, and difficulty sleeping.
Measured: Collected at two time points: pre-test and 2 months later at study completion to measure change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start1 Jul 2015
- Primary completion12 Sep 2016
- Study completion12 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 3-C Institute for Social Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melanie Livet, PhD, Principal investigator, 3-C Institute for Social DevelopmentJaney McMillen, PhD, Principal investigator, 3-C Institute for Social Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861157
- Sponsor's protocol ID
- 2R44DP003101 Diabetes
- Other IDs
- 2R44DP003101
- Acronym
- OMMS
- Status last verified
- Jan 2017
- First submitted
- 1 Aug 2016
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Technology & Online Tools to Track Adherence in Chronic Illness Patients
- ClinicalTrials.gov ID
- NCT02861157
- Acronym / sponsor ID
- OMMS / 2R44DP003101 Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes, Adolescents, T1D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- 3-C Institute for Social DevelopmentIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 12 Sep 2016 (actual)
- Study completion
- 12 Sep 2016 (actual)
- First posted
- 10 Aug 2016 (estimated)
- 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.
The purpose of this project is to test the efficacy of Planet T1D, a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops. Investigators will examine the effectiveness of the Planet T1D mobile app and website in improving treatment adherence, disease-related knowledge, transition readiness, condition management, and the psychological correlates of these variables in youth with type 1 diabetes.
Detailed description
Advances in medical treatment options over the past several decades have translated into substantially higher survival rates for those who suffer with chronic illness. Consequently, the prevalence of chronic illness has risen significantly in recent years, such that one out of every four youth in the United States currently lives with a chronic illness. The health and well-being of these youth is directly impacted by the degree to which they adhere to their treatment regimen. However, treatment regimens for chronic illness can be highly complex, making adherence problematic, particularly when combined with deficits in memory and executive functioning concomitant with many chronic illnesses. Adherence also tends to deteriorate over time; the youth's motivation or commitment to treatment may decline as symptoms improve or negative side effects occur. With low adherence comes worsening symptoms and significantly greater risk for serious medical complications and mortality in young adulthood. The costs associated with low adherence, such as the need for additional care, are also substantial both for the patient and society.
While a number of factors have been found to impact treatment adherence, risk for non-adherence-across varied forms of chronic illness-is markedly elevated when the youth lacks disease- and treatment-related knowledge and when parents provide little supervision for carrying out regimen tasks. With nearly 90% of youth with chronic illness expected to survive and therefore transition from pediatric care into adult-focused healthcare systems, it is critically important to empower youth to take ownership of their own healthcare. To do so, we need to provide accessible, affordable tools that can effectively increase patients' skills and knowledge for managing their illness and support on-going adherence to their treatment regimen.
The purpose of this project is to test the efficacy of Planet T1D, a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops. Investigators will examine the effectiveness of the Planet T1D mobile app and website in improving treatment adherence, disease-related knowledge, transition readiness, condition management, and the psychological correlates of these variables in youth with type 1 diabetes.
All participants will complete study measures at pre- and post-assessment time points. In total, participants will take part in this study for approximately 2 months from pre- to post-assessment. Families will be recruited to participate in either the treatment condition or the control group. Families in the treatment condition will receive the Planet T1D app and access to the associated website for the full duration of the study (2 months) between pre-test and post-test. Families in the control group will not receive access to the app and website, but instead will be asked to complete a series of online questionnaires at each of the two data collection time points (pre-test, post-test).
Investigators hypothesize that greater use (i.e., dosage) and prolonged use of Planet T1D and access to the associated website will: increase disease-related knowledge, treatment adherence, self-efficacy for management of type 1 diabetes, current type 1 diabetes self-management behaviors, readiness to transition to independent self-care, and perceived benefits of type 1 diabetes treatment, while also decreasing perceived barriers to type 1 diabetes treatment. Moreover, investigators believe that improvement of these outcomes through use of Planet T1D will result in more positive mental health outcomes for patients, including higher reported quality of life. Investigators expect that those in the treatment condition will have better outcomes than those in the control group on all of these measures at both midpoint and post-assessment time points. Finally, investigators expect all participants to report high usability, quality, and value of the Planet T1D mobile app and website and to positively rate their experience with Planet T1D.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TX Condition: Planet T1D Intervention | Experimental | Behavioral: Planet T1DFamilies participating in the TX condition will be asked to attend a one-hour orientation session, during which study expectations and tasks will be explained. Families will be asked to watch a short 2-minute study overview video that summarizes study requirements and expectations. Parents and their children will then have the opportunity to provide informed consent/assent prior to their participation in the study. Youth participants will then receive a mobile phone preloaded with the Planet T1D app and a brief orientation to the app and associated website. Participants in the TX condition will receive immediate access to the Planet T1D application and website following the orientation session and will have four months to freely use the application. The TX group will be provided with a mobile phone for the full 2-months of the study. |
| CO Condition: Treatment-As-Usual | No intervention | –A national sample of type 1 diabetes participants will be recruited through a partnership with Medikidz Ltd. Because of the inability to meet with remotely located participants for orientation and distribution of phones, these participants will be assigned to the treatment-as-usual, online control (CO) condition. For recruitment of the online control group, youth and parents interested in participating will be asked to complete a brief eligibility survey. Participants in the treatment-as-usual CO condition will not receive access to the Planet T1D app and website but will receive email reminders to complete surveys online at each time point. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Type 1 Diabetes diagnosis
- Between Ages of 12-17 years old
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Planet T1DPlanet T1D is a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops. | Behavioural | TX Condition: Planet T1D Intervention |
Primary outcome
Knowledge of Type 1 Diabetes Disease
Time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change
Both parent and adolescent participants will complete a consultant-created 25 item questionnaire to assess their knowledge of type 1 diabetes.
Diabetes Management Questionnaire (DMQ)
Time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change
Both adolescent and parent participants will complete a modified version of the Diabetes Management Questionnaire (DMQ; Mehta, Nansel, Volkening, Butler, Haynie and Laffel, 2015). This 20-item measure assesses treatment adherence behaviors to help regulate blood sugar.
Perceived Treatment Benefits
Time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change
Both adolescents and their parents will report on their perceptions of the benefits and barriers of adherence to the condition treatment regimen. This measure was adapted from the Beliefs about Dietary Compliance scale (BDCS; Bennett et al, 2001) and contains 9 items on both the parent and youth versions.
STARx Transition Readiness Questionnaire
Time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change
Adolescents will complete the STARx Transition Readiness Questionnaire. This 18-item measure assesses the extent to which youth are ready to transition to independent care and manage their health-related needs independently. Items assess adolescents' independence in scheduling doctor's appointments, remembering to take medication, finding answers to health-related questions, knowledge of their condition, and how easy/difficult these tasks are for the youth.
4 secondary outcomes
Diabetes Self-Efficacy scale
Time frame: Collected at two time points: pre-test and 2 months later at study completion to measure changetest
Self-Management: Self-Efficacy for Managing Chronic Disease Scale
Time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change
Self-Management: Partners in Health Scale
Time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change
Quality of Life
Time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change
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 30 Jan 2017.
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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.
Melanie Livet, PhD principal investigator
3-C Institute for Social Development
Janey McMillen, PhD principal investigator
3-C Institute for Social Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Planet T1D in people with Diabetes Mellitus, Type 1, run by 3-C Institute for Social Development 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 2 inclusion and 0 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 30 Jan 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Knowledge of Type 1 Diabetes Disease (time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change). The study lists 4 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 30 Jan 2017.