Type 1 DiabetesNCT01938807
Audio Health Engagement Analysis in Diabetes: The AHEAD Study
A study testing CareCoach mobile application to assist in diabetes management in people with Type 1 Diabetes, run by University of California, San Francisco.
Trial summary
Despite multidisciplinary care and advancements in therapeutics and technology, health outcomes remain suboptimal in pediatric diabetes centers world-wide. A major contributor to poor outcomes is suboptimal diabetes management in pediatric patients and their families. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- CareCoach mobile application to assist in diabetes management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to 29 Sep 2015
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- parent of a child with diagnosis of type 1 diabetes for at least one year
- parent of a child with type 1 diabetes between the ages of 7-12
- provide informed consent in English
- have access to the internet from home
Who cannot join
- no access to the internet
- shorter duration of type 1 diabetes than one year
About this study
Despite multidisciplinary care and advancements in therapeutics and technology, health outcomes remain suboptimal in pediatric diabetes centers world-wide. A major contributor to poor outcomes is suboptimal diabetes management in pediatric patients and their families. The premise of this research project is that patients and families do not have adequate resources to meet the level of diabetes management that translates to better outcomes. Therefore, we will give them a valuable tool to improve their overall management. The tool is CareCoach.
Research shows that enhancing communication and partnership among patients, parents, and providers is especially critical for optimal outcomes in pediatric diabetes. Communication gaps and conflict can complicate the already complex provider-patient interactions and daily management. We have therefore designed, refined, and made available to consumers a new mobile-based intervention, CareCoach, to improve communication; build trust among providers, patients and parents; and increase overall satisfaction with the quality of diabetes care. This web/mobile application is designed to help patients unobtrusively audio record their clinical encounters, track their medical consults and treatment plans, review information from past visits, create visit discussion guides, and track adherence to medication and dosing schedules. In addition, because mobile-based applications are inexpensive to administer, portable, and available at all times of day, CareCoach holds great promise for communication coaching and contributing to improved diabetes management.
We hypothesize that CareCoach will improve patient-parent-provider communications, build patient-parent-provider trust, and increase overall satisfaction with clinical interactions in a sample of children with type 1 diabetes and their parents. These improvements will lead to significant gains in diabetes management, setting the stage for optimal health outcomes. To test the effectiveness of CareCoach, we will conduct a randomized controlled trial comparing the CareCoach intervention to standard care in a sample of 60 children with type 1 diabetes and their parents.
- Conditions
- Type 1 Diabetes
- Being tested
- CareCoach mobile application to assist in diabetes management
- Keywords
- type 1 diabetes, parents, mobile application, diabetes management
- 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.
CareCoach mobile application to assist in diabetes managementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group receives the CareCoach mobile application Receives: Behavioral: CareCoach mobile application to assist in diabetes management |
| Control | Active comparator | The control group receives standard care. Receives: Behavioral: CareCoach mobile application to assist in diabetes management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Management
Measured: 6 months post-baseline
Secondary outcomes (1)
Hemoglobin A1c
Measured: 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startOct 2013
- Primary completion29 Sep 2015
- Study completion29 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Naranjo, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938807
- Sponsor's protocol ID
- UCSF 12-09213
- Status last verified
- Jan 2020
- First submitted
- 5 Sep 2013
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audio Health Engagement Analysis in Diabetes: The AHEAD Study
- ClinicalTrials.gov ID
- NCT01938807
- Acronym / sponsor ID
- UCSF 12-09213
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, parents, mobile application, diabetes management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 29 Sep 2015 (actual)
- Study completion
- 29 Sep 2015 (actual)
- First posted
- 10 Sep 2013 (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.
Despite multidisciplinary care and advancements in therapeutics and technology, health outcomes remain suboptimal in pediatric diabetes centers world-wide. A major contributor to poor outcomes is suboptimal diabetes management in pediatric patients and their families. The premise of this research project is that patients and families do not have adequate resources to meet the level of diabetes management that translates to better outcomes. Therefore, we will give them a valuable tool to improve their overall management. The tool is CareCoach.
Research shows that enhancing communication and partnership among patients, parents, and providers is especially critical for optimal outcomes in pediatric diabetes. Communication gaps and conflict can complicate the already complex provider-patient interactions and daily management. We have therefore designed, refined, and made available to consumers a new mobile-based intervention, CareCoach, to improve communication; build trust among providers, patients and parents; and increase overall satisfaction with the quality of diabetes care. This web/mobile application is designed to help patients unobtrusively audio record their clinical encounters, track their medical consults and treatment plans, review information from past visits, create visit discussion guides, and track adherence to medication and dosing schedules. In addition, because mobile-based applications are inexpensive to administer, portable, and available at all times of day, CareCoach holds great promise for communication coaching and contributing to improved diabetes management.
We hypothesize that CareCoach will improve patient-parent-provider communications, build patient-parent-provider trust, and increase overall satisfaction with clinical interactions in a sample of children with type 1 diabetes and their parents. These improvements will lead to significant gains in diabetes management, setting the stage for optimal health outcomes. To test the effectiveness of CareCoach, we will conduct a randomized controlled trial comparing the CareCoach intervention to standard care in a sample of 60 children with type 1 diabetes and their parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: CareCoach mobile application to assist in diabetes managementThe intervention group receives the CareCoach mobile application |
| Control | Active comparator | Behavioral: CareCoach mobile application to assist in diabetes managementThe control group receives standard care. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- parent of a child with diagnosis of type 1 diabetes for at least one year
- parent of a child with type 1 diabetes between the ages of 7-12
- provide informed consent in English
- have access to the internet from home
Key exclusion criteria (2 listed)
- no access to the internet
- shorter duration of type 1 diabetes than one year
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 |
|---|---|---|
| CareCoach mobile application to assist in diabetes management | Behavioural | Control, Intervention |
Primary outcome
Diabetes Management
Time frame: 6 months post-baseline
1 secondary outcome
Hemoglobin A1c
Time frame: 6 months post-baseline
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 27 Jan 2020.
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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.
Diana Naranjo, PhD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing CareCoach mobile application to assist in diabetes management in people with Type 1 Diabetes, run by University of California, San Francisco.
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 2 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Diabetes Management (time frame: 6 months post-baseline). 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 27 Jan 2020.