Type 1 DiabetesPhase 4SKYPENCT02274103
Skype for Youth With Poorly Controlled Diabetes
A Phase 4 study testing BFST in people with Type 1 Diabetes, run by Oregon Health and Science University.
Trial summary
Compared family-based skills training (aka, Behavioral Family Systems Therapy) to youth with poorly controlled type 1 diabetes and their parents either face-to-face or over SkypeTM. Examined the differential impact on the youth's adherence to the diabetes medical regimen and the youth's blood sugar control. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- BFST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Dec 2012
- Phase
- Phase 4
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth between the ages of 12 and 18 with type 1 diabetes characterized by an HbA1c value great than 9%
- Caregivers willing to participate
- Family members reading English at 5th grade level
- Willing to be randomized.
Who cannot join
- Youth with intellectual disability
- Parent or youth who doesn't speak English
About this study
Official title: Improving Health Through SkypeTM: Family-Based Intervention for Teens With Poorly Controlled Diabetes
Compared family-based skills training (aka, Behavioral Family Systems Therapy) to youth with poorly controlled type 1 diabetes and their parents either face-to-face or over SkypeTM. Examined the differential impact on the youth's adherence to the diabetes medical regimen and the youth's blood sugar control.
- Conditions
- Type 1 Diabetes
- Being tested
- BFST
- 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.
BFSTBehavioural
Family-based skills training.
| Study group | Role | What they receive |
|---|---|---|
| Clinic | Active comparator | BFST delivered to youth with poorly controlled diabetes and their families in the clinic, face-to-face. Receives: Behavioral: BFST |
| Skype | Active comparator | BFST delivered to youth with poorly controlled diabetes and their families using Skype. Receives: Behavioral: BFST |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1c values for both intervention groups improved from baseline to 3 months and from 3 months to 6 months.
Measured: Change from Baseline to 3 months and from 3 months to 6 months
Secondary outcomes (1)
Adherence to diabetes treatment using the Diabetes Self Management Profile (DSMP) (Harris et al, 2001).
DSMP scores for both intervention groups improved from baseline to 3 months and from 3 months to 6 months.
Measured: Change from Baseline to 3 months and from 3 months to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael A. Harris, PhD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274103
- Sponsor's protocol ID
- 6000
- Acronym
- SKYPE
- Status last verified
- Oct 2014
- First submitted
- 21 Oct 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Duke DC, Wagner DV, Ulrich J, Freeman KA, Harris MA. Videoconferencing for Teens With Diabetes: Family Matters. J Diabetes Sci Technol. 2016 Jun 28;10(4):816-23. doi: 10.1177/1932296816642577. Print 2016 Jul.
PubMed 27075708Harris MA, Freeman KA, Duke DC. Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. Diabetes Care. 2015 Aug;38(8):1427-34. doi: 10.2337/dc14-2469. Epub 2015 Jun 1.
PubMed 26033508Riley AR, Duke DC, Freeman KA, Hood KK, Harris MA. Depressive Symptoms in a Trial Behavioral Family Systems Therapy for Diabetes: A Post Hoc Analysis of Change. Diabetes Care. 2015 Aug;38(8):1435-40. doi: 10.2337/dc14-2519. Epub 2015 May 26.
PubMed 26015558
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Through SkypeTM: Family-Based Intervention for Teens With Poorly Controlled Diabetes
- ClinicalTrials.gov ID
- NCT02274103
- Acronym / sponsor ID
- SKYPE / 6000
- Conditions
- Type 1 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Oct 2014 (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.
Compared family-based skills training (aka, Behavioral Family Systems Therapy) to youth with poorly controlled type 1 diabetes and their parents either face-to-face or over SkypeTM. Examined the differential impact on the youth's adherence to the diabetes medical regimen and the youth's blood sugar control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic | Active comparator | Behavioral: BFSTBFST delivered to youth with poorly controlled diabetes and their families in the clinic, face-to-face. |
| Skype | Active comparator | Behavioral: BFSTBFST delivered to youth with poorly controlled diabetes and their families using Skype. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Youth between the ages of 12 and 18 with type 1 diabetes characterized by an HbA1c value great than 9%
- Caregivers willing to participate
- Family members reading English at 5th grade level
- Willing to be randomized.
Key exclusion criteria (2 listed)
- Youth with intellectual disability
- Parent or youth who doesn't speak English
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 |
|---|---|---|
| BFSTFamily-based skills training. | Behavioural | Clinic, Skype |
Primary outcome
HbA1c
Time frame: Change from Baseline to 3 months and from 3 months to 6 months
HbA1c values for both intervention groups improved from baseline to 3 months and from 3 months to 6 months.
1 secondary outcome
Adherence to diabetes treatment using the Diabetes Self Management Profile (DSMP) (Harris et al, 2001).
Time frame: Change from Baseline to 3 months and from 3 months to 6 months
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 24 Oct 2014.
- Derived from this study: PubMed 27075708Duke DC, Wagner DV, Ulrich J, Freeman KA, Harris MA. Videoconferencing for Teens With Diabetes: Family Matters. J Diabetes Sci Technol. 2016 Jun 28;10(4):816-23. doi: 10.1177/1932296816642577. Print 2016 Jul.
- Derived from this study: PubMed 26033508Harris MA, Freeman KA, Duke DC. Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. Diabetes Care. 2015 Aug;38(8):1427-34. doi: 10.2337/dc14-2469. Epub 2015 Jun 1.
- Derived from this study: PubMed 26015558Riley AR, Duke DC, Freeman KA, Hood KK, Harris MA. Depressive Symptoms in a Trial Behavioral Family Systems Therapy for Diabetes: A Post Hoc Analysis of Change. Diabetes Care. 2015 Aug;38(8):1435-40. doi: 10.2337/dc14-2519. Epub 2015 May 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BFST in people with Type 1 Diabetes, run by Oregon Health and Science University.
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 24 Oct 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
HbA1c (time frame: Change from Baseline to 3 months and from 3 months to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02274103, which also lists 3 linked publications.
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 24 Oct 2014.