Type 1 Diabetes MellitusNCT01782547
Telehealth Intervention for Youth With T1DM
A study testing Telehealth Intervention in people with Type 1 Diabetes Mellitus, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Hospitalization of youth with established diabetes is both costly and frequently preventable. Poor glycemic control is a risk factor for hospitalization and is also associated with adolescent age and lower socioeconomic status. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Telehealth Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to May 2014
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 13 to 17 years
- Type 1 diabetes for ≥1 year
- HbA1c>8%
- Able to speak and read English (Child)
- Able to speak and read English (Parent)
- Parent agrees to participate
- Parent and child each have email addresses
Who cannot join
- Plan to transition diabetes care to a center other than Boston Children's Hospital
- No visit to Boston Children's Hospital Diabetes Program in year prior to recruitment
- Current participation in another diabetes-related study with an intervention
- Living with or related to another study participant
- Significant psychopathology or medical illness that would limit the subject's ability to provide assent and/or participate in the study procedures as determined by the PI.
- No internet access
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Telehealth Intervention for Youth With Type 1 Diabetes
Hospitalization of youth with established diabetes is both costly and frequently preventable. Poor glycemic control is a risk factor for hospitalization and is also associated with adolescent age and lower socioeconomic status. This is a randomized, controlled trial for high-risk adolescent youth with T1DM and suboptimal glycemic control with an intervention arm and usual care control arm matched for frequency of contacts. There will be 110 subjects with T1DM and HbA1c>8%, aged 13 to 17 years, recruited from the Diabetes Program at Boston Children's Hospital and followed for 6 months. The intervention will be implemented by a diabetes nurse educator and social worker, who will each have monthly contact with the adolescent and a parent/guardian through a telehealth (videoconference) visit. Care will be guided by a diabetes action plan. Telehealth interventions have been utilized successfully in both adults and youth with diabetes. They facilitate frequent contact with the care team allowing barriers to adherence to be addressed, education to be reinforced, care plans to be updated, and diabetes-specific family support to be provided.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Telehealth Intervention, Usual Care
- Keywords
- diabetes mellitus, adolescents
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth InterventionBehavioural
Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan;
Usual CareOther
Standard diabetes care- typically a visit with a diabetes health care provider every 3 months and referrals to a dietitian or mental health specialist as deemed appropriate; Study participation reminder cards twice per month
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Intervention | Experimental | Telehealth intervention - 6 months Receives: Behavioral: Telehealth Intervention |
| Usual care | Active comparator | Usual care control with comparable frequency of contact Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c
Change in hemoglobin A1c over 6 months
Measured: baseline and 6 months
Secondary outcomes (7)
% patients meeting ADA HbA1c target
proportion of patients meeting the American Diabetes Association target for optimal glycemic control in this age group, which is <7.5%
Measured: At 6 months
Diabetes-related adverse events
number of diabetes-related hospitalizations, ED visits, and episodes of severe hypoglycemia
Measured: Up to 6 months
Change in Diabetes self-efficacy
change over 6 months assessed by questionnaire
Measured: Baseline and 6 months
Change in Adherence to diabetes self-management
change over 6 months assessed by questionnaire
Measured: Baseline and 6 months
Change in competence with diabetes skills
change over 6 months assessed by questionnaire
Measured: Baseline and 6 months
Change in Health related quality of life
change over 6 months assessed by questionnaire
Measured: Baseline and 6 months
Change in Diabetes Knowledge
Change over 6 months assessed by questionnaire
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erinn T. Rhodes, Boston Children's Hospital
- Investigators
- Erinn T Rhodes, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782547
- Sponsor's protocol ID
- P00006175
- Status last verified
- Aug 2016
- First submitted
- 28 Jan 2013
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Intervention for Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01782547
- Acronym / sponsor ID
- P00006175
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- diabetes mellitus, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 4 Feb 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.
Hospitalization of youth with established diabetes is both costly and frequently preventable. Poor glycemic control is a risk factor for hospitalization and is also associated with adolescent age and lower socioeconomic status. This is a randomized, controlled trial for high-risk adolescent youth with T1DM and suboptimal glycemic control with an intervention arm and usual care control arm matched for frequency of contacts. There will be 110 subjects with T1DM and HbA1c>8%, aged 13 to 17 years, recruited from the Diabetes Program at Boston Children's Hospital and followed for 6 months. The intervention will be implemented by a diabetes nurse educator and social worker, who will each have monthly contact with the adolescent and a parent/guardian through a telehealth (videoconference) visit. Care will be guided by a diabetes action plan. Telehealth interventions have been utilized successfully in both adults and youth with diabetes. They facilitate frequent contact with the care team allowing barriers to adherence to be addressed, education to be reinforced, care plans to be updated, and diabetes-specific family support to be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth Intervention | Experimental | Behavioral: Telehealth InterventionTelehealth intervention - 6 months |
| Usual care | Active comparator | Other: Usual CareUsual care control with comparable frequency of contact |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 13 to 17 years
- Type 1 diabetes for ≥1 year
- HbA1c>8%
- Able to speak and read English (Child)
- Able to speak and read English (Parent)
Key exclusion criteria (6 listed)
- Plan to transition diabetes care to a center other than Boston Children's Hospital
- No visit to Boston Children's Hospital Diabetes Program in year prior to recruitment
- Current participation in another diabetes-related study with an intervention
- Living with or related to another study participant
- Significant psychopathology or medical illness that would limit the subject's ability to provide assent and/or participate in the study procedures as determined by the PI.
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 |
|---|---|---|
| Telehealth InterventionMonthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan; | Behavioural | Telehealth Intervention |
| Usual CareStandard diabetes care- typically a visit with a diabetes health care provider every 3 months and referrals to a dietitian or mental health specialist as deemed appropriate; Study participation reminder cards twice per month | Other | Usual care |
Primary outcome
Change in Hemoglobin A1c
Time frame: baseline and 6 months
Change in hemoglobin A1c over 6 months
7 secondary outcomes
% patients meeting ADA HbA1c target
Time frame: At 6 months
Diabetes-related adverse events
Time frame: Up to 6 months
Change in Diabetes self-efficacy
Time frame: Baseline and 6 months
Change in Adherence to diabetes self-management
Time frame: Baseline and 6 months
Change in competence with diabetes skills
Time frame: Baseline and 6 months
Change in Health related quality of life
Time frame: Baseline and 6 months
Change in Diabetes Knowledge
Time frame: Baseline and 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 15 Aug 2016.
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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.
Erinn T Rhodes, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Intervention in people with Type 1 Diabetes Mellitus, run by Boston Children's Hospital 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 7 inclusion and 6 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 15 Aug 2016. 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 Hemoglobin A1c (time frame: baseline and 6 months). 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 15 Aug 2016.