Diabetes Mellitus, Type 1TeensConnectNCT01783327
Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes
A study testing Teens-Connect and Planet D in people with Diabetes Mellitus, Type 1, run by Yale University at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the use of a state-of the art internet psycho-educational program in clinical practice (Teens-Connect), compared to use of a standard and widely available internet diabetes program for youth (Planet D™) in a mixed-method randomized clinical trial design. Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Teens-Connect and Planet D
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Aug 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 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with type 1 diabetes for at least 6 months
- Age 11 to 14 years
- English-speaking
- Assent
- Parent/guardian consent to participate in study
Who cannot join
- Previous exposure to TEENCOPE and/or Managing Diabetes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale University School of Nursing
New Haven, Connecticut, 06519
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to evaluate the use of a state-of the art internet psycho-educational program in clinical practice (Teens-Connect), compared to use of a standard and widely available internet diabetes program for youth (Planet D™) in a mixed-method randomized clinical trial design.
Read the detailed description
The aims are:
- To evaluate the efficacy and cost-effectiveness of provider-prescribed Teens-Connect (TEENCOPE™+Managing Diabetes) in pediatric diabetes practice compared to prescription of Planet D™. The hypotheses to be studied are:
- Youth who participate in Teens-Connect will have better metabolic control (A1c) and quality of life (QOL) than those who participate in Planet D.
- These effects will be mediated by improvements in stress/coping, self-efficacy, diabetes problem-solving, and self-management.
- Teens-Connect prescribed by providers in diabetes clinics will be a cost-effective approach to reduce A1c and improve quality-adjusted life years (QALYs) for youth with T1D.
- To compare the reach, efficacy, adoption, implementation, and maintenance (RE-AIM) of the two provider-prescribed psycho-educational internet programs.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Teens-Connect, Planet D
- Keywords
- Diabetes Mellitus, Type 1, Self care, Coping skills, Adolescent, Internet, Intervention Studies, Chronic Disease
- Medical subject headings
- Diabetes Mellitus, Type 1, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teens-ConnectBehavioural
Teens-Connect combines Managing Diabetes and TEENCOPE. Managing Diabetes consists of 5 sessions on age-appropriate, educational content related to diabetes problem-solving and self-efficacy to improve self-management. TEENCOPE consists of 5 sessions designed to increase youth's sense of competence and mastery by retraining inappropriate or non-constructive coping styles and forming more positive styles and patterns of behavior. The program is highly interactive and youth can talk with each other on an online moderated discussion board. Youth will be asked to use the website at least twice per week for 4 weeks.
Planet DBehavioural
Planet D provides age-appropriate diabetes education on a variety of topics and social networking discussion boards on diabetes, food and exercise, personal interests, and diabetes camp. Planet D addresses emotions and self-management through education and social networking. Youth who register can also create a profile, upload and share pictures, identify favorite news and blog feeds as well as provide comments or tags to other members. Planet D has been online since 2007 and contains numerous diabetes-related articles geared toward youth as well as a secure message board. Youth will be asked to interact with the website twice a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Teens-Connect | Experimental | The Teens-Connect Program is an internet-based program that combines Managing Diabetes and TEENCOPE. Receives: Behavioral: Teens-Connect |
| Planet D | Active comparator | Planet D is an internet program developed by the American Diabetes Association for children and adolescents with diabetes. Receives: Behavioral: Planet D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline hemoglobin A1c over 12 months
Measured: Baseline, 6 weeks, 6 months, 12 months
Change from baseline quality of life over 12 months
Measured: Baseline, 6 weeks, 6 months, 12 months
Secondary outcomes (6)
Change from baseline coping/Stress over 12 months
Coping/stress will be measured using the Perceived Stress Scale
Measured: Baseline, 6 weeks, 6 months, 12 months
Change from baseline self-efficacy over 12 months
Self-efficacy will be assessed using the Self-efficacy for Diabetes Scale
Measured: Baseline, 6 weeks, 6 months, 12 months
Change from baseline problem-solving over 12 months
Problem-solving will be assessed using the Self-Management of Diabetes-Adolescent (SMOD-A) questionnaire
Measured: Baseline, 6 weeks, 6 months, 12 months
Change from baseline self-management over 12 months
Self-management will be assessed using the Self-care Inventory (SCI)
Measured: Baseline, 6 weeks, 6 months, 12 months
Costs
Costs will be assessed using financial and staff records
Measured: 6 months
Change from baseline quality adjusted life years over 12 months
Quality adjusted life years will be assessed using the Health Utilities Index Step 3 (Adolescent and Parent)
Measured: Baseline, 6 weeks, 6 months, 12 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 startJul 2012
- Primary completionMay 2015
- Study completionAug 2015
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.
- More trials run by Yale 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Margaret Grey, DrPH, Principal investigator, Yale School of NursingRobin Whittemore, PhD, Principal investigator, Yale School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783327
- Sponsor's protocol ID
- 1112009416
- Acronym
- TeensConnect
- Status last verified
- Jan 2016
- First submitted
- 28 Jan 2013
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes
- ClinicalTrials.gov ID
- NCT01783327
- Acronym / sponsor ID
- TeensConnect / 1112009416
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, Self care, Coping skills, Adolescent, Internet, Intervention Studies, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Jul 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (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.
The purpose of this study is to evaluate the use of a state-of the art internet psycho-educational program in clinical practice (Teens-Connect), compared to use of a standard and widely available internet diabetes program for youth (Planet D™) in a mixed-method randomized clinical trial design.
Detailed description
The aims are:
- To evaluate the efficacy and cost-effectiveness of provider-prescribed Teens-Connect (TEENCOPE™+Managing Diabetes) in pediatric diabetes practice compared to prescription of Planet D™. The hypotheses to be studied are:
- Youth who participate in Teens-Connect will have better metabolic control (A1c) and quality of life (QOL) than those who participate in Planet D.
- These effects will be mediated by improvements in stress/coping, self-efficacy, diabetes problem-solving, and self-management.
- Teens-Connect prescribed by providers in diabetes clinics will be a cost-effective approach to reduce A1c and improve quality-adjusted life years (QALYs) for youth with T1D.
- To compare the reach, efficacy, adoption, implementation, and maintenance (RE-AIM) of the two provider-prescribed psycho-educational internet programs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teens-Connect | Experimental | Behavioral: Teens-ConnectThe Teens-Connect Program is an internet-based program that combines Managing Diabetes and TEENCOPE. |
| Planet D | Active comparator | Behavioral: Planet DPlanet D is an internet program developed by the American Diabetes Association for children and adolescents with diabetes. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosed with type 1 diabetes for at least 6 months
- Age 11 to 14 years
- English-speaking
- Assent
- Parent/guardian consent to participate in study
Key exclusion criteria (1 listed)
- Previous exposure to TEENCOPE and/or Managing Diabetes
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 |
|---|---|---|
| Teens-ConnectTeens-Connect combines Managing Diabetes and TEENCOPE. Managing Diabetes consists of 5 sessions on age-appropriate, educational content related to diabetes problem-solving and self-efficacy to improve self-management. TEENCOPE consists of 5 sessions designed to increase youth's sense of competence and mastery by retraining inappropriate or non-constructive coping styles and forming more positive styles and patterns of behavior. The program is highly interactive and youth can talk with each other on an online moderated discussion board. Youth will be asked to use the website at least twice per week for 4 weeks. | Behavioural | Teens-Connect |
| Planet DPlanet D provides age-appropriate diabetes education on a variety of topics and social networking discussion boards on diabetes, food and exercise, personal interests, and diabetes camp. Planet D addresses emotions and self-management through education and social networking. Youth who register can also create a profile, upload and share pictures, identify favorite news and blog feeds as well as provide comments or tags to other members. Planet D has been online since 2007 and contains numerous diabetes-related articles geared toward youth as well as a secure message board. Youth will be asked to interact with the website twice a week for 4 weeks. | Behavioural | Planet D |
Primary outcome
Change from baseline hemoglobin A1c over 12 months
Time frame: Baseline, 6 weeks, 6 months, 12 months
Change from baseline quality of life over 12 months
Time frame: Baseline, 6 weeks, 6 months, 12 months
6 secondary outcomes
Change from baseline coping/Stress over 12 months
Time frame: Baseline, 6 weeks, 6 months, 12 months
Change from baseline self-efficacy over 12 months
Time frame: Baseline, 6 weeks, 6 months, 12 months
Change from baseline problem-solving over 12 months
Time frame: Baseline, 6 weeks, 6 months, 12 months
Change from baseline self-management over 12 months
Time frame: Baseline, 6 weeks, 6 months, 12 months
Costs
Time frame: 6 months
Change from baseline quality adjusted life years over 12 months
Time frame: Baseline, 6 weeks, 6 months, 12 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 8 Jan 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.
Margaret Grey, DrPH principal investigator
Yale School of Nursing
Robin Whittemore, PhD principal investigator
Yale School of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teens-Connect and Planet D in people with Diabetes Mellitus, Type 1, run by Yale University at 2 sites 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 5 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 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 from baseline hemoglobin A1c over 12 months (time frame: Baseline, 6 weeks, 6 months, 12 months). The study lists 2 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 8 Jan 2016.