Type 1 DiabetesNCT00961974
Intensive Care Program for Youth With Diabetes
A study testing Care Ambassador Intervention and Psychoeducational Intervention in people with Type 1 Diabetes, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The purpose of this study was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Care Ambassador Intervention and Psychoeducational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Jun 2005
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8-16 years
- Type 1 diabetes diagnosed by standard American Diabetes Association criteria
- Type 1 diabetes duration of at least 6 months
- Residence in northeastern U.S.
- Established clinic patient
- Fluency in English or Spanish
Who cannot join
- Major psychiatric disorder (e.g., major depression, severe eating disorder, mental retardation)
- Unstable living environment (e.g., Department of Social Services or Department of Youth Services involvement)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with type 1 diabetes.
- Conditions
- Type 1 Diabetes
- Being tested
- Care Ambassador Intervention, Psychoeducational Intervention
- Keywords
- type 1 diabetes, hemoglobin A1c, family, involvement, responsibility, conflict, quality of life, children
- Medical subject headings
- Diabetes Mellitus, Type 1, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Ambassador InterventionBehavioural
Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.
Psychoeducational InterventionBehavioural
A psychoeducational intervention module is reviewed with the family by the Care Ambassador at each clinic visit. The intervention focuses on incorporating intensive therapy into the daily routine of the child through positive family support for blood glucose monitoring and healthy eating. The intervention modules review positive family communication, realistic expectations, ways to avoid perfectionism and maintain family involvement, prevention of hypoglycemia, avoidance of diabetes-specific family conflict, and approaches to reducing "diabetes burnout".
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | * Routine diabetes support and education from diabetes health care team * Assistance from a non-medical case manager (Care Ambassador) to schedule appointments, provide reminders about appointments, and help families contact health care providers about questions or concerns |
| Care Plus | Experimental | * Routine diabetes support and education from diabetes health care team
* Assistance from a non-medical case manager (Care Ambassador) to schedule appointments, provide reminders about appointments, and help families contact health care providers about questions or concerns Receives: Behavioral: Care Ambassador Intervention |
| Care Ultra | Experimental | * Routine diabetes support and education from diabetes health care team
* Assistance from a non-medical case manager (Care Ambassador) to schedule appointments, provide reminders about appointments, and help families contact health care providers about questions or concerns Receives: Behavioral: Care Ambassador Intervention; Behavioral: Psychoeducational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control, assessed by hemoglobin A1c
Measured: Every 3 months
Secondary outcomes (3)
Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors)
Measured: Annually
Weight, assessed by z-BMI (age- and gender-adjusted body mass index)
Measured: Every 3 months
Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startApr 2002
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Charles H. Hood Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Lori Laffel, Joslin Diabetes Center
- Investigators
- Lori Laffel, MD, MPH, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961974
- Sponsor's protocol ID
- 02-06
- Other IDs
- R01DK046887
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2009
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Butler DA, Zuehlke JB, Tovar A, Volkening LK, Anderson BJ, Laffel LM. The impact of modifiable family factors on glycemic control among youth with type 1 diabetes. Pediatr Diabetes. 2008 Aug;9(4 Pt 2):373-81. doi: 10.1111/j.1399-5448.2008.00370.x.
PubMed 18774997Svoren BM, Volkening LK, Butler DA, Moreland EC, Anderson BJ, Laffel LM. Temporal trends in the treatment of pediatric type 1 diabetes and impact on acute outcomes. J Pediatr. 2007 Mar;150(3):279-85. doi: 10.1016/j.jpeds.2006.12.009.
PubMed 17307546Moreland EC, Tovar A, Zuehlke JB, Butler DA, Milaszewski K, Laffel LM. The impact of physiological, therapeutic and psychosocial variables on glycemic control in youth with type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2004 Nov;17(11):1533-44. doi: 10.1515/jpem.2004.17.11.1533.
PubMed 15570991Katz ML, Volkening LK, Butler DA, Anderson BJ, Laffel LM. Family-based psychoeducation and Care Ambassador intervention to improve glycemic control in youth with type 1 diabetes: a randomized trial. Pediatr Diabetes. 2014 Mar;15(2):142-50. doi: 10.1111/pedi.12065. Epub 2013 Aug 5.
PubMed 23914987
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Care Program for Youth With Diabetes
- ClinicalTrials.gov ID
- NCT00961974
- Acronym / sponsor ID
- 02-06
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, hemoglobin A1c, family, involvement, responsibility, conflict, quality of life, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Charles H. Hood Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2002
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 19 Aug 2009 (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 was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –* Routine diabetes support and education from diabetes health care team * Assistance from a non-medical case manager (Care Ambassador) to schedule appointments, provide reminders about appointments, and help families contact health care providers about questions or concerns |
| Care Plus | Experimental | Behavioral: Care Ambassador Intervention* Routine diabetes support and education from diabetes health care team * Assistance from a non-medical case manager (Care Ambassador) to schedule appointments, provide reminders about appointments, and help families contact health care providers about questions or concerns |
| Care Ultra | Experimental | Behavioral: Care Ambassador Intervention, Behavioral: Psychoeducational Intervention* Routine diabetes support and education from diabetes health care team * Assistance from a non-medical case manager (Care Ambassador) to schedule appointments, provide reminders about appointments, and help families contact health care providers about questions or concerns |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 8-16 years
- Type 1 diabetes diagnosed by standard American Diabetes Association criteria
- Type 1 diabetes duration of at least 6 months
- Residence in northeastern U.S.
- Established clinic patient
Key exclusion criteria (2 listed)
- Major psychiatric disorder (e.g., major depression, severe eating disorder, mental retardation)
- Unstable living environment (e.g., Department of Social Services or Department of Youth Services involvement)
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 |
|---|---|---|
| Care Ambassador InterventionCare Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits. | Behavioural | Care Plus, Care Ultra |
| Psychoeducational InterventionA psychoeducational intervention module is reviewed with the family by the Care Ambassador at each clinic visit. The intervention focuses on incorporating intensive therapy into the daily routine of the child through positive family support for blood glucose monitoring and healthy eating. The intervention modules review positive family communication, realistic expectations, ways to avoid perfectionism and maintain family involvement, prevention of hypoglycemia, avoidance of diabetes-specific family conflict, and approaches to reducing "diabetes burnout". | Behavioural | Care Ultra |
Primary outcome
Glycemic control, assessed by hemoglobin A1c
Time frame: Every 3 months
3 secondary outcomes
Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors)
Time frame: Annually
Weight, assessed by z-BMI (age- and gender-adjusted body mass index)
Time frame: Every 3 months
Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia
Time frame: Every 3 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 4 Aug 2021.
- Background: PubMed 18774997Butler DA, Zuehlke JB, Tovar A, Volkening LK, Anderson BJ, Laffel LM. The impact of modifiable family factors on glycemic control among youth with type 1 diabetes. Pediatr Diabetes. 2008 Aug;9(4 Pt 2):373-81. doi: 10.1111/j.1399-5448.2008.00370.x.
- Background: PubMed 17307546Svoren BM, Volkening LK, Butler DA, Moreland EC, Anderson BJ, Laffel LM. Temporal trends in the treatment of pediatric type 1 diabetes and impact on acute outcomes. J Pediatr. 2007 Mar;150(3):279-85. doi: 10.1016/j.jpeds.2006.12.009.
- Background: PubMed 15570991Moreland EC, Tovar A, Zuehlke JB, Butler DA, Milaszewski K, Laffel LM. The impact of physiological, therapeutic and psychosocial variables on glycemic control in youth with type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2004 Nov;17(11):1533-44. doi: 10.1515/jpem.2004.17.11.1533.
- Results publication: PubMed 23914987Katz ML, Volkening LK, Butler DA, Anderson BJ, Laffel LM. Family-based psychoeducation and Care Ambassador intervention to improve glycemic control in youth with type 1 diabetes: a randomized trial. Pediatr Diabetes. 2014 Mar;15(2):142-50. doi: 10.1111/pedi.12065. Epub 2013 Aug 5.
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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.
Lori Laffel, MD, MPH principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Ambassador Intervention and Psychoeducational Intervention in people with Type 1 Diabetes, run by Joslin Diabetes Center 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 6 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 4 Aug 2021. 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?
Glycemic control, assessed by hemoglobin A1c (time frame: Every 3 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 NCT00961974, which also lists 4 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 4 Aug 2021.