Optimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)

NCT ID: NCT00745342

Last Updated: 2021-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-03-31

Study Completion Date

2002-10-31

Brief Summary

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This 2-year randomized, controlled trial examined the impact of a clinic-based, family teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Teamwork Group

Families randomized to the Teamwork Group received the behavioral family teamwork intervention.

Group Type EXPERIMENTAL

Family Teamwork Intervention

Intervention Type BEHAVIORAL

Families in the teamwork group received quarterly psychoeducational interventions at regular clinic visits, focusing on promoting family teamwork and reducing diabetes-specific family conflict and diabetes burnout.

Standard Care

Families in the Standard Care group received standard diabetes care and equal attention from study staff between visits to schedule appointments and encourage regular diabetes follow-up care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Family Teamwork Intervention

Families in the teamwork group received quarterly psychoeducational interventions at regular clinic visits, focusing on promoting family teamwork and reducing diabetes-specific family conflict and diabetes burnout.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 8 to 17 years old
* Duration of type 1 diabetes between 2 months and 6 years
* Residence in New England or New York
* At least 1 outpatient visit in the past year

Exclusion Criteria

* Major co-morbid psychiatric or medical illness in youth
* Diagnosis of an active major psychiatric disorder in either parent
* Diagnosis of a life-threatening medical illness in either parent
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Joslin Diabetes Center

OTHER

Sponsor Role lead

Responsible Party

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Lori Laffel

Chief, Pediatric, Adolescent, & Young Adult Section; Investigator, Genetics & Epidemiology Section

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lori MB Laffel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Locations

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Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Anderson BJ, Vangsness L, Connell A, Butler D, Goebel-Fabbri A, Laffel LM. Family conflict, adherence, and glycaemic control in youth with short duration Type 1 diabetes. Diabet Med. 2002 Aug;19(8):635-42. doi: 10.1046/j.1464-5491.2002.00752.x.

Reference Type RESULT
PMID: 12147143 (View on PubMed)

Laffel LM, Vangsness L, Connell A, Goebel-Fabbri A, Butler D, Anderson BJ. Impact of ambulatory, family-focused teamwork intervention on glycemic control in youth with type 1 diabetes. J Pediatr. 2003 Apr;142(4):409-16. doi: 10.1067/mpd.2003.138.

Reference Type RESULT
PMID: 12712059 (View on PubMed)

Laffel LM, Connell A, Vangsness L, Goebel-Fabbri A, Mansfield A, Anderson BJ. General quality of life in youth with type 1 diabetes: relationship to patient management and diabetes-specific family conflict. Diabetes Care. 2003 Nov;26(11):3067-73. doi: 10.2337/diacare.26.11.3067.

Reference Type RESULT
PMID: 14578241 (View on PubMed)

Other Identifiers

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R01DK046887

Identifier Type: NIH

Identifier Source: secondary_id

View Link

92-23

Identifier Type: -

Identifier Source: org_study_id

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