Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study
調査の概要
詳細な説明
Glycemic control deteriorates during adolescence as parents become less involved in teens' diabetes management and adherence declines. Thus, there is a need to improve adherence and glycemic control in mid to older teens with type 1 diabetes by strengthening the teens' self-efficacy for daily diabetes self-management to help prepare them for the transition between pediatric and adult care. This 18-month, multi-center RCT is designed to increase frequency of blood glucose monitoring and improve glycemic control in teens with type 1 diabetes through a behavioral intervention called Teenwork with or without text message reminders to check blood glucose levels.
We will implement and evaluate the Teenwork intervention and text message reminders to check blood glucose levels in a 2x2 factorial design in which 300 participants, across two sites, will be randomized to 1 of 4 groups: Teenwork, Text Message, Teenwork/Text Message, or Usual Care.
Participants in the Teenwork Group will meet with a research assistant during each study visit to review strategies for improving self-care, including self-management and self-advocacy, focusing on two areas: blood glucose monitoring and insulin administration. Participants in the Text Message Group will be instructed in the use of the text messaging system. They will receive 2-way text message reminders to check blood glucose levels at self-selected times and to reply by text message with blood glucose results. Participants in the Teenwork/Text Message Group will receive both the Teenwork intervention and the text message reminders (as described above). Participants in the Usual Care Group will receive the same intervention as the Teenwork/Text Message Group, but not until after 1 year.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Joslin Diabetes Center
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-
Texas
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Houston、Texas、アメリカ、77030
- Texas Children's Hospital/Baylor College of Medicine
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Youth age 13-17 years
- Diagnosis of type 1 diabetes according to American Diabetes Association criteria
- Diabetes duration ≥6 months
- Daily insulin dose ≥0.5 units/kg
- A1c ≥6.5%and ≤11%
- Willingness to check blood glucose levels
- Cell phone with text messaging ability
Clinic attendance
- At least one clinic visit at the clinical site in the previous 12 months
- Anticipated care at the clinical site for the duration of the study
- Fluency in English (reading, writing, and speaking) for child and parent/guardian
- Enrollment no later than December of the teen's senior year of high school
Exclusion Criteria:
- Pregnancy in the youth participant
- Significant developmental or cognitive disorder that would prevent full study participation
- Significant mental illness, defined by either major psychiatric disorder (e.g., diagnosed eating disorder, major psychoses) or inpatient psychiatric admission within the previous 6 months
- Failure to understand that the 2-way text messaging does NOT result in immediate response from a health care professional; this will be assessed at the time of informed consent/assent
- Participation in another intervention study within the 3 months prior to enrollment
- Other psychosocial, medical, or family issues, as assessed by the teen's pediatric team, that would prevent full study participation
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Teenwork Group
Teen/family will receive the Teenwork intervention at each quarterly study visit.
|
Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration
|
|
実験的：Teenwork/Text Message Group
Teen/family will receive the Teenwork intervention at each quarterly study visit.
Teen will receive text message reminders to check blood glucose levels at self-selected times.
|
Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration
Text message reminders to check blood glucose levels at self-selected times
|
|
実験的：Text Message Group
Teen will receive text message reminders to check blood glucose levels at self-selected times.
|
Text message reminders to check blood glucose levels at self-selected times
|
|
介入なし：Usual Care Group
Teen/family will receive routine clinical care for the first year of the study (the time period for assessment of primary outcomes).
After year 1, teen/family will receive the Teenwork intervention at each remaining study visit and teen will receive text message reminders to check blood glucose levels at self-selected times.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in glycemic control from baseline to 1 year
時間枠：Baseline and 1 year
|
Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)
|
Baseline and 1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in glycemic control from 1 year to 18 months
時間枠：1 year and 18 months
|
Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)
|
1 year and 18 months
|
|
Psychosocial factors (self-report surveys)
時間枠：Baseline, 6 months, 1 year, 18 months
|
We will assess psychosocial factors (e.g., diabetes-specific family conflict, diabetes burden, negative affect around blood glucose monitoring, quality of life, depressive symptoms, self-efficacy, disordered eating behaviors) every 6 months
|
Baseline, 6 months, 1 year, 18 months
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Barbara J. Anderson, PhD、Texas Children's Hospital/Baylor College of Medicine
出版物と役立つリンク
一般刊行物
- Commissariat PV, Volkening LK, Guo Z, ElBach JL, Butler DA, Laffel LM. Associations between major life events and adherence, glycemic control, and psychosocial characteristics in teens with type 1 diabetes. Pediatr Diabetes. 2018 Feb;19(1):85-91. doi: 10.1111/pedi.12523. Epub 2017 Apr 19.
- McGill DE, Volkening LK, Butler DA, Wasserman RM, Anderson BJ, Laffel LM. Text-message responsiveness to blood glucose monitoring reminders is associated with HbA1c benefit in teenagers with Type 1 diabetes. Diabet Med. 2019 May;36(5):600-605. doi: 10.1111/dme.13929. Epub 2019 Feb 25.
- Cecilia-Costa R, Volkening LK, Laffel LM. Factors associated with disordered eating behaviours in adolescents with Type 1 diabetes. Diabet Med. 2019 Aug;36(8):1020-1027. doi: 10.1111/dme.13890. Epub 2019 Mar 4.
- McGill DE, Laffel LM, Volkening LK, Butler DA, Levy WL, Wasserman RM, Anderson BJ. Text Message Intervention for Teens with Type 1 Diabetes Preserves HbA1c: Results of a Randomized Controlled Trial. Diabetes Technol Ther. 2020 May;22(5):374-382. doi: 10.1089/dia.2019.0350.
- Harrington KR, Shapira A, Volkening LK, Butler DA, Anderson BJ, Wasserman RM, Laffel LM. Associations of diabetes self-management characteristics, HbA1c, and psychosocial outcomes with depressive symptoms in a contemporary sample of adolescents with type 1 diabetes. J Diabetes Complications. 2021 Mar;35(3):107838. doi: 10.1016/j.jdiacomp.2020.107838. Epub 2021 Jan 6.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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