Home-Based Interventions for Adolescents With Type 1 Diabetes (R34)
Translating Home-Based Interventions for Adolescents With Poorly Controlled TID
調査の概要
詳細な説明
The proposed study is a planning grant in which MST will be adapted for delivery by community health workers and will be conducted in collaboration with CHASS, a community agency providing health care to underserved residents of Detroit with diabetes. The new intervention, Fit Families (FF), will be tested in a pilot randomized controlled trial in order to evaluate FF feasibility, finalize outcome measures, estimate intervention effect sizes on health outcomes (i.e., youth adherence, glycemic control, quality of life) and determine potential cost savings associated with reduced hospital admissions. These steps will allow for finalization of intervention content and other trial parameters in preparation for a larger R18 dissemination trial.
The design for the proposed study is a randomized, controlled trial using a sample of 60 adolescents. Half will be randomly assigned to the treatment intervention, Fit Families plus standard medical care, and the other half will be assigned to standard medical care alone. Families who are randomized to FF receive intensive, home-based family therapy delivered by a community health worker (CHW) for approximately six months.
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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Michigan
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Detroit、Michigan、アメリカ、48201
- Children's Hospital of Michigan
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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:
- a current hemoglobin A1c(HbA1c) of >9.0%
- an average HbA1c of >9.0% during the past year
- reside in the metro Detroit tri-county area
- diagnosed with Type 1 diabetes for at least one year
- aged 10-17
- patient of Children's Hospital of Michigan Diabetes Clinic
Exclusion Criteria:
- severe mental impairment/thought disorder
- Active suicidality
- Active homicidality
- Diabetes secondary to another comorbid medical condition and/or medical management differing substantially from that of most children with diabetes.
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：単一グループの割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Fit Familes plus Standard Medical Care
Participants will receive the intervention Fit Families plus Standard Medical Care which is an adaptation of Multisystemic Therapy for Type 1 Diabetes delivered by Community Health Workers (CHWs) in addition to standard medical care.
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Adolescents will receive the Fit Families plus Standard Medical Care which consists of twice weekly home-based, family psychotherapy from a CHW for 6 months
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介入なし：Standard Medical Care
Standard medical care is provided at Children's Hospital of Michigan consistent with the standards for the care of children with T1D outlined by the American Diabetes Association.
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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 |
|---|---|---|
|
Metabolic Control: Hemoglobin A1c (HbA1c)
時間枠：Change from Baseline at 7 months, Change from Baseline at 9 months
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retrospective measure of blood glucose control, encompasses the previous 2-3 months
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Change from Baseline at 7 months, Change from Baseline at 9 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
時間枠：Change from Baseline at 7 months, Change from Baseline at 9 months
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The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.
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Change from Baseline at 7 months, Change from Baseline at 9 months
|
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Quality of life
時間枠：Change from Baseline at 7 months, Change from Baseline at 9 months
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44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.
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Change from Baseline at 7 months, Change from Baseline at 9 months
|
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Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
時間枠：Change from Baseline at 7 months, Change from Baseline at 9 months
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The DMS assesses a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision.
Glucose meters only assess blood glucose monitoring, but are empirically linked to metabolic control
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Change from Baseline at 7 months, Change from Baseline at 9 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Deborah A Ellis, Ph.D、Wayne State University
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。