Home-Based Interventions for Adolescents With Type 1 Diabetes (R34)
Translating Home-Based Interventions for Adolescents With Poorly Controlled TID
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Michigan
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Detroit, Michigan, 미국, 48201
- Children's Hospital of Michigan
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Metabolic Control: Hemoglobin A1c (HbA1c)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
기간: 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
기간: 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
기간: 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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Deborah A Ellis, Ph.D, Wayne State University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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