- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01106885
Effective Care Management of Depressed Diabetes Patients (The Positive Steps Study)
Effective Care Management of Depressed Diabetes Patients
연구 개요
상태
상세 설명
Research Plan: 382 patients ages 21-80, including 177 women, and 123 Blacks from the Ann Arbor VA HCS, UM, and the Genesys Health Care System in Flint. Patients will be randomized to: (1) brief education about depression, diabetes self-care, and physical activity; or (2) telephone care management including antidepressant medication care management (MCM) and/or cognitive behavioral therapy (CBT). The MCM module uses a standard algorithm to identify efficacious antidepressants and promote adherence. The CBT module addresses symptoms, exercise, and communication skills.
Methods: Surveys: Patients will complete clinic-based surveys at baseline and 12-months to measure their health status, self-care, provider-patient communication, and resource use. At 4 months, they will complete a mailed questionnaire to capture short-term changes in depressive symptoms, walking, patient-provider communication, medication adherence, and quality-of-life. Physiologic Measures: At baseline and 12-months, patients' A1c and cholesterol will be measured via a fingerstick blood test. We also will measure blood pressure, height, and weight. With patients' 4-month mailed surveys, they will complete fingerstick A1c tests and return the results via mail. The blood tests are identical to those diabetes patients use to self-monitor their blood glucose. Pedometers: We will measure distance walked at baseline, 4 months, and 12 months using a pedometer. Patients will record their walk distances for one week and return the results via mail. Electronic data: Utilization and billing databases will be used to identify health service utilization (ER visits, outpatient care, hospitalizations) occurring during patients' participation and the prior 12 months. Physician feedback. At patients' 12-month assessment, the physician will complete a brief survey about the patient's communication style. All patients will provide written consent administered prior to their face-to-face screening and baseline interviews. Physician 12-month surveys about patients' communication style will be anonymous.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan Health System
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Ann Arbor, Michigan, 미국, 48105
- VA Ann Arbor Healthcare System
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Grand Blanc, Michigan, 미국, 48439
- Genesys Regional Medical Center
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria. Patients must meet all of the following criteria:
- Active Diabetes (Type 1 & 2)
- Diagnosis of depression
- Using hypoglycemic medications
- At least 1 outpatient visit in last 12 months
- At least 21 years old
Exclusion Criteria. Patients who have any of the following will be excluded:
- Limited life expectancy (heart failure/ on oxygen/ advanced stage cancer/ dialysis)
- End stage renal disease
- Lung cancer
- Dementia
- Bipolar
- Schizophrenia
- Can't speak English
- Memory problems
- Alcohol problems
- Illegal drug use
- Minimal depressive symptoms
- Blood pressure 180/110 or higher
- Problems with loss of consciousness
- Can't walk 10 minutes on level surface
- Not planning to get their care at study site
- PCP not affiliated with study site
- Are not on a stable regimen (change in depression Rx in last 28-30 days)
- Type 1 diabetic if diagnosed before age 15
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Enhanced Usual Care
Adult patients with diabetes and depression.
|
|
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실험적: Staged Care Management
Adult patients with diabetes and depression
|
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Participant HbA1c levels
기간: one year
|
one year
|
|
Participant cardiovascular risk index
기간: one year
|
one year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
건강 관련 삶의 질
기간: 1년
|
1년
|
|
|
Proximal intervention targets
기간: one year
|
(e.g., depressive symptoms, physical activity levels, and provider-patient communication)
|
one year
|
|
Other self-care behaviors
기간: one year
|
one year
|
|
|
Treatment satisfaction
기간: one year
|
one year
|
|
|
Resource use
기간: one year
|
one year
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: John D Piette, PhD, VA Ann Arbor Healthcare System
간행물 및 유용한 링크
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .