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临床试验/NCT02643797
NCT02643797已完成3 期

Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings

Scripps Whittier Diabetes Institute2 个研究点 分布在 1 个国家目标入组 602 人开始时间: 2016年3月7日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
602
试验地点
2
主要终点
Glycosylated Hemoglobin (Hba1c); % units

研究概览

简要总结

This study is a cluster (clinic level) randomized pragmatic trial to compare the effectiveness of MA Health Coaching (MAC) delivered by non-clinician primary care staff (i.e., MAs) versus usual care (UC) in improving diabetes clinical control among individuals with poorly controlled type 2 diabetes mellitus (T2DM).

详细描述

The study will be conducted in the primary care environments of two distinct, yet representative healthcare systems in San Diego County: Neighborhood Healthcare (a San Diego County FQHC system and designated Patient-Centered Medical Home, serving predominantly ethnic minority, low income patients) and Scripps (a large, non-profit, private insurance-based health system, serving predominantly Caucasian, middle-to-higher income patients). Six hundred patients at intervention (n=2; patient N=300) and control (n=2; patient N=300) clinics, aged 18 and older, with T2DM, and glycosylated hemoglobin (HbA1c) ≥ 8.0%, and/or low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL, and/or systolic blood pressure (SBP) ≥ 140 within the last 60 days, will be identified and enrolled using electronic health records (EHRs). Primary clinical outcomes of HbA1c, LDL-C, and SBP assessed as part of quarterly (or annual, for LDL-C), standard-of-care medical visits will be extracted from EHRs over 12 months. Changes in patient-reported behavioral (diabetes self-care) and psychosocial (quality of life, patient activation) outcomes will be evaluated via telephone assessment in a subset of intervention and control (N=300 total) participants at baseline, month 6, and month 12. A thorough process evaluation will be conducted to establish reach, acceptability/feasibility, adoption/maintenance, and fidelity of the intervention and will integrate patient, MA, and primary care provider perspectives. Cost-effectiveness will also be examined from the health system perspective. Principles of community engaged research were incorporated in intervention and study planning and will be sustained throughout the research period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be a patient at selected Scripps or Neighborhood Healthcare clinic,
  • Must be age 18 years or older,
  • Must have a T2DM diagnosis,
  • Must show evidence of poor clinical control, defined as HbA1c ≥ 8% and/or LDL-C ≥ 100 mg/dL, and/or SBP ≥ 140 mmHg.

排除标准

  • None as this is a pragmatic trial.

结局指标

主要结局

Glycosylated Hemoglobin (Hba1c); % units

时间窗: 12 months

Systolic blood pressure (SBP); mmHg units

时间窗: 12 months

Low-density lipoprotein-cholesterol (LDL-c); mg/dL units

时间窗: 12 months

次要结局

  • Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome(12 months)
  • Patient Reported Outcomes Measurement Information System (PROMIS) General Health Scale - patient-reported outcome(12 months)
  • Patient Activation Measure (PAM) - patient-reported outcome(12 months)
  • Patient Assessment of Care for Chronic Conditions (PACIC) - patient-reported outcome(12 months)
  • Morisky Medication Adherence Scale (MMAS) - patient-reported outcome(12 months)

研究者

发起方
Scripps Whittier Diabetes Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Athena Philis-Tsimikas

Prinicipal Investigator

Scripps Whittier Diabetes Institute

研究点 (2)

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