跳至主要内容
临床试验/NCT01886170
NCT01886170已完成不适用

Using Patient Feedback to Improve the Ways we Communicate Information Regarding Glycemic Control to Patients With Poorly Controlled Diabetes

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
For Phase I of the Study: Metrics Used to Understand Diabetes Control

研究概览

简要总结

In this two-phase mixed methods study, the investigators will first use patient feedback from semi-structured interviews to explore the ways in which patients with diabetes understand their diabetes and assess their disease control. The investigators will also use these interviews to elicit patient feedback on promising alternative communication formats to the hemoglobin A1C (A1C). In the second phase of the study, the investigators will test new formats to communicate information regarding diabetes control to patients with poorly controlled diabetes. This phase will be a three arm RCT comparing the effect of A1C (standard medical information) versus two alternative formats on several participant outcomes, primarily glycemic control at 6 months post-intervention.

详细描述

The noted importance of understanding glycemic control is concerning given studies estimating that only 25% of patients understand the hemoglobin A1C value (A1C). The A1C is a blood test value reflecting average blood sugars over the previous 3 months and is used as both a clinical indicator of diabetes control with guideline-set targets and as a communication format to express level of disease control to patients.Past work has demonstrated the potential effectiveness of translating poorly understood medical values, like the A1C, into more universally understood forms. We believe applications can be used to address the problem of the poorly understood A1C. This study is two-phase mixed methods approach. We will design alternative communication formats to convey the information provided by the A1C to patients and evaluate the effectiveness of these formats in improving glycemic control, increasing patient understanding of their diabetes control, and altering patient behaviors. In Phase I of the study,we will use patient feedback from semi-structured interviews with 17-25 patients with diabetes to explore the ways in which patients assess and gauge their diabetes control, as well as to elicit patient feedback on promising communication formats. Potential alternative communication formats include categories represented by color-based scales (red/yellow/green), comparisons to averages or norms, trajectories of control over time and modified medical terminology (i.e., changing the name of the test). In phase II, patients with poorly controlled diabetes will be randomized to receive information on their glycemic control through one of three study arms, A1C (control) or one of two experimental format arms (chosen based on phase I results) and the effects of these different communication formats will be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • Adults who report a diagnosis of diabetes

排除标准

  • People without diabetes
  • For Phase II:
  • Inclusion Criteria
  • Adults seen at University of Pennsylvania primary care practice with a diagnosis of diabetes documented in the electronic health record and a recent hemoglobin A1C >8 %
  • No diabetes
  • No A1C or recent A1C <8%

结局指标

主要结局

For Phase I of the Study: Metrics Used to Understand Diabetes Control

时间窗: 4 months

Identification of common factors patients use to understand their diabetes and diabetes control via a qualitative analysis of the patient interview responses

For Phase II of the Study: Change in Hemoglobin A1C

时间窗: 6 months following enrollment

Change in A1C between enrollment and 6-months compared between study arms.

次要结局

  • For Phase II of the Study: Understanding of diabetes control(At the time of enrollment)
  • For Phase I of the study: Feedback on alternative formats(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anjali Gopalan

Robert Wood Johnson Clinical Scholar

University of Pennsylvania

研究点 (2)

Loading locations...

相似试验

已完成
不适用
Symptom Communication in Advanced CancerCommunicationCancerSymptom, Behavioral
NCT05667571National Taiwan University Hospital52
进行中(未招募)
不适用
Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider InterventionsAnatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Prognostic Stage 0 Breast Cancer AJCC v8Prognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8
NCT04549571Alliance for Clinical Trials in Oncology543
已完成
不适用
Effective Feedback to Improve Primary Care Prescribing SafetyComplications of Surgical and Medical Care: General Terms
NCT01602705University of Dundee262
已完成
不适用
The Effect of Feedback Regarding Illness Behavior on Patient Satisfaction in Hand SurgeryHand Surgery
NCT02209246Massachusetts General Hospital128
已完成
不适用
Patient-Centered Intervention to Reduce Cancer Patients' Financial ToxicityGynecologic CancerColorectal CancerLung Cancer
NCT04314284Washington University School of Medicine150
Using Patient Feedback to Improve Communication... | 临床试验