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临床试验/NCT00657800
NCT00657800已完成不适用

The Effect of a Coordinated Inpatient Diabetes Education Program on Glycemic Control, Diabetes Self-Management, Patient Satisfaction, and Quality of Life in the Outpatient Setting

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Diabetes Self-Management Practices

研究概览

简要总结

Patients will be recruited from comparable inpatient units that have been randomized as either interventional (Group 1) or control (Group 2) units. Patients in the interventional group will receive a comprehensive individualized diabetes education program coordinated by a certified diabetes educator. Patients in Group 2 will receive education from clinical staff as it is typically provided. Assessment of patient satisfaction with both inpatient and outpatient care, quality of life, and diabetes self-management skills (including emergency room visits and readmissions) will be measured using surveys completed during hospitalization and 4 months after discharge to determine any differences between the two groups.

详细描述

Patients will be recruited from matched sets of inpatient units determined to be comparable in terms of staffing and types of patients admitted. One unit from each matched set will be selected as the intervention unit (Group 1) or the control unit (Group 2) as determined by a random draw.

Group 1 patients will receive the coordinated inpatient diabetes education program (IDEP). Patients will be initially evaluated by a certified diabetes educator (CDE) to assess diabetes knowledge and to set priorities for "survival skills" education. Based on this individualized evaluation, a structured education plan will be devised and implemented by the CDE. The structured education plan will be modified as needed throughout the hospital stay to utilize more appropriate educational methods based on patient availability, condition or educational needs.

Group 2 (Control) will receive diabetes education as it is presently provided in our facility by the clinical staff. The staff nurse will be alerted that the patient is a participant in the research study and will record education provided in the electronic medical records.

The modified Michigan Diabetes Research and Training Center's Brief Diabetes Knowledge Test (DKT) and the Diabetes Treatment Satisfaction Questionnaire (DTSQs), if diabetes was pre-existing, will be administered initially to all patients by a member of the research team. If appropriate, the patient will be asked by the research team to complete a Quality of Life Survey (The Medical Outcomes Survey (MOS) Short-Form 36 (SF-36) General Health Survey prior to discharge. Completion of the Diabetes Treatment Satisfaction Questionnaire - Inpatient (DTSQ-IP) will also be requested of the patient prior to discharge.

All participants will be contacted 4 months after discharge for a similar assessment of quality of life and patient satisfaction with diabetes treatment, and for an additional assessment of diabetes self-management practices which includes the number of emergency room visits and readmissions since discharge. Comparisons will be made between the two groups and between baseline and follow-up assessments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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
否

入选标准

  • •Hospitalized patients with diabetes as defined by ADA criteria
  • •Ability to understand informed consent document
  • •Community-dwelling adults

排除标准

  • •Patients using CSII (continuous subcutaneous insulin infusion)
  • •Patients with Do Not Resuscitate (DNR) orders
  • •Decisionally impaired patients
  • •Patients admitted for 24 hour observation
  • •Patients in Intensive Care settings
  • •Patients with language barriers or sensory deficits mandating the need for specialized instruction
  • •Patients who are pregnant
  • •Patients for whom transfer to a skilled nursing or other assisted care living facilities is anticipated after discharge.

研究组 & 干预措施

Group 1

Experimental

Behavioral - Intensified coordinated inpatient diabetes education program (IDEP)

干预措施: Intensified inpatient diabetes education program (IDEP) (Behavioral)

Group 2

No Intervention

Diabetes education as is typically provided by clinical staff

结局指标

主要结局

Diabetes Self-Management Practices

时间窗: 4 months post-discharge

Patient Satisfaction

时间窗: Discharge date, 4 months post-discharge

Quality of Life (QoL)

时间窗: Baseline and 4 months post-discharge

次要结局

  • Glycemic and Metabolic Control(4 months post-discharge)
  • Emergency Room visits; admissions(4 months post-discharge)

研究者

申办方类型
Other

研究点 (1)

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