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临床试验/NCT01067963
NCT01067963终止不适用

Self-management of Type 2 Diabetes and Chronic Kidney Disease

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009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
终止
入组人数
80
试验地点
2
主要终点
Primary outcomes utilized in this study will be disease burden (measured as diabetes-related distress), quality of life (measured as health related QOL), and glycemic health (measured as hemoglobin A1C).

研究概览

简要总结

The purpose of this study is to establish the usefulness and the impact of a tailored behavioral-education and counseling intervention titled Self-Management and Resourceful Transition (S.M.a.R.T) among patients with type 2 diabetes mellitus and stage 3 chronic kidney disease, in order to help them to manage their behaviors related to their condition and health.

详细描述

The SMaRT intervention is a 3-week intervention that uses a combined behavioral-education and counseling methodology. The combined intervention involves computer-aided education alongside telephone counseling via motivational interviewing. The computer-aided education is tailored to the diagnoses of type 2 diabetes and chronic kidney disease and designed in a learning module approach to facilitate goal-setting and discussion of health concerns with greater efficacy and in a more informed way during the brief office visit. Such Computer-aided education has been used to improve diabetes self-management and glycemic control in middle-aged to older adults with moderate success. The inclusion of CKD information will augment current diabetes self-management intervention. The telephone counseling using the evidence-based behavioral change approach of motivational interviewing is a patient-centered approach of partnering with patients by eliciting their health-related concerns. This approach tailors the SMaRT intervention to include collaborative goal-setting with guidance based upon the patient's readiness for change.

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 (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed Type 2 Diabetes
  • •18-85 years old
  • •Stage 3 Chronic Kidney Disease
  • •Speaks and reads English

排除标准

  • •Hypoglycemia with 3rd party treatment in past 3 months
  • •Type 1 Diabetes
  • •On Dialysis
  • •Does not speak English
  • •Factors likely to preclude protocol adherence

研究组 & 干预措施

Behavioral-education/counseling

Experimental

Computer assisted education and telephone counseling using motivational interviewing.

Computer assisted education and motivational interviewing

干预措施: Computer assisted education and motivational interviewing. (Behavioral)

Group talks/social chat

Placebo Comparator

Group session talks on general topics about healthy lifestyle, printed power point handouts, telephone calls comprised of social conversation to discuss the handout content.

干预措施: Group talks/social chat (Behavioral)

结局指标

主要结局

Primary outcomes utilized in this study will be disease burden (measured as diabetes-related distress), quality of life (measured as health related QOL), and glycemic health (measured as hemoglobin A1C).

时间窗: One year

次要结局

  • Secondary exploratory outcomes for quality of life include measures of health-related quality of life for diabetes and overall quality of life.(One year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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