NCT01182701已完成不适用
Cognitive Behavioral Intervention in Diabetes Self-Management
University of Hawaii2 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2004年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 2
- 主要终点
- Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
研究概览
简要总结
The proposed study is a two arm randomized controlled trial with longitudinal follow-up that compares cognitive behavioral interventions (ENHANCE) to a control group with attention. The experiment will consist of a repeated measure 2 X 3 design; Condition (Experiment vs. Control) by Time (Pre, Post, Follow Up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asian/Pacific Islander Men and Women with type 2 diabetes; asymptomatic for hyperglycemia
- •Both men and women will be included in the study if they have a diagnosis of type 2 diabetes made by a physician and meet classification and diagnostic criteria established by the American Diabetes Association (American Diabetes Association, 1997)
- •Between 18 and 76 years
- •Participation in diabetes education program of University Specialty Clinics
排除标准
- •Crippling arthritis
- •Joint replacements that limit movement
- •Neuromuscular disease with paralysis
- •Severe eye disease or visually impaired
- •Chronic renal failure and/or End Stage Renal Disease requiring hemodialysis or peritoneal dialysis
- •Transplant recipient
- •Foot Amputation
- •Congestive Heart Failure
- •New York Heart Class III/IV
- •Previous Cerebral Vascular Accident (stroke) with residual paralysis
- •Malignancy
- •Chronic hepatitis C
- •HIV disease
- •Individuals who contemplate changing residence within the period of study and becoming inaccessible to the study should be discouraged from the study
结局指标
主要结局
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
时间窗: 1 year
次要结局
- Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.(1 year)
研究者
研究点 (2)
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