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临床试验/NCT02076256
NCT02076256Unknown不适用

The Influence of Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With Chronic Kidney Disease: A Longitudinal Study

National Cheng Kung University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
250
试验地点
1
主要终点
Waist to Hip Ratio

研究概览

简要总结

Helping relationships from significant others may assist patients with chronic kidney diseases to exercise health behaviors. Patients will adhere on the suggestions from medical staff and perform health lifestyle to maintain healthy behavior. The progress of the disease may be delayed.

The research is a 3-year study to explore the influence of helping relationships on healthy behaviors among patients with chronic kidney disease. Building on the findings from the past three years study and the literature on trans-theoretical Model, helping relationships will be articulated. A helping relation intervention will be applied to evaluate its effect on healthy lifestyle and quality of life.

The first year study will be a survey design. An instrument to measure the helping relationship will be established and tested. Total of 200 participants will be recruited to test the reliability and validity of the instrument. After evaluating the psychometric properties of the instrument, items may be revised according to the results. The second year of research will be a cross-section study. Of 250 subjects will be recruited to explore the correlations between helping relationships, healthy life styles, and quality of life. Data will be analyzed using hierarchical linear regression. In the third year, an experimental design will be applied to test the effect of a helping relationship intervention. One hundred and twenty subjects will be recruited and randomly assigned to the experimental and the control group for 60 subjects in each group. The helping relationships intervention program will be implemented on the experimental group. And the control group will be provided with routine nursing care. Data will be collected at baseline, the sixth and the ninth month of the third year of study. Data will be analyzed using generalized estimating equation measures to evaluate the effect of the intervention program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Investigator)

入排标准

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

入选标准

  • 20 years and older
  • diagnosed with chronic kidney disease stage 1 to 4 or GFR≧30ml/min/1.73m2
  • patients who has significant others
  • patients who can speak Mandarin or Taiwanese
  • Exclusion criteria:
  • Patient who limited to exercise

排除标准

  • 未提供

结局指标

主要结局

Waist to Hip Ratio

时间窗: six months

Helping Relationship Scale

时间窗: The third year

Health Promotion Lifestyle Profile

时间窗: The third year

Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).

World Health Organization Quality of Life (WHOQOL-BREF) with the Short-Form 36 (SF-36)

时间窗: The third year

The study will use WHOQOL-BREF to measure the outcome.

International Physical Activity Questionnaire Taiwan Version

时间窗: The third year

The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.

body weight

时间窗: six months

次要结局

未报告次要终点

研究者

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

Miaofen Yen

PhD, RN, FAAN

National Cheng Kung University

研究点 (1)

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