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临床试验/NCT01194518
NCT01194518已完成不适用

Exploring Life Experience and Lifestyle Intervention Program Among Patients With Chronic Kidney Disease: A Longitudinal Study

National Cheng Kung University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Body weight

研究概览

简要总结

to compare the effectiveness of tailored TTM-based interventions (intervention group) compared to usual care (control group) on biomarkers of kidney function, physical indicators, adoption of health-promoting lifestyle behaviors, kidney disease knowledge, perceived self-efficacy, perceived benefits and barriers to physical activity changes, and quality of life among patients with early-stage CKD over a 30 month period.

详细描述

A thirty-month clinical trial (ClinicalTrials.gov registration NCT01194518) was conducted from October 2010 through October 2013. The CONSORT checklist (Schulz et al., 2010) guided the study. Data were collected at baseline and at 6, 12, 18, 24, and 30 months post-intervention.

Participants and Setting After obtaining approval to conduct the study from the Institutional Review Board, the nephrology case managers from the outpatient clinics of two medical centers in southern Taiwan were contacted and asked to refer patients to the study. Participants were included if they were at least 20 years old, diagnosed with stages 1 to 3 CKD, spoke Mandarin, and could be followed up every 6 months when they returned for an outpatient visit. Patients who were unable to participate in moderate exercise, unable to verbalize that they understood the study, or were already enrolled in another program were excluded. Upon obtaining written informed consent subjects were randomly assigned to the control or intervention group at a ratio of 1 to 1 using paper ballots.

The Bureau of National Health Insurance (BNHI) in Taiwan launched the CKD care program for pre-ESRD care which suggested that CKD management and education depended on the stage of CKD (Chen et al., 2011). In addition, Taiwan established a medical system protocol to standardize and regulate pre-ESRD care with all medical expenditures covered by the National Health Insurance (NHI). Therefore, patients receive regular follow-ups as nephrology outpatients with the nephrology case managers providing usual care.

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
Single (Participant)

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

  • 1.at least 20 years old
  • diagnosed as stage 1-3 CKD (eGFR greater than ≧ 44 ml/min per 1.73 m2),
  • spoke Mandarin, 4.could be followed up every 6 months when they returned for a clinic outpatient visit.

排除标准

  • could not participate in moderate exercise
  • not able to verbalize understanding of the study
  • already enrolled in another program.

结局指标

主要结局

Body weight

时间窗: six months

Waist to hip ratio

时间窗: six months

Overall knowledge of renal protection

时间窗: six months

The 20 item Renal Protection Knowledge Checklist was developed by researchers will use to measure three dimensions of knowledge: renal function protection, use of Chinese herbs and diet.

Health promotion lifestyle

时间窗: six months

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

Quality of Life

时间窗: six months

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

Physical activity

时间窗: six months

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

General Health Perceptions

时间窗: six months

The study will use General Health Perceptions Subscale of SF-36 Health Status Scale to measure the outcome.

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 (2)

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