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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01194518
Recruitment Status : Unknown
Verified September 2010 by National Cheng Kung University.
Recruitment status was:  Active, not recruiting
First Posted : September 3, 2010
Last Update Posted : September 17, 2010
Sponsor:
Collaborators:
National Cheng-Kung University Hospital
E-DA Hospital
Information provided by:
National Cheng Kung University

Tracking Information
First Submitted Date  ICMJE August 31, 2010
First Posted Date  ICMJE September 3, 2010
Last Update Posted Date September 17, 2010
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September¬†2,¬†2010)
  • Body weight [ Time Frame: six months ]
  • Waist to hip ratio [ Time Frame: six months ]
  • Overall knowledge of renal protection [ Time Frame: 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 [ Time Frame: six months ]
    Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).
  • Quality of Life [ Time Frame: six months ]
    The study will use WHOQOL-BREF to measure the outcome.
  • Physical activity [ Time Frame: six months ]
    The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.
  • General Health Perceptions [ Time Frame: six months ]
    The study will use General Health Perceptions Subscale of SF-36 Health Status Scale to measure the outcome.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploring Life Experience and Lifestyle Intervention Program Among Patients With Chronic Kidney Disease: A Longitudinal Study
Official Title  ICMJE Exploring Life Experience and Lifestyle Intervention Program Among Patients
Brief Summary The lifestyle consulting program through one year follow-up could effective increase the scores of health responsibility and nutrition according to the past three-year study. Behavior change is a dynamic and complex process. Using a long-term follow up approach will be able to understand the trajectory of behavior change. The purpose of this study is to explore life experience and lifestyle intervention program for patients with chronic kidney disease using mixed methods with a longitudinal approach. The first year of this study will include a qualitative study with in depth interview of the subjects who attend previous study in the research team and have the scores of health promoting lifestyle among the highest 27% and lowest 27%. The life experience will be explored. The quantitative study will be an experimental design. Qualified subjects will be randomly assigned to intervention or control group. The intervention protocol is based on trans-theoretical model. Each subject will be followed every six months. The second and third year of studies will continue to use the qualitative and quantitative approach to understand the life experience and meaning among patients with chronic kidney diseases. The trajectory of life experience and life style changes will be explored. The method may strengthen the effectiveness of lifestyle program and may provide comprehensive understanding of the trajectory of behavior changes among patient with chronic kidney disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Prevention
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE Behavioral: Lifestyle Intervention Program
Study Arms  ICMJE Experimental: Lifestyle Intervention Program
Intervention: Behavioral: Lifestyle Intervention Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of Early Stages of Chronic Kidney Disease (GFR≧30ml/min/1.73㎡)
  • Must be able to commmunicate in Chinese or Taiwanese
  • Muse be voluntarily to attend
  • Patient who does not exercise regularly
  • Patient whose blood pressure higher than 140/90 mmHg
  • Patient who is overweight or BMI>25kg/㎡

Exclusion Criteria:

  • Patient who limited to exercise
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01194518
Other Study ID Numbers  ICMJE NSC992314B006048MY3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Miaofen Yen, National Cheng Kung University
Study Sponsor  ICMJE National Cheng Kung University
Collaborators  ICMJE
  • National Cheng-Kung University Hospital
  • E-DA Hospital
Investigators  ICMJE Not Provided
PRS Account National Cheng Kung University
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP