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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

National Cheng-Kung University Hospital

E-DA Hospital

Information provided by:

National Cheng Kung University

ClinicalTrials.gov Identifier:

NCT01194518

First received: August 31, 2010

Last updated: September 16, 2010

Last verified: September 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	August 31, 2010
Last Updated Date	September 16, 2010
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 ] [ Designated as safety issue: No ] Waist to hip ratio [ Time Frame: six months ] [ Designated as safety issue: No ] Overall knowledge of renal protection [ Time Frame: six months ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II). Quality of Life [ Time Frame: six months ] [ Designated as safety issue: No ] The study will use WHOQOL-BREF to measure the outcome. Physical activity [ Time Frame: six months ] [ Designated as safety issue: No ] The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome. General Health Perceptions [ Time Frame: six months ] [ Designated as safety issue: No ] 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	Complete list of historical versions of study NCT01194518 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Not Provided
Study Design ^ICMJE	Primary Purpose: Prevention
Condition ^ICMJE	Chronic Kidney Disease
Intervention ^ICMJE	Behavioral: Lifestyle Intervention Program
Study Arm (s)	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	Active, not recruiting
Enrollment ^ICMJE	Not Provided
Estimated Completion Date	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
Gender	Both
Ages	20 Years and older
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Taiwan

Administrative Information
NCT Number ^ICMJE	NCT01194518
Other Study ID Numbers ^ICMJE	NSC992314B006048MY3
Has Data Monitoring Committee	Yes
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
Information Provided By	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

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