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

Primary Purpose

Chronic Kidney Disease

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lifestyle Intervention Program
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Life experience, Life style, Health behavior, Mixed method

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • National Cheng Kung University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle Intervention Program

Arm Description

Outcomes

Primary Outcome Measures

Body weight
Waist to hip ratio
Overall knowledge of renal protection
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
Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).
Quality of Life
The study will use WHOQOL-BREF to measure the outcome.
Physical activity
The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.
General Health Perceptions
The study will use General Health Perceptions Subscale of SF-36 Health Status Scale to measure the outcome.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2010
Last Updated
September 16, 2010
Sponsor
National Cheng Kung University
Collaborators
National Cheng-Kung University Hospital, E-DA Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01194518
Brief Title
Exploring Life Experience and Lifestyle Intervention Program Among Patients With Chronic Kidney Disease: A Longitudinal Study
Official Title
Exploring Life Experience and Lifestyle Intervention Program Among Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Cheng Kung University
Collaborators
National Cheng-Kung University Hospital, E-DA Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Life experience, Life style, Health behavior, Mixed method

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention Program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention Program
Primary Outcome Measure Information:
Title
Body weight
Time Frame
six months
Title
Waist to hip ratio
Time Frame
six months
Title
Overall knowledge of renal protection
Description
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.
Time Frame
six months
Title
Health promotion lifestyle
Description
Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).
Time Frame
six months
Title
Quality of Life
Description
The study will use WHOQOL-BREF to measure the outcome.
Time Frame
six months
Title
Physical activity
Description
The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.
Time Frame
six months
Title
General Health Perceptions
Description
The study will use General Health Perceptions Subscale of SF-36 Health Status Scale to measure the outcome.
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Eligibility Criteria
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
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan City
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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