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

Chronic Kidney Disease Clinical Trial

Official title:

Exploring Life Experience and Lifestyle Intervention Program Among Patients

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01194518
• Other study ID #: NSC992314B006048MY3
• Status: Unknown status
• Phase: N/A
• First received: August 31, 2010
• Last updated: September 16, 2010
• Start date: August 2010
• Est. completion date: July 2013

Study information

• Verified date: September 2010
• Source: National Cheng Kung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 0
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Lifestyle Intervention Program

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan City

Sponsors (3)

Lead Sponsor	Collaborator
National Cheng Kung University	E-DA Hospital, National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		six months
Primary	Waist to hip ratio		six months
Primary	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.	six months
Primary	Health promotion lifestyle	Health promotion was measured by 52 item health promotion lifestyle profile? ( HPLP-II).	six months
Primary	Quality of Life	The study will use WHOQOL-BREF to measure the outcome.	six months
Primary	Physical activity	The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.	six months
Primary	General Health Perceptions	The study will use General Health Perceptions Subscale of SF-36 Health Status Scale to measure the outcome.	six months