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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Cheng Kung University.
Recruitment status was  Active, not recruiting
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
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Behavioral: Lifestyle Intervention Program

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Exploring Life Experience and Lifestyle Intervention Program Among Patients

Resource links provided by NLM:


Further study details as provided by National Cheng Kung University:

Primary Outcome Measures:
  • 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.


Study Start Date: August 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Intervention Program Behavioral: Lifestyle Intervention Program

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194518

Locations
Taiwan
National Cheng Kung University
Tainan City, Taiwan
Sponsors and Collaborators
National Cheng Kung University
National Cheng-Kung University Hospital
E-DA Hospital
  More Information

No publications provided

Responsible Party: Miaofen Yen, National Cheng Kung University
ClinicalTrials.gov Identifier: NCT01194518     History of Changes
Other Study ID Numbers: NSC992314B006048MY3
Study First Received: August 31, 2010
Last Updated: September 16, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Cheng Kung University:
Life experience
Life style
Health behavior
Mixed method

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014