The Influence of Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With Chronic Kidney Disease: A Longitudinal Study

Overview

Helping relationships from significant others may assist patients with chronic kidney diseases to exercise health behaviors. Patients will adhere on the suggestions from medical staff and perform health lifestyle to maintain healthy behavior. The progress of the disease may be delayed. The research is a 3-year study to explore the influence of helping relationships on healthy behaviors among patients with chronic kidney disease. Building on the findings from the past three years study and the literature on trans-theoretical Model, helping relationships will be articulated. A helping relation intervention will be applied to evaluate its effect on healthy lifestyle and quality of life. The first year study will be a survey design. An instrument to measure the helping relationship will be established and tested. Total of 200 participants will be recruited to test the reliability and validity of the instrument. After evaluating the psychometric properties of the instrument, items may be revised according to the results. The second year of research will be a cross-section study. Of 250 subjects will be recruited to explore the correlations between helping relationships, healthy life styles, and quality of life. Data will be analyzed using hierarchical linear regression. In the third year, an experimental design will be applied to test the effect of a helping relationship intervention. One hundred and twenty subjects will be recruited and randomly assigned to the experimental and the control group for 60 subjects in each group. The helping relationships intervention program will be implemented on the experimental group. And the control group will be provided with routine nursing care. Data will be collected at baseline, the sixth and the ninth month of the third year of study. Data will be analyzed using generalized estimating equation measures to evaluate the effect of the intervention program.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Investigator)
  • Study Primary Completion Date: July 2016

Interventions

  • Behavioral: The helping relationships intervention program

Arms, Groups and Cohorts

  • No Intervention: Control Group
  • Experimental: The helping relationships intervention program
    • The helping relationships intervention program will be implemented on the experimental group. And the control group will be provided with routine nursing care. Data will be collected at baseline, the sixth and the ninth month of the third year of study. Data will be analyzed using generalized estimating equation measures to evaluate the effect of the intervention program.

Clinical Trial Outcome Measures

Primary Measures

  • Helping Relationship Scale
    • Time Frame: First year
  • Health Promotion Lifestyle Profile
    • Time Frame: First year
    • Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).
  • World Health Organization Quality of Life (WHOQOL-BREF) with the Short-Form 36 (SF-36)
    • Time Frame: First year
    • The study will use WHOQOL-BREF to measure the outcome.
  • International Physical Activity Questionnaire Taiwan Version
    • Time Frame: First year
    • The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.
  • Helping Relationship Scale
    • Time Frame: Second year
  • Health Promotion Lifestyle Profile
    • Time Frame: Second year
    • Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).
  • World Health Organization Quality of Life (WHOQOL-BREF) with the Short-Form 36 (SF-36)
    • Time Frame: Second year
    • The study will use WHOQOL-BREF to measure the outcome.
  • International Physical Activity Questionnaire Taiwan Version
    • Time Frame: Second year
    • The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.
  • Helping Relationship Scale
    • Time Frame: The third year
  • Health Promotion Lifestyle Profile
    • Time Frame: The third year
    • Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).
  • World Health Organization Quality of Life (WHOQOL-BREF) with the Short-Form 36 (SF-36)
    • Time Frame: The third year
    • The study will use WHOQOL-BREF to measure the outcome.
  • International Physical Activity Questionnaire Taiwan Version
    • Time Frame: The third year
    • The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.
  • body weight
    • Time Frame: six months
  • Waist to Hip Ratio
    • Time Frame: six months

Participating in This Clinical Trial

Inclusion Criteria

  • 20 years and older – diagnosed with chronic kidney disease stage 1 to 4 or GFR≧30ml/min/1.73m2 – patients who has significant others – patients who can speak Mandarin or Taiwanese Exclusion criteria:

  • Patient who limited to exercise

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National Cheng Kung University
  • Collaborator
    • National Cheng-Kung University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Miaofen Yen, PhD, RN, FAAN – National Cheng Kung University
  • Overall Official(s)
    • Miaofen Yen, Principal Investigator, National Cheng Kung University
  • Overall Contact(s)
    • Miaofen Yen, +886-6-2353535, miaofen@mail.ncku.edu.tw

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