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

October 9, 2014 updated by: Miaofen Yen, National Cheng Kung University

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan City, Taiwan
        • Recruiting
        • National Cheng Kung University
        • Contact:
        • Principal Investigator:
          • Miaofen Yen, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: The helping relationships intervention program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Helping Relationship Scale
Time Frame: First year
First year
Health Promotion Lifestyle Profile
Time Frame: First year
Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).
First year
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.
First year
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.
First year
Helping Relationship Scale
Time Frame: Second year
Second year
Health Promotion Lifestyle Profile
Time Frame: Second year
Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).
Second year
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.
Second year
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.
Second year
Helping Relationship Scale
Time Frame: The third year
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).
The third year
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.
The third year
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.
The third year
body weight
Time Frame: six months
six months
Waist to Hip Ratio
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng Kung University

Collaborators

National Cheng-Kung University Hospital
E-DA Hospital

Investigators

  • Principal Investigator: Miaofen Yen, National Cheng Kung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

February 21, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Estimate)

October 10, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSC102-2314-B-006-013-MY3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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