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

Primary Purpose

Chronic Kidney Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
The helping relationships 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 Diseases focused on measuring helping relationships, healthy lifestyle, quality of life

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Cheng Kung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

The helping relationships intervention program

Arm Description

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.

Outcomes

Primary Outcome Measures

Helping Relationship Scale
Health Promotion Lifestyle Profile
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)
The study will use WHOQOL-BREF to measure the outcome.
International Physical Activity Questionnaire Taiwan Version
The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.
Helping Relationship Scale
Health Promotion Lifestyle Profile
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)
The study will use WHOQOL-BREF to measure the outcome.
International Physical Activity Questionnaire Taiwan Version
The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.
Helping Relationship Scale
Health Promotion Lifestyle Profile
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)
The study will use WHOQOL-BREF to measure the outcome.
International Physical Activity Questionnaire Taiwan Version
The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.
body weight
Waist to Hip Ratio

Secondary Outcome Measures

Full Information

First Posted
February 21, 2014
Last Updated
October 9, 2014
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
NCT02076256
Brief Title
The Influence of Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With Chronic Kidney Disease: A Longitudinal Study
Official Title
The Influence of Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With Chronic Kidney Disease: A Longitudinal Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University
Collaborators
National Cheng-Kung University Hospital, E-DA Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
helping relationships, healthy lifestyle, quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Title
The helping relationships intervention program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The helping relationships intervention program
Primary Outcome Measure Information:
Title
Helping Relationship Scale
Time Frame
First year
Title
Health Promotion Lifestyle Profile
Description
Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).
Time Frame
First year
Title
World Health Organization Quality of Life (WHOQOL-BREF) with the Short-Form 36 (SF-36)
Description
The study will use WHOQOL-BREF to measure the outcome.
Time Frame
First year
Title
International Physical Activity Questionnaire Taiwan Version
Description
The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.
Time Frame
First year
Title
Helping Relationship Scale
Time Frame
Second year
Title
Health Promotion Lifestyle Profile
Description
Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).
Time Frame
Second year
Title
World Health Organization Quality of Life (WHOQOL-BREF) with the Short-Form 36 (SF-36)
Description
The study will use WHOQOL-BREF to measure the outcome.
Time Frame
Second year
Title
International Physical Activity Questionnaire Taiwan Version
Description
The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.
Time Frame
Second year
Title
Helping Relationship Scale
Time Frame
The third year
Title
Health Promotion Lifestyle Profile
Description
Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).
Time Frame
The third year
Title
World Health Organization Quality of Life (WHOQOL-BREF) with the Short-Form 36 (SF-36)
Description
The study will use WHOQOL-BREF to measure the outcome.
Time Frame
The third year
Title
International Physical Activity Questionnaire Taiwan Version
Description
The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.
Time Frame
The third year
Title
body weight
Time Frame
six months
Title
Waist to Hip Ratio
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miaofen Yen
Phone
+886-6-2353535
Ext
5823
Email
miaofen@mail.ncku.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miaofen Yen
Organizational Affiliation
National Cheng Kung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miaofen Yen, Doctor
Phone
886-6-2353535
Ext
5823
Email
miaofen@mail.ncku.edu.tw
First Name & Middle Initial & Last Name & Degree
Miaofen Yen, Doctor

12. IPD Sharing Statement

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

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