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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Behavioral: The helping relationships intervention program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br> | |
| Experimental: The helping relationships intervention program<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helping Relationship Scale |  | First year | 
| Health Promotion Lifestyle Profile | 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) | The study will use WHOQOL-BREF to measure the outcome. | First year | 
| International Physical Activity Questionnaire Taiwan Version | The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome. | First year | 
| Helping Relationship Scale |  | Second year | 
| Health Promotion Lifestyle Profile | 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) | The study will use WHOQOL-BREF to measure the outcome. | Second year | 
| International Physical Activity Questionnaire Taiwan Version | The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome. | Second year | 
| Helping Relationship Scale |  | The third year | 
| Health Promotion Lifestyle Profile | 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) | The study will use WHOQOL-BREF to measure the outcome. | The third year | 
| International Physical Activity Questionnaire Taiwan Version | The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome. | The third year | 
| body weight |  | six months | 
| Waist to Hip Ratio |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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helping relationships, healthy lifestyle, quality of life