The Influence of Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With Chronic Kidney Disease: A Longitudinal Study
NCT ID: NCT02076256
Last Updated: 2014-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2013-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Control Group
No interventions assigned to this group
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.
The helping relationships intervention program
Interventions
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The helping relationships intervention program
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
ALL
Yes
Sponsors
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National Cheng-Kung University Hospital
OTHER
E-DA Hospital
OTHER
National Cheng Kung University
OTHER
Responsible Party
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Miaofen Yen
PhD, RN, FAAN
Principal Investigators
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Miaofen Yen
Role: PRINCIPAL_INVESTIGATOR
National Cheng Kung University
Locations
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National Cheng Kung University
Tainan City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NSC102-2314-B-006-013-MY3
Identifier Type: -
Identifier Source: org_study_id
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