The Influence of Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With Chronic Kidney Disease: A Longitudinal Study
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 21, 2014
CompletedFirst Posted
Study publicly available on registry
March 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedOctober 10, 2014
October 1, 2014
2.9 years
February 21, 2014
October 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
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
Study Arms (2)
Control Group
NO INTERVENTIONThe helping relationships intervention program
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient who limited to exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cheng Kung Universitylead
- National Cheng-Kung University Hospitalcollaborator
- E-DA Hospitalcollaborator
Study Sites (1)
National Cheng Kung University
Tainan, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miaofen Yen
National Cheng Kung University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, RN, FAAN
Study Record Dates
First Submitted
February 21, 2014
First Posted
March 3, 2014
Study Start
August 1, 2013
Primary Completion
July 1, 2016
Last Updated
October 10, 2014
Record last verified: 2014-10