Clinical trial NCT02076256: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: helping relationships, healthy lifestyle, quality of life
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: National Cheng-Kung University Hospital
name: E-DA Hospital
First posted: 2014-03-03
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Helping Relationship Scale
timeFrame: First year
measure: Health Promotion Lifestyle Profile
timeFrame: First year
measure: World Health Organization Quality of Life (WHOQOL-BREF) with the Short-Form 36 (SF-36)
timeFrame: First year
measure: International Physical Activity Questionnaire Taiwan Version
timeFrame: First year
measure: Helping Relationship Scale
timeFrame: Second year
measure: Health Promotion Lifestyle Profile
timeFrame: Second year
measure: World Health Organization Quality of Life (WHOQOL-BREF) with the Short-Form 36 (SF-36)
timeFrame: Second year
measure: International Physical Activity Questionnaire Taiwan Version
timeFrame: Second year
measure: Helping Relationship Scale
timeFrame: The third year
measure: Health Promotion Lifestyle Profile
timeFrame: The third year
measure: World Health Organization Quality of Life (WHOQOL-BREF) with the Short-Form 36 (SF-36)
timeFrame: The third year
measure: International Physical Activity Questionnaire Taiwan Version
timeFrame: The third year
measure: body weight
timeFrame: six months
measure: Waist to Hip Ratio
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: National Cheng Kung University
name: Miaofen Yen
role: PRINCIPAL_INVESTIGATOR
References: