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

Chronic Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02076256
• Other study ID #: NSC102-2314-B-006-013-MY3
• Status: Recruiting
• Phase: N/A
• First received: February 21, 2014
• Last updated: October 9, 2014
• Start date: August 2013

Study information

• Verified date: October 2014
• Source: National Cheng Kung University
• Contact: Miaofen Yen
• Phone: +886-6-2353535
• Email: miaofen[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• The helping relationships intervention program

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan City

Sponsors (3)

Lead Sponsor	Collaborator
National Cheng Kung University	E-DA Hospital, National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helping Relationship Scale		First year	No
Primary	Health Promotion Lifestyle Profile	Health promotion was measured by 52 item health promotion lifestyle profile? ( HPLP-II).	First year	No
Primary	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	Yes
Primary	International Physical Activity Questionnaire Taiwan Version	The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.	First year	No
Primary	Helping Relationship Scale		Second year	No
Primary	Health Promotion Lifestyle Profile	Health promotion was measured by 52 item health promotion lifestyle profile? ( HPLP-II).	Second year	No
Primary	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	Yes
Primary	International Physical Activity Questionnaire Taiwan Version	The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.	Second year	No
Primary	Helping Relationship Scale		The third year	No
Primary	Health Promotion Lifestyle Profile	Health promotion was measured by 52 item health promotion lifestyle profile? ( HPLP-II).	The third year	No
Primary	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	Yes
Primary	International Physical Activity Questionnaire Taiwan Version	The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.	The third year	No
Primary	body weight		six months	No
Primary	Waist to Hip Ratio		six months	No